ACC 2011

NEW ORLEANS – Drug-eluting stents outperformed bare-metal stents when placed in saphenous vein graft lesions that developed post-coronary artery bypass graft, according to the largest study ever performed to compare these two types of stents in this setting.

Specifically, drug-eluting stents (DES) significantly reduced the rate for the combined primary end point of death, myocardial infarction, and repeat revascularization procedures in the ISAR (Intracoronary Stenting and Antithrombotic Regimen) –CABG trial, presented at the annual meeting of the American College of Cardiology on April 4.

"This study shows us that we don’t have to be afraid of DES in patients with these high-risk lesions, because use of DES cuts down the need for target vessel revascularization by 50% and does not increase myocardial infarction mortality and stent thrombosis formation when compared with BMS [bare-metal stents]," said Dr. Julinda Mehilli, director of clinical research and data coordinating ISAR at the German Heart Center in Munich.

DES have been shown to be more effective and as safe as BMS in native coronary artery lesions. Saphenous vein grafts are used extensively in CABG surgery, but in a high percentage of patients, these grafts are vulnerable to atherosclerosis and subsequent restenosis. The options for re-opening the vein graft include angioplasty with a stent and a second CABG, which carries higher mortality and morbidity risks than the first CABG.

Only two small studies have compared DES versus BMS in saphenous vein graft lesions, and they had conflicting results. The larger ISAR-CABG is powered for clinical events.

ISAR-CABG enrolled 610 patients who underwent a first CABG with a saphenous vein graft and developed at least one stenotic lesion of at least 50% in the graft. Patients were randomized to receive either a DES or a BMS in a 1:1 ratio. In the DES group, patients were assigned 1:1:1 to three commonly used types of drug-eluting stents (Cypher, Taxus, and BP Sirolimus) to mirror real-world use, Dr. Mehilli explained.

The primary end point was a composite of death, myocardial infarction, and target-vessel revascularization at 1 year of follow-up post percutaneous coronary intervention (PCI) for stent placement. Secondary end points were each of those events separately, as well as ARC (Academic Research Consortium)-definite stent thrombosis.

Both groups had comparable characteristics at baseline. Mean age was about 71.5 years; about 15% were female, about 72% had hypertension, about 36% had diabetes, about 7% were current smokers, about 87% had hyperlipidemia, the saphenous vein graft was about 13.5 years old, and about 55% had a previous history of myocardial infarction. Also, disease characteristics were similar between the two groups. About 50% of patients had diffuse disease. More than 60% had unstable angina, and 99% had multivessel disease. Lesions were evenly distributed in the saphenous vein graft. The degeneration score for saphenous vein grafts and the distribution of lesions within the graft were similar between groups, with about 40% of patients having moderate or severely degenerative grafts. TIMI flow rates pre- and post-PCI were similar between the two groups as well.

At 1 year, DES reduced the risk of the primary end point by 35%, compared with BMS, with rates of 15.4% and 22.1%, respectively, a significant difference. The reduction in the DES group was driven primarily by a significant 52% reduction in target vessel revascularizations, which occurred in 7.2% of the DES patients, compared with 13.1% of the BMS recipients.

Both types of stent were comparable in safety, with a similar rate of stent thrombosis, death, or myocardial infarction, said Dr. Mehilli. The rates of all-cause death or myocardial infarction were similar between the two groups, at 8.5% and 10.9% of patients in the DES and BMS groups, respectively. One patient and zero patients, respectively, experienced ARC-definite stent thrombosis.

"Although saphenous vein graft lesions remain a challenging disease subset for angioplasty, this study demonstrates that DES can be safely used to reduce adverse events in this high-risk subset of patients," Dr. Mehilli said.

Dr. Steven R. Bailey commented that, "This study was designed to answer appropriate questions." However, "It is surprising that there were so few females," added Dr. Bailey of the University of Texas Health Sciences Center, San Antonio.

He asked Dr. Mehilli if drug-eluting stents were compared with bare metal stents in subsets related to the complexity of saphenous vein graft lesions. She replied that a subgroup analysis of ISAR-CABG will be forthcoming.

Dr. Mehilli said that, in Germany, the overwhelming number of stents used in saphenous vein graft lesions are DES, and that the current study supports this practice.

The study was funded by the German Heart Center in Munich and by Cordis. Dr. Mehilli disclosed lecture fees from Abbott. Dr. Bailey has received consulting fees/honoraria from Volcano Corp.

NEW ORLEANS – Drug-eluting stents outperformed bare-metal stents when placed in saphenous vein graft lesions that developed post-coronary artery bypass graft, according to the largest study ever performed to compare these two types of stents in this setting.

Specifically, drug-eluting stents (DES) significantly reduced the rate for the combined primary end point of death, myocardial infarction, and repeat revascularization procedures in the ISAR (Intracoronary Stenting and Antithrombotic Regimen) –CABG trial, presented at the annual meeting of the American College of Cardiology on April 4.

"This study shows us that we don’t have to be afraid of DES in patients with these high-risk lesions, because use of DES cuts down the need for target vessel revascularization by 50% and does not increase myocardial infarction mortality and stent thrombosis formation when compared with BMS [bare-metal stents]," said Dr. Julinda Mehilli, director of clinical research and data coordinating ISAR at the German Heart Center in Munich.

DES have been shown to be more effective and as safe as BMS in native coronary artery lesions. Saphenous vein grafts are used extensively in CABG surgery, but in a high percentage of patients, these grafts are vulnerable to atherosclerosis and subsequent restenosis. The options for re-opening the vein graft include angioplasty with a stent and a second CABG, which carries higher mortality and morbidity risks than the first CABG.

Only two small studies have compared DES versus BMS in saphenous vein graft lesions, and they had conflicting results. The larger ISAR-CABG is powered for clinical events.

ISAR-CABG enrolled 610 patients who underwent a first CABG with a saphenous vein graft and developed at least one stenotic lesion of at least 50% in the graft. Patients were randomized to receive either a DES or a BMS in a 1:1 ratio. In the DES group, patients were assigned 1:1:1 to three commonly used types of drug-eluting stents (Cypher, Taxus, and BP Sirolimus) to mirror real-world use, Dr. Mehilli explained.

The primary end point was a composite of death, myocardial infarction, and target-vessel revascularization at 1 year of follow-up post percutaneous coronary intervention (PCI) for stent placement. Secondary end points were each of those events separately, as well as ARC (Academic Research Consortium)-definite stent thrombosis.

Both groups had comparable characteristics at baseline. Mean age was about 71.5 years; about 15% were female, about 72% had hypertension, about 36% had diabetes, about 7% were current smokers, about 87% had hyperlipidemia, the saphenous vein graft was about 13.5 years old, and about 55% had a previous history of myocardial infarction. Also, disease characteristics were similar between the two groups. About 50% of patients had diffuse disease. More than 60% had unstable angina, and 99% had multivessel disease. Lesions were evenly distributed in the saphenous vein graft. The degeneration score for saphenous vein grafts and the distribution of lesions within the graft were similar between groups, with about 40% of patients having moderate or severely degenerative grafts. TIMI flow rates pre- and post-PCI were similar between the two groups as well.

At 1 year, DES reduced the risk of the primary end point by 35%, compared with BMS, with rates of 15.4% and 22.1%, respectively, a significant difference. The reduction in the DES group was driven primarily by a significant 52% reduction in target vessel revascularizations, which occurred in 7.2% of the DES patients, compared with 13.1% of the BMS recipients.

Both types of stent were comparable in safety, with a similar rate of stent thrombosis, death, or myocardial infarction, said Dr. Mehilli. The rates of all-cause death or myocardial infarction were similar between the two groups, at 8.5% and 10.9% of patients in the DES and BMS groups, respectively. One patient and zero patients, respectively, experienced ARC-definite stent thrombosis.

"Although saphenous vein graft lesions remain a challenging disease subset for angioplasty, this study demonstrates that DES can be safely used to reduce adverse events in this high-risk subset of patients," Dr. Mehilli said.

Dr. Steven R. Bailey commented that, "This study was designed to answer appropriate questions." However, "It is surprising that there were so few females," added Dr. Bailey of the University of Texas Health Sciences Center, San Antonio.

He asked Dr. Mehilli if drug-eluting stents were compared with bare metal stents in subsets related to the complexity of saphenous vein graft lesions. She replied that a subgroup analysis of ISAR-CABG will be forthcoming.

Dr. Mehilli said that, in Germany, the overwhelming number of stents used in saphenous vein graft lesions are DES, and that the current study supports this practice.

The study was funded by the German Heart Center in Munich and by Cordis. Dr. Mehilli disclosed lecture fees from Abbott. Dr. Bailey has received consulting fees/honoraria from Volcano Corp.

NEW ORLEANS – Drug-eluting stents outperformed bare-metal stents when placed in saphenous vein graft lesions that developed post-coronary artery bypass graft, according to the largest study ever performed to compare these two types of stents in this setting.

Specifically, drug-eluting stents (DES) significantly reduced the rate for the combined primary end point of death, myocardial infarction, and repeat revascularization procedures in the ISAR (Intracoronary Stenting and Antithrombotic Regimen) –CABG trial, presented at the annual meeting of the American College of Cardiology on April 4.

"This study shows us that we don’t have to be afraid of DES in patients with these high-risk lesions, because use of DES cuts down the need for target vessel revascularization by 50% and does not increase myocardial infarction mortality and stent thrombosis formation when compared with BMS [bare-metal stents]," said Dr. Julinda Mehilli, director of clinical research and data coordinating ISAR at the German Heart Center in Munich.

DES have been shown to be more effective and as safe as BMS in native coronary artery lesions. Saphenous vein grafts are used extensively in CABG surgery, but in a high percentage of patients, these grafts are vulnerable to atherosclerosis and subsequent restenosis. The options for re-opening the vein graft include angioplasty with a stent and a second CABG, which carries higher mortality and morbidity risks than the first CABG.

Only two small studies have compared DES versus BMS in saphenous vein graft lesions, and they had conflicting results. The larger ISAR-CABG is powered for clinical events.

ISAR-CABG enrolled 610 patients who underwent a first CABG with a saphenous vein graft and developed at least one stenotic lesion of at least 50% in the graft. Patients were randomized to receive either a DES or a BMS in a 1:1 ratio. In the DES group, patients were assigned 1:1:1 to three commonly used types of drug-eluting stents (Cypher, Taxus, and BP Sirolimus) to mirror real-world use, Dr. Mehilli explained.

The primary end point was a composite of death, myocardial infarction, and target-vessel revascularization at 1 year of follow-up post percutaneous coronary intervention (PCI) for stent placement. Secondary end points were each of those events separately, as well as ARC (Academic Research Consortium)-definite stent thrombosis.

Both groups had comparable characteristics at baseline. Mean age was about 71.5 years; about 15% were female, about 72% had hypertension, about 36% had diabetes, about 7% were current smokers, about 87% had hyperlipidemia, the saphenous vein graft was about 13.5 years old, and about 55% had a previous history of myocardial infarction. Also, disease characteristics were similar between the two groups. About 50% of patients had diffuse disease. More than 60% had unstable angina, and 99% had multivessel disease. Lesions were evenly distributed in the saphenous vein graft. The degeneration score for saphenous vein grafts and the distribution of lesions within the graft were similar between groups, with about 40% of patients having moderate or severely degenerative grafts. TIMI flow rates pre- and post-PCI were similar between the two groups as well.

At 1 year, DES reduced the risk of the primary end point by 35%, compared with BMS, with rates of 15.4% and 22.1%, respectively, a significant difference. The reduction in the DES group was driven primarily by a significant 52% reduction in target vessel revascularizations, which occurred in 7.2% of the DES patients, compared with 13.1% of the BMS recipients.

Both types of stent were comparable in safety, with a similar rate of stent thrombosis, death, or myocardial infarction, said Dr. Mehilli. The rates of all-cause death or myocardial infarction were similar between the two groups, at 8.5% and 10.9% of patients in the DES and BMS groups, respectively. One patient and zero patients, respectively, experienced ARC-definite stent thrombosis.

"Although saphenous vein graft lesions remain a challenging disease subset for angioplasty, this study demonstrates that DES can be safely used to reduce adverse events in this high-risk subset of patients," Dr. Mehilli said.

Dr. Steven R. Bailey commented that, "This study was designed to answer appropriate questions." However, "It is surprising that there were so few females," added Dr. Bailey of the University of Texas Health Sciences Center, San Antonio.

He asked Dr. Mehilli if drug-eluting stents were compared with bare metal stents in subsets related to the complexity of saphenous vein graft lesions. She replied that a subgroup analysis of ISAR-CABG will be forthcoming.

Dr. Mehilli said that, in Germany, the overwhelming number of stents used in saphenous vein graft lesions are DES, and that the current study supports this practice.

The study was funded by the German Heart Center in Munich and by Cordis. Dr. Mehilli disclosed lecture fees from Abbott. Dr. Bailey has received consulting fees/honoraria from Volcano Corp.

NEW ORLEANS – With broader use of radial-artery access for percutaneous coronary interventions already gaining momentum in the United States, results from the largest study by far to compare radial- and femoral-artery approaches may give an extra boost to the radial camp.

While results from the Radial vs Femoral Access for Coronary Intervention (RIVAL) trial showed primary end point equivalence for the two arterial access strategies in a 7,000-patient randomized trial, radial access may have won by not losing.

"The similar efficacy helps the radial approach, because there was a persistent uncertainty whether it really was as good as femoral, Dr. Sanjit S. Jolly, lead investigator of the trial, said at the annual meeting of the American College of Cardiology.

In addition, the study’s findings "in high-volume centers and in patients with ST elevation myocardial infarctions will produce more momentum for a shift," he predicted.

Interventional cardiologists in some countries have embraced radial-artery access for placing catheters aimed at the coronaries into patients. Dr. Jolly, a cardiologist at McMaster University in Hamilton, Canada, cited a greater than 90% rate among French interventionalists and a greater than 95% rate in Canada. But as recently as last summer, U.S. cardiologists used radial access for a mere 4% of their coronary catheterizations, based on data collected by the National Cardiovascular Data Registry, said Dr. Edward J. McNulty, an interventional cardiologist at Kaiser Permanente San Francisco.

The U.S. numbers clearly have a long way to go before they start to resemble what is now routine in many other places, but some clues at the meeting suggest they began trending up even before Dr. Jolly delivered the RIVAL results. For example, in a separate talk earlier in the meeting, Detroit interventionalist Dr. Akshay Khandelwal recounted his personal experience introducing radial access into his practice starting about 18 months ago. His cases gradually shifted, and by March roughly 75% of his coronary procedures used radial access. Following his lead, his colleagues at Henry Ford Hospital, Detroit, began to become radialists, too, and as of March 2011 a quarter of his cath lab’s coronary work occurred via the patient’s wrist, said Dr. Khandelwal, director of outpatient cardiovascular services at Henry Ford.

"At Columbia [University’s Center for Interventional Vascular Therapy] the frequency of radial access has increased," agreed Dr. Martin B. Leon, who directs the center in New York. "It was in single digits in 2010, but now, for the first time, it’s more than 20%. It’s climbing quickly. Many operators are becoming more interested in gaining expertise, particularly younger operators," he said.

Part of this shift is driven by physicians who believe they might achieve better results, with less bleeding and access site complications, and part comes from patient demand because most patients find the radial approach more comfortable. "Patients like it, and I think that will drive the option," Dr. McNulty said. Another important factor is cost.

"There is a recent trend in the U.S. to do more outpatient angioplasty in low-risk and stable patients," Dr. Leon said, and radial access makes same-day discharge feasible much more often than does femoral access. "If that trend continues, and the predictions are it will, you can imagine that the radial approach will be attractive."

Until RIVAL, prior comparisons of radial and femoral entry had been too small for a definitive comparison. Dr. Jolly and his associates designed their study to test their hunch that radial entry might actually produce better outcomes. (Dr. Jolly admitted that in his own interventional practice he performs about 80% of his cases by radial entry.) "Our hypothesis was a paradigm shift" that radial would result in a significantly reduced rate of a primary outcome of death, myocardial infarction, stroke, and bleeding not related to coronary bypass during the 30 days following percutaneous coronary intervention in patients with acute coronary syndrome.

The ambitious study enrolled 7,021 patients at 158 sites in 32 countries, piggybacked onto an acute coronary syndrome trial that tested clopidogrel and aspirin treatment (CURRENT–OASIS 7). The patient’s average age was 62 years, nearly three-quarters were men, and 45% had unstable angina, with the remaining patients split evenly between ST elevation myocardial infarction (MI) and non–ST-elevation MI.

The combined end point occurred in roughly 4% of patients in both groups. The rate of major bleeds not associated with coronary artery bypass surgery also occurred at roughly similar rates, just under 1%, in both the radial and femoral groups, an unexpected failure for the radial approach. "We expected to see a large decrease in major bleeds" in the radial access patients, Dr. Jolly said. "A take-home message is that in acute coronary syndrome both access site and non–access site bleeds are important." Concurrently with Dr. Jolly’s report, an article with the results was published online in The Lancet (Lancet 2011 April 4 [doi:10.1016/S0140-6736(11)60404-2]).

The only prespecified end point where radial access outperformed femoral access was in the secondary measure of major vascular access site complications: large hematomas, pseudoaneurysms requiring closure, arteriovenous fistula, and other vascular surgery related to the access site. In the radial group, this occurred in 1.4% of patients and in 3.7% of those in the femoral group, a statistically significant 63% relative risk reduction.

"By going radial you prevent complications at the access site," explained Dr. Jolly. These complications "don’t cause deaths," he admitted, "but they are important to patients. They can cause significant discomfort."

But others minimized the importance of access site complications.

"Access-site hematomas don’t impact mortality. Large bleeds are associated with mortality. Gastrointestinal bleeds, genitourinary bleeds, and intracranial bleeds really impact mortality," commented Dr. Gregg W. Stone, professor of medicine and director of cardiovascular research and education at Columbia. Dr. Stone noted that he performs 99% of his coronary interventions via the femoral route.

Aside from the basic findings, perhaps the most notable results focused on the importance of operator and center experience in performing radial catheterizations. One prespecified subgroup analysis split the participating centers into tertiles based on their annual volume of radial-access procedures: those that did at least 146 a year (the highest tertile), those that did 61-145 radial procedures annually (middle tertile), and those performing 60 or fewer annually. The highest tertile centers showed a statistically significant reduction in the study’s primary end point when using radial access.

Also, focusing on outcomes in patients with an ST elevation MI showed that in this subgroup radial access produced a statistically significant reduction in the primary end point, an effect that Dr. Jolly speculated related to individual operator experience. "Radial access in the ST elevation MI patients primarily was done by the high-volume operators because of the time pressure." Only the most experienced operators were comfortable treating these patients radially, he said. Another issue was that these patients are more heavily treated with antiplatelet drugs, which magnified the benefit from radial access in cutting bleeding complications.

The subgroup findings convinced some cardiologists that RIVAL, in sum, scored a triumph for radial access.

"At the least, radial access reduced bleeding, and at best it improved the hard outcomes of death and MI" at the high volume centers, noted Dr. Khandelwal. "Perhaps our goal should be to emulate the operators in the top tertile," he said in an interview.

But Dr. Stone had the take of a femoral-artery enthusiast. "I don’t think in and of itself these data will change practice. What might change practice," he conceded, "is patient comfort."

Dr. Jolly said that he has received consultant fees or honoraria from Boehringer-Ingelheim, GlaxoSmithKline, and Sanofi-Aventis, and research grants from Merck. Dr. McNulty said he had no disclosures. Dr. Leon said he has been an unpaid consultant to Abbott, Boston Scientific, and Medtronic. Dr. Stone said that he has been a consultant to Inspire MD, Reva, Osprey, Lilly, BMS/Sanofi, Medtronic, AstraZeneca, Vascular Solutions, Gilead, The Medicines Company, Abbott Vascular, Boston Scientific, Ortho-McNeil, Edwards, and Merck; he has an ownership or partnership role in MiCardia, Biostar I and II, FlowCardia, Embrella, Caliber, Medfocus I and II, Accelerator, and Access Closure; and he has received research funds from InfraReDx, TherOx, Atrium, and Volcano. Dr. Khandelwal said he had no disclosures.

NEW ORLEANS – With broader use of radial-artery access for percutaneous coronary interventions already gaining momentum in the United States, results from the largest study by far to compare radial- and femoral-artery approaches may give an extra boost to the radial camp.

While results from the Radial vs Femoral Access for Coronary Intervention (RIVAL) trial showed primary end point equivalence for the two arterial access strategies in a 7,000-patient randomized trial, radial access may have won by not losing.

"The similar efficacy helps the radial approach, because there was a persistent uncertainty whether it really was as good as femoral, Dr. Sanjit S. Jolly, lead investigator of the trial, said at the annual meeting of the American College of Cardiology.

In addition, the study’s findings "in high-volume centers and in patients with ST elevation myocardial infarctions will produce more momentum for a shift," he predicted.

Interventional cardiologists in some countries have embraced radial-artery access for placing catheters aimed at the coronaries into patients. Dr. Jolly, a cardiologist at McMaster University in Hamilton, Canada, cited a greater than 90% rate among French interventionalists and a greater than 95% rate in Canada. But as recently as last summer, U.S. cardiologists used radial access for a mere 4% of their coronary catheterizations, based on data collected by the National Cardiovascular Data Registry, said Dr. Edward J. McNulty, an interventional cardiologist at Kaiser Permanente San Francisco.

The U.S. numbers clearly have a long way to go before they start to resemble what is now routine in many other places, but some clues at the meeting suggest they began trending up even before Dr. Jolly delivered the RIVAL results. For example, in a separate talk earlier in the meeting, Detroit interventionalist Dr. Akshay Khandelwal recounted his personal experience introducing radial access into his practice starting about 18 months ago. His cases gradually shifted, and by March roughly 75% of his coronary procedures used radial access. Following his lead, his colleagues at Henry Ford Hospital, Detroit, began to become radialists, too, and as of March 2011 a quarter of his cath lab’s coronary work occurred via the patient’s wrist, said Dr. Khandelwal, director of outpatient cardiovascular services at Henry Ford.

"At Columbia [University’s Center for Interventional Vascular Therapy] the frequency of radial access has increased," agreed Dr. Martin B. Leon, who directs the center in New York. "It was in single digits in 2010, but now, for the first time, it’s more than 20%. It’s climbing quickly. Many operators are becoming more interested in gaining expertise, particularly younger operators," he said.

Part of this shift is driven by physicians who believe they might achieve better results, with less bleeding and access site complications, and part comes from patient demand because most patients find the radial approach more comfortable. "Patients like it, and I think that will drive the option," Dr. McNulty said. Another important factor is cost.

"There is a recent trend in the U.S. to do more outpatient angioplasty in low-risk and stable patients," Dr. Leon said, and radial access makes same-day discharge feasible much more often than does femoral access. "If that trend continues, and the predictions are it will, you can imagine that the radial approach will be attractive."

Until RIVAL, prior comparisons of radial and femoral entry had been too small for a definitive comparison. Dr. Jolly and his associates designed their study to test their hunch that radial entry might actually produce better outcomes. (Dr. Jolly admitted that in his own interventional practice he performs about 80% of his cases by radial entry.) "Our hypothesis was a paradigm shift" that radial would result in a significantly reduced rate of a primary outcome of death, myocardial infarction, stroke, and bleeding not related to coronary bypass during the 30 days following percutaneous coronary intervention in patients with acute coronary syndrome.

The ambitious study enrolled 7,021 patients at 158 sites in 32 countries, piggybacked onto an acute coronary syndrome trial that tested clopidogrel and aspirin treatment (CURRENT–OASIS 7). The patient’s average age was 62 years, nearly three-quarters were men, and 45% had unstable angina, with the remaining patients split evenly between ST elevation myocardial infarction (MI) and non–ST-elevation MI.

The combined end point occurred in roughly 4% of patients in both groups. The rate of major bleeds not associated with coronary artery bypass surgery also occurred at roughly similar rates, just under 1%, in both the radial and femoral groups, an unexpected failure for the radial approach. "We expected to see a large decrease in major bleeds" in the radial access patients, Dr. Jolly said. "A take-home message is that in acute coronary syndrome both access site and non–access site bleeds are important." Concurrently with Dr. Jolly’s report, an article with the results was published online in The Lancet (Lancet 2011 April 4 [doi:10.1016/S0140-6736(11)60404-2]).

The only prespecified end point where radial access outperformed femoral access was in the secondary measure of major vascular access site complications: large hematomas, pseudoaneurysms requiring closure, arteriovenous fistula, and other vascular surgery related to the access site. In the radial group, this occurred in 1.4% of patients and in 3.7% of those in the femoral group, a statistically significant 63% relative risk reduction.

"By going radial you prevent complications at the access site," explained Dr. Jolly. These complications "don’t cause deaths," he admitted, "but they are important to patients. They can cause significant discomfort."

But others minimized the importance of access site complications.

"Access-site hematomas don’t impact mortality. Large bleeds are associated with mortality. Gastrointestinal bleeds, genitourinary bleeds, and intracranial bleeds really impact mortality," commented Dr. Gregg W. Stone, professor of medicine and director of cardiovascular research and education at Columbia. Dr. Stone noted that he performs 99% of his coronary interventions via the femoral route.

Aside from the basic findings, perhaps the most notable results focused on the importance of operator and center experience in performing radial catheterizations. One prespecified subgroup analysis split the participating centers into tertiles based on their annual volume of radial-access procedures: those that did at least 146 a year (the highest tertile), those that did 61-145 radial procedures annually (middle tertile), and those performing 60 or fewer annually. The highest tertile centers showed a statistically significant reduction in the study’s primary end point when using radial access.

Also, focusing on outcomes in patients with an ST elevation MI showed that in this subgroup radial access produced a statistically significant reduction in the primary end point, an effect that Dr. Jolly speculated related to individual operator experience. "Radial access in the ST elevation MI patients primarily was done by the high-volume operators because of the time pressure." Only the most experienced operators were comfortable treating these patients radially, he said. Another issue was that these patients are more heavily treated with antiplatelet drugs, which magnified the benefit from radial access in cutting bleeding complications.

The subgroup findings convinced some cardiologists that RIVAL, in sum, scored a triumph for radial access.

"At the least, radial access reduced bleeding, and at best it improved the hard outcomes of death and MI" at the high volume centers, noted Dr. Khandelwal. "Perhaps our goal should be to emulate the operators in the top tertile," he said in an interview.

But Dr. Stone had the take of a femoral-artery enthusiast. "I don’t think in and of itself these data will change practice. What might change practice," he conceded, "is patient comfort."

Dr. Jolly said that he has received consultant fees or honoraria from Boehringer-Ingelheim, GlaxoSmithKline, and Sanofi-Aventis, and research grants from Merck. Dr. McNulty said he had no disclosures. Dr. Leon said he has been an unpaid consultant to Abbott, Boston Scientific, and Medtronic. Dr. Stone said that he has been a consultant to Inspire MD, Reva, Osprey, Lilly, BMS/Sanofi, Medtronic, AstraZeneca, Vascular Solutions, Gilead, The Medicines Company, Abbott Vascular, Boston Scientific, Ortho-McNeil, Edwards, and Merck; he has an ownership or partnership role in MiCardia, Biostar I and II, FlowCardia, Embrella, Caliber, Medfocus I and II, Accelerator, and Access Closure; and he has received research funds from InfraReDx, TherOx, Atrium, and Volcano. Dr. Khandelwal said he had no disclosures.

NEW ORLEANS – With broader use of radial-artery access for percutaneous coronary interventions already gaining momentum in the United States, results from the largest study by far to compare radial- and femoral-artery approaches may give an extra boost to the radial camp.

While results from the Radial vs Femoral Access for Coronary Intervention (RIVAL) trial showed primary end point equivalence for the two arterial access strategies in a 7,000-patient randomized trial, radial access may have won by not losing.

"The similar efficacy helps the radial approach, because there was a persistent uncertainty whether it really was as good as femoral, Dr. Sanjit S. Jolly, lead investigator of the trial, said at the annual meeting of the American College of Cardiology.

In addition, the study’s findings "in high-volume centers and in patients with ST elevation myocardial infarctions will produce more momentum for a shift," he predicted.

Interventional cardiologists in some countries have embraced radial-artery access for placing catheters aimed at the coronaries into patients. Dr. Jolly, a cardiologist at McMaster University in Hamilton, Canada, cited a greater than 90% rate among French interventionalists and a greater than 95% rate in Canada. But as recently as last summer, U.S. cardiologists used radial access for a mere 4% of their coronary catheterizations, based on data collected by the National Cardiovascular Data Registry, said Dr. Edward J. McNulty, an interventional cardiologist at Kaiser Permanente San Francisco.

The U.S. numbers clearly have a long way to go before they start to resemble what is now routine in many other places, but some clues at the meeting suggest they began trending up even before Dr. Jolly delivered the RIVAL results. For example, in a separate talk earlier in the meeting, Detroit interventionalist Dr. Akshay Khandelwal recounted his personal experience introducing radial access into his practice starting about 18 months ago. His cases gradually shifted, and by March roughly 75% of his coronary procedures used radial access. Following his lead, his colleagues at Henry Ford Hospital, Detroit, began to become radialists, too, and as of March 2011 a quarter of his cath lab’s coronary work occurred via the patient’s wrist, said Dr. Khandelwal, director of outpatient cardiovascular services at Henry Ford.

"At Columbia [University’s Center for Interventional Vascular Therapy] the frequency of radial access has increased," agreed Dr. Martin B. Leon, who directs the center in New York. "It was in single digits in 2010, but now, for the first time, it’s more than 20%. It’s climbing quickly. Many operators are becoming more interested in gaining expertise, particularly younger operators," he said.

Part of this shift is driven by physicians who believe they might achieve better results, with less bleeding and access site complications, and part comes from patient demand because most patients find the radial approach more comfortable. "Patients like it, and I think that will drive the option," Dr. McNulty said. Another important factor is cost.

"There is a recent trend in the U.S. to do more outpatient angioplasty in low-risk and stable patients," Dr. Leon said, and radial access makes same-day discharge feasible much more often than does femoral access. "If that trend continues, and the predictions are it will, you can imagine that the radial approach will be attractive."

Until RIVAL, prior comparisons of radial and femoral entry had been too small for a definitive comparison. Dr. Jolly and his associates designed their study to test their hunch that radial entry might actually produce better outcomes. (Dr. Jolly admitted that in his own interventional practice he performs about 80% of his cases by radial entry.) "Our hypothesis was a paradigm shift" that radial would result in a significantly reduced rate of a primary outcome of death, myocardial infarction, stroke, and bleeding not related to coronary bypass during the 30 days following percutaneous coronary intervention in patients with acute coronary syndrome.

The ambitious study enrolled 7,021 patients at 158 sites in 32 countries, piggybacked onto an acute coronary syndrome trial that tested clopidogrel and aspirin treatment (CURRENT–OASIS 7). The patient’s average age was 62 years, nearly three-quarters were men, and 45% had unstable angina, with the remaining patients split evenly between ST elevation myocardial infarction (MI) and non–ST-elevation MI.

The combined end point occurred in roughly 4% of patients in both groups. The rate of major bleeds not associated with coronary artery bypass surgery also occurred at roughly similar rates, just under 1%, in both the radial and femoral groups, an unexpected failure for the radial approach. "We expected to see a large decrease in major bleeds" in the radial access patients, Dr. Jolly said. "A take-home message is that in acute coronary syndrome both access site and non–access site bleeds are important." Concurrently with Dr. Jolly’s report, an article with the results was published online in The Lancet (Lancet 2011 April 4 [doi:10.1016/S0140-6736(11)60404-2]).

The only prespecified end point where radial access outperformed femoral access was in the secondary measure of major vascular access site complications: large hematomas, pseudoaneurysms requiring closure, arteriovenous fistula, and other vascular surgery related to the access site. In the radial group, this occurred in 1.4% of patients and in 3.7% of those in the femoral group, a statistically significant 63% relative risk reduction.

"By going radial you prevent complications at the access site," explained Dr. Jolly. These complications "don’t cause deaths," he admitted, "but they are important to patients. They can cause significant discomfort."

But others minimized the importance of access site complications.

"Access-site hematomas don’t impact mortality. Large bleeds are associated with mortality. Gastrointestinal bleeds, genitourinary bleeds, and intracranial bleeds really impact mortality," commented Dr. Gregg W. Stone, professor of medicine and director of cardiovascular research and education at Columbia. Dr. Stone noted that he performs 99% of his coronary interventions via the femoral route.

Aside from the basic findings, perhaps the most notable results focused on the importance of operator and center experience in performing radial catheterizations. One prespecified subgroup analysis split the participating centers into tertiles based on their annual volume of radial-access procedures: those that did at least 146 a year (the highest tertile), those that did 61-145 radial procedures annually (middle tertile), and those performing 60 or fewer annually. The highest tertile centers showed a statistically significant reduction in the study’s primary end point when using radial access.

Also, focusing on outcomes in patients with an ST elevation MI showed that in this subgroup radial access produced a statistically significant reduction in the primary end point, an effect that Dr. Jolly speculated related to individual operator experience. "Radial access in the ST elevation MI patients primarily was done by the high-volume operators because of the time pressure." Only the most experienced operators were comfortable treating these patients radially, he said. Another issue was that these patients are more heavily treated with antiplatelet drugs, which magnified the benefit from radial access in cutting bleeding complications.

The subgroup findings convinced some cardiologists that RIVAL, in sum, scored a triumph for radial access.

"At the least, radial access reduced bleeding, and at best it improved the hard outcomes of death and MI" at the high volume centers, noted Dr. Khandelwal. "Perhaps our goal should be to emulate the operators in the top tertile," he said in an interview.

But Dr. Stone had the take of a femoral-artery enthusiast. "I don’t think in and of itself these data will change practice. What might change practice," he conceded, "is patient comfort."

Dr. Jolly said that he has received consultant fees or honoraria from Boehringer-Ingelheim, GlaxoSmithKline, and Sanofi-Aventis, and research grants from Merck. Dr. McNulty said he had no disclosures. Dr. Leon said he has been an unpaid consultant to Abbott, Boston Scientific, and Medtronic. Dr. Stone said that he has been a consultant to Inspire MD, Reva, Osprey, Lilly, BMS/Sanofi, Medtronic, AstraZeneca, Vascular Solutions, Gilead, The Medicines Company, Abbott Vascular, Boston Scientific, Ortho-McNeil, Edwards, and Merck; he has an ownership or partnership role in MiCardia, Biostar I and II, FlowCardia, Embrella, Caliber, Medfocus I and II, Accelerator, and Access Closure; and he has received research funds from InfraReDx, TherOx, Atrium, and Volcano. Dr. Khandelwal said he had no disclosures.

NEW ORLEANS – With broader use of radial-artery access for percutaneous coronary interventions already gaining momentum in the United States, results from the largest study by far to compare radial- and femoral-artery approaches may give an extra boost to the radial camp.

While results from the Radial vs Femoral Access for Coronary Intervention (RIVAL) trial showed primary end point equivalence for the two arterial access strategies in a 7,000-patient randomized trial, radial access may have won by not losing.

"The similar efficacy helps the radial approach, because there was a persistent uncertainty whether it really was as good as femoral, Dr. Sanjit S. Jolly, lead investigator of the trial, said at the annual meeting of the American College of Cardiology.

In addition, the study’s findings "in high-volume centers and in patients with ST elevation myocardial infarctions will produce more momentum for a shift," he predicted.

Interventional cardiologists in some countries have embraced radial-artery access for placing catheters aimed at the coronaries into patients. Dr. Jolly, a cardiologist at McMaster University in Hamilton, Canada, cited a greater than 90% rate among French interventionalists and a greater than 95% rate in Canada. But as recently as last summer, U.S. cardiologists used radial access for a mere 4% of their coronary catheterizations, based on data collected by the National Cardiovascular Data Registry, said Dr. Edward J. McNulty, an interventional cardiologist at Kaiser Permanente San Francisco.

The U.S. numbers clearly have a long way to go before they start to resemble what is now routine in many other places, but some clues at the meeting suggest they began trending up even before Dr. Jolly delivered the RIVAL results. For example, in a separate talk earlier in the meeting, Detroit interventionalist Dr. Akshay Khandelwal recounted his personal experience introducing radial access into his practice starting about 18 months ago. His cases gradually shifted, and by March roughly 75% of his coronary procedures used radial access. Following his lead, his colleagues at Henry Ford Hospital, Detroit, began to become radialists, too, and as of March 2011 a quarter of his cath lab’s coronary work occurred via the patient’s wrist, said Dr. Khandelwal, director of outpatient cardiovascular services at Henry Ford.

"At Columbia [University’s Center for Interventional Vascular Therapy] the frequency of radial access has increased," agreed Dr. Martin B. Leon, who directs the center in New York. "It was in single digits in 2010, but now, for the first time, it’s more than 20%. It’s climbing quickly. Many operators are becoming more interested in gaining expertise, particularly younger operators," he said.

Part of this shift is driven by physicians who believe they might achieve better results, with less bleeding and access site complications, and part comes from patient demand because most patients find the radial approach more comfortable. "Patients like it, and I think that will drive the option," Dr. McNulty said. Another important factor is cost.

"There is a recent trend in the U.S. to do more outpatient angioplasty in low-risk and stable patients," Dr. Leon said, and radial access makes same-day discharge feasible much more often than does femoral access. "If that trend continues, and the predictions are it will, you can imagine that the radial approach will be attractive."

Until RIVAL, prior comparisons of radial and femoral entry had been too small for a definitive comparison. Dr. Jolly and his associates designed their study to test their hunch that radial entry might actually produce better outcomes. (Dr. Jolly admitted that in his own interventional practice he performs about 80% of his cases by radial entry.) "Our hypothesis was a paradigm shift" that radial would result in a significantly reduced rate of a primary outcome of death, myocardial infarction, stroke, and bleeding not related to coronary bypass during the 30 days following percutaneous coronary intervention in patients with acute coronary syndrome.

The ambitious study enrolled 7,021 patients at 158 sites in 32 countries, piggybacked onto an acute coronary syndrome trial that tested clopidogrel and aspirin treatment (CURRENT–OASIS 7). The patient’s average age was 62 years, nearly three-quarters were men, and 45% had unstable angina, with the remaining patients split evenly between ST elevation myocardial infarction (MI) and non–ST-elevation MI.

The combined end point occurred in roughly 4% of patients in both groups. The rate of major bleeds not associated with coronary artery bypass surgery also occurred at roughly similar rates, just under 1%, in both the radial and femoral groups, an unexpected failure for the radial approach. "We expected to see a large decrease in major bleeds" in the radial access patients, Dr. Jolly said. "A take-home message is that in acute coronary syndrome both access site and non–access site bleeds are important." Concurrently with Dr. Jolly’s report, an article with the results was published online in The Lancet (Lancet 2011 April 4 [doi:10.1016/S0140-6736(11)60404-2]).

The only prespecified end point where radial access outperformed femoral access was in the secondary measure of major vascular access site complications: large hematomas, pseudoaneurysms requiring closure, arteriovenous fistula, and other vascular surgery related to the access site. In the radial group, this occurred in 1.4% of patients and in 3.7% of those in the femoral group, a statistically significant 63% relative risk reduction.

"By going radial you prevent complications at the access site," explained Dr. Jolly. These complications "don’t cause deaths," he admitted, "but they are important to patients. They can cause significant discomfort."

But others minimized the importance of access site complications.

"Access-site hematomas don’t impact mortality. Large bleeds are associated with mortality. Gastrointestinal bleeds, genitourinary bleeds, and intracranial bleeds really impact mortality," commented Dr. Gregg W. Stone, professor of medicine and director of cardiovascular research and education at Columbia. Dr. Stone noted that he performs 99% of his coronary interventions via the femoral route.

Aside from the basic findings, perhaps the most notable results focused on the importance of operator and center experience in performing radial catheterizations. One prespecified subgroup analysis split the participating centers into tertiles based on their annual volume of radial-access procedures: those that did at least 146 a year (the highest tertile), those that did 61-145 radial procedures annually (middle tertile), and those performing 60 or fewer annually. The highest tertile centers showed a statistically significant reduction in the study’s primary end point when using radial access.

Also, focusing on outcomes in patients with an ST elevation MI showed that in this subgroup radial access produced a statistically significant reduction in the primary end point, an effect that Dr. Jolly speculated related to individual operator experience. "Radial access in the ST elevation MI patients primarily was done by the high-volume operators because of the time pressure." Only the most experienced operators were comfortable treating these patients radially, he said. Another issue was that these patients are more heavily treated with antiplatelet drugs, which magnified the benefit from radial access in cutting bleeding complications.

The subgroup findings convinced some cardiologists that RIVAL, in sum, scored a triumph for radial access.

"At the least, radial access reduced bleeding, and at best it improved the hard outcomes of death and MI" at the high volume centers, noted Dr. Khandelwal. "Perhaps our goal should be to emulate the operators in the top tertile," he said in an interview.

But Dr. Stone had the take of a femoral-artery enthusiast. "I don’t think in and of itself these data will change practice. What might change practice," he conceded, "is patient comfort."

Dr. Jolly said that he has received consultant fees or honoraria from Boehringer-Ingelheim, GlaxoSmithKline, and Sanofi-Aventis, and research grants from Merck. Dr. McNulty said he had no disclosures. Dr. Leon said he has been an unpaid consultant to Abbott, Boston Scientific, and Medtronic. Dr. Stone said that he has been a consultant to Inspire MD, Reva, Osprey, Lilly, BMS/Sanofi, Medtronic, AstraZeneca, Vascular Solutions, Gilead, The Medicines Company, Abbott Vascular, Boston Scientific, Ortho-McNeil, Edwards, and Merck; he has an ownership or partnership role in MiCardia, Biostar I and II, FlowCardia, Embrella, Caliber, Medfocus I and II, Accelerator, and Access Closure; and he has received research funds from InfraReDx, TherOx, Atrium, and Volcano. Dr. Khandelwal said he had no disclosures.

NEW ORLEANS – With broader use of radial-artery access for percutaneous coronary interventions already gaining momentum in the United States, results from the largest study by far to compare radial- and femoral-artery approaches may give an extra boost to the radial camp.

While results from the Radial vs Femoral Access for Coronary Intervention (RIVAL) trial showed primary end point equivalence for the two arterial access strategies in a 7,000-patient randomized trial, radial access may have won by not losing.

"The similar efficacy helps the radial approach, because there was a persistent uncertainty whether it really was as good as femoral, Dr. Sanjit S. Jolly, lead investigator of the trial, said at the annual meeting of the American College of Cardiology.

In addition, the study’s findings "in high-volume centers and in patients with ST elevation myocardial infarctions will produce more momentum for a shift," he predicted.

Interventional cardiologists in some countries have embraced radial-artery access for placing catheters aimed at the coronaries into patients. Dr. Jolly, a cardiologist at McMaster University in Hamilton, Canada, cited a greater than 90% rate among French interventionalists and a greater than 95% rate in Canada. But as recently as last summer, U.S. cardiologists used radial access for a mere 4% of their coronary catheterizations, based on data collected by the National Cardiovascular Data Registry, said Dr. Edward J. McNulty, an interventional cardiologist at Kaiser Permanente San Francisco.

The U.S. numbers clearly have a long way to go before they start to resemble what is now routine in many other places, but some clues at the meeting suggest they began trending up even before Dr. Jolly delivered the RIVAL results. For example, in a separate talk earlier in the meeting, Detroit interventionalist Dr. Akshay Khandelwal recounted his personal experience introducing radial access into his practice starting about 18 months ago. His cases gradually shifted, and by March roughly 75% of his coronary procedures used radial access. Following his lead, his colleagues at Henry Ford Hospital, Detroit, began to become radialists, too, and as of March 2011 a quarter of his cath lab’s coronary work occurred via the patient’s wrist, said Dr. Khandelwal, director of outpatient cardiovascular services at Henry Ford.

"At Columbia [University’s Center for Interventional Vascular Therapy] the frequency of radial access has increased," agreed Dr. Martin B. Leon, who directs the center in New York. "It was in single digits in 2010, but now, for the first time, it’s more than 20%. It’s climbing quickly. Many operators are becoming more interested in gaining expertise, particularly younger operators," he said.

Part of this shift is driven by physicians who believe they might achieve better results, with less bleeding and access site complications, and part comes from patient demand because most patients find the radial approach more comfortable. "Patients like it, and I think that will drive the option," Dr. McNulty said. Another important factor is cost.

"There is a recent trend in the U.S. to do more outpatient angioplasty in low-risk and stable patients," Dr. Leon said, and radial access makes same-day discharge feasible much more often than does femoral access. "If that trend continues, and the predictions are it will, you can imagine that the radial approach will be attractive."

Until RIVAL, prior comparisons of radial and femoral entry had been too small for a definitive comparison. Dr. Jolly and his associates designed their study to test their hunch that radial entry might actually produce better outcomes. (Dr. Jolly admitted that in his own interventional practice he performs about 80% of his cases by radial entry.) "Our hypothesis was a paradigm shift" that radial would result in a significantly reduced rate of a primary outcome of death, myocardial infarction, stroke, and bleeding not related to coronary bypass during the 30 days following percutaneous coronary intervention in patients with acute coronary syndrome.

The ambitious study enrolled 7,021 patients at 158 sites in 32 countries, piggybacked onto an acute coronary syndrome trial that tested clopidogrel and aspirin treatment (CURRENT–OASIS 7). The patient’s average age was 62 years, nearly three-quarters were men, and 45% had unstable angina, with the remaining patients split evenly between ST elevation myocardial infarction (MI) and non–ST-elevation MI.

The combined end point occurred in roughly 4% of patients in both groups. The rate of major bleeds not associated with coronary artery bypass surgery also occurred at roughly similar rates, just under 1%, in both the radial and femoral groups, an unexpected failure for the radial approach. "We expected to see a large decrease in major bleeds" in the radial access patients, Dr. Jolly said. "A take-home message is that in acute coronary syndrome both access site and non–access site bleeds are important." Concurrently with Dr. Jolly’s report, an article with the results was published online in The Lancet (Lancet 2011 April 4 [doi:10.1016/S0140-6736(11)60404-2]).

The only prespecified end point where radial access outperformed femoral access was in the secondary measure of major vascular access site complications: large hematomas, pseudoaneurysms requiring closure, arteriovenous fistula, and other vascular surgery related to the access site. In the radial group, this occurred in 1.4% of patients and in 3.7% of those in the femoral group, a statistically significant 63% relative risk reduction.

"By going radial you prevent complications at the access site," explained Dr. Jolly. These complications "don’t cause deaths," he admitted, "but they are important to patients. They can cause significant discomfort."

But others minimized the importance of access site complications.

"Access-site hematomas don’t impact mortality. Large bleeds are associated with mortality. Gastrointestinal bleeds, genitourinary bleeds, and intracranial bleeds really impact mortality," commented Dr. Gregg W. Stone, professor of medicine and director of cardiovascular research and education at Columbia. Dr. Stone noted that he performs 99% of his coronary interventions via the femoral route.

Aside from the basic findings, perhaps the most notable results focused on the importance of operator and center experience in performing radial catheterizations. One prespecified subgroup analysis split the participating centers into tertiles based on their annual volume of radial-access procedures: those that did at least 146 a year (the highest tertile), those that did 61-145 radial procedures annually (middle tertile), and those performing 60 or fewer annually. The highest tertile centers showed a statistically significant reduction in the study’s primary end point when using radial access.

Also, focusing on outcomes in patients with an ST elevation MI showed that in this subgroup radial access produced a statistically significant reduction in the primary end point, an effect that Dr. Jolly speculated related to individual operator experience. "Radial access in the ST elevation MI patients primarily was done by the high-volume operators because of the time pressure." Only the most experienced operators were comfortable treating these patients radially, he said. Another issue was that these patients are more heavily treated with antiplatelet drugs, which magnified the benefit from radial access in cutting bleeding complications.

The subgroup findings convinced some cardiologists that RIVAL, in sum, scored a triumph for radial access.

"At the least, radial access reduced bleeding, and at best it improved the hard outcomes of death and MI" at the high volume centers, noted Dr. Khandelwal. "Perhaps our goal should be to emulate the operators in the top tertile," he said in an interview.

But Dr. Stone had the take of a femoral-artery enthusiast. "I don’t think in and of itself these data will change practice. What might change practice," he conceded, "is patient comfort."

Dr. Jolly said that he has received consultant fees or honoraria from Boehringer-Ingelheim, GlaxoSmithKline, and Sanofi-Aventis, and research grants from Merck. Dr. McNulty said he had no disclosures. Dr. Leon said he has been an unpaid consultant to Abbott, Boston Scientific, and Medtronic. Dr. Stone said that he has been a consultant to Inspire MD, Reva, Osprey, Lilly, BMS/Sanofi, Medtronic, AstraZeneca, Vascular Solutions, Gilead, The Medicines Company, Abbott Vascular, Boston Scientific, Ortho-McNeil, Edwards, and Merck; he has an ownership or partnership role in MiCardia, Biostar I and II, FlowCardia, Embrella, Caliber, Medfocus I and II, Accelerator, and Access Closure; and he has received research funds from InfraReDx, TherOx, Atrium, and Volcano. Dr. Khandelwal said he had no disclosures.

NEW ORLEANS – With broader use of radial-artery access for percutaneous coronary interventions already gaining momentum in the United States, results from the largest study by far to compare radial- and femoral-artery approaches may give an extra boost to the radial camp.

While results from the Radial vs Femoral Access for Coronary Intervention (RIVAL) trial showed primary end point equivalence for the two arterial access strategies in a 7,000-patient randomized trial, radial access may have won by not losing.

"The similar efficacy helps the radial approach, because there was a persistent uncertainty whether it really was as good as femoral, Dr. Sanjit S. Jolly, lead investigator of the trial, said at the annual meeting of the American College of Cardiology.

In addition, the study’s findings "in high-volume centers and in patients with ST elevation myocardial infarctions will produce more momentum for a shift," he predicted.

Interventional cardiologists in some countries have embraced radial-artery access for placing catheters aimed at the coronaries into patients. Dr. Jolly, a cardiologist at McMaster University in Hamilton, Canada, cited a greater than 90% rate among French interventionalists and a greater than 95% rate in Canada. But as recently as last summer, U.S. cardiologists used radial access for a mere 4% of their coronary catheterizations, based on data collected by the National Cardiovascular Data Registry, said Dr. Edward J. McNulty, an interventional cardiologist at Kaiser Permanente San Francisco.

The U.S. numbers clearly have a long way to go before they start to resemble what is now routine in many other places, but some clues at the meeting suggest they began trending up even before Dr. Jolly delivered the RIVAL results. For example, in a separate talk earlier in the meeting, Detroit interventionalist Dr. Akshay Khandelwal recounted his personal experience introducing radial access into his practice starting about 18 months ago. His cases gradually shifted, and by March roughly 75% of his coronary procedures used radial access. Following his lead, his colleagues at Henry Ford Hospital, Detroit, began to become radialists, too, and as of March 2011 a quarter of his cath lab’s coronary work occurred via the patient’s wrist, said Dr. Khandelwal, director of outpatient cardiovascular services at Henry Ford.

"At Columbia [University’s Center for Interventional Vascular Therapy] the frequency of radial access has increased," agreed Dr. Martin B. Leon, who directs the center in New York. "It was in single digits in 2010, but now, for the first time, it’s more than 20%. It’s climbing quickly. Many operators are becoming more interested in gaining expertise, particularly younger operators," he said.

Part of this shift is driven by physicians who believe they might achieve better results, with less bleeding and access site complications, and part comes from patient demand because most patients find the radial approach more comfortable. "Patients like it, and I think that will drive the option," Dr. McNulty said. Another important factor is cost.

"There is a recent trend in the U.S. to do more outpatient angioplasty in low-risk and stable patients," Dr. Leon said, and radial access makes same-day discharge feasible much more often than does femoral access. "If that trend continues, and the predictions are it will, you can imagine that the radial approach will be attractive."

Until RIVAL, prior comparisons of radial and femoral entry had been too small for a definitive comparison. Dr. Jolly and his associates designed their study to test their hunch that radial entry might actually produce better outcomes. (Dr. Jolly admitted that in his own interventional practice he performs about 80% of his cases by radial entry.) "Our hypothesis was a paradigm shift" that radial would result in a significantly reduced rate of a primary outcome of death, myocardial infarction, stroke, and bleeding not related to coronary bypass during the 30 days following percutaneous coronary intervention in patients with acute coronary syndrome.

The ambitious study enrolled 7,021 patients at 158 sites in 32 countries, piggybacked onto an acute coronary syndrome trial that tested clopidogrel and aspirin treatment (CURRENT–OASIS 7). The patient’s average age was 62 years, nearly three-quarters were men, and 45% had unstable angina, with the remaining patients split evenly between ST elevation myocardial infarction (MI) and non–ST-elevation MI.

The combined end point occurred in roughly 4% of patients in both groups. The rate of major bleeds not associated with coronary artery bypass surgery also occurred at roughly similar rates, just under 1%, in both the radial and femoral groups, an unexpected failure for the radial approach. "We expected to see a large decrease in major bleeds" in the radial access patients, Dr. Jolly said. "A take-home message is that in acute coronary syndrome both access site and non–access site bleeds are important." Concurrently with Dr. Jolly’s report, an article with the results was published online in The Lancet (Lancet 2011 April 4 [doi:10.1016/S0140-6736(11)60404-2]).

The only prespecified end point where radial access outperformed femoral access was in the secondary measure of major vascular access site complications: large hematomas, pseudoaneurysms requiring closure, arteriovenous fistula, and other vascular surgery related to the access site. In the radial group, this occurred in 1.4% of patients and in 3.7% of those in the femoral group, a statistically significant 63% relative risk reduction.

"By going radial you prevent complications at the access site," explained Dr. Jolly. These complications "don’t cause deaths," he admitted, "but they are important to patients. They can cause significant discomfort."

But others minimized the importance of access site complications.

"Access-site hematomas don’t impact mortality. Large bleeds are associated with mortality. Gastrointestinal bleeds, genitourinary bleeds, and intracranial bleeds really impact mortality," commented Dr. Gregg W. Stone, professor of medicine and director of cardiovascular research and education at Columbia. Dr. Stone noted that he performs 99% of his coronary interventions via the femoral route.

Aside from the basic findings, perhaps the most notable results focused on the importance of operator and center experience in performing radial catheterizations. One prespecified subgroup analysis split the participating centers into tertiles based on their annual volume of radial-access procedures: those that did at least 146 a year (the highest tertile), those that did 61-145 radial procedures annually (middle tertile), and those performing 60 or fewer annually. The highest tertile centers showed a statistically significant reduction in the study’s primary end point when using radial access.

Also, focusing on outcomes in patients with an ST elevation MI showed that in this subgroup radial access produced a statistically significant reduction in the primary end point, an effect that Dr. Jolly speculated related to individual operator experience. "Radial access in the ST elevation MI patients primarily was done by the high-volume operators because of the time pressure." Only the most experienced operators were comfortable treating these patients radially, he said. Another issue was that these patients are more heavily treated with antiplatelet drugs, which magnified the benefit from radial access in cutting bleeding complications.

The subgroup findings convinced some cardiologists that RIVAL, in sum, scored a triumph for radial access.

"At the least, radial access reduced bleeding, and at best it improved the hard outcomes of death and MI" at the high volume centers, noted Dr. Khandelwal. "Perhaps our goal should be to emulate the operators in the top tertile," he said in an interview.

But Dr. Stone had the take of a femoral-artery enthusiast. "I don’t think in and of itself these data will change practice. What might change practice," he conceded, "is patient comfort."

Dr. Jolly said that he has received consultant fees or honoraria from Boehringer-Ingelheim, GlaxoSmithKline, and Sanofi-Aventis, and research grants from Merck. Dr. McNulty said he had no disclosures. Dr. Leon said he has been an unpaid consultant to Abbott, Boston Scientific, and Medtronic. Dr. Stone said that he has been a consultant to Inspire MD, Reva, Osprey, Lilly, BMS/Sanofi, Medtronic, AstraZeneca, Vascular Solutions, Gilead, The Medicines Company, Abbott Vascular, Boston Scientific, Ortho-McNeil, Edwards, and Merck; he has an ownership or partnership role in MiCardia, Biostar I and II, FlowCardia, Embrella, Caliber, Medfocus I and II, Accelerator, and Access Closure; and he has received research funds from InfraReDx, TherOx, Atrium, and Volcano. Dr. Khandelwal said he had no disclosures.

NEW ORLEANS – With broader use of radial-artery access for percutaneous coronary interventions already gaining momentum in the United States, results from the largest study by far to compare radial- and femoral-artery approaches may give an extra boost to the radial camp.

While results from the Radial vs Femoral Access for Coronary Intervention (RIVAL) trial showed primary end point equivalence for the two arterial access strategies in a 7,000-patient randomized trial, radial access may have won by not losing.

"The similar efficacy helps the radial approach, because there was a persistent uncertainty whether it really was as good as femoral, Dr. Sanjit S. Jolly, lead investigator of the trial, said at the annual meeting of the American College of Cardiology.

In addition, the study’s findings "in high-volume centers and in patients with ST elevation myocardial infarctions will produce more momentum for a shift," he predicted.

Interventional cardiologists in some countries have embraced radial-artery access for placing catheters aimed at the coronaries into patients. Dr. Jolly, a cardiologist at McMaster University in Hamilton, Canada, cited a greater than 90% rate among French interventionalists and a greater than 95% rate in Canada. But as recently as last summer, U.S. cardiologists used radial access for a mere 4% of their coronary catheterizations, based on data collected by the National Cardiovascular Data Registry, said Dr. Edward J. McNulty, an interventional cardiologist at Kaiser Permanente San Francisco.

The U.S. numbers clearly have a long way to go before they start to resemble what is now routine in many other places, but some clues at the meeting suggest they began trending up even before Dr. Jolly delivered the RIVAL results. For example, in a separate talk earlier in the meeting, Detroit interventionalist Dr. Akshay Khandelwal recounted his personal experience introducing radial access into his practice starting about 18 months ago. His cases gradually shifted, and by March roughly 75% of his coronary procedures used radial access. Following his lead, his colleagues at Henry Ford Hospital, Detroit, began to become radialists, too, and as of March 2011 a quarter of his cath lab’s coronary work occurred via the patient’s wrist, said Dr. Khandelwal, director of outpatient cardiovascular services at Henry Ford.

"At Columbia [University’s Center for Interventional Vascular Therapy] the frequency of radial access has increased," agreed Dr. Martin B. Leon, who directs the center in New York. "It was in single digits in 2010, but now, for the first time, it’s more than 20%. It’s climbing quickly. Many operators are becoming more interested in gaining expertise, particularly younger operators," he said.

Part of this shift is driven by physicians who believe they might achieve better results, with less bleeding and access site complications, and part comes from patient demand because most patients find the radial approach more comfortable. "Patients like it, and I think that will drive the option," Dr. McNulty said. Another important factor is cost.

"There is a recent trend in the U.S. to do more outpatient angioplasty in low-risk and stable patients," Dr. Leon said, and radial access makes same-day discharge feasible much more often than does femoral access. "If that trend continues, and the predictions are it will, you can imagine that the radial approach will be attractive."

Until RIVAL, prior comparisons of radial and femoral entry had been too small for a definitive comparison. Dr. Jolly and his associates designed their study to test their hunch that radial entry might actually produce better outcomes. (Dr. Jolly admitted that in his own interventional practice he performs about 80% of his cases by radial entry.) "Our hypothesis was a paradigm shift" that radial would result in a significantly reduced rate of a primary outcome of death, myocardial infarction, stroke, and bleeding not related to coronary bypass during the 30 days following percutaneous coronary intervention in patients with acute coronary syndrome.

The ambitious study enrolled 7,021 patients at 158 sites in 32 countries, piggybacked onto an acute coronary syndrome trial that tested clopidogrel and aspirin treatment (CURRENT–OASIS 7). The patient’s average age was 62 years, nearly three-quarters were men, and 45% had unstable angina, with the remaining patients split evenly between ST elevation myocardial infarction (MI) and non–ST-elevation MI.

The combined end point occurred in roughly 4% of patients in both groups. The rate of major bleeds not associated with coronary artery bypass surgery also occurred at roughly similar rates, just under 1%, in both the radial and femoral groups, an unexpected failure for the radial approach. "We expected to see a large decrease in major bleeds" in the radial access patients, Dr. Jolly said. "A take-home message is that in acute coronary syndrome both access site and non–access site bleeds are important." Concurrently with Dr. Jolly’s report, an article with the results was published online in The Lancet (Lancet 2011 April 4 [doi:10.1016/S0140-6736(11)60404-2]).

The only prespecified end point where radial access outperformed femoral access was in the secondary measure of major vascular access site complications: large hematomas, pseudoaneurysms requiring closure, arteriovenous fistula, and other vascular surgery related to the access site. In the radial group, this occurred in 1.4% of patients and in 3.7% of those in the femoral group, a statistically significant 63% relative risk reduction.

"By going radial you prevent complications at the access site," explained Dr. Jolly. These complications "don’t cause deaths," he admitted, "but they are important to patients. They can cause significant discomfort."

But others minimized the importance of access site complications.

"Access-site hematomas don’t impact mortality. Large bleeds are associated with mortality. Gastrointestinal bleeds, genitourinary bleeds, and intracranial bleeds really impact mortality," commented Dr. Gregg W. Stone, professor of medicine and director of cardiovascular research and education at Columbia. Dr. Stone noted that he performs 99% of his coronary interventions via the femoral route.

Aside from the basic findings, perhaps the most notable results focused on the importance of operator and center experience in performing radial catheterizations. One prespecified subgroup analysis split the participating centers into tertiles based on their annual volume of radial-access procedures: those that did at least 146 a year (the highest tertile), those that did 61-145 radial procedures annually (middle tertile), and those performing 60 or fewer annually. The highest tertile centers showed a statistically significant reduction in the study’s primary end point when using radial access.

Also, focusing on outcomes in patients with an ST elevation MI showed that in this subgroup radial access produced a statistically significant reduction in the primary end point, an effect that Dr. Jolly speculated related to individual operator experience. "Radial access in the ST elevation MI patients primarily was done by the high-volume operators because of the time pressure." Only the most experienced operators were comfortable treating these patients radially, he said. Another issue was that these patients are more heavily treated with antiplatelet drugs, which magnified the benefit from radial access in cutting bleeding complications.

The subgroup findings convinced some cardiologists that RIVAL, in sum, scored a triumph for radial access.

"At the least, radial access reduced bleeding, and at best it improved the hard outcomes of death and MI" at the high volume centers, noted Dr. Khandelwal. "Perhaps our goal should be to emulate the operators in the top tertile," he said in an interview.

But Dr. Stone had the take of a femoral-artery enthusiast. "I don’t think in and of itself these data will change practice. What might change practice," he conceded, "is patient comfort."

Dr. Jolly said that he has received consultant fees or honoraria from Boehringer-Ingelheim, GlaxoSmithKline, and Sanofi-Aventis, and research grants from Merck. Dr. McNulty said he had no disclosures. Dr. Leon said he has been an unpaid consultant to Abbott, Boston Scientific, and Medtronic. Dr. Stone said that he has been a consultant to Inspire MD, Reva, Osprey, Lilly, BMS/Sanofi, Medtronic, AstraZeneca, Vascular Solutions, Gilead, The Medicines Company, Abbott Vascular, Boston Scientific, Ortho-McNeil, Edwards, and Merck; he has an ownership or partnership role in MiCardia, Biostar I and II, FlowCardia, Embrella, Caliber, Medfocus I and II, Accelerator, and Access Closure; and he has received research funds from InfraReDx, TherOx, Atrium, and Volcano. Dr. Khandelwal said he had no disclosures.

NEW ORLEANS – With broader use of radial-artery access for percutaneous coronary interventions already gaining momentum in the United States, results from the largest study by far to compare radial- and femoral-artery approaches may give an extra boost to the radial camp.

While results from the Radial vs Femoral Access for Coronary Intervention (RIVAL) trial showed primary end point equivalence for the two arterial access strategies in a 7,000-patient randomized trial, radial access may have won by not losing.

"The similar efficacy helps the radial approach, because there was a persistent uncertainty whether it really was as good as femoral, Dr. Sanjit S. Jolly, lead investigator of the trial, said at the annual meeting of the American College of Cardiology.

In addition, the study’s findings "in high-volume centers and in patients with ST elevation myocardial infarctions will produce more momentum for a shift," he predicted.

Interventional cardiologists in some countries have embraced radial-artery access for placing catheters aimed at the coronaries into patients. Dr. Jolly, a cardiologist at McMaster University in Hamilton, Canada, cited a greater than 90% rate among French interventionalists and a greater than 95% rate in Canada. But as recently as last summer, U.S. cardiologists used radial access for a mere 4% of their coronary catheterizations, based on data collected by the National Cardiovascular Data Registry, said Dr. Edward J. McNulty, an interventional cardiologist at Kaiser Permanente San Francisco.

The U.S. numbers clearly have a long way to go before they start to resemble what is now routine in many other places, but some clues at the meeting suggest they began trending up even before Dr. Jolly delivered the RIVAL results. For example, in a separate talk earlier in the meeting, Detroit interventionalist Dr. Akshay Khandelwal recounted his personal experience introducing radial access into his practice starting about 18 months ago. His cases gradually shifted, and by March roughly 75% of his coronary procedures used radial access. Following his lead, his colleagues at Henry Ford Hospital, Detroit, began to become radialists, too, and as of March 2011 a quarter of his cath lab’s coronary work occurred via the patient’s wrist, said Dr. Khandelwal, director of outpatient cardiovascular services at Henry Ford.

"At Columbia [University’s Center for Interventional Vascular Therapy] the frequency of radial access has increased," agreed Dr. Martin B. Leon, who directs the center in New York. "It was in single digits in 2010, but now, for the first time, it’s more than 20%. It’s climbing quickly. Many operators are becoming more interested in gaining expertise, particularly younger operators," he said.

Part of this shift is driven by physicians who believe they might achieve better results, with less bleeding and access site complications, and part comes from patient demand because most patients find the radial approach more comfortable. "Patients like it, and I think that will drive the option," Dr. McNulty said. Another important factor is cost.

"There is a recent trend in the U.S. to do more outpatient angioplasty in low-risk and stable patients," Dr. Leon said, and radial access makes same-day discharge feasible much more often than does femoral access. "If that trend continues, and the predictions are it will, you can imagine that the radial approach will be attractive."

Until RIVAL, prior comparisons of radial and femoral entry had been too small for a definitive comparison. Dr. Jolly and his associates designed their study to test their hunch that radial entry might actually produce better outcomes. (Dr. Jolly admitted that in his own interventional practice he performs about 80% of his cases by radial entry.) "Our hypothesis was a paradigm shift" that radial would result in a significantly reduced rate of a primary outcome of death, myocardial infarction, stroke, and bleeding not related to coronary bypass during the 30 days following percutaneous coronary intervention in patients with acute coronary syndrome.

The ambitious study enrolled 7,021 patients at 158 sites in 32 countries, piggybacked onto an acute coronary syndrome trial that tested clopidogrel and aspirin treatment (CURRENT–OASIS 7). The patient’s average age was 62 years, nearly three-quarters were men, and 45% had unstable angina, with the remaining patients split evenly between ST elevation myocardial infarction (MI) and non–ST-elevation MI.

The combined end point occurred in roughly 4% of patients in both groups. The rate of major bleeds not associated with coronary artery bypass surgery also occurred at roughly similar rates, just under 1%, in both the radial and femoral groups, an unexpected failure for the radial approach. "We expected to see a large decrease in major bleeds" in the radial access patients, Dr. Jolly said. "A take-home message is that in acute coronary syndrome both access site and non–access site bleeds are important." Concurrently with Dr. Jolly’s report, an article with the results was published online in The Lancet (Lancet 2011 April 4 [doi:10.1016/S0140-6736(11)60404-2]).

The only prespecified end point where radial access outperformed femoral access was in the secondary measure of major vascular access site complications: large hematomas, pseudoaneurysms requiring closure, arteriovenous fistula, and other vascular surgery related to the access site. In the radial group, this occurred in 1.4% of patients and in 3.7% of those in the femoral group, a statistically significant 63% relative risk reduction.

"By going radial you prevent complications at the access site," explained Dr. Jolly. These complications "don’t cause deaths," he admitted, "but they are important to patients. They can cause significant discomfort."

But others minimized the importance of access site complications.

"Access-site hematomas don’t impact mortality. Large bleeds are associated with mortality. Gastrointestinal bleeds, genitourinary bleeds, and intracranial bleeds really impact mortality," commented Dr. Gregg W. Stone, professor of medicine and director of cardiovascular research and education at Columbia. Dr. Stone noted that he performs 99% of his coronary interventions via the femoral route.

Aside from the basic findings, perhaps the most notable results focused on the importance of operator and center experience in performing radial catheterizations. One prespecified subgroup analysis split the participating centers into tertiles based on their annual volume of radial-access procedures: those that did at least 146 a year (the highest tertile), those that did 61-145 radial procedures annually (middle tertile), and those performing 60 or fewer annually. The highest tertile centers showed a statistically significant reduction in the study’s primary end point when using radial access.

Also, focusing on outcomes in patients with an ST elevation MI showed that in this subgroup radial access produced a statistically significant reduction in the primary end point, an effect that Dr. Jolly speculated related to individual operator experience. "Radial access in the ST elevation MI patients primarily was done by the high-volume operators because of the time pressure." Only the most experienced operators were comfortable treating these patients radially, he said. Another issue was that these patients are more heavily treated with antiplatelet drugs, which magnified the benefit from radial access in cutting bleeding complications.

The subgroup findings convinced some cardiologists that RIVAL, in sum, scored a triumph for radial access.

"At the least, radial access reduced bleeding, and at best it improved the hard outcomes of death and MI" at the high volume centers, noted Dr. Khandelwal. "Perhaps our goal should be to emulate the operators in the top tertile," he said in an interview.

But Dr. Stone had the take of a femoral-artery enthusiast. "I don’t think in and of itself these data will change practice. What might change practice," he conceded, "is patient comfort."

Dr. Jolly said that he has received consultant fees or honoraria from Boehringer-Ingelheim, GlaxoSmithKline, and Sanofi-Aventis, and research grants from Merck. Dr. McNulty said he had no disclosures. Dr. Leon said he has been an unpaid consultant to Abbott, Boston Scientific, and Medtronic. Dr. Stone said that he has been a consultant to Inspire MD, Reva, Osprey, Lilly, BMS/Sanofi, Medtronic, AstraZeneca, Vascular Solutions, Gilead, The Medicines Company, Abbott Vascular, Boston Scientific, Ortho-McNeil, Edwards, and Merck; he has an ownership or partnership role in MiCardia, Biostar I and II, FlowCardia, Embrella, Caliber, Medfocus I and II, Accelerator, and Access Closure; and he has received research funds from InfraReDx, TherOx, Atrium, and Volcano. Dr. Khandelwal said he had no disclosures.

NEW ORLEANS – With broader use of radial-artery access for percutaneous coronary interventions already gaining momentum in the United States, results from the largest study by far to compare radial- and femoral-artery approaches may give an extra boost to the radial camp.

While results from the Radial vs Femoral Access for Coronary Intervention (RIVAL) trial showed primary end point equivalence for the two arterial access strategies in a 7,000-patient randomized trial, radial access may have won by not losing.

"The similar efficacy helps the radial approach, because there was a persistent uncertainty whether it really was as good as femoral, Dr. Sanjit S. Jolly, lead investigator of the trial, said at the annual meeting of the American College of Cardiology.

In addition, the study’s findings "in high-volume centers and in patients with ST elevation myocardial infarctions will produce more momentum for a shift," he predicted.

Interventional cardiologists in some countries have embraced radial-artery access for placing catheters aimed at the coronaries into patients. Dr. Jolly, a cardiologist at McMaster University in Hamilton, Canada, cited a greater than 90% rate among French interventionalists and a greater than 95% rate in Canada. But as recently as last summer, U.S. cardiologists used radial access for a mere 4% of their coronary catheterizations, based on data collected by the National Cardiovascular Data Registry, said Dr. Edward J. McNulty, an interventional cardiologist at Kaiser Permanente San Francisco.

The U.S. numbers clearly have a long way to go before they start to resemble what is now routine in many other places, but some clues at the meeting suggest they began trending up even before Dr. Jolly delivered the RIVAL results. For example, in a separate talk earlier in the meeting, Detroit interventionalist Dr. Akshay Khandelwal recounted his personal experience introducing radial access into his practice starting about 18 months ago. His cases gradually shifted, and by March roughly 75% of his coronary procedures used radial access. Following his lead, his colleagues at Henry Ford Hospital, Detroit, began to become radialists, too, and as of March 2011 a quarter of his cath lab’s coronary work occurred via the patient’s wrist, said Dr. Khandelwal, director of outpatient cardiovascular services at Henry Ford.

"At Columbia [University’s Center for Interventional Vascular Therapy] the frequency of radial access has increased," agreed Dr. Martin B. Leon, who directs the center in New York. "It was in single digits in 2010, but now, for the first time, it’s more than 20%. It’s climbing quickly. Many operators are becoming more interested in gaining expertise, particularly younger operators," he said.

Part of this shift is driven by physicians who believe they might achieve better results, with less bleeding and access site complications, and part comes from patient demand because most patients find the radial approach more comfortable. "Patients like it, and I think that will drive the option," Dr. McNulty said. Another important factor is cost.

"There is a recent trend in the U.S. to do more outpatient angioplasty in low-risk and stable patients," Dr. Leon said, and radial access makes same-day discharge feasible much more often than does femoral access. "If that trend continues, and the predictions are it will, you can imagine that the radial approach will be attractive."

Until RIVAL, prior comparisons of radial and femoral entry had been too small for a definitive comparison. Dr. Jolly and his associates designed their study to test their hunch that radial entry might actually produce better outcomes. (Dr. Jolly admitted that in his own interventional practice he performs about 80% of his cases by radial entry.) "Our hypothesis was a paradigm shift" that radial would result in a significantly reduced rate of a primary outcome of death, myocardial infarction, stroke, and bleeding not related to coronary bypass during the 30 days following percutaneous coronary intervention in patients with acute coronary syndrome.

The ambitious study enrolled 7,021 patients at 158 sites in 32 countries, piggybacked onto an acute coronary syndrome trial that tested clopidogrel and aspirin treatment (CURRENT–OASIS 7). The patient’s average age was 62 years, nearly three-quarters were men, and 45% had unstable angina, with the remaining patients split evenly between ST elevation myocardial infarction (MI) and non–ST-elevation MI.

The combined end point occurred in roughly 4% of patients in both groups. The rate of major bleeds not associated with coronary artery bypass surgery also occurred at roughly similar rates, just under 1%, in both the radial and femoral groups, an unexpected failure for the radial approach. "We expected to see a large decrease in major bleeds" in the radial access patients, Dr. Jolly said. "A take-home message is that in acute coronary syndrome both access site and non–access site bleeds are important." Concurrently with Dr. Jolly’s report, an article with the results was published online in The Lancet (Lancet 2011 April 4 [doi:10.1016/S0140-6736(11)60404-2]).

The only prespecified end point where radial access outperformed femoral access was in the secondary measure of major vascular access site complications: large hematomas, pseudoaneurysms requiring closure, arteriovenous fistula, and other vascular surgery related to the access site. In the radial group, this occurred in 1.4% of patients and in 3.7% of those in the femoral group, a statistically significant 63% relative risk reduction.

"By going radial you prevent complications at the access site," explained Dr. Jolly. These complications "don’t cause deaths," he admitted, "but they are important to patients. They can cause significant discomfort."

But others minimized the importance of access site complications.

"Access-site hematomas don’t impact mortality. Large bleeds are associated with mortality. Gastrointestinal bleeds, genitourinary bleeds, and intracranial bleeds really impact mortality," commented Dr. Gregg W. Stone, professor of medicine and director of cardiovascular research and education at Columbia. Dr. Stone noted that he performs 99% of his coronary interventions via the femoral route.

Aside from the basic findings, perhaps the most notable results focused on the importance of operator and center experience in performing radial catheterizations. One prespecified subgroup analysis split the participating centers into tertiles based on their annual volume of radial-access procedures: those that did at least 146 a year (the highest tertile), those that did 61-145 radial procedures annually (middle tertile), and those performing 60 or fewer annually. The highest tertile centers showed a statistically significant reduction in the study’s primary end point when using radial access.

Also, focusing on outcomes in patients with an ST elevation MI showed that in this subgroup radial access produced a statistically significant reduction in the primary end point, an effect that Dr. Jolly speculated related to individual operator experience. "Radial access in the ST elevation MI patients primarily was done by the high-volume operators because of the time pressure." Only the most experienced operators were comfortable treating these patients radially, he said. Another issue was that these patients are more heavily treated with antiplatelet drugs, which magnified the benefit from radial access in cutting bleeding complications.

The subgroup findings convinced some cardiologists that RIVAL, in sum, scored a triumph for radial access.

"At the least, radial access reduced bleeding, and at best it improved the hard outcomes of death and MI" at the high volume centers, noted Dr. Khandelwal. "Perhaps our goal should be to emulate the operators in the top tertile," he said in an interview.

But Dr. Stone had the take of a femoral-artery enthusiast. "I don’t think in and of itself these data will change practice. What might change practice," he conceded, "is patient comfort."

Dr. Jolly said that he has received consultant fees or honoraria from Boehringer-Ingelheim, GlaxoSmithKline, and Sanofi-Aventis, and research grants from Merck. Dr. McNulty said he had no disclosures. Dr. Leon said he has been an unpaid consultant to Abbott, Boston Scientific, and Medtronic. Dr. Stone said that he has been a consultant to Inspire MD, Reva, Osprey, Lilly, BMS/Sanofi, Medtronic, AstraZeneca, Vascular Solutions, Gilead, The Medicines Company, Abbott Vascular, Boston Scientific, Ortho-McNeil, Edwards, and Merck; he has an ownership or partnership role in MiCardia, Biostar I and II, FlowCardia, Embrella, Caliber, Medfocus I and II, Accelerator, and Access Closure; and he has received research funds from InfraReDx, TherOx, Atrium, and Volcano. Dr. Khandelwal said he had no disclosures.

NEW ORLEANS – The durability and safety of treating mitral regurgitation with a percutaneous device as compared with that of surgical repair or replacement persisted at 2 years, based on an updated analysis of the EVEREST II trial results presented April 4 at the annual meeting of the American College of Cardiology.

"Our fundamental finding is that outcomes are very stable between 1 and 2 years of follow-up," Dr. Ted Feldman, principal investigator, announced at a press briefing. "The Kaplan-Meier curves for mortality and re-operation remain literally and completely flat through that time period, and clinical outcomes are durable."

Based on data from the first year of the study, percutaneous repair with the MitraClip was safer than surgery, but surgery yielded more complete reduction in mitral regurgitation (MR). (epub ahead of print, Feldman T et al. N Engl J Med 2011;April 4)

The 2-year follow-up results, presented at the meeting, show both approaches reduced MR, and meaningful clinical benefits persisted, said Dr. Feldman, who is director of the cardiac catheterization laboratory at the NorthShore University HealthSystem in Evanston, Ill.

Clinical outcome measures at 2 years showed MR grade and LV volumes remained stable between 1 and 2 years in both groups. The inter-group comparison showed a more favorable reduction in MR and a greater reduction in LV diastolic volume with surgery at 1 and 2 years, and no difference in systolic volume reduction.

Also, NYHA functional class was stable between years 1 and 2. "Interestingly, the inter-group comparison showed a more favorable NYHA class outcome at both years with the clip," he reported.

The safety profile continued to be favorable, as well. "We saw no percutaneous device embolization; no device fracture, erosion or migration; and no additional occurrence of single leaflet device attachment," he reported.

"Stability is the major message in the examination of 2-year outcomes," Dr. Feldman said. "The randomized trial represents our very early experience with the device. Our procedural rate was 86% in the trial but in the post-randomization registry is in the 96% range. We are certainly going to get better at doing this."

At a panel convened to comment on the study results, Dr. Gregg W. Stone, professor of medicine at New York Presbyterian Hospital and Columbia University, New York, said that the follow-up analysis of EVEREST II is "very well done" and has, "for the most part, shown stability and fairly comparable mortality, though 22% of patients still need surgery if they take the route of the percutaneous option."

Steven F. Bolling, professor of surgery at the University of Michigan, Ann Arbor, maintained that while EVEREST II "suffers a little from awkward analyses," the results are promising, pending the right patient selection and longer follow-up. Patients at high surgical risk and those with cardiomyopathy-associated MR would be the appropriate subset for further study in order to refine the optimal use of the device.

EVEREST II (Endovascular Valve Edge-to-Edge Repair Study) is a prospective, multicenter, randomized controlled phase II trial comparing the safety and efficacy of the MitraClip System with mitral valve surgery in the treatment of MR. The study enrolled 279 patients with 3+ or 4+ MR who were either symptomatic or were asymptomatic with a baseline left ejection fraction of 60%; 27% had functional MR and 73% had degenerative MR. Approximately half of the patients had New York Heart Association (NYHA) functional class III or IV heart failure.

The patients were randomized 2:1 to receive the MitraClip device (n = 184) or mitral valve (MV) repair or replacement (n = 95). Over 90% of the study cohort was available for the 2-year analysis.

Outcomes through 1 year (primary safety and efficacy end points) were recently reported (epub ahead of print, Feldman T et al. N Engl J Med 2011;April 4), showing increased safety with the Mitraclip device compared to surgery, but greater reduction in MR with surgery. At 30 days, major adverse events occurred in 15% of the percutaneous arm versus 48% of the surgical arm. LV function improved in both groups, as did New York Heart Association (NYHA) functional class and quality of life at 1 year.

At the meeting, Dr. Feldman presented two analyses of the 2-year data. The first was an intention-to-treat analysis, in which any MV surgery following percutaneous repair was considered an end point event. The second was a comparison of treatment strategies, in which MV surgery following unsuccessful in-hospital percutaneous repair was not considered an end point event. In the latter analysis, subsequent surgery within 90 days of the percutaneous procedure was still considered a "success" for the MitraClip.

The composite primary efficacy endpoint was freedom from death, MV surgery for valve dysfunction (for device patients) or re-operation (for surgery patients), and MR greater than 2+ at 12 months.

In the intention-to-treat analysis, the primary composite endpoint was met at 2 years by 52% of the percutaneous group and by 66% of the surgery group; in the 1-year analysis, these figures were 55% and 73%, respectively.

More patients receiving the clip later underwent MV surgery (22%) compared to the few patients in the surgery arm who required re-operation (3.6%). There was no significant difference in mortality or recurrent MR.

In the second analysis, there was no statistical difference in the effectiveness end point between the two arms of the study. "When subsequent surgery within 90 days on device patients is considered a success, we see similarly stable results at 1 and 2 years," he noted.

In this analysis, the primary endpoint was met at 2 years by 63% of the percutaneous group and by 66% of the surgery group. By removing the subsequent need for MV surgery as an end point event, 6.2% of the percutaneous group and 3.6% of the surgery group had MV surgery or re-operation.

There was no difference in the Kaplan-Meier mortality plot for the intention-to-treat analysis at any time point, he stressed. At 1 year, 95% of the patients in each arm were alive; at 2 years, 91% of the surgery arm and 90% of the percutaneous arm were still alive.

The Kaplan-Meier plot for freedom from MV surgery/re-operation, however, favored the surgical arm: 96% versus 78% at 2 years.

The "need for surgery in patients in the clip group was almost entirely in the first several months after therapy, and after 6 months the curves overlapped at 1 and 2 years," he observed. "Importantly, 78% of device patients are free from MV surgery at 2 years."

When these early failures were excluded, there were no differences in need for MV surgery or reoperation.

At a press conference, Dr. Feldman explained that the two analyses "answer different questions." "The intention-to-treat analysis gives the patient the odds of success with the clip at the end of the year," he said. "It tells them that 78% will be free of the need for surgery at 2 years, and 97% will have NYHA functional class I or II."

The second analysis answers the question, ‘What if I am in the 20% needing surgery?’ It counts the combined strategy of the clip, with surgery as needed.

Dr. Feldman reported consulting fees, honoraria and research grants from Abbott Vascular. Dr. Stone reported consulting fees and honoraria from Abbott Vascular and numerous other pharmaceutical and device companies. Dr. Bolling reported no relevant disclosures.

NEW ORLEANS – The durability and safety of treating mitral regurgitation with a percutaneous device as compared with that of surgical repair or replacement persisted at 2 years, based on an updated analysis of the EVEREST II trial results presented April 4 at the annual meeting of the American College of Cardiology.

"Our fundamental finding is that outcomes are very stable between 1 and 2 years of follow-up," Dr. Ted Feldman, principal investigator, announced at a press briefing. "The Kaplan-Meier curves for mortality and re-operation remain literally and completely flat through that time period, and clinical outcomes are durable."

Based on data from the first year of the study, percutaneous repair with the MitraClip was safer than surgery, but surgery yielded more complete reduction in mitral regurgitation (MR). (epub ahead of print, Feldman T et al. N Engl J Med 2011;April 4)

The 2-year follow-up results, presented at the meeting, show both approaches reduced MR, and meaningful clinical benefits persisted, said Dr. Feldman, who is director of the cardiac catheterization laboratory at the NorthShore University HealthSystem in Evanston, Ill.

Clinical outcome measures at 2 years showed MR grade and LV volumes remained stable between 1 and 2 years in both groups. The inter-group comparison showed a more favorable reduction in MR and a greater reduction in LV diastolic volume with surgery at 1 and 2 years, and no difference in systolic volume reduction.

Also, NYHA functional class was stable between years 1 and 2. "Interestingly, the inter-group comparison showed a more favorable NYHA class outcome at both years with the clip," he reported.

The safety profile continued to be favorable, as well. "We saw no percutaneous device embolization; no device fracture, erosion or migration; and no additional occurrence of single leaflet device attachment," he reported.

"Stability is the major message in the examination of 2-year outcomes," Dr. Feldman said. "The randomized trial represents our very early experience with the device. Our procedural rate was 86% in the trial but in the post-randomization registry is in the 96% range. We are certainly going to get better at doing this."

At a panel convened to comment on the study results, Dr. Gregg W. Stone, professor of medicine at New York Presbyterian Hospital and Columbia University, New York, said that the follow-up analysis of EVEREST II is "very well done" and has, "for the most part, shown stability and fairly comparable mortality, though 22% of patients still need surgery if they take the route of the percutaneous option."

Steven F. Bolling, professor of surgery at the University of Michigan, Ann Arbor, maintained that while EVEREST II "suffers a little from awkward analyses," the results are promising, pending the right patient selection and longer follow-up. Patients at high surgical risk and those with cardiomyopathy-associated MR would be the appropriate subset for further study in order to refine the optimal use of the device.

EVEREST II (Endovascular Valve Edge-to-Edge Repair Study) is a prospective, multicenter, randomized controlled phase II trial comparing the safety and efficacy of the MitraClip System with mitral valve surgery in the treatment of MR. The study enrolled 279 patients with 3+ or 4+ MR who were either symptomatic or were asymptomatic with a baseline left ejection fraction of 60%; 27% had functional MR and 73% had degenerative MR. Approximately half of the patients had New York Heart Association (NYHA) functional class III or IV heart failure.

The patients were randomized 2:1 to receive the MitraClip device (n = 184) or mitral valve (MV) repair or replacement (n = 95). Over 90% of the study cohort was available for the 2-year analysis.

Outcomes through 1 year (primary safety and efficacy end points) were recently reported (epub ahead of print, Feldman T et al. N Engl J Med 2011;April 4), showing increased safety with the Mitraclip device compared to surgery, but greater reduction in MR with surgery. At 30 days, major adverse events occurred in 15% of the percutaneous arm versus 48% of the surgical arm. LV function improved in both groups, as did New York Heart Association (NYHA) functional class and quality of life at 1 year.

At the meeting, Dr. Feldman presented two analyses of the 2-year data. The first was an intention-to-treat analysis, in which any MV surgery following percutaneous repair was considered an end point event. The second was a comparison of treatment strategies, in which MV surgery following unsuccessful in-hospital percutaneous repair was not considered an end point event. In the latter analysis, subsequent surgery within 90 days of the percutaneous procedure was still considered a "success" for the MitraClip.

The composite primary efficacy endpoint was freedom from death, MV surgery for valve dysfunction (for device patients) or re-operation (for surgery patients), and MR greater than 2+ at 12 months.

In the intention-to-treat analysis, the primary composite endpoint was met at 2 years by 52% of the percutaneous group and by 66% of the surgery group; in the 1-year analysis, these figures were 55% and 73%, respectively.

More patients receiving the clip later underwent MV surgery (22%) compared to the few patients in the surgery arm who required re-operation (3.6%). There was no significant difference in mortality or recurrent MR.

In the second analysis, there was no statistical difference in the effectiveness end point between the two arms of the study. "When subsequent surgery within 90 days on device patients is considered a success, we see similarly stable results at 1 and 2 years," he noted.

In this analysis, the primary endpoint was met at 2 years by 63% of the percutaneous group and by 66% of the surgery group. By removing the subsequent need for MV surgery as an end point event, 6.2% of the percutaneous group and 3.6% of the surgery group had MV surgery or re-operation.

There was no difference in the Kaplan-Meier mortality plot for the intention-to-treat analysis at any time point, he stressed. At 1 year, 95% of the patients in each arm were alive; at 2 years, 91% of the surgery arm and 90% of the percutaneous arm were still alive.

The Kaplan-Meier plot for freedom from MV surgery/re-operation, however, favored the surgical arm: 96% versus 78% at 2 years.

The "need for surgery in patients in the clip group was almost entirely in the first several months after therapy, and after 6 months the curves overlapped at 1 and 2 years," he observed. "Importantly, 78% of device patients are free from MV surgery at 2 years."

When these early failures were excluded, there were no differences in need for MV surgery or reoperation.

At a press conference, Dr. Feldman explained that the two analyses "answer different questions." "The intention-to-treat analysis gives the patient the odds of success with the clip at the end of the year," he said. "It tells them that 78% will be free of the need for surgery at 2 years, and 97% will have NYHA functional class I or II."

The second analysis answers the question, ‘What if I am in the 20% needing surgery?’ It counts the combined strategy of the clip, with surgery as needed.

Dr. Feldman reported consulting fees, honoraria and research grants from Abbott Vascular. Dr. Stone reported consulting fees and honoraria from Abbott Vascular and numerous other pharmaceutical and device companies. Dr. Bolling reported no relevant disclosures.

NEW ORLEANS – The durability and safety of treating mitral regurgitation with a percutaneous device as compared with that of surgical repair or replacement persisted at 2 years, based on an updated analysis of the EVEREST II trial results presented April 4 at the annual meeting of the American College of Cardiology.

"Our fundamental finding is that outcomes are very stable between 1 and 2 years of follow-up," Dr. Ted Feldman, principal investigator, announced at a press briefing. "The Kaplan-Meier curves for mortality and re-operation remain literally and completely flat through that time period, and clinical outcomes are durable."

Based on data from the first year of the study, percutaneous repair with the MitraClip was safer than surgery, but surgery yielded more complete reduction in mitral regurgitation (MR). (epub ahead of print, Feldman T et al. N Engl J Med 2011;April 4)

The 2-year follow-up results, presented at the meeting, show both approaches reduced MR, and meaningful clinical benefits persisted, said Dr. Feldman, who is director of the cardiac catheterization laboratory at the NorthShore University HealthSystem in Evanston, Ill.

Clinical outcome measures at 2 years showed MR grade and LV volumes remained stable between 1 and 2 years in both groups. The inter-group comparison showed a more favorable reduction in MR and a greater reduction in LV diastolic volume with surgery at 1 and 2 years, and no difference in systolic volume reduction.

Also, NYHA functional class was stable between years 1 and 2. "Interestingly, the inter-group comparison showed a more favorable NYHA class outcome at both years with the clip," he reported.

The safety profile continued to be favorable, as well. "We saw no percutaneous device embolization; no device fracture, erosion or migration; and no additional occurrence of single leaflet device attachment," he reported.

"Stability is the major message in the examination of 2-year outcomes," Dr. Feldman said. "The randomized trial represents our very early experience with the device. Our procedural rate was 86% in the trial but in the post-randomization registry is in the 96% range. We are certainly going to get better at doing this."

At a panel convened to comment on the study results, Dr. Gregg W. Stone, professor of medicine at New York Presbyterian Hospital and Columbia University, New York, said that the follow-up analysis of EVEREST II is "very well done" and has, "for the most part, shown stability and fairly comparable mortality, though 22% of patients still need surgery if they take the route of the percutaneous option."

Steven F. Bolling, professor of surgery at the University of Michigan, Ann Arbor, maintained that while EVEREST II "suffers a little from awkward analyses," the results are promising, pending the right patient selection and longer follow-up. Patients at high surgical risk and those with cardiomyopathy-associated MR would be the appropriate subset for further study in order to refine the optimal use of the device.

EVEREST II (Endovascular Valve Edge-to-Edge Repair Study) is a prospective, multicenter, randomized controlled phase II trial comparing the safety and efficacy of the MitraClip System with mitral valve surgery in the treatment of MR. The study enrolled 279 patients with 3+ or 4+ MR who were either symptomatic or were asymptomatic with a baseline left ejection fraction of 60%; 27% had functional MR and 73% had degenerative MR. Approximately half of the patients had New York Heart Association (NYHA) functional class III or IV heart failure.

The patients were randomized 2:1 to receive the MitraClip device (n = 184) or mitral valve (MV) repair or replacement (n = 95). Over 90% of the study cohort was available for the 2-year analysis.

Outcomes through 1 year (primary safety and efficacy end points) were recently reported (epub ahead of print, Feldman T et al. N Engl J Med 2011;April 4), showing increased safety with the Mitraclip device compared to surgery, but greater reduction in MR with surgery. At 30 days, major adverse events occurred in 15% of the percutaneous arm versus 48% of the surgical arm. LV function improved in both groups, as did New York Heart Association (NYHA) functional class and quality of life at 1 year.

At the meeting, Dr. Feldman presented two analyses of the 2-year data. The first was an intention-to-treat analysis, in which any MV surgery following percutaneous repair was considered an end point event. The second was a comparison of treatment strategies, in which MV surgery following unsuccessful in-hospital percutaneous repair was not considered an end point event. In the latter analysis, subsequent surgery within 90 days of the percutaneous procedure was still considered a "success" for the MitraClip.

The composite primary efficacy endpoint was freedom from death, MV surgery for valve dysfunction (for device patients) or re-operation (for surgery patients), and MR greater than 2+ at 12 months.

In the intention-to-treat analysis, the primary composite endpoint was met at 2 years by 52% of the percutaneous group and by 66% of the surgery group; in the 1-year analysis, these figures were 55% and 73%, respectively.

More patients receiving the clip later underwent MV surgery (22%) compared to the few patients in the surgery arm who required re-operation (3.6%). There was no significant difference in mortality or recurrent MR.

In the second analysis, there was no statistical difference in the effectiveness end point between the two arms of the study. "When subsequent surgery within 90 days on device patients is considered a success, we see similarly stable results at 1 and 2 years," he noted.

In this analysis, the primary endpoint was met at 2 years by 63% of the percutaneous group and by 66% of the surgery group. By removing the subsequent need for MV surgery as an end point event, 6.2% of the percutaneous group and 3.6% of the surgery group had MV surgery or re-operation.

There was no difference in the Kaplan-Meier mortality plot for the intention-to-treat analysis at any time point, he stressed. At 1 year, 95% of the patients in each arm were alive; at 2 years, 91% of the surgery arm and 90% of the percutaneous arm were still alive.

The Kaplan-Meier plot for freedom from MV surgery/re-operation, however, favored the surgical arm: 96% versus 78% at 2 years.

The "need for surgery in patients in the clip group was almost entirely in the first several months after therapy, and after 6 months the curves overlapped at 1 and 2 years," he observed. "Importantly, 78% of device patients are free from MV surgery at 2 years."

When these early failures were excluded, there were no differences in need for MV surgery or reoperation.

At a press conference, Dr. Feldman explained that the two analyses "answer different questions." "The intention-to-treat analysis gives the patient the odds of success with the clip at the end of the year," he said. "It tells them that 78% will be free of the need for surgery at 2 years, and 97% will have NYHA functional class I or II."

The second analysis answers the question, ‘What if I am in the 20% needing surgery?’ It counts the combined strategy of the clip, with surgery as needed.

Dr. Feldman reported consulting fees, honoraria and research grants from Abbott Vascular. Dr. Stone reported consulting fees and honoraria from Abbott Vascular and numerous other pharmaceutical and device companies. Dr. Bolling reported no relevant disclosures.

NEW ORLEANS – The durability and safety of treating mitral regurgitation with a percutaneous device as compared with that of surgical repair or replacement persisted at 2 years, based on an updated analysis of the EVEREST II trial results presented April 4 at the annual meeting of the American College of Cardiology.

"Our fundamental finding is that outcomes are very stable between 1 and 2 years of follow-up," Dr. Ted Feldman, principal investigator, announced at a press briefing. "The Kaplan-Meier curves for mortality and re-operation remain literally and completely flat through that time period, and clinical outcomes are durable."

Based on data from the first year of the study, percutaneous repair with the MitraClip was safer than surgery, but surgery yielded more complete reduction in mitral regurgitation (MR). (epub ahead of print, Feldman T et al. N Engl J Med 2011;April 4)

The 2-year follow-up results, presented at the meeting, show both approaches reduced MR, and meaningful clinical benefits persisted, said Dr. Feldman, who is director of the cardiac catheterization laboratory at the NorthShore University HealthSystem in Evanston, Ill.

Clinical outcome measures at 2 years showed MR grade and LV volumes remained stable between 1 and 2 years in both groups. The inter-group comparison showed a more favorable reduction in MR and a greater reduction in LV diastolic volume with surgery at 1 and 2 years, and no difference in systolic volume reduction.

Also, NYHA functional class was stable between years 1 and 2. "Interestingly, the inter-group comparison showed a more favorable NYHA class outcome at both years with the clip," he reported.

The safety profile continued to be favorable, as well. "We saw no percutaneous device embolization; no device fracture, erosion or migration; and no additional occurrence of single leaflet device attachment," he reported.

"Stability is the major message in the examination of 2-year outcomes," Dr. Feldman said. "The randomized trial represents our very early experience with the device. Our procedural rate was 86% in the trial but in the post-randomization registry is in the 96% range. We are certainly going to get better at doing this."

At a panel convened to comment on the study results, Dr. Gregg W. Stone, professor of medicine at New York Presbyterian Hospital and Columbia University, New York, said that the follow-up analysis of EVEREST II is "very well done" and has, "for the most part, shown stability and fairly comparable mortality, though 22% of patients still need surgery if they take the route of the percutaneous option."

Steven F. Bolling, professor of surgery at the University of Michigan, Ann Arbor, maintained that while EVEREST II "suffers a little from awkward analyses," the results are promising, pending the right patient selection and longer follow-up. Patients at high surgical risk and those with cardiomyopathy-associated MR would be the appropriate subset for further study in order to refine the optimal use of the device.

EVEREST II (Endovascular Valve Edge-to-Edge Repair Study) is a prospective, multicenter, randomized controlled phase II trial comparing the safety and efficacy of the MitraClip System with mitral valve surgery in the treatment of MR. The study enrolled 279 patients with 3+ or 4+ MR who were either symptomatic or were asymptomatic with a baseline left ejection fraction of 60%; 27% had functional MR and 73% had degenerative MR. Approximately half of the patients had New York Heart Association (NYHA) functional class III or IV heart failure.

The patients were randomized 2:1 to receive the MitraClip device (n = 184) or mitral valve (MV) repair or replacement (n = 95). Over 90% of the study cohort was available for the 2-year analysis.

Outcomes through 1 year (primary safety and efficacy end points) were recently reported (epub ahead of print, Feldman T et al. N Engl J Med 2011;April 4), showing increased safety with the Mitraclip device compared to surgery, but greater reduction in MR with surgery. At 30 days, major adverse events occurred in 15% of the percutaneous arm versus 48% of the surgical arm. LV function improved in both groups, as did New York Heart Association (NYHA) functional class and quality of life at 1 year.

At the meeting, Dr. Feldman presented two analyses of the 2-year data. The first was an intention-to-treat analysis, in which any MV surgery following percutaneous repair was considered an end point event. The second was a comparison of treatment strategies, in which MV surgery following unsuccessful in-hospital percutaneous repair was not considered an end point event. In the latter analysis, subsequent surgery within 90 days of the percutaneous procedure was still considered a "success" for the MitraClip.

The composite primary efficacy endpoint was freedom from death, MV surgery for valve dysfunction (for device patients) or re-operation (for surgery patients), and MR greater than 2+ at 12 months.

In the intention-to-treat analysis, the primary composite endpoint was met at 2 years by 52% of the percutaneous group and by 66% of the surgery group; in the 1-year analysis, these figures were 55% and 73%, respectively.

More patients receiving the clip later underwent MV surgery (22%) compared to the few patients in the surgery arm who required re-operation (3.6%). There was no significant difference in mortality or recurrent MR.

In the second analysis, there was no statistical difference in the effectiveness end point between the two arms of the study. "When subsequent surgery within 90 days on device patients is considered a success, we see similarly stable results at 1 and 2 years," he noted.

In this analysis, the primary endpoint was met at 2 years by 63% of the percutaneous group and by 66% of the surgery group. By removing the subsequent need for MV surgery as an end point event, 6.2% of the percutaneous group and 3.6% of the surgery group had MV surgery or re-operation.

There was no difference in the Kaplan-Meier mortality plot for the intention-to-treat analysis at any time point, he stressed. At 1 year, 95% of the patients in each arm were alive; at 2 years, 91% of the surgery arm and 90% of the percutaneous arm were still alive.

The Kaplan-Meier plot for freedom from MV surgery/re-operation, however, favored the surgical arm: 96% versus 78% at 2 years.

The "need for surgery in patients in the clip group was almost entirely in the first several months after therapy, and after 6 months the curves overlapped at 1 and 2 years," he observed. "Importantly, 78% of device patients are free from MV surgery at 2 years."

When these early failures were excluded, there were no differences in need for MV surgery or reoperation.

At a press conference, Dr. Feldman explained that the two analyses "answer different questions." "The intention-to-treat analysis gives the patient the odds of success with the clip at the end of the year," he said. "It tells them that 78% will be free of the need for surgery at 2 years, and 97% will have NYHA functional class I or II."

The second analysis answers the question, ‘What if I am in the 20% needing surgery?’ It counts the combined strategy of the clip, with surgery as needed.

Dr. Feldman reported consulting fees, honoraria and research grants from Abbott Vascular. Dr. Stone reported consulting fees and honoraria from Abbott Vascular and numerous other pharmaceutical and device companies. Dr. Bolling reported no relevant disclosures.

NEW ORLEANS – The durability and safety of treating mitral regurgitation with a percutaneous device as compared with that of surgical repair or replacement persisted at 2 years, based on an updated analysis of the EVEREST II trial results presented April 4 at the annual meeting of the American College of Cardiology.

"Our fundamental finding is that outcomes are very stable between 1 and 2 years of follow-up," Dr. Ted Feldman, principal investigator, announced at a press briefing. "The Kaplan-Meier curves for mortality and re-operation remain literally and completely flat through that time period, and clinical outcomes are durable."

Based on data from the first year of the study, percutaneous repair with the MitraClip was safer than surgery, but surgery yielded more complete reduction in mitral regurgitation (MR). (epub ahead of print, Feldman T et al. N Engl J Med 2011;April 4)

The 2-year follow-up results, presented at the meeting, show both approaches reduced MR, and meaningful clinical benefits persisted, said Dr. Feldman, who is director of the cardiac catheterization laboratory at the NorthShore University HealthSystem in Evanston, Ill.

Clinical outcome measures at 2 years showed MR grade and LV volumes remained stable between 1 and 2 years in both groups. The inter-group comparison showed a more favorable reduction in MR and a greater reduction in LV diastolic volume with surgery at 1 and 2 years, and no difference in systolic volume reduction.

Also, NYHA functional class was stable between years 1 and 2. "Interestingly, the inter-group comparison showed a more favorable NYHA class outcome at both years with the clip," he reported.

The safety profile continued to be favorable, as well. "We saw no percutaneous device embolization; no device fracture, erosion or migration; and no additional occurrence of single leaflet device attachment," he reported.

"Stability is the major message in the examination of 2-year outcomes," Dr. Feldman said. "The randomized trial represents our very early experience with the device. Our procedural rate was 86% in the trial but in the post-randomization registry is in the 96% range. We are certainly going to get better at doing this."

At a panel convened to comment on the study results, Dr. Gregg W. Stone, professor of medicine at New York Presbyterian Hospital and Columbia University, New York, said that the follow-up analysis of EVEREST II is "very well done" and has, "for the most part, shown stability and fairly comparable mortality, though 22% of patients still need surgery if they take the route of the percutaneous option."

Steven F. Bolling, professor of surgery at the University of Michigan, Ann Arbor, maintained that while EVEREST II "suffers a little from awkward analyses," the results are promising, pending the right patient selection and longer follow-up. Patients at high surgical risk and those with cardiomyopathy-associated MR would be the appropriate subset for further study in order to refine the optimal use of the device.

EVEREST II (Endovascular Valve Edge-to-Edge Repair Study) is a prospective, multicenter, randomized controlled phase II trial comparing the safety and efficacy of the MitraClip System with mitral valve surgery in the treatment of MR. The study enrolled 279 patients with 3+ or 4+ MR who were either symptomatic or were asymptomatic with a baseline left ejection fraction of 60%; 27% had functional MR and 73% had degenerative MR. Approximately half of the patients had New York Heart Association (NYHA) functional class III or IV heart failure.

The patients were randomized 2:1 to receive the MitraClip device (n = 184) or mitral valve (MV) repair or replacement (n = 95). Over 90% of the study cohort was available for the 2-year analysis.

Outcomes through 1 year (primary safety and efficacy end points) were recently reported (epub ahead of print, Feldman T et al. N Engl J Med 2011;April 4), showing increased safety with the Mitraclip device compared to surgery, but greater reduction in MR with surgery. At 30 days, major adverse events occurred in 15% of the percutaneous arm versus 48% of the surgical arm. LV function improved in both groups, as did New York Heart Association (NYHA) functional class and quality of life at 1 year.

At the meeting, Dr. Feldman presented two analyses of the 2-year data. The first was an intention-to-treat analysis, in which any MV surgery following percutaneous repair was considered an end point event. The second was a comparison of treatment strategies, in which MV surgery following unsuccessful in-hospital percutaneous repair was not considered an end point event. In the latter analysis, subsequent surgery within 90 days of the percutaneous procedure was still considered a "success" for the MitraClip.

The composite primary efficacy endpoint was freedom from death, MV surgery for valve dysfunction (for device patients) or re-operation (for surgery patients), and MR greater than 2+ at 12 months.

In the intention-to-treat analysis, the primary composite endpoint was met at 2 years by 52% of the percutaneous group and by 66% of the surgery group; in the 1-year analysis, these figures were 55% and 73%, respectively.

More patients receiving the clip later underwent MV surgery (22%) compared to the few patients in the surgery arm who required re-operation (3.6%). There was no significant difference in mortality or recurrent MR.

In the second analysis, there was no statistical difference in the effectiveness end point between the two arms of the study. "When subsequent surgery within 90 days on device patients is considered a success, we see similarly stable results at 1 and 2 years," he noted.

In this analysis, the primary endpoint was met at 2 years by 63% of the percutaneous group and by 66% of the surgery group. By removing the subsequent need for MV surgery as an end point event, 6.2% of the percutaneous group and 3.6% of the surgery group had MV surgery or re-operation.

There was no difference in the Kaplan-Meier mortality plot for the intention-to-treat analysis at any time point, he stressed. At 1 year, 95% of the patients in each arm were alive; at 2 years, 91% of the surgery arm and 90% of the percutaneous arm were still alive.

The Kaplan-Meier plot for freedom from MV surgery/re-operation, however, favored the surgical arm: 96% versus 78% at 2 years.

The "need for surgery in patients in the clip group was almost entirely in the first several months after therapy, and after 6 months the curves overlapped at 1 and 2 years," he observed. "Importantly, 78% of device patients are free from MV surgery at 2 years."

When these early failures were excluded, there were no differences in need for MV surgery or reoperation.

At a press conference, Dr. Feldman explained that the two analyses "answer different questions." "The intention-to-treat analysis gives the patient the odds of success with the clip at the end of the year," he said. "It tells them that 78% will be free of the need for surgery at 2 years, and 97% will have NYHA functional class I or II."

The second analysis answers the question, ‘What if I am in the 20% needing surgery?’ It counts the combined strategy of the clip, with surgery as needed.

Dr. Feldman reported consulting fees, honoraria and research grants from Abbott Vascular. Dr. Stone reported consulting fees and honoraria from Abbott Vascular and numerous other pharmaceutical and device companies. Dr. Bolling reported no relevant disclosures.

NEW ORLEANS – The durability and safety of treating mitral regurgitation with a percutaneous device as compared with that of surgical repair or replacement persisted at 2 years, based on an updated analysis of the EVEREST II trial results presented April 4 at the annual meeting of the American College of Cardiology.

"Our fundamental finding is that outcomes are very stable between 1 and 2 years of follow-up," Dr. Ted Feldman, principal investigator, announced at a press briefing. "The Kaplan-Meier curves for mortality and re-operation remain literally and completely flat through that time period, and clinical outcomes are durable."

Based on data from the first year of the study, percutaneous repair with the MitraClip was safer than surgery, but surgery yielded more complete reduction in mitral regurgitation (MR). (epub ahead of print, Feldman T et al. N Engl J Med 2011;April 4)

The 2-year follow-up results, presented at the meeting, show both approaches reduced MR, and meaningful clinical benefits persisted, said Dr. Feldman, who is director of the cardiac catheterization laboratory at the NorthShore University HealthSystem in Evanston, Ill.

Clinical outcome measures at 2 years showed MR grade and LV volumes remained stable between 1 and 2 years in both groups. The inter-group comparison showed a more favorable reduction in MR and a greater reduction in LV diastolic volume with surgery at 1 and 2 years, and no difference in systolic volume reduction.

Also, NYHA functional class was stable between years 1 and 2. "Interestingly, the inter-group comparison showed a more favorable NYHA class outcome at both years with the clip," he reported.

The safety profile continued to be favorable, as well. "We saw no percutaneous device embolization; no device fracture, erosion or migration; and no additional occurrence of single leaflet device attachment," he reported.

"Stability is the major message in the examination of 2-year outcomes," Dr. Feldman said. "The randomized trial represents our very early experience with the device. Our procedural rate was 86% in the trial but in the post-randomization registry is in the 96% range. We are certainly going to get better at doing this."

At a panel convened to comment on the study results, Dr. Gregg W. Stone, professor of medicine at New York Presbyterian Hospital and Columbia University, New York, said that the follow-up analysis of EVEREST II is "very well done" and has, "for the most part, shown stability and fairly comparable mortality, though 22% of patients still need surgery if they take the route of the percutaneous option."

Steven F. Bolling, professor of surgery at the University of Michigan, Ann Arbor, maintained that while EVEREST II "suffers a little from awkward analyses," the results are promising, pending the right patient selection and longer follow-up. Patients at high surgical risk and those with cardiomyopathy-associated MR would be the appropriate subset for further study in order to refine the optimal use of the device.

EVEREST II (Endovascular Valve Edge-to-Edge Repair Study) is a prospective, multicenter, randomized controlled phase II trial comparing the safety and efficacy of the MitraClip System with mitral valve surgery in the treatment of MR. The study enrolled 279 patients with 3+ or 4+ MR who were either symptomatic or were asymptomatic with a baseline left ejection fraction of 60%; 27% had functional MR and 73% had degenerative MR. Approximately half of the patients had New York Heart Association (NYHA) functional class III or IV heart failure.

The patients were randomized 2:1 to receive the MitraClip device (n = 184) or mitral valve (MV) repair or replacement (n = 95). Over 90% of the study cohort was available for the 2-year analysis.

Outcomes through 1 year (primary safety and efficacy end points) were recently reported (epub ahead of print, Feldman T et al. N Engl J Med 2011;April 4), showing increased safety with the Mitraclip device compared to surgery, but greater reduction in MR with surgery. At 30 days, major adverse events occurred in 15% of the percutaneous arm versus 48% of the surgical arm. LV function improved in both groups, as did New York Heart Association (NYHA) functional class and quality of life at 1 year.

At the meeting, Dr. Feldman presented two analyses of the 2-year data. The first was an intention-to-treat analysis, in which any MV surgery following percutaneous repair was considered an end point event. The second was a comparison of treatment strategies, in which MV surgery following unsuccessful in-hospital percutaneous repair was not considered an end point event. In the latter analysis, subsequent surgery within 90 days of the percutaneous procedure was still considered a "success" for the MitraClip.

The composite primary efficacy endpoint was freedom from death, MV surgery for valve dysfunction (for device patients) or re-operation (for surgery patients), and MR greater than 2+ at 12 months.

In the intention-to-treat analysis, the primary composite endpoint was met at 2 years by 52% of the percutaneous group and by 66% of the surgery group; in the 1-year analysis, these figures were 55% and 73%, respectively.

More patients receiving the clip later underwent MV surgery (22%) compared to the few patients in the surgery arm who required re-operation (3.6%). There was no significant difference in mortality or recurrent MR.

In the second analysis, there was no statistical difference in the effectiveness end point between the two arms of the study. "When subsequent surgery within 90 days on device patients is considered a success, we see similarly stable results at 1 and 2 years," he noted.

In this analysis, the primary endpoint was met at 2 years by 63% of the percutaneous group and by 66% of the surgery group. By removing the subsequent need for MV surgery as an end point event, 6.2% of the percutaneous group and 3.6% of the surgery group had MV surgery or re-operation.

There was no difference in the Kaplan-Meier mortality plot for the intention-to-treat analysis at any time point, he stressed. At 1 year, 95% of the patients in each arm were alive; at 2 years, 91% of the surgery arm and 90% of the percutaneous arm were still alive.

The Kaplan-Meier plot for freedom from MV surgery/re-operation, however, favored the surgical arm: 96% versus 78% at 2 years.

The "need for surgery in patients in the clip group was almost entirely in the first several months after therapy, and after 6 months the curves overlapped at 1 and 2 years," he observed. "Importantly, 78% of device patients are free from MV surgery at 2 years."

When these early failures were excluded, there were no differences in need for MV surgery or reoperation.

At a press conference, Dr. Feldman explained that the two analyses "answer different questions." "The intention-to-treat analysis gives the patient the odds of success with the clip at the end of the year," he said. "It tells them that 78% will be free of the need for surgery at 2 years, and 97% will have NYHA functional class I or II."

The second analysis answers the question, ‘What if I am in the 20% needing surgery?’ It counts the combined strategy of the clip, with surgery as needed.

Dr. Feldman reported consulting fees, honoraria and research grants from Abbott Vascular. Dr. Stone reported consulting fees and honoraria from Abbott Vascular and numerous other pharmaceutical and device companies. Dr. Bolling reported no relevant disclosures.

NEW ORLEANS – The durability and safety of treating mitral regurgitation with a percutaneous device as compared with that of surgical repair or replacement persisted at 2 years, based on an updated analysis of the EVEREST II trial results presented April 4 at the annual meeting of the American College of Cardiology.

"Our fundamental finding is that outcomes are very stable between 1 and 2 years of follow-up," Dr. Ted Feldman, principal investigator, announced at a press briefing. "The Kaplan-Meier curves for mortality and re-operation remain literally and completely flat through that time period, and clinical outcomes are durable."

Based on data from the first year of the study, percutaneous repair with the MitraClip was safer than surgery, but surgery yielded more complete reduction in mitral regurgitation (MR). (epub ahead of print, Feldman T et al. N Engl J Med 2011;April 4)

The 2-year follow-up results, presented at the meeting, show both approaches reduced MR, and meaningful clinical benefits persisted, said Dr. Feldman, who is director of the cardiac catheterization laboratory at the NorthShore University HealthSystem in Evanston, Ill.

Clinical outcome measures at 2 years showed MR grade and LV volumes remained stable between 1 and 2 years in both groups. The inter-group comparison showed a more favorable reduction in MR and a greater reduction in LV diastolic volume with surgery at 1 and 2 years, and no difference in systolic volume reduction.

Also, NYHA functional class was stable between years 1 and 2. "Interestingly, the inter-group comparison showed a more favorable NYHA class outcome at both years with the clip," he reported.

The safety profile continued to be favorable, as well. "We saw no percutaneous device embolization; no device fracture, erosion or migration; and no additional occurrence of single leaflet device attachment," he reported.

"Stability is the major message in the examination of 2-year outcomes," Dr. Feldman said. "The randomized trial represents our very early experience with the device. Our procedural rate was 86% in the trial but in the post-randomization registry is in the 96% range. We are certainly going to get better at doing this."

At a panel convened to comment on the study results, Dr. Gregg W. Stone, professor of medicine at New York Presbyterian Hospital and Columbia University, New York, said that the follow-up analysis of EVEREST II is "very well done" and has, "for the most part, shown stability and fairly comparable mortality, though 22% of patients still need surgery if they take the route of the percutaneous option."

Steven F. Bolling, professor of surgery at the University of Michigan, Ann Arbor, maintained that while EVEREST II "suffers a little from awkward analyses," the results are promising, pending the right patient selection and longer follow-up. Patients at high surgical risk and those with cardiomyopathy-associated MR would be the appropriate subset for further study in order to refine the optimal use of the device.

EVEREST II (Endovascular Valve Edge-to-Edge Repair Study) is a prospective, multicenter, randomized controlled phase II trial comparing the safety and efficacy of the MitraClip System with mitral valve surgery in the treatment of MR. The study enrolled 279 patients with 3+ or 4+ MR who were either symptomatic or were asymptomatic with a baseline left ejection fraction of 60%; 27% had functional MR and 73% had degenerative MR. Approximately half of the patients had New York Heart Association (NYHA) functional class III or IV heart failure.

The patients were randomized 2:1 to receive the MitraClip device (n = 184) or mitral valve (MV) repair or replacement (n = 95). Over 90% of the study cohort was available for the 2-year analysis.

Outcomes through 1 year (primary safety and efficacy end points) were recently reported (epub ahead of print, Feldman T et al. N Engl J Med 2011;April 4), showing increased safety with the Mitraclip device compared to surgery, but greater reduction in MR with surgery. At 30 days, major adverse events occurred in 15% of the percutaneous arm versus 48% of the surgical arm. LV function improved in both groups, as did New York Heart Association (NYHA) functional class and quality of life at 1 year.

At the meeting, Dr. Feldman presented two analyses of the 2-year data. The first was an intention-to-treat analysis, in which any MV surgery following percutaneous repair was considered an end point event. The second was a comparison of treatment strategies, in which MV surgery following unsuccessful in-hospital percutaneous repair was not considered an end point event. In the latter analysis, subsequent surgery within 90 days of the percutaneous procedure was still considered a "success" for the MitraClip.

The composite primary efficacy endpoint was freedom from death, MV surgery for valve dysfunction (for device patients) or re-operation (for surgery patients), and MR greater than 2+ at 12 months.

In the intention-to-treat analysis, the primary composite endpoint was met at 2 years by 52% of the percutaneous group and by 66% of the surgery group; in the 1-year analysis, these figures were 55% and 73%, respectively.

More patients receiving the clip later underwent MV surgery (22%) compared to the few patients in the surgery arm who required re-operation (3.6%). There was no significant difference in mortality or recurrent MR.

In the second analysis, there was no statistical difference in the effectiveness end point between the two arms of the study. "When subsequent surgery within 90 days on device patients is considered a success, we see similarly stable results at 1 and 2 years," he noted.

In this analysis, the primary endpoint was met at 2 years by 63% of the percutaneous group and by 66% of the surgery group. By removing the subsequent need for MV surgery as an end point event, 6.2% of the percutaneous group and 3.6% of the surgery group had MV surgery or re-operation.

There was no difference in the Kaplan-Meier mortality plot for the intention-to-treat analysis at any time point, he stressed. At 1 year, 95% of the patients in each arm were alive; at 2 years, 91% of the surgery arm and 90% of the percutaneous arm were still alive.

The Kaplan-Meier plot for freedom from MV surgery/re-operation, however, favored the surgical arm: 96% versus 78% at 2 years.

The "need for surgery in patients in the clip group was almost entirely in the first several months after therapy, and after 6 months the curves overlapped at 1 and 2 years," he observed. "Importantly, 78% of device patients are free from MV surgery at 2 years."

When these early failures were excluded, there were no differences in need for MV surgery or reoperation.

At a press conference, Dr. Feldman explained that the two analyses "answer different questions." "The intention-to-treat analysis gives the patient the odds of success with the clip at the end of the year," he said. "It tells them that 78% will be free of the need for surgery at 2 years, and 97% will have NYHA functional class I or II."

The second analysis answers the question, ‘What if I am in the 20% needing surgery?’ It counts the combined strategy of the clip, with surgery as needed.

Dr. Feldman reported consulting fees, honoraria and research grants from Abbott Vascular. Dr. Stone reported consulting fees and honoraria from Abbott Vascular and numerous other pharmaceutical and device companies. Dr. Bolling reported no relevant disclosures.

NEW ORLEANS – The durability and safety of treating mitral regurgitation with a percutaneous device as compared with that of surgical repair or replacement persisted at 2 years, based on an updated analysis of the EVEREST II trial results presented April 4 at the annual meeting of the American College of Cardiology.

"Our fundamental finding is that outcomes are very stable between 1 and 2 years of follow-up," Dr. Ted Feldman, principal investigator, announced at a press briefing. "The Kaplan-Meier curves for mortality and re-operation remain literally and completely flat through that time period, and clinical outcomes are durable."

Based on data from the first year of the study, percutaneous repair with the MitraClip was safer than surgery, but surgery yielded more complete reduction in mitral regurgitation (MR). (epub ahead of print, Feldman T et al. N Engl J Med 2011;April 4)

The 2-year follow-up results, presented at the meeting, show both approaches reduced MR, and meaningful clinical benefits persisted, said Dr. Feldman, who is director of the cardiac catheterization laboratory at the NorthShore University HealthSystem in Evanston, Ill.

Clinical outcome measures at 2 years showed MR grade and LV volumes remained stable between 1 and 2 years in both groups. The inter-group comparison showed a more favorable reduction in MR and a greater reduction in LV diastolic volume with surgery at 1 and 2 years, and no difference in systolic volume reduction.

Also, NYHA functional class was stable between years 1 and 2. "Interestingly, the inter-group comparison showed a more favorable NYHA class outcome at both years with the clip," he reported.

The safety profile continued to be favorable, as well. "We saw no percutaneous device embolization; no device fracture, erosion or migration; and no additional occurrence of single leaflet device attachment," he reported.

"Stability is the major message in the examination of 2-year outcomes," Dr. Feldman said. "The randomized trial represents our very early experience with the device. Our procedural rate was 86% in the trial but in the post-randomization registry is in the 96% range. We are certainly going to get better at doing this."

At a panel convened to comment on the study results, Dr. Gregg W. Stone, professor of medicine at New York Presbyterian Hospital and Columbia University, New York, said that the follow-up analysis of EVEREST II is "very well done" and has, "for the most part, shown stability and fairly comparable mortality, though 22% of patients still need surgery if they take the route of the percutaneous option."

Steven F. Bolling, professor of surgery at the University of Michigan, Ann Arbor, maintained that while EVEREST II "suffers a little from awkward analyses," the results are promising, pending the right patient selection and longer follow-up. Patients at high surgical risk and those with cardiomyopathy-associated MR would be the appropriate subset for further study in order to refine the optimal use of the device.

EVEREST II (Endovascular Valve Edge-to-Edge Repair Study) is a prospective, multicenter, randomized controlled phase II trial comparing the safety and efficacy of the MitraClip System with mitral valve surgery in the treatment of MR. The study enrolled 279 patients with 3+ or 4+ MR who were either symptomatic or were asymptomatic with a baseline left ejection fraction of 60%; 27% had functional MR and 73% had degenerative MR. Approximately half of the patients had New York Heart Association (NYHA) functional class III or IV heart failure.

The patients were randomized 2:1 to receive the MitraClip device (n = 184) or mitral valve (MV) repair or replacement (n = 95). Over 90% of the study cohort was available for the 2-year analysis.

Outcomes through 1 year (primary safety and efficacy end points) were recently reported (epub ahead of print, Feldman T et al. N Engl J Med 2011;April 4), showing increased safety with the Mitraclip device compared to surgery, but greater reduction in MR with surgery. At 30 days, major adverse events occurred in 15% of the percutaneous arm versus 48% of the surgical arm. LV function improved in both groups, as did New York Heart Association (NYHA) functional class and quality of life at 1 year.

At the meeting, Dr. Feldman presented two analyses of the 2-year data. The first was an intention-to-treat analysis, in which any MV surgery following percutaneous repair was considered an end point event. The second was a comparison of treatment strategies, in which MV surgery following unsuccessful in-hospital percutaneous repair was not considered an end point event. In the latter analysis, subsequent surgery within 90 days of the percutaneous procedure was still considered a "success" for the MitraClip.

The composite primary efficacy endpoint was freedom from death, MV surgery for valve dysfunction (for device patients) or re-operation (for surgery patients), and MR greater than 2+ at 12 months.

In the intention-to-treat analysis, the primary composite endpoint was met at 2 years by 52% of the percutaneous group and by 66% of the surgery group; in the 1-year analysis, these figures were 55% and 73%, respectively.

More patients receiving the clip later underwent MV surgery (22%) compared to the few patients in the surgery arm who required re-operation (3.6%). There was no significant difference in mortality or recurrent MR.

In the second analysis, there was no statistical difference in the effectiveness end point between the two arms of the study. "When subsequent surgery within 90 days on device patients is considered a success, we see similarly stable results at 1 and 2 years," he noted.

In this analysis, the primary endpoint was met at 2 years by 63% of the percutaneous group and by 66% of the surgery group. By removing the subsequent need for MV surgery as an end point event, 6.2% of the percutaneous group and 3.6% of the surgery group had MV surgery or re-operation.

There was no difference in the Kaplan-Meier mortality plot for the intention-to-treat analysis at any time point, he stressed. At 1 year, 95% of the patients in each arm were alive; at 2 years, 91% of the surgery arm and 90% of the percutaneous arm were still alive.

The Kaplan-Meier plot for freedom from MV surgery/re-operation, however, favored the surgical arm: 96% versus 78% at 2 years.

The "need for surgery in patients in the clip group was almost entirely in the first several months after therapy, and after 6 months the curves overlapped at 1 and 2 years," he observed. "Importantly, 78% of device patients are free from MV surgery at 2 years."

When these early failures were excluded, there were no differences in need for MV surgery or reoperation.

At a press conference, Dr. Feldman explained that the two analyses "answer different questions." "The intention-to-treat analysis gives the patient the odds of success with the clip at the end of the year," he said. "It tells them that 78% will be free of the need for surgery at 2 years, and 97% will have NYHA functional class I or II."

The second analysis answers the question, ‘What if I am in the 20% needing surgery?’ It counts the combined strategy of the clip, with surgery as needed.

Dr. Feldman reported consulting fees, honoraria and research grants from Abbott Vascular. Dr. Stone reported consulting fees and honoraria from Abbott Vascular and numerous other pharmaceutical and device companies. Dr. Bolling reported no relevant disclosures.

NEW ORLEANS – The durability and safety of treating mitral regurgitation with a percutaneous device as compared with that of surgical repair or replacement persisted at 2 years, based on an updated analysis of the EVEREST II trial results presented April 4 at the annual meeting of the American College of Cardiology.

"Our fundamental finding is that outcomes are very stable between 1 and 2 years of follow-up," Dr. Ted Feldman, principal investigator, announced at a press briefing. "The Kaplan-Meier curves for mortality and re-operation remain literally and completely flat through that time period, and clinical outcomes are durable."

Based on data from the first year of the study, percutaneous repair with the MitraClip was safer than surgery, but surgery yielded more complete reduction in mitral regurgitation (MR). (epub ahead of print, Feldman T et al. N Engl J Med 2011;April 4)

The 2-year follow-up results, presented at the meeting, show both approaches reduced MR, and meaningful clinical benefits persisted, said Dr. Feldman, who is director of the cardiac catheterization laboratory at the NorthShore University HealthSystem in Evanston, Ill.

Clinical outcome measures at 2 years showed MR grade and LV volumes remained stable between 1 and 2 years in both groups. The inter-group comparison showed a more favorable reduction in MR and a greater reduction in LV diastolic volume with surgery at 1 and 2 years, and no difference in systolic volume reduction.

Also, NYHA functional class was stable between years 1 and 2. "Interestingly, the inter-group comparison showed a more favorable NYHA class outcome at both years with the clip," he reported.

The safety profile continued to be favorable, as well. "We saw no percutaneous device embolization; no device fracture, erosion or migration; and no additional occurrence of single leaflet device attachment," he reported.

"Stability is the major message in the examination of 2-year outcomes," Dr. Feldman said. "The randomized trial represents our very early experience with the device. Our procedural rate was 86% in the trial but in the post-randomization registry is in the 96% range. We are certainly going to get better at doing this."

At a panel convened to comment on the study results, Dr. Gregg W. Stone, professor of medicine at New York Presbyterian Hospital and Columbia University, New York, said that the follow-up analysis of EVEREST II is "very well done" and has, "for the most part, shown stability and fairly comparable mortality, though 22% of patients still need surgery if they take the route of the percutaneous option."

Steven F. Bolling, professor of surgery at the University of Michigan, Ann Arbor, maintained that while EVEREST II "suffers a little from awkward analyses," the results are promising, pending the right patient selection and longer follow-up. Patients at high surgical risk and those with cardiomyopathy-associated MR would be the appropriate subset for further study in order to refine the optimal use of the device.

EVEREST II (Endovascular Valve Edge-to-Edge Repair Study) is a prospective, multicenter, randomized controlled phase II trial comparing the safety and efficacy of the MitraClip System with mitral valve surgery in the treatment of MR. The study enrolled 279 patients with 3+ or 4+ MR who were either symptomatic or were asymptomatic with a baseline left ejection fraction of 60%; 27% had functional MR and 73% had degenerative MR. Approximately half of the patients had New York Heart Association (NYHA) functional class III or IV heart failure.

The patients were randomized 2:1 to receive the MitraClip device (n = 184) or mitral valve (MV) repair or replacement (n = 95). Over 90% of the study cohort was available for the 2-year analysis.

Outcomes through 1 year (primary safety and efficacy end points) were recently reported (epub ahead of print, Feldman T et al. N Engl J Med 2011;April 4), showing increased safety with the Mitraclip device compared to surgery, but greater reduction in MR with surgery. At 30 days, major adverse events occurred in 15% of the percutaneous arm versus 48% of the surgical arm. LV function improved in both groups, as did New York Heart Association (NYHA) functional class and quality of life at 1 year.

At the meeting, Dr. Feldman presented two analyses of the 2-year data. The first was an intention-to-treat analysis, in which any MV surgery following percutaneous repair was considered an end point event. The second was a comparison of treatment strategies, in which MV surgery following unsuccessful in-hospital percutaneous repair was not considered an end point event. In the latter analysis, subsequent surgery within 90 days of the percutaneous procedure was still considered a "success" for the MitraClip.

The composite primary efficacy endpoint was freedom from death, MV surgery for valve dysfunction (for device patients) or re-operation (for surgery patients), and MR greater than 2+ at 12 months.

In the intention-to-treat analysis, the primary composite endpoint was met at 2 years by 52% of the percutaneous group and by 66% of the surgery group; in the 1-year analysis, these figures were 55% and 73%, respectively.

More patients receiving the clip later underwent MV surgery (22%) compared to the few patients in the surgery arm who required re-operation (3.6%). There was no significant difference in mortality or recurrent MR.

In the second analysis, there was no statistical difference in the effectiveness end point between the two arms of the study. "When subsequent surgery within 90 days on device patients is considered a success, we see similarly stable results at 1 and 2 years," he noted.

In this analysis, the primary endpoint was met at 2 years by 63% of the percutaneous group and by 66% of the surgery group. By removing the subsequent need for MV surgery as an end point event, 6.2% of the percutaneous group and 3.6% of the surgery group had MV surgery or re-operation.

There was no difference in the Kaplan-Meier mortality plot for the intention-to-treat analysis at any time point, he stressed. At 1 year, 95% of the patients in each arm were alive; at 2 years, 91% of the surgery arm and 90% of the percutaneous arm were still alive.

The Kaplan-Meier plot for freedom from MV surgery/re-operation, however, favored the surgical arm: 96% versus 78% at 2 years.

The "need for surgery in patients in the clip group was almost entirely in the first several months after therapy, and after 6 months the curves overlapped at 1 and 2 years," he observed. "Importantly, 78% of device patients are free from MV surgery at 2 years."

When these early failures were excluded, there were no differences in need for MV surgery or reoperation.

At a press conference, Dr. Feldman explained that the two analyses "answer different questions." "The intention-to-treat analysis gives the patient the odds of success with the clip at the end of the year," he said. "It tells them that 78% will be free of the need for surgery at 2 years, and 97% will have NYHA functional class I or II."

The second analysis answers the question, ‘What if I am in the 20% needing surgery?’ It counts the combined strategy of the clip, with surgery as needed.

Dr. Feldman reported consulting fees, honoraria and research grants from Abbott Vascular. Dr. Stone reported consulting fees and honoraria from Abbott Vascular and numerous other pharmaceutical and device companies. Dr. Bolling reported no relevant disclosures.

NEW ORLEANS – Transcatheter aortic valve replacement was associated with the same survival rates at 1 year as was conventional surgery in older, high-risk patients with severe, symptomatic aortic stenosis in the PARTNER trial.

All-cause mortality at 30 days favored transcatheter aortic valve replacement (TAVR) at 3.4%, compared with 6.5% for open surgery, and was similar at 1 year (24% and 27%, respectively). The difference at 1 year reached the trial’s prespecified noninferiority margin with a P value of .001.

"We already learned from the previous cohort that TAVR is the standard of care for patients who can’t tolerate surgery. So this [finding] opens up a new set of patients who may very well benefit as much with TAVR as with the gold standard surgery," coprincipal investigator Dr. Craig B. Smith said at the annual meeting of the American College of Cardiology.

The stroke rate with TAVR in the industry-sponsored PARTNER (Placement of Aortic Transcatheter Valve) trial, however, was associated with a stroke rate that was twice the rate observed with surgery.

Stroke plus transient ischemic attack (TIA) rates were significantly more frequent with TAVR than surgery at both 30 days (5.5% vs. 2.4%) and 1 year (8.3% vs. 4.3%). When only major strokes were compared, the difference was not significant between TAVR and surgery at 30 days (3.8% vs. 2.1%) or 1 year (5.1% vs. 2.4%), said Dr. Smith, chief of cardiothoracic surgery at New York–Presbyterian Hospital/Columbia University Medical Center in New York City.

Notably, patients who underwent conventional surgery were significantly more likely than TAVR patients to experience major bleeding at 30 days (19.5% vs. 9.3%) and 1 year (26% vs. 15%), as well as new atrial fibrillation at both 30 days (16% vs. 8.6%) and 1 year (17% vs. 12%).

Echocardiographic findings indicated a small hemodynamic benefit with TAVR vs. surgery at 1 year, but significantly increased paravalvular aortic regurgitation at 30 days, 6 months, and 1 year.

"TAVR and AVR [aortic valve replacement] are both acceptable therapies in these high-risk patients; differing periprocedural hazards should influence case-based decision making," Dr. Smith said.

Dr. David Moliterno, chair of the intervention program (i2 Summit) at the meeting, told reporters that they were witnessing history in the making.

"This will probably be seen as one of the biggest steps in cardiovascular medicine, as far as intervention is concerned, potentially in our lifetime," said Dr. Moliterno, chief of cardiovascular medicine at the University of Kentucky, Lexington. "If we look back to balloon angioplasty, the advent of stents and drug-eluting stents, ... this will be seen as the next major turning point."

Last year, the PARTNER trial investigators reported a 20% survival benefit at 1 year in a separate cohort of 358 inoperable patients with severe aortic stenosis who underwent transfemoral TAVR vs. standard therapy, including balloon aortic valvuloplasty (N. Engl. J. Med. 2010;363:1597-607). TAVR was associated with significantly more major vascular complications (16% vs. 1%) and a higher incidence of major strokes (5% vs. 1%).

The current portion of PARTNER randomly assigned 699 patients at 26 centers to surgery or TAVR, using the transfemoral approach in 492 patients and the transapical approach in 207.

Severe stenosis was defined as an aortic valve area of less than 0.8 cm² and mean aortic valve gradient of more than 40 mm Hg or a peak aortic jet velocity of more than 4.0 m/second. The patients had a New York Heart Association heart failure class II or greater, and had a predicted risk of operative mortality of at least 15% as determined by the site surgeon and cardiologist, coupled with a Society of Thoracic Surgery score of at least 10.

Their mean age was 83 years, and 94% were NYHA class III or IV. In all, 42 patients were not treated as assigned, Dr. Smith said.

All-cause mortality at 1 year was similar for the transfemoral TAVR subgroup, at 22.2% and 26.4% for surgery, as well as for the transapical TAVR subgroup (29% vs. 28%, respectively).

A preliminary subgroup analysis suggests that there may be a possible benefit with TAVR in women and patients without prior coronary artery bypass surgery, but Dr. Smith said that those results should be interpreted cautiously.

Overall, the TAVR mortality of 3.4% at 30-days was the lowest reported in any series, despite the use of an early-generation device and limited previous operator experience, he said, noting that nine of the participating centers had never performed TAVR before the trial.

Symptom improvement, including NYHA class and 6-minute walk distance, favored TAVR at 30 days and was similar to conventional surgery at 1 year, he said.

Coinvestigator Dr. Murat Tuzcu, vice chair of the department of cardiovascular medicine at the Cleveland Clinic, stressed that the results were accomplished only through unprecedented teamwork among cardiologists, surgeons, and imaging experts, who consulted on each case in the trial.

"I want to emphasize that if we fail to pay equal attention to what we have done in this trial after the device is approved, I don’t think we will be able to replicate the same results," he said.

Several speakers at the press conference noted the balancing act that all clinicians will face regarding public demand for the new procedure.

Dr. Michael Crawford, chief of clinical cardiology at the University of California, San Francisco, observed that centers will face substantial up-front costs in the adoption of TAVR, including hybrid surgical/interventional suites, and that this will restrict initial uptake to high-volume centers of excellence.

The 3.4% mortality rate represents an "amazing effort," particularly in the use of the larger, first-generation device, said invited discussant Dr. Martyn Thomas, clinical director of cardiothoracic services at St. Thomas’ Hospital, London. The delivery catheters used in PARTNER are sized at 22 and 24 French, which corresponds to an outside diameter of 7-8 mm. The size of catheters is down to 16-Fr in Europe, where more than 5,000 TAVR procedures have been done and where both the Edwards Lifesciences Corp.’s Sapien valve that was used in PARTNER and the Medtronic Inc.’s CoreValve are already on the market.

Recruitment began in February for the PARTNER II trial that evaluated the smaller Edwards Sapien XT device and the later generation NovaFlex delivery system among inoperable patients with symptomatic severe aortic stenosis. The trial is expected to enroll 600 patients, and is targeted for primary completion in December 2011.

When asked whether the advent of newer, thinner devices will mean adoption in patients with lower risk, Dr. Smith replied that the adoption of TAVR will "march steadily down the risk categories."

Edwards Lifesciences sponsored the trial. Dr. Smith and his coauthors reported no conflicts of interest.

NEW ORLEANS – Transcatheter aortic valve replacement was associated with the same survival rates at 1 year as was conventional surgery in older, high-risk patients with severe, symptomatic aortic stenosis in the PARTNER trial.

All-cause mortality at 30 days favored transcatheter aortic valve replacement (TAVR) at 3.4%, compared with 6.5% for open surgery, and was similar at 1 year (24% and 27%, respectively). The difference at 1 year reached the trial’s prespecified noninferiority margin with a P value of .001.

"We already learned from the previous cohort that TAVR is the standard of care for patients who can’t tolerate surgery. So this [finding] opens up a new set of patients who may very well benefit as much with TAVR as with the gold standard surgery," coprincipal investigator Dr. Craig B. Smith said at the annual meeting of the American College of Cardiology.

The stroke rate with TAVR in the industry-sponsored PARTNER (Placement of Aortic Transcatheter Valve) trial, however, was associated with a stroke rate that was twice the rate observed with surgery.

Stroke plus transient ischemic attack (TIA) rates were significantly more frequent with TAVR than surgery at both 30 days (5.5% vs. 2.4%) and 1 year (8.3% vs. 4.3%). When only major strokes were compared, the difference was not significant between TAVR and surgery at 30 days (3.8% vs. 2.1%) or 1 year (5.1% vs. 2.4%), said Dr. Smith, chief of cardiothoracic surgery at New York–Presbyterian Hospital/Columbia University Medical Center in New York City.

Notably, patients who underwent conventional surgery were significantly more likely than TAVR patients to experience major bleeding at 30 days (19.5% vs. 9.3%) and 1 year (26% vs. 15%), as well as new atrial fibrillation at both 30 days (16% vs. 8.6%) and 1 year (17% vs. 12%).

Echocardiographic findings indicated a small hemodynamic benefit with TAVR vs. surgery at 1 year, but significantly increased paravalvular aortic regurgitation at 30 days, 6 months, and 1 year.

"TAVR and AVR [aortic valve replacement] are both acceptable therapies in these high-risk patients; differing periprocedural hazards should influence case-based decision making," Dr. Smith said.

Dr. David Moliterno, chair of the intervention program (i2 Summit) at the meeting, told reporters that they were witnessing history in the making.

"This will probably be seen as one of the biggest steps in cardiovascular medicine, as far as intervention is concerned, potentially in our lifetime," said Dr. Moliterno, chief of cardiovascular medicine at the University of Kentucky, Lexington. "If we look back to balloon angioplasty, the advent of stents and drug-eluting stents, ... this will be seen as the next major turning point."

Last year, the PARTNER trial investigators reported a 20% survival benefit at 1 year in a separate cohort of 358 inoperable patients with severe aortic stenosis who underwent transfemoral TAVR vs. standard therapy, including balloon aortic valvuloplasty (N. Engl. J. Med. 2010;363:1597-607). TAVR was associated with significantly more major vascular complications (16% vs. 1%) and a higher incidence of major strokes (5% vs. 1%).

The current portion of PARTNER randomly assigned 699 patients at 26 centers to surgery or TAVR, using the transfemoral approach in 492 patients and the transapical approach in 207.

Severe stenosis was defined as an aortic valve area of less than 0.8 cm² and mean aortic valve gradient of more than 40 mm Hg or a peak aortic jet velocity of more than 4.0 m/second. The patients had a New York Heart Association heart failure class II or greater, and had a predicted risk of operative mortality of at least 15% as determined by the site surgeon and cardiologist, coupled with a Society of Thoracic Surgery score of at least 10.

Their mean age was 83 years, and 94% were NYHA class III or IV. In all, 42 patients were not treated as assigned, Dr. Smith said.

All-cause mortality at 1 year was similar for the transfemoral TAVR subgroup, at 22.2% and 26.4% for surgery, as well as for the transapical TAVR subgroup (29% vs. 28%, respectively).

A preliminary subgroup analysis suggests that there may be a possible benefit with TAVR in women and patients without prior coronary artery bypass surgery, but Dr. Smith said that those results should be interpreted cautiously.

Overall, the TAVR mortality of 3.4% at 30-days was the lowest reported in any series, despite the use of an early-generation device and limited previous operator experience, he said, noting that nine of the participating centers had never performed TAVR before the trial.

Symptom improvement, including NYHA class and 6-minute walk distance, favored TAVR at 30 days and was similar to conventional surgery at 1 year, he said.

Coinvestigator Dr. Murat Tuzcu, vice chair of the department of cardiovascular medicine at the Cleveland Clinic, stressed that the results were accomplished only through unprecedented teamwork among cardiologists, surgeons, and imaging experts, who consulted on each case in the trial.

"I want to emphasize that if we fail to pay equal attention to what we have done in this trial after the device is approved, I don’t think we will be able to replicate the same results," he said.

Several speakers at the press conference noted the balancing act that all clinicians will face regarding public demand for the new procedure.

Dr. Michael Crawford, chief of clinical cardiology at the University of California, San Francisco, observed that centers will face substantial up-front costs in the adoption of TAVR, including hybrid surgical/interventional suites, and that this will restrict initial uptake to high-volume centers of excellence.

The 3.4% mortality rate represents an "amazing effort," particularly in the use of the larger, first-generation device, said invited discussant Dr. Martyn Thomas, clinical director of cardiothoracic services at St. Thomas’ Hospital, London. The delivery catheters used in PARTNER are sized at 22 and 24 French, which corresponds to an outside diameter of 7-8 mm. The size of catheters is down to 16-Fr in Europe, where more than 5,000 TAVR procedures have been done and where both the Edwards Lifesciences Corp.’s Sapien valve that was used in PARTNER and the Medtronic Inc.’s CoreValve are already on the market.

Recruitment began in February for the PARTNER II trial that evaluated the smaller Edwards Sapien XT device and the later generation NovaFlex delivery system among inoperable patients with symptomatic severe aortic stenosis. The trial is expected to enroll 600 patients, and is targeted for primary completion in December 2011.

When asked whether the advent of newer, thinner devices will mean adoption in patients with lower risk, Dr. Smith replied that the adoption of TAVR will "march steadily down the risk categories."

Edwards Lifesciences sponsored the trial. Dr. Smith and his coauthors reported no conflicts of interest.

NEW ORLEANS – Transcatheter aortic valve replacement was associated with the same survival rates at 1 year as was conventional surgery in older, high-risk patients with severe, symptomatic aortic stenosis in the PARTNER trial.

All-cause mortality at 30 days favored transcatheter aortic valve replacement (TAVR) at 3.4%, compared with 6.5% for open surgery, and was similar at 1 year (24% and 27%, respectively). The difference at 1 year reached the trial’s prespecified noninferiority margin with a P value of .001.

"We already learned from the previous cohort that TAVR is the standard of care for patients who can’t tolerate surgery. So this [finding] opens up a new set of patients who may very well benefit as much with TAVR as with the gold standard surgery," coprincipal investigator Dr. Craig B. Smith said at the annual meeting of the American College of Cardiology.

The stroke rate with TAVR in the industry-sponsored PARTNER (Placement of Aortic Transcatheter Valve) trial, however, was associated with a stroke rate that was twice the rate observed with surgery.

Stroke plus transient ischemic attack (TIA) rates were significantly more frequent with TAVR than surgery at both 30 days (5.5% vs. 2.4%) and 1 year (8.3% vs. 4.3%). When only major strokes were compared, the difference was not significant between TAVR and surgery at 30 days (3.8% vs. 2.1%) or 1 year (5.1% vs. 2.4%), said Dr. Smith, chief of cardiothoracic surgery at New York–Presbyterian Hospital/Columbia University Medical Center in New York City.

Notably, patients who underwent conventional surgery were significantly more likely than TAVR patients to experience major bleeding at 30 days (19.5% vs. 9.3%) and 1 year (26% vs. 15%), as well as new atrial fibrillation at both 30 days (16% vs. 8.6%) and 1 year (17% vs. 12%).

Echocardiographic findings indicated a small hemodynamic benefit with TAVR vs. surgery at 1 year, but significantly increased paravalvular aortic regurgitation at 30 days, 6 months, and 1 year.

"TAVR and AVR [aortic valve replacement] are both acceptable therapies in these high-risk patients; differing periprocedural hazards should influence case-based decision making," Dr. Smith said.

Dr. David Moliterno, chair of the intervention program (i2 Summit) at the meeting, told reporters that they were witnessing history in the making.

"This will probably be seen as one of the biggest steps in cardiovascular medicine, as far as intervention is concerned, potentially in our lifetime," said Dr. Moliterno, chief of cardiovascular medicine at the University of Kentucky, Lexington. "If we look back to balloon angioplasty, the advent of stents and drug-eluting stents, ... this will be seen as the next major turning point."

Last year, the PARTNER trial investigators reported a 20% survival benefit at 1 year in a separate cohort of 358 inoperable patients with severe aortic stenosis who underwent transfemoral TAVR vs. standard therapy, including balloon aortic valvuloplasty (N. Engl. J. Med. 2010;363:1597-607). TAVR was associated with significantly more major vascular complications (16% vs. 1%) and a higher incidence of major strokes (5% vs. 1%).

The current portion of PARTNER randomly assigned 699 patients at 26 centers to surgery or TAVR, using the transfemoral approach in 492 patients and the transapical approach in 207.

Severe stenosis was defined as an aortic valve area of less than 0.8 cm² and mean aortic valve gradient of more than 40 mm Hg or a peak aortic jet velocity of more than 4.0 m/second. The patients had a New York Heart Association heart failure class II or greater, and had a predicted risk of operative mortality of at least 15% as determined by the site surgeon and cardiologist, coupled with a Society of Thoracic Surgery score of at least 10.

Their mean age was 83 years, and 94% were NYHA class III or IV. In all, 42 patients were not treated as assigned, Dr. Smith said.

All-cause mortality at 1 year was similar for the transfemoral TAVR subgroup, at 22.2% and 26.4% for surgery, as well as for the transapical TAVR subgroup (29% vs. 28%, respectively).

A preliminary subgroup analysis suggests that there may be a possible benefit with TAVR in women and patients without prior coronary artery bypass surgery, but Dr. Smith said that those results should be interpreted cautiously.

Overall, the TAVR mortality of 3.4% at 30-days was the lowest reported in any series, despite the use of an early-generation device and limited previous operator experience, he said, noting that nine of the participating centers had never performed TAVR before the trial.

Symptom improvement, including NYHA class and 6-minute walk distance, favored TAVR at 30 days and was similar to conventional surgery at 1 year, he said.

Coinvestigator Dr. Murat Tuzcu, vice chair of the department of cardiovascular medicine at the Cleveland Clinic, stressed that the results were accomplished only through unprecedented teamwork among cardiologists, surgeons, and imaging experts, who consulted on each case in the trial.

"I want to emphasize that if we fail to pay equal attention to what we have done in this trial after the device is approved, I don’t think we will be able to replicate the same results," he said.

Several speakers at the press conference noted the balancing act that all clinicians will face regarding public demand for the new procedure.

Dr. Michael Crawford, chief of clinical cardiology at the University of California, San Francisco, observed that centers will face substantial up-front costs in the adoption of TAVR, including hybrid surgical/interventional suites, and that this will restrict initial uptake to high-volume centers of excellence.

The 3.4% mortality rate represents an "amazing effort," particularly in the use of the larger, first-generation device, said invited discussant Dr. Martyn Thomas, clinical director of cardiothoracic services at St. Thomas’ Hospital, London. The delivery catheters used in PARTNER are sized at 22 and 24 French, which corresponds to an outside diameter of 7-8 mm. The size of catheters is down to 16-Fr in Europe, where more than 5,000 TAVR procedures have been done and where both the Edwards Lifesciences Corp.’s Sapien valve that was used in PARTNER and the Medtronic Inc.’s CoreValve are already on the market.

Recruitment began in February for the PARTNER II trial that evaluated the smaller Edwards Sapien XT device and the later generation NovaFlex delivery system among inoperable patients with symptomatic severe aortic stenosis. The trial is expected to enroll 600 patients, and is targeted for primary completion in December 2011.

When asked whether the advent of newer, thinner devices will mean adoption in patients with lower risk, Dr. Smith replied that the adoption of TAVR will "march steadily down the risk categories."

Edwards Lifesciences sponsored the trial. Dr. Smith and his coauthors reported no conflicts of interest.

NEW ORLEANS – Transcatheter aortic valve replacement was associated with the same survival rates at 1 year as was conventional surgery in older, high-risk patients with severe, symptomatic aortic stenosis in the PARTNER trial.

All-cause mortality at 30 days favored transcatheter aortic valve replacement (TAVR) at 3.4%, compared with 6.5% for open surgery, and was similar at 1 year (24% and 27%, respectively). The difference at 1 year reached the trial’s prespecified noninferiority margin with a P value of .001.

"We already learned from the previous cohort that TAVR is the standard of care for patients who can’t tolerate surgery. So this [finding] opens up a new set of patients who may very well benefit as much with TAVR as with the gold standard surgery," coprincipal investigator Dr. Craig B. Smith said at the annual meeting of the American College of Cardiology.

The stroke rate with TAVR in the industry-sponsored PARTNER (Placement of Aortic Transcatheter Valve) trial, however, was associated with a stroke rate that was twice the rate observed with surgery.

Stroke plus transient ischemic attack (TIA) rates were significantly more frequent with TAVR than surgery at both 30 days (5.5% vs. 2.4%) and 1 year (8.3% vs. 4.3%). When only major strokes were compared, the difference was not significant between TAVR and surgery at 30 days (3.8% vs. 2.1%) or 1 year (5.1% vs. 2.4%), said Dr. Smith, chief of cardiothoracic surgery at New York–Presbyterian Hospital/Columbia University Medical Center in New York City.

Notably, patients who underwent conventional surgery were significantly more likely than TAVR patients to experience major bleeding at 30 days (19.5% vs. 9.3%) and 1 year (26% vs. 15%), as well as new atrial fibrillation at both 30 days (16% vs. 8.6%) and 1 year (17% vs. 12%).

Echocardiographic findings indicated a small hemodynamic benefit with TAVR vs. surgery at 1 year, but significantly increased paravalvular aortic regurgitation at 30 days, 6 months, and 1 year.

"TAVR and AVR [aortic valve replacement] are both acceptable therapies in these high-risk patients; differing periprocedural hazards should influence case-based decision making," Dr. Smith said.

Dr. David Moliterno, chair of the intervention program (i2 Summit) at the meeting, told reporters that they were witnessing history in the making.

"This will probably be seen as one of the biggest steps in cardiovascular medicine, as far as intervention is concerned, potentially in our lifetime," said Dr. Moliterno, chief of cardiovascular medicine at the University of Kentucky, Lexington. "If we look back to balloon angioplasty, the advent of stents and drug-eluting stents, ... this will be seen as the next major turning point."

Last year, the PARTNER trial investigators reported a 20% survival benefit at 1 year in a separate cohort of 358 inoperable patients with severe aortic stenosis who underwent transfemoral TAVR vs. standard therapy, including balloon aortic valvuloplasty (N. Engl. J. Med. 2010;363:1597-607). TAVR was associated with significantly more major vascular complications (16% vs. 1%) and a higher incidence of major strokes (5% vs. 1%).

The current portion of PARTNER randomly assigned 699 patients at 26 centers to surgery or TAVR, using the transfemoral approach in 492 patients and the transapical approach in 207.

Severe stenosis was defined as an aortic valve area of less than 0.8 cm² and mean aortic valve gradient of more than 40 mm Hg or a peak aortic jet velocity of more than 4.0 m/second. The patients had a New York Heart Association heart failure class II or greater, and had a predicted risk of operative mortality of at least 15% as determined by the site surgeon and cardiologist, coupled with a Society of Thoracic Surgery score of at least 10.

Their mean age was 83 years, and 94% were NYHA class III or IV. In all, 42 patients were not treated as assigned, Dr. Smith said.

All-cause mortality at 1 year was similar for the transfemoral TAVR subgroup, at 22.2% and 26.4% for surgery, as well as for the transapical TAVR subgroup (29% vs. 28%, respectively).

A preliminary subgroup analysis suggests that there may be a possible benefit with TAVR in women and patients without prior coronary artery bypass surgery, but Dr. Smith said that those results should be interpreted cautiously.

Overall, the TAVR mortality of 3.4% at 30-days was the lowest reported in any series, despite the use of an early-generation device and limited previous operator experience, he said, noting that nine of the participating centers had never performed TAVR before the trial.

Symptom improvement, including NYHA class and 6-minute walk distance, favored TAVR at 30 days and was similar to conventional surgery at 1 year, he said.

Coinvestigator Dr. Murat Tuzcu, vice chair of the department of cardiovascular medicine at the Cleveland Clinic, stressed that the results were accomplished only through unprecedented teamwork among cardiologists, surgeons, and imaging experts, who consulted on each case in the trial.

"I want to emphasize that if we fail to pay equal attention to what we have done in this trial after the device is approved, I don’t think we will be able to replicate the same results," he said.

Several speakers at the press conference noted the balancing act that all clinicians will face regarding public demand for the new procedure.

Dr. Michael Crawford, chief of clinical cardiology at the University of California, San Francisco, observed that centers will face substantial up-front costs in the adoption of TAVR, including hybrid surgical/interventional suites, and that this will restrict initial uptake to high-volume centers of excellence.

The 3.4% mortality rate represents an "amazing effort," particularly in the use of the larger, first-generation device, said invited discussant Dr. Martyn Thomas, clinical director of cardiothoracic services at St. Thomas’ Hospital, London. The delivery catheters used in PARTNER are sized at 22 and 24 French, which corresponds to an outside diameter of 7-8 mm. The size of catheters is down to 16-Fr in Europe, where more than 5,000 TAVR procedures have been done and where both the Edwards Lifesciences Corp.’s Sapien valve that was used in PARTNER and the Medtronic Inc.’s CoreValve are already on the market.

Recruitment began in February for the PARTNER II trial that evaluated the smaller Edwards Sapien XT device and the later generation NovaFlex delivery system among inoperable patients with symptomatic severe aortic stenosis. The trial is expected to enroll 600 patients, and is targeted for primary completion in December 2011.

When asked whether the advent of newer, thinner devices will mean adoption in patients with lower risk, Dr. Smith replied that the adoption of TAVR will "march steadily down the risk categories."

Edwards Lifesciences sponsored the trial. Dr. Smith and his coauthors reported no conflicts of interest.

NEW ORLEANS – Transcatheter aortic valve replacement was associated with the same survival rates at 1 year as was conventional surgery in older, high-risk patients with severe, symptomatic aortic stenosis in the PARTNER trial.

All-cause mortality at 30 days favored transcatheter aortic valve replacement (TAVR) at 3.4%, compared with 6.5% for open surgery, and was similar at 1 year (24% and 27%, respectively). The difference at 1 year reached the trial’s prespecified noninferiority margin with a P value of .001.

"We already learned from the previous cohort that TAVR is the standard of care for patients who can’t tolerate surgery. So this [finding] opens up a new set of patients who may very well benefit as much with TAVR as with the gold standard surgery," coprincipal investigator Dr. Craig B. Smith said at the annual meeting of the American College of Cardiology.

The stroke rate with TAVR in the industry-sponsored PARTNER (Placement of Aortic Transcatheter Valve) trial, however, was associated with a stroke rate that was twice the rate observed with surgery.

Stroke plus transient ischemic attack (TIA) rates were significantly more frequent with TAVR than surgery at both 30 days (5.5% vs. 2.4%) and 1 year (8.3% vs. 4.3%). When only major strokes were compared, the difference was not significant between TAVR and surgery at 30 days (3.8% vs. 2.1%) or 1 year (5.1% vs. 2.4%), said Dr. Smith, chief of cardiothoracic surgery at New York–Presbyterian Hospital/Columbia University Medical Center in New York City.

Notably, patients who underwent conventional surgery were significantly more likely than TAVR patients to experience major bleeding at 30 days (19.5% vs. 9.3%) and 1 year (26% vs. 15%), as well as new atrial fibrillation at both 30 days (16% vs. 8.6%) and 1 year (17% vs. 12%).

Echocardiographic findings indicated a small hemodynamic benefit with TAVR vs. surgery at 1 year, but significantly increased paravalvular aortic regurgitation at 30 days, 6 months, and 1 year.

"TAVR and AVR [aortic valve replacement] are both acceptable therapies in these high-risk patients; differing periprocedural hazards should influence case-based decision making," Dr. Smith said.

Dr. David Moliterno, chair of the intervention program (i2 Summit) at the meeting, told reporters that they were witnessing history in the making.

"This will probably be seen as one of the biggest steps in cardiovascular medicine, as far as intervention is concerned, potentially in our lifetime," said Dr. Moliterno, chief of cardiovascular medicine at the University of Kentucky, Lexington. "If we look back to balloon angioplasty, the advent of stents and drug-eluting stents, ... this will be seen as the next major turning point."

Last year, the PARTNER trial investigators reported a 20% survival benefit at 1 year in a separate cohort of 358 inoperable patients with severe aortic stenosis who underwent transfemoral TAVR vs. standard therapy, including balloon aortic valvuloplasty (N. Engl. J. Med. 2010;363:1597-607). TAVR was associated with significantly more major vascular complications (16% vs. 1%) and a higher incidence of major strokes (5% vs. 1%).

The current portion of PARTNER randomly assigned 699 patients at 26 centers to surgery or TAVR, using the transfemoral approach in 492 patients and the transapical approach in 207.

Severe stenosis was defined as an aortic valve area of less than 0.8 cm² and mean aortic valve gradient of more than 40 mm Hg or a peak aortic jet velocity of more than 4.0 m/second. The patients had a New York Heart Association heart failure class II or greater, and had a predicted risk of operative mortality of at least 15% as determined by the site surgeon and cardiologist, coupled with a Society of Thoracic Surgery score of at least 10.

Their mean age was 83 years, and 94% were NYHA class III or IV. In all, 42 patients were not treated as assigned, Dr. Smith said.

All-cause mortality at 1 year was similar for the transfemoral TAVR subgroup, at 22.2% and 26.4% for surgery, as well as for the transapical TAVR subgroup (29% vs. 28%, respectively).

A preliminary subgroup analysis suggests that there may be a possible benefit with TAVR in women and patients without prior coronary artery bypass surgery, but Dr. Smith said that those results should be interpreted cautiously.

Overall, the TAVR mortality of 3.4% at 30-days was the lowest reported in any series, despite the use of an early-generation device and limited previous operator experience, he said, noting that nine of the participating centers had never performed TAVR before the trial.

Symptom improvement, including NYHA class and 6-minute walk distance, favored TAVR at 30 days and was similar to conventional surgery at 1 year, he said.

Coinvestigator Dr. Murat Tuzcu, vice chair of the department of cardiovascular medicine at the Cleveland Clinic, stressed that the results were accomplished only through unprecedented teamwork among cardiologists, surgeons, and imaging experts, who consulted on each case in the trial.

"I want to emphasize that if we fail to pay equal attention to what we have done in this trial after the device is approved, I don’t think we will be able to replicate the same results," he said.

Several speakers at the press conference noted the balancing act that all clinicians will face regarding public demand for the new procedure.

Dr. Michael Crawford, chief of clinical cardiology at the University of California, San Francisco, observed that centers will face substantial up-front costs in the adoption of TAVR, including hybrid surgical/interventional suites, and that this will restrict initial uptake to high-volume centers of excellence.

The 3.4% mortality rate represents an "amazing effort," particularly in the use of the larger, first-generation device, said invited discussant Dr. Martyn Thomas, clinical director of cardiothoracic services at St. Thomas’ Hospital, London. The delivery catheters used in PARTNER are sized at 22 and 24 French, which corresponds to an outside diameter of 7-8 mm. The size of catheters is down to 16-Fr in Europe, where more than 5,000 TAVR procedures have been done and where both the Edwards Lifesciences Corp.’s Sapien valve that was used in PARTNER and the Medtronic Inc.’s CoreValve are already on the market.

Recruitment began in February for the PARTNER II trial that evaluated the smaller Edwards Sapien XT device and the later generation NovaFlex delivery system among inoperable patients with symptomatic severe aortic stenosis. The trial is expected to enroll 600 patients, and is targeted for primary completion in December 2011.

When asked whether the advent of newer, thinner devices will mean adoption in patients with lower risk, Dr. Smith replied that the adoption of TAVR will "march steadily down the risk categories."

Edwards Lifesciences sponsored the trial. Dr. Smith and his coauthors reported no conflicts of interest.

NEW ORLEANS – Transcatheter aortic valve replacement was associated with the same survival rates at 1 year as was conventional surgery in older, high-risk patients with severe, symptomatic aortic stenosis in the PARTNER trial.

All-cause mortality at 30 days favored transcatheter aortic valve replacement (TAVR) at 3.4%, compared with 6.5% for open surgery, and was similar at 1 year (24% and 27%, respectively). The difference at 1 year reached the trial’s prespecified noninferiority margin with a P value of .001.

"We already learned from the previous cohort that TAVR is the standard of care for patients who can’t tolerate surgery. So this [finding] opens up a new set of patients who may very well benefit as much with TAVR as with the gold standard surgery," coprincipal investigator Dr. Craig B. Smith said at the annual meeting of the American College of Cardiology.

The stroke rate with TAVR in the industry-sponsored PARTNER (Placement of Aortic Transcatheter Valve) trial, however, was associated with a stroke rate that was twice the rate observed with surgery.

Stroke plus transient ischemic attack (TIA) rates were significantly more frequent with TAVR than surgery at both 30 days (5.5% vs. 2.4%) and 1 year (8.3% vs. 4.3%). When only major strokes were compared, the difference was not significant between TAVR and surgery at 30 days (3.8% vs. 2.1%) or 1 year (5.1% vs. 2.4%), said Dr. Smith, chief of cardiothoracic surgery at New York–Presbyterian Hospital/Columbia University Medical Center in New York City.

Notably, patients who underwent conventional surgery were significantly more likely than TAVR patients to experience major bleeding at 30 days (19.5% vs. 9.3%) and 1 year (26% vs. 15%), as well as new atrial fibrillation at both 30 days (16% vs. 8.6%) and 1 year (17% vs. 12%).

Echocardiographic findings indicated a small hemodynamic benefit with TAVR vs. surgery at 1 year, but significantly increased paravalvular aortic regurgitation at 30 days, 6 months, and 1 year.

"TAVR and AVR [aortic valve replacement] are both acceptable therapies in these high-risk patients; differing periprocedural hazards should influence case-based decision making," Dr. Smith said.

Dr. David Moliterno, chair of the intervention program (i2 Summit) at the meeting, told reporters that they were witnessing history in the making.

"This will probably be seen as one of the biggest steps in cardiovascular medicine, as far as intervention is concerned, potentially in our lifetime," said Dr. Moliterno, chief of cardiovascular medicine at the University of Kentucky, Lexington. "If we look back to balloon angioplasty, the advent of stents and drug-eluting stents, ... this will be seen as the next major turning point."

Last year, the PARTNER trial investigators reported a 20% survival benefit at 1 year in a separate cohort of 358 inoperable patients with severe aortic stenosis who underwent transfemoral TAVR vs. standard therapy, including balloon aortic valvuloplasty (N. Engl. J. Med. 2010;363:1597-607). TAVR was associated with significantly more major vascular complications (16% vs. 1%) and a higher incidence of major strokes (5% vs. 1%).

The current portion of PARTNER randomly assigned 699 patients at 26 centers to surgery or TAVR, using the transfemoral approach in 492 patients and the transapical approach in 207.

Severe stenosis was defined as an aortic valve area of less than 0.8 cm² and mean aortic valve gradient of more than 40 mm Hg or a peak aortic jet velocity of more than 4.0 m/second. The patients had a New York Heart Association heart failure class II or greater, and had a predicted risk of operative mortality of at least 15% as determined by the site surgeon and cardiologist, coupled with a Society of Thoracic Surgery score of at least 10.

Their mean age was 83 years, and 94% were NYHA class III or IV. In all, 42 patients were not treated as assigned, Dr. Smith said.

All-cause mortality at 1 year was similar for the transfemoral TAVR subgroup, at 22.2% and 26.4% for surgery, as well as for the transapical TAVR subgroup (29% vs. 28%, respectively).

A preliminary subgroup analysis suggests that there may be a possible benefit with TAVR in women and patients without prior coronary artery bypass surgery, but Dr. Smith said that those results should be interpreted cautiously.

Overall, the TAVR mortality of 3.4% at 30-days was the lowest reported in any series, despite the use of an early-generation device and limited previous operator experience, he said, noting that nine of the participating centers had never performed TAVR before the trial.

Symptom improvement, including NYHA class and 6-minute walk distance, favored TAVR at 30 days and was similar to conventional surgery at 1 year, he said.

Coinvestigator Dr. Murat Tuzcu, vice chair of the department of cardiovascular medicine at the Cleveland Clinic, stressed that the results were accomplished only through unprecedented teamwork among cardiologists, surgeons, and imaging experts, who consulted on each case in the trial.

"I want to emphasize that if we fail to pay equal attention to what we have done in this trial after the device is approved, I don’t think we will be able to replicate the same results," he said.

Several speakers at the press conference noted the balancing act that all clinicians will face regarding public demand for the new procedure.

Dr. Michael Crawford, chief of clinical cardiology at the University of California, San Francisco, observed that centers will face substantial up-front costs in the adoption of TAVR, including hybrid surgical/interventional suites, and that this will restrict initial uptake to high-volume centers of excellence.

The 3.4% mortality rate represents an "amazing effort," particularly in the use of the larger, first-generation device, said invited discussant Dr. Martyn Thomas, clinical director of cardiothoracic services at St. Thomas’ Hospital, London. The delivery catheters used in PARTNER are sized at 22 and 24 French, which corresponds to an outside diameter of 7-8 mm. The size of catheters is down to 16-Fr in Europe, where more than 5,000 TAVR procedures have been done and where both the Edwards Lifesciences Corp.’s Sapien valve that was used in PARTNER and the Medtronic Inc.’s CoreValve are already on the market.

Recruitment began in February for the PARTNER II trial that evaluated the smaller Edwards Sapien XT device and the later generation NovaFlex delivery system among inoperable patients with symptomatic severe aortic stenosis. The trial is expected to enroll 600 patients, and is targeted for primary completion in December 2011.

When asked whether the advent of newer, thinner devices will mean adoption in patients with lower risk, Dr. Smith replied that the adoption of TAVR will "march steadily down the risk categories."

Edwards Lifesciences sponsored the trial. Dr. Smith and his coauthors reported no conflicts of interest.

NEW ORLEANS – Transcatheter aortic valve replacement was associated with the same survival rates at 1 year as was conventional surgery in older, high-risk patients with severe, symptomatic aortic stenosis in the PARTNER trial.

All-cause mortality at 30 days favored transcatheter aortic valve replacement (TAVR) at 3.4%, compared with 6.5% for open surgery, and was similar at 1 year (24% and 27%, respectively). The difference at 1 year reached the trial’s prespecified noninferiority margin with a P value of .001.

"We already learned from the previous cohort that TAVR is the standard of care for patients who can’t tolerate surgery. So this [finding] opens up a new set of patients who may very well benefit as much with TAVR as with the gold standard surgery," coprincipal investigator Dr. Craig B. Smith said at the annual meeting of the American College of Cardiology.

The stroke rate with TAVR in the industry-sponsored PARTNER (Placement of Aortic Transcatheter Valve) trial, however, was associated with a stroke rate that was twice the rate observed with surgery.

Stroke plus transient ischemic attack (TIA) rates were significantly more frequent with TAVR than surgery at both 30 days (5.5% vs. 2.4%) and 1 year (8.3% vs. 4.3%). When only major strokes were compared, the difference was not significant between TAVR and surgery at 30 days (3.8% vs. 2.1%) or 1 year (5.1% vs. 2.4%), said Dr. Smith, chief of cardiothoracic surgery at New York–Presbyterian Hospital/Columbia University Medical Center in New York City.

Notably, patients who underwent conventional surgery were significantly more likely than TAVR patients to experience major bleeding at 30 days (19.5% vs. 9.3%) and 1 year (26% vs. 15%), as well as new atrial fibrillation at both 30 days (16% vs. 8.6%) and 1 year (17% vs. 12%).

Echocardiographic findings indicated a small hemodynamic benefit with TAVR vs. surgery at 1 year, but significantly increased paravalvular aortic regurgitation at 30 days, 6 months, and 1 year.

"TAVR and AVR [aortic valve replacement] are both acceptable therapies in these high-risk patients; differing periprocedural hazards should influence case-based decision making," Dr. Smith said.

Dr. David Moliterno, chair of the intervention program (i2 Summit) at the meeting, told reporters that they were witnessing history in the making.

"This will probably be seen as one of the biggest steps in cardiovascular medicine, as far as intervention is concerned, potentially in our lifetime," said Dr. Moliterno, chief of cardiovascular medicine at the University of Kentucky, Lexington. "If we look back to balloon angioplasty, the advent of stents and drug-eluting stents, ... this will be seen as the next major turning point."

Last year, the PARTNER trial investigators reported a 20% survival benefit at 1 year in a separate cohort of 358 inoperable patients with severe aortic stenosis who underwent transfemoral TAVR vs. standard therapy, including balloon aortic valvuloplasty (N. Engl. J. Med. 2010;363:1597-607). TAVR was associated with significantly more major vascular complications (16% vs. 1%) and a higher incidence of major strokes (5% vs. 1%).

The current portion of PARTNER randomly assigned 699 patients at 26 centers to surgery or TAVR, using the transfemoral approach in 492 patients and the transapical approach in 207.

Severe stenosis was defined as an aortic valve area of less than 0.8 cm² and mean aortic valve gradient of more than 40 mm Hg or a peak aortic jet velocity of more than 4.0 m/second. The patients had a New York Heart Association heart failure class II or greater, and had a predicted risk of operative mortality of at least 15% as determined by the site surgeon and cardiologist, coupled with a Society of Thoracic Surgery score of at least 10.

Their mean age was 83 years, and 94% were NYHA class III or IV. In all, 42 patients were not treated as assigned, Dr. Smith said.

All-cause mortality at 1 year was similar for the transfemoral TAVR subgroup, at 22.2% and 26.4% for surgery, as well as for the transapical TAVR subgroup (29% vs. 28%, respectively).

A preliminary subgroup analysis suggests that there may be a possible benefit with TAVR in women and patients without prior coronary artery bypass surgery, but Dr. Smith said that those results should be interpreted cautiously.

Overall, the TAVR mortality of 3.4% at 30-days was the lowest reported in any series, despite the use of an early-generation device and limited previous operator experience, he said, noting that nine of the participating centers had never performed TAVR before the trial.

Symptom improvement, including NYHA class and 6-minute walk distance, favored TAVR at 30 days and was similar to conventional surgery at 1 year, he said.

Coinvestigator Dr. Murat Tuzcu, vice chair of the department of cardiovascular medicine at the Cleveland Clinic, stressed that the results were accomplished only through unprecedented teamwork among cardiologists, surgeons, and imaging experts, who consulted on each case in the trial.

"I want to emphasize that if we fail to pay equal attention to what we have done in this trial after the device is approved, I don’t think we will be able to replicate the same results," he said.

Several speakers at the press conference noted the balancing act that all clinicians will face regarding public demand for the new procedure.

Dr. Michael Crawford, chief of clinical cardiology at the University of California, San Francisco, observed that centers will face substantial up-front costs in the adoption of TAVR, including hybrid surgical/interventional suites, and that this will restrict initial uptake to high-volume centers of excellence.

The 3.4% mortality rate represents an "amazing effort," particularly in the use of the larger, first-generation device, said invited discussant Dr. Martyn Thomas, clinical director of cardiothoracic services at St. Thomas’ Hospital, London. The delivery catheters used in PARTNER are sized at 22 and 24 French, which corresponds to an outside diameter of 7-8 mm. The size of catheters is down to 16-Fr in Europe, where more than 5,000 TAVR procedures have been done and where both the Edwards Lifesciences Corp.’s Sapien valve that was used in PARTNER and the Medtronic Inc.’s CoreValve are already on the market.

Recruitment began in February for the PARTNER II trial that evaluated the smaller Edwards Sapien XT device and the later generation NovaFlex delivery system among inoperable patients with symptomatic severe aortic stenosis. The trial is expected to enroll 600 patients, and is targeted for primary completion in December 2011.

When asked whether the advent of newer, thinner devices will mean adoption in patients with lower risk, Dr. Smith replied that the adoption of TAVR will "march steadily down the risk categories."

Edwards Lifesciences sponsored the trial. Dr. Smith and his coauthors reported no conflicts of interest.

NEW ORLEANS – Transcatheter aortic valve replacement was associated with the same survival rates at 1 year as was conventional surgery in older, high-risk patients with severe, symptomatic aortic stenosis in the PARTNER trial.

All-cause mortality at 30 days favored transcatheter aortic valve replacement (TAVR) at 3.4%, compared with 6.5% for open surgery, and was similar at 1 year (24% and 27%, respectively). The difference at 1 year reached the trial’s prespecified noninferiority margin with a P value of .001.

"We already learned from the previous cohort that TAVR is the standard of care for patients who can’t tolerate surgery. So this [finding] opens up a new set of patients who may very well benefit as much with TAVR as with the gold standard surgery," coprincipal investigator Dr. Craig B. Smith said at the annual meeting of the American College of Cardiology.

The stroke rate with TAVR in the industry-sponsored PARTNER (Placement of Aortic Transcatheter Valve) trial, however, was associated with a stroke rate that was twice the rate observed with surgery.

Stroke plus transient ischemic attack (TIA) rates were significantly more frequent with TAVR than surgery at both 30 days (5.5% vs. 2.4%) and 1 year (8.3% vs. 4.3%). When only major strokes were compared, the difference was not significant between TAVR and surgery at 30 days (3.8% vs. 2.1%) or 1 year (5.1% vs. 2.4%), said Dr. Smith, chief of cardiothoracic surgery at New York–Presbyterian Hospital/Columbia University Medical Center in New York City.

Notably, patients who underwent conventional surgery were significantly more likely than TAVR patients to experience major bleeding at 30 days (19.5% vs. 9.3%) and 1 year (26% vs. 15%), as well as new atrial fibrillation at both 30 days (16% vs. 8.6%) and 1 year (17% vs. 12%).

Echocardiographic findings indicated a small hemodynamic benefit with TAVR vs. surgery at 1 year, but significantly increased paravalvular aortic regurgitation at 30 days, 6 months, and 1 year.

"TAVR and AVR [aortic valve replacement] are both acceptable therapies in these high-risk patients; differing periprocedural hazards should influence case-based decision making," Dr. Smith said.

Dr. David Moliterno, chair of the intervention program (i2 Summit) at the meeting, told reporters that they were witnessing history in the making.

"This will probably be seen as one of the biggest steps in cardiovascular medicine, as far as intervention is concerned, potentially in our lifetime," said Dr. Moliterno, chief of cardiovascular medicine at the University of Kentucky, Lexington. "If we look back to balloon angioplasty, the advent of stents and drug-eluting stents, ... this will be seen as the next major turning point."

Last year, the PARTNER trial investigators reported a 20% survival benefit at 1 year in a separate cohort of 358 inoperable patients with severe aortic stenosis who underwent transfemoral TAVR vs. standard therapy, including balloon aortic valvuloplasty (N. Engl. J. Med. 2010;363:1597-607). TAVR was associated with significantly more major vascular complications (16% vs. 1%) and a higher incidence of major strokes (5% vs. 1%).

The current portion of PARTNER randomly assigned 699 patients at 26 centers to surgery or TAVR, using the transfemoral approach in 492 patients and the transapical approach in 207.

Severe stenosis was defined as an aortic valve area of less than 0.8 cm² and mean aortic valve gradient of more than 40 mm Hg or a peak aortic jet velocity of more than 4.0 m/second. The patients had a New York Heart Association heart failure class II or greater, and had a predicted risk of operative mortality of at least 15% as determined by the site surgeon and cardiologist, coupled with a Society of Thoracic Surgery score of at least 10.

Their mean age was 83 years, and 94% were NYHA class III or IV. In all, 42 patients were not treated as assigned, Dr. Smith said.

All-cause mortality at 1 year was similar for the transfemoral TAVR subgroup, at 22.2% and 26.4% for surgery, as well as for the transapical TAVR subgroup (29% vs. 28%, respectively).

A preliminary subgroup analysis suggests that there may be a possible benefit with TAVR in women and patients without prior coronary artery bypass surgery, but Dr. Smith said that those results should be interpreted cautiously.

Overall, the TAVR mortality of 3.4% at 30-days was the lowest reported in any series, despite the use of an early-generation device and limited previous operator experience, he said, noting that nine of the participating centers had never performed TAVR before the trial.

Symptom improvement, including NYHA class and 6-minute walk distance, favored TAVR at 30 days and was similar to conventional surgery at 1 year, he said.

Coinvestigator Dr. Murat Tuzcu, vice chair of the department of cardiovascular medicine at the Cleveland Clinic, stressed that the results were accomplished only through unprecedented teamwork among cardiologists, surgeons, and imaging experts, who consulted on each case in the trial.

"I want to emphasize that if we fail to pay equal attention to what we have done in this trial after the device is approved, I don’t think we will be able to replicate the same results," he said.

Several speakers at the press conference noted the balancing act that all clinicians will face regarding public demand for the new procedure.

Dr. Michael Crawford, chief of clinical cardiology at the University of California, San Francisco, observed that centers will face substantial up-front costs in the adoption of TAVR, including hybrid surgical/interventional suites, and that this will restrict initial uptake to high-volume centers of excellence.

The 3.4% mortality rate represents an "amazing effort," particularly in the use of the larger, first-generation device, said invited discussant Dr. Martyn Thomas, clinical director of cardiothoracic services at St. Thomas’ Hospital, London. The delivery catheters used in PARTNER are sized at 22 and 24 French, which corresponds to an outside diameter of 7-8 mm. The size of catheters is down to 16-Fr in Europe, where more than 5,000 TAVR procedures have been done and where both the Edwards Lifesciences Corp.’s Sapien valve that was used in PARTNER and the Medtronic Inc.’s CoreValve are already on the market.

Recruitment began in February for the PARTNER II trial that evaluated the smaller Edwards Sapien XT device and the later generation NovaFlex delivery system among inoperable patients with symptomatic severe aortic stenosis. The trial is expected to enroll 600 patients, and is targeted for primary completion in December 2011.

When asked whether the advent of newer, thinner devices will mean adoption in patients with lower risk, Dr. Smith replied that the adoption of TAVR will "march steadily down the risk categories."

Edwards Lifesciences sponsored the trial. Dr. Smith and his coauthors reported no conflicts of interest.

NEW ORLEANS – Transcatheter aortic valve replacement was associated with the same survival rates at 1 year as was conventional surgery in older, high-risk patients with severe, symptomatic aortic stenosis in the PARTNER trial.

All-cause mortality at 30 days favored transcatheter aortic valve replacement (TAVR) at 3.4%, compared with 6.5% for open surgery, and was similar at 1 year (24% and 27%, respectively). The difference at 1 year reached the trial’s prespecified noninferiority margin with a P value of .001.

"We already learned from the previous cohort that TAVR is the standard of care for patients who can’t tolerate surgery. So this [finding] opens up a new set of patients who may very well benefit as much with TAVR as with the gold standard surgery," coprincipal investigator Dr. Craig B. Smith said at the annual meeting of the American College of Cardiology.

The stroke rate with TAVR in the industry-sponsored PARTNER (Placement of Aortic Transcatheter Valve) trial, however, was associated with a stroke rate that was twice the rate observed with surgery.

Stroke plus transient ischemic attack (TIA) rates were significantly more frequent with TAVR than surgery at both 30 days (5.5% vs. 2.4%) and 1 year (8.3% vs. 4.3%). When only major strokes were compared, the difference was not significant between TAVR and surgery at 30 days (3.8% vs. 2.1%) or 1 year (5.1% vs. 2.4%), said Dr. Smith, chief of cardiothoracic surgery at New York–Presbyterian Hospital/Columbia University Medical Center in New York City.

Notably, patients who underwent conventional surgery were significantly more likely than TAVR patients to experience major bleeding at 30 days (19.5% vs. 9.3%) and 1 year (26% vs. 15%), as well as new atrial fibrillation at both 30 days (16% vs. 8.6%) and 1 year (17% vs. 12%).

Echocardiographic findings indicated a small hemodynamic benefit with TAVR vs. surgery at 1 year, but significantly increased paravalvular aortic regurgitation at 30 days, 6 months, and 1 year.

"TAVR and AVR [aortic valve replacement] are both acceptable therapies in these high-risk patients; differing periprocedural hazards should influence case-based decision making," Dr. Smith said.

Dr. David Moliterno, chair of the intervention program (i2 Summit) at the meeting, told reporters that they were witnessing history in the making.

"This will probably be seen as one of the biggest steps in cardiovascular medicine, as far as intervention is concerned, potentially in our lifetime," said Dr. Moliterno, chief of cardiovascular medicine at the University of Kentucky, Lexington. "If we look back to balloon angioplasty, the advent of stents and drug-eluting stents, ... this will be seen as the next major turning point."

Last year, the PARTNER trial investigators reported a 20% survival benefit at 1 year in a separate cohort of 358 inoperable patients with severe aortic stenosis who underwent transfemoral TAVR vs. standard therapy, including balloon aortic valvuloplasty (N. Engl. J. Med. 2010;363:1597-607). TAVR was associated with significantly more major vascular complications (16% vs. 1%) and a higher incidence of major strokes (5% vs. 1%).

The current portion of PARTNER randomly assigned 699 patients at 26 centers to surgery or TAVR, using the transfemoral approach in 492 patients and the transapical approach in 207.

Severe stenosis was defined as an aortic valve area of less than 0.8 cm² and mean aortic valve gradient of more than 40 mm Hg or a peak aortic jet velocity of more than 4.0 m/second. The patients had a New York Heart Association heart failure class II or greater, and had a predicted risk of operative mortality of at least 15% as determined by the site surgeon and cardiologist, coupled with a Society of Thoracic Surgery score of at least 10.

Their mean age was 83 years, and 94% were NYHA class III or IV. In all, 42 patients were not treated as assigned, Dr. Smith said.

All-cause mortality at 1 year was similar for the transfemoral TAVR subgroup, at 22.2% and 26.4% for surgery, as well as for the transapical TAVR subgroup (29% vs. 28%, respectively).

A preliminary subgroup analysis suggests that there may be a possible benefit with TAVR in women and patients without prior coronary artery bypass surgery, but Dr. Smith said that those results should be interpreted cautiously.

Overall, the TAVR mortality of 3.4% at 30-days was the lowest reported in any series, despite the use of an early-generation device and limited previous operator experience, he said, noting that nine of the participating centers had never performed TAVR before the trial.

Symptom improvement, including NYHA class and 6-minute walk distance, favored TAVR at 30 days and was similar to conventional surgery at 1 year, he said.

Coinvestigator Dr. Murat Tuzcu, vice chair of the department of cardiovascular medicine at the Cleveland Clinic, stressed that the results were accomplished only through unprecedented teamwork among cardiologists, surgeons, and imaging experts, who consulted on each case in the trial.

"I want to emphasize that if we fail to pay equal attention to what we have done in this trial after the device is approved, I don’t think we will be able to replicate the same results," he said.

Several speakers at the press conference noted the balancing act that all clinicians will face regarding public demand for the new procedure.

Dr. Michael Crawford, chief of clinical cardiology at the University of California, San Francisco, observed that centers will face substantial up-front costs in the adoption of TAVR, including hybrid surgical/interventional suites, and that this will restrict initial uptake to high-volume centers of excellence.

The 3.4% mortality rate represents an "amazing effort," particularly in the use of the larger, first-generation device, said invited discussant Dr. Martyn Thomas, clinical director of cardiothoracic services at St. Thomas’ Hospital, London. The delivery catheters used in PARTNER are sized at 22 and 24 French, which corresponds to an outside diameter of 7-8 mm. The size of catheters is down to 16-Fr in Europe, where more than 5,000 TAVR procedures have been done and where both the Edwards Lifesciences Corp.’s Sapien valve that was used in PARTNER and the Medtronic Inc.’s CoreValve are already on the market.

Recruitment began in February for the PARTNER II trial that evaluated the smaller Edwards Sapien XT device and the later generation NovaFlex delivery system among inoperable patients with symptomatic severe aortic stenosis. The trial is expected to enroll 600 patients, and is targeted for primary completion in December 2011.

When asked whether the advent of newer, thinner devices will mean adoption in patients with lower risk, Dr. Smith replied that the adoption of TAVR will "march steadily down the risk categories."

Edwards Lifesciences sponsored the trial. Dr. Smith and his coauthors reported no conflicts of interest.