Alice Goodman

NEW ORLEANS – A specialized clinic that relies on a three-pronged–team approach for the treatment of atrial fibrillation achieved substantial reductions in cardiovascular hospitalizations and cardiovascular deaths, compared with usual care, in a randomized, open-label trial.

Specifically, cardiovascular death was reduced by nearly three-fourths with the specialized intervention. The three pillars of the program were nurse-led care, guideline-directed management of atrial fibrillation (AF), and support software based on clinical guidelines.

"Effective AF management can enhance appropriate treatment, coordinate the delivery of care more efficiently, and lead to improved outcomes, as we have shown in this trial. We can’t pinpoint the nurses or guidelines or software as the sole reason for our results. I think the secret is the integrated approach, combining these three ingredients," said principal investigator Dr. Robert G. Tieleman of Martini Hospital Groningen (the Netherlands), who presented the results jointly with Jeroen M.L. Hendriks, M.Sc., a nurse at Maastricht (the Netherlands) Hospital, at the annual meeting of the American College of Cardiology.

AF treatment guidelines are followed only about 60% of the time, according to the European Heart Survey of 5,000 patients in 35 countries. The survey findings led the Dutch researchers to design an AF treatment program based on established guidelines.

At visit 1, nurses gave patients extensive questionnaires to fill out, took medical histories, performed physical exams, and administered additional tests as needed. At visit 2, a supervising cardiologist and the nurse examined the patient’s profile (created from a computerized database of information obtained on that patient at visit 1), and the software provided a treatment plan for each patient based on AF guidelines and oral anticoagulation therapy to prevent clotting. Follow-up visits with the nurse focused on treatment according to guidelines, including medications, devices, smoking cessation, lifestyle, and education.

For the study, 712 patients with newly diagnosed AF were randomized to nurse-led care or usual care by a general cardiologist, and were followed for at least 1 year. The patients’ mean age was 66 years. About 55% of the nurse-led group and 62% of the usual care group were men. Overall, about 54% of patients had paroxysmal AF, about 15% had persistent AF, and about 22% had permanent AF. About 83% were symptomatic.

At a mean follow-up of 22 months, the primary composite end point of cardiovascular death or hospitalization occurred in 51 patients (14.3%) in the nurse-led group and in 74 patients (20.8%) in the usual care group, representing a significant relative risk reduction of 35% for those randomized to nurse-led care.

Cardiovascular death was reduced by 72% in the nurse-led care group: 4 patients (1.1%) vs. 14 patients (3.9%), respectively. Cardiovascular hospitalizations were reduced by 34% in the nurse-led care group: 48 patients (13.5%) vs. 68 patients (19.1%), respectively.

Guidelines for AF were followed much more often in the nurse-led group, as would be expected. Six different recommendations (two related to diagnostics and four to therapy) were followed. In the nurse-led group, these six guidelines were followed 80% of the time, compared with 40% of the time in the usual care group. Importantly, 99% of the nurse-led group adhered to the recommendation related to appropriate antithrombotic therapy, compared with 83% of the usual-care group.

The AF clinic has been incorporated into the official outpatient clinic at the university hospital. The Maastricht team is helping other hospitals in the Netherlands to set up similar AF clinics.

Dr. Byron Kwock Lee of the University of California, San Francisco, said "this study underscores the complexity of AF and how important it is to stay on top of all the angles."

Dr. Prakash C. Deedwania, professor of medicine at the University of California, San Francisco in Fresno, commented, "This is a relevant study that touches on the crux of the problem of managing AF in this current cost-control environment. I’m struck by the excellent outcomes achieved by this team approach."

Dr. Tieleman said that a cost analysis will be conducted, but that he is confident that the team (nurse-led) approach will be cost effective. "Hospital admissions are costly. Nurses are cheaper," he commented.

Dr. Tieleman, Mr. Hendriks, and Dr. Deedwania said that they had no relevant financial disclosures.

NEW ORLEANS – A specialized clinic that relies on a three-pronged–team approach for the treatment of atrial fibrillation achieved substantial reductions in cardiovascular hospitalizations and cardiovascular deaths, compared with usual care, in a randomized, open-label trial.

Specifically, cardiovascular death was reduced by nearly three-fourths with the specialized intervention. The three pillars of the program were nurse-led care, guideline-directed management of atrial fibrillation (AF), and support software based on clinical guidelines.

"Effective AF management can enhance appropriate treatment, coordinate the delivery of care more efficiently, and lead to improved outcomes, as we have shown in this trial. We can’t pinpoint the nurses or guidelines or software as the sole reason for our results. I think the secret is the integrated approach, combining these three ingredients," said principal investigator Dr. Robert G. Tieleman of Martini Hospital Groningen (the Netherlands), who presented the results jointly with Jeroen M.L. Hendriks, M.Sc., a nurse at Maastricht (the Netherlands) Hospital, at the annual meeting of the American College of Cardiology.

AF treatment guidelines are followed only about 60% of the time, according to the European Heart Survey of 5,000 patients in 35 countries. The survey findings led the Dutch researchers to design an AF treatment program based on established guidelines.

At visit 1, nurses gave patients extensive questionnaires to fill out, took medical histories, performed physical exams, and administered additional tests as needed. At visit 2, a supervising cardiologist and the nurse examined the patient’s profile (created from a computerized database of information obtained on that patient at visit 1), and the software provided a treatment plan for each patient based on AF guidelines and oral anticoagulation therapy to prevent clotting. Follow-up visits with the nurse focused on treatment according to guidelines, including medications, devices, smoking cessation, lifestyle, and education.

For the study, 712 patients with newly diagnosed AF were randomized to nurse-led care or usual care by a general cardiologist, and were followed for at least 1 year. The patients’ mean age was 66 years. About 55% of the nurse-led group and 62% of the usual care group were men. Overall, about 54% of patients had paroxysmal AF, about 15% had persistent AF, and about 22% had permanent AF. About 83% were symptomatic.

At a mean follow-up of 22 months, the primary composite end point of cardiovascular death or hospitalization occurred in 51 patients (14.3%) in the nurse-led group and in 74 patients (20.8%) in the usual care group, representing a significant relative risk reduction of 35% for those randomized to nurse-led care.

Cardiovascular death was reduced by 72% in the nurse-led care group: 4 patients (1.1%) vs. 14 patients (3.9%), respectively. Cardiovascular hospitalizations were reduced by 34% in the nurse-led care group: 48 patients (13.5%) vs. 68 patients (19.1%), respectively.

Guidelines for AF were followed much more often in the nurse-led group, as would be expected. Six different recommendations (two related to diagnostics and four to therapy) were followed. In the nurse-led group, these six guidelines were followed 80% of the time, compared with 40% of the time in the usual care group. Importantly, 99% of the nurse-led group adhered to the recommendation related to appropriate antithrombotic therapy, compared with 83% of the usual-care group.

The AF clinic has been incorporated into the official outpatient clinic at the university hospital. The Maastricht team is helping other hospitals in the Netherlands to set up similar AF clinics.

Dr. Byron Kwock Lee of the University of California, San Francisco, said "this study underscores the complexity of AF and how important it is to stay on top of all the angles."

Dr. Prakash C. Deedwania, professor of medicine at the University of California, San Francisco in Fresno, commented, "This is a relevant study that touches on the crux of the problem of managing AF in this current cost-control environment. I’m struck by the excellent outcomes achieved by this team approach."

Dr. Tieleman said that a cost analysis will be conducted, but that he is confident that the team (nurse-led) approach will be cost effective. "Hospital admissions are costly. Nurses are cheaper," he commented.

Dr. Tieleman, Mr. Hendriks, and Dr. Deedwania said that they had no relevant financial disclosures.

NEW ORLEANS – A specialized clinic that relies on a three-pronged–team approach for the treatment of atrial fibrillation achieved substantial reductions in cardiovascular hospitalizations and cardiovascular deaths, compared with usual care, in a randomized, open-label trial.

Specifically, cardiovascular death was reduced by nearly three-fourths with the specialized intervention. The three pillars of the program were nurse-led care, guideline-directed management of atrial fibrillation (AF), and support software based on clinical guidelines.

"Effective AF management can enhance appropriate treatment, coordinate the delivery of care more efficiently, and lead to improved outcomes, as we have shown in this trial. We can’t pinpoint the nurses or guidelines or software as the sole reason for our results. I think the secret is the integrated approach, combining these three ingredients," said principal investigator Dr. Robert G. Tieleman of Martini Hospital Groningen (the Netherlands), who presented the results jointly with Jeroen M.L. Hendriks, M.Sc., a nurse at Maastricht (the Netherlands) Hospital, at the annual meeting of the American College of Cardiology.

AF treatment guidelines are followed only about 60% of the time, according to the European Heart Survey of 5,000 patients in 35 countries. The survey findings led the Dutch researchers to design an AF treatment program based on established guidelines.

At visit 1, nurses gave patients extensive questionnaires to fill out, took medical histories, performed physical exams, and administered additional tests as needed. At visit 2, a supervising cardiologist and the nurse examined the patient’s profile (created from a computerized database of information obtained on that patient at visit 1), and the software provided a treatment plan for each patient based on AF guidelines and oral anticoagulation therapy to prevent clotting. Follow-up visits with the nurse focused on treatment according to guidelines, including medications, devices, smoking cessation, lifestyle, and education.

For the study, 712 patients with newly diagnosed AF were randomized to nurse-led care or usual care by a general cardiologist, and were followed for at least 1 year. The patients’ mean age was 66 years. About 55% of the nurse-led group and 62% of the usual care group were men. Overall, about 54% of patients had paroxysmal AF, about 15% had persistent AF, and about 22% had permanent AF. About 83% were symptomatic.

At a mean follow-up of 22 months, the primary composite end point of cardiovascular death or hospitalization occurred in 51 patients (14.3%) in the nurse-led group and in 74 patients (20.8%) in the usual care group, representing a significant relative risk reduction of 35% for those randomized to nurse-led care.

Cardiovascular death was reduced by 72% in the nurse-led care group: 4 patients (1.1%) vs. 14 patients (3.9%), respectively. Cardiovascular hospitalizations were reduced by 34% in the nurse-led care group: 48 patients (13.5%) vs. 68 patients (19.1%), respectively.

Guidelines for AF were followed much more often in the nurse-led group, as would be expected. Six different recommendations (two related to diagnostics and four to therapy) were followed. In the nurse-led group, these six guidelines were followed 80% of the time, compared with 40% of the time in the usual care group. Importantly, 99% of the nurse-led group adhered to the recommendation related to appropriate antithrombotic therapy, compared with 83% of the usual-care group.

The AF clinic has been incorporated into the official outpatient clinic at the university hospital. The Maastricht team is helping other hospitals in the Netherlands to set up similar AF clinics.

Dr. Byron Kwock Lee of the University of California, San Francisco, said "this study underscores the complexity of AF and how important it is to stay on top of all the angles."

Dr. Prakash C. Deedwania, professor of medicine at the University of California, San Francisco in Fresno, commented, "This is a relevant study that touches on the crux of the problem of managing AF in this current cost-control environment. I’m struck by the excellent outcomes achieved by this team approach."

Dr. Tieleman said that a cost analysis will be conducted, but that he is confident that the team (nurse-led) approach will be cost effective. "Hospital admissions are costly. Nurses are cheaper," he commented.

Dr. Tieleman, Mr. Hendriks, and Dr. Deedwania said that they had no relevant financial disclosures.

NEW ORLEANS – Using speckle tracking echocardiography to guide pacemaker lead placement improved the outcomes of cardiac resynchronization therapy for patients with severe heart failure in TARGET, said to be the first randomized clinical trial to study the feasibility and outcomes of a targeted approach to left ventricular lead placement.

When speckle-tracking echocardiography (STE) was used to identify target sites for pacemaker lead placement for individual patients, leads were more likely to be placed at concordant sites. The result was improved echocardiographic response at 6 months – defined as a greater than 15% change in left ventricular end systolic volume (LVESV) from baseline to 6-month follow-up. The STE group had a 70% response as compared with a 55% response in the group with conventional lead placement without echocardiography guidance (P = .031), reported Dr. Fakhar Z. Khan, of Cambridge (U.K.) University, who reported the results of TARGET on April 5 at the annual meeting of the American College of Cardiology.

Lower rates were also seen with STE for the combined end point of all-cause mortality and heart failure hospitalization. The difference was primarily driven by fewer heart failure hospitalizations. Looking at mortality alone at a mean follow-up of 400 days, the two groups did not significantly differ.

"This is a well-designed, well-conducted study with impressive differences in clinical outcomes," said Dr. Byron Kwock Lee, who is with the University of California, San Francisco, and chaired the session where the TARGET results were presented. "Other studies have shown echocardiographic outcomes but have had difficulty showing clinical differences."

"I am impressed that the modest echocardiographic changes translated to dramatic clinical effects," commented Dr. Michael Crawford, also of the University of California, San Francisco, and a panelist at the presentation of the study results.

Up to 40% of patients fail to gain significant clinical benefit from cardiac resynchronization therapy, Dr. Khan noted. The position of the left ventricular lead has emerged as an important determinant of response, with better results achieved when pacing at the latest site of contraction and lesser responses noted when pacing areas of scar.

Speckle tracking radial strain imaging correlates with delayed enhanced cardiac MRI for determination of scar, Dr. Khan said. In patients undergoing cardiac resynchronization therapy, less than 10% amplitude of radial strain at the left ventricular pacing site has a high negative predictive value (91%) for response.

Using STE, "we found that concordant lead placement, baseline dyssynchrony, and pacing away from areas of scar are strongly related to improved outcomes," he said.

The single blinded, randomized, controlled trial enrolled 220 patients recruited from three different hospitals in the U.K. Participants were in sinus rhythm, had severe heart failure (NYHA Class III/IV), left ventricular ejection fractions less than 35%, and QRS intervals greater than 120 msec. Patients were randomized in a 1:1 ratio to receive either standard lead placement without the benefit of echocardiographic guidance or targeted lead placement using STE to position the lead at the latest site of contraction and away from areas of scar. Following implantation, all devices were optimized using echocardiography.

Concordant lead placement was achieved in 61% of the STE group vs. 45% of control group. Placement was adjacent in 25% of the STE group and 28% of the control group, and was remote in 10% and 24%, respectively.

At baseline, both groups were comparable in demographic and disease characteristics. Mean age was about 70 years, about 86% were male, about 94% had NYHA Class III heart failure, and 56% had underlying ischemic cardiomyopathy.

Both groups had a 14% rate of implant-related complications. Procedural length of time was similar for both groups.

In addition to the primary end point improvements in echocardiographic response at 6-month follow-up, the STE group also had significantly improved clinical end points, compared with the standard placement group. Statistically significant differences from baseline to follow-up for the STE group vs. the standard placement group included improvement in heart failure class (P = .002), 6-mile walk test results (P = .01), and quality-of-life scores. (P = .02).

Patients in the study will continue to have ongoing follow-up.

"STE software can be applied to any existing echocardiographic image at no additional risk to the patient," Dr. Khan said. "STE makes targeting of the lead feasible at any facility that performs echocardiography and has the software available to analyze their images, so it is widely accessible at smaller centers and nonacademic hospitals where more and more pacemakers are being implanted. That being said, it requires training and experience."

Dr. Khan had no relevant financial disclosures.

NEW ORLEANS – Using speckle tracking echocardiography to guide pacemaker lead placement improved the outcomes of cardiac resynchronization therapy for patients with severe heart failure in TARGET, said to be the first randomized clinical trial to study the feasibility and outcomes of a targeted approach to left ventricular lead placement.

When speckle-tracking echocardiography (STE) was used to identify target sites for pacemaker lead placement for individual patients, leads were more likely to be placed at concordant sites. The result was improved echocardiographic response at 6 months – defined as a greater than 15% change in left ventricular end systolic volume (LVESV) from baseline to 6-month follow-up. The STE group had a 70% response as compared with a 55% response in the group with conventional lead placement without echocardiography guidance (P = .031), reported Dr. Fakhar Z. Khan, of Cambridge (U.K.) University, who reported the results of TARGET on April 5 at the annual meeting of the American College of Cardiology.

Lower rates were also seen with STE for the combined end point of all-cause mortality and heart failure hospitalization. The difference was primarily driven by fewer heart failure hospitalizations. Looking at mortality alone at a mean follow-up of 400 days, the two groups did not significantly differ.

"This is a well-designed, well-conducted study with impressive differences in clinical outcomes," said Dr. Byron Kwock Lee, who is with the University of California, San Francisco, and chaired the session where the TARGET results were presented. "Other studies have shown echocardiographic outcomes but have had difficulty showing clinical differences."

"I am impressed that the modest echocardiographic changes translated to dramatic clinical effects," commented Dr. Michael Crawford, also of the University of California, San Francisco, and a panelist at the presentation of the study results.

Up to 40% of patients fail to gain significant clinical benefit from cardiac resynchronization therapy, Dr. Khan noted. The position of the left ventricular lead has emerged as an important determinant of response, with better results achieved when pacing at the latest site of contraction and lesser responses noted when pacing areas of scar.

Speckle tracking radial strain imaging correlates with delayed enhanced cardiac MRI for determination of scar, Dr. Khan said. In patients undergoing cardiac resynchronization therapy, less than 10% amplitude of radial strain at the left ventricular pacing site has a high negative predictive value (91%) for response.

Using STE, "we found that concordant lead placement, baseline dyssynchrony, and pacing away from areas of scar are strongly related to improved outcomes," he said.

The single blinded, randomized, controlled trial enrolled 220 patients recruited from three different hospitals in the U.K. Participants were in sinus rhythm, had severe heart failure (NYHA Class III/IV), left ventricular ejection fractions less than 35%, and QRS intervals greater than 120 msec. Patients were randomized in a 1:1 ratio to receive either standard lead placement without the benefit of echocardiographic guidance or targeted lead placement using STE to position the lead at the latest site of contraction and away from areas of scar. Following implantation, all devices were optimized using echocardiography.

Concordant lead placement was achieved in 61% of the STE group vs. 45% of control group. Placement was adjacent in 25% of the STE group and 28% of the control group, and was remote in 10% and 24%, respectively.

At baseline, both groups were comparable in demographic and disease characteristics. Mean age was about 70 years, about 86% were male, about 94% had NYHA Class III heart failure, and 56% had underlying ischemic cardiomyopathy.

Both groups had a 14% rate of implant-related complications. Procedural length of time was similar for both groups.

In addition to the primary end point improvements in echocardiographic response at 6-month follow-up, the STE group also had significantly improved clinical end points, compared with the standard placement group. Statistically significant differences from baseline to follow-up for the STE group vs. the standard placement group included improvement in heart failure class (P = .002), 6-mile walk test results (P = .01), and quality-of-life scores. (P = .02).

Patients in the study will continue to have ongoing follow-up.

"STE software can be applied to any existing echocardiographic image at no additional risk to the patient," Dr. Khan said. "STE makes targeting of the lead feasible at any facility that performs echocardiography and has the software available to analyze their images, so it is widely accessible at smaller centers and nonacademic hospitals where more and more pacemakers are being implanted. That being said, it requires training and experience."

Dr. Khan had no relevant financial disclosures.

NEW ORLEANS – Using speckle tracking echocardiography to guide pacemaker lead placement improved the outcomes of cardiac resynchronization therapy for patients with severe heart failure in TARGET, said to be the first randomized clinical trial to study the feasibility and outcomes of a targeted approach to left ventricular lead placement.

When speckle-tracking echocardiography (STE) was used to identify target sites for pacemaker lead placement for individual patients, leads were more likely to be placed at concordant sites. The result was improved echocardiographic response at 6 months – defined as a greater than 15% change in left ventricular end systolic volume (LVESV) from baseline to 6-month follow-up. The STE group had a 70% response as compared with a 55% response in the group with conventional lead placement without echocardiography guidance (P = .031), reported Dr. Fakhar Z. Khan, of Cambridge (U.K.) University, who reported the results of TARGET on April 5 at the annual meeting of the American College of Cardiology.

Lower rates were also seen with STE for the combined end point of all-cause mortality and heart failure hospitalization. The difference was primarily driven by fewer heart failure hospitalizations. Looking at mortality alone at a mean follow-up of 400 days, the two groups did not significantly differ.

"This is a well-designed, well-conducted study with impressive differences in clinical outcomes," said Dr. Byron Kwock Lee, who is with the University of California, San Francisco, and chaired the session where the TARGET results were presented. "Other studies have shown echocardiographic outcomes but have had difficulty showing clinical differences."

"I am impressed that the modest echocardiographic changes translated to dramatic clinical effects," commented Dr. Michael Crawford, also of the University of California, San Francisco, and a panelist at the presentation of the study results.

Up to 40% of patients fail to gain significant clinical benefit from cardiac resynchronization therapy, Dr. Khan noted. The position of the left ventricular lead has emerged as an important determinant of response, with better results achieved when pacing at the latest site of contraction and lesser responses noted when pacing areas of scar.

Speckle tracking radial strain imaging correlates with delayed enhanced cardiac MRI for determination of scar, Dr. Khan said. In patients undergoing cardiac resynchronization therapy, less than 10% amplitude of radial strain at the left ventricular pacing site has a high negative predictive value (91%) for response.

Using STE, "we found that concordant lead placement, baseline dyssynchrony, and pacing away from areas of scar are strongly related to improved outcomes," he said.

The single blinded, randomized, controlled trial enrolled 220 patients recruited from three different hospitals in the U.K. Participants were in sinus rhythm, had severe heart failure (NYHA Class III/IV), left ventricular ejection fractions less than 35%, and QRS intervals greater than 120 msec. Patients were randomized in a 1:1 ratio to receive either standard lead placement without the benefit of echocardiographic guidance or targeted lead placement using STE to position the lead at the latest site of contraction and away from areas of scar. Following implantation, all devices were optimized using echocardiography.

Concordant lead placement was achieved in 61% of the STE group vs. 45% of control group. Placement was adjacent in 25% of the STE group and 28% of the control group, and was remote in 10% and 24%, respectively.

At baseline, both groups were comparable in demographic and disease characteristics. Mean age was about 70 years, about 86% were male, about 94% had NYHA Class III heart failure, and 56% had underlying ischemic cardiomyopathy.

Both groups had a 14% rate of implant-related complications. Procedural length of time was similar for both groups.

In addition to the primary end point improvements in echocardiographic response at 6-month follow-up, the STE group also had significantly improved clinical end points, compared with the standard placement group. Statistically significant differences from baseline to follow-up for the STE group vs. the standard placement group included improvement in heart failure class (P = .002), 6-mile walk test results (P = .01), and quality-of-life scores. (P = .02).

Patients in the study will continue to have ongoing follow-up.

"STE software can be applied to any existing echocardiographic image at no additional risk to the patient," Dr. Khan said. "STE makes targeting of the lead feasible at any facility that performs echocardiography and has the software available to analyze their images, so it is widely accessible at smaller centers and nonacademic hospitals where more and more pacemakers are being implanted. That being said, it requires training and experience."

Dr. Khan had no relevant financial disclosures.

NEW ORLEANS – Using speckle tracking echocardiography to guide pacemaker lead placement improved the outcomes of cardiac resynchronization therapy for patients with severe heart failure in TARGET, said to be the first randomized clinical trial to study the feasibility and outcomes of a targeted approach to left ventricular lead placement.

When speckle-tracking echocardiography (STE) was used to identify target sites for pacemaker lead placement for individual patients, leads were more likely to be placed at concordant sites. The result was improved echocardiographic response at 6 months – defined as a greater than 15% change in left ventricular end systolic volume (LVESV) from baseline to 6-month follow-up. The STE group had a 70% response as compared with a 55% response in the group with conventional lead placement without echocardiography guidance (P = .031), reported Dr. Fakhar Z. Khan, of Cambridge (U.K.) University, who reported the results of TARGET on April 5 at the annual meeting of the American College of Cardiology.

Lower rates were also seen with STE for the combined end point of all-cause mortality and heart failure hospitalization. The difference was primarily driven by fewer heart failure hospitalizations. Looking at mortality alone at a mean follow-up of 400 days, the two groups did not significantly differ.

"This is a well-designed, well-conducted study with impressive differences in clinical outcomes," said Dr. Byron Kwock Lee, who is with the University of California, San Francisco, and chaired the session where the TARGET results were presented. "Other studies have shown echocardiographic outcomes but have had difficulty showing clinical differences."

"I am impressed that the modest echocardiographic changes translated to dramatic clinical effects," commented Dr. Michael Crawford, also of the University of California, San Francisco, and a panelist at the presentation of the study results.

Up to 40% of patients fail to gain significant clinical benefit from cardiac resynchronization therapy, Dr. Khan noted. The position of the left ventricular lead has emerged as an important determinant of response, with better results achieved when pacing at the latest site of contraction and lesser responses noted when pacing areas of scar.

Speckle tracking radial strain imaging correlates with delayed enhanced cardiac MRI for determination of scar, Dr. Khan said. In patients undergoing cardiac resynchronization therapy, less than 10% amplitude of radial strain at the left ventricular pacing site has a high negative predictive value (91%) for response.

Using STE, "we found that concordant lead placement, baseline dyssynchrony, and pacing away from areas of scar are strongly related to improved outcomes," he said.

The single blinded, randomized, controlled trial enrolled 220 patients recruited from three different hospitals in the U.K. Participants were in sinus rhythm, had severe heart failure (NYHA Class III/IV), left ventricular ejection fractions less than 35%, and QRS intervals greater than 120 msec. Patients were randomized in a 1:1 ratio to receive either standard lead placement without the benefit of echocardiographic guidance or targeted lead placement using STE to position the lead at the latest site of contraction and away from areas of scar. Following implantation, all devices were optimized using echocardiography.

Concordant lead placement was achieved in 61% of the STE group vs. 45% of control group. Placement was adjacent in 25% of the STE group and 28% of the control group, and was remote in 10% and 24%, respectively.

At baseline, both groups were comparable in demographic and disease characteristics. Mean age was about 70 years, about 86% were male, about 94% had NYHA Class III heart failure, and 56% had underlying ischemic cardiomyopathy.

Both groups had a 14% rate of implant-related complications. Procedural length of time was similar for both groups.

In addition to the primary end point improvements in echocardiographic response at 6-month follow-up, the STE group also had significantly improved clinical end points, compared with the standard placement group. Statistically significant differences from baseline to follow-up for the STE group vs. the standard placement group included improvement in heart failure class (P = .002), 6-mile walk test results (P = .01), and quality-of-life scores. (P = .02).

Patients in the study will continue to have ongoing follow-up.

"STE software can be applied to any existing echocardiographic image at no additional risk to the patient," Dr. Khan said. "STE makes targeting of the lead feasible at any facility that performs echocardiography and has the software available to analyze their images, so it is widely accessible at smaller centers and nonacademic hospitals where more and more pacemakers are being implanted. That being said, it requires training and experience."

Dr. Khan had no relevant financial disclosures.

NEW ORLEANS – Using speckle tracking echocardiography to guide pacemaker lead placement improved the outcomes of cardiac resynchronization therapy for patients with severe heart failure in TARGET, said to be the first randomized clinical trial to study the feasibility and outcomes of a targeted approach to left ventricular lead placement.

When speckle-tracking echocardiography (STE) was used to identify target sites for pacemaker lead placement for individual patients, leads were more likely to be placed at concordant sites. The result was improved echocardiographic response at 6 months – defined as a greater than 15% change in left ventricular end systolic volume (LVESV) from baseline to 6-month follow-up. The STE group had a 70% response as compared with a 55% response in the group with conventional lead placement without echocardiography guidance (P = .031), reported Dr. Fakhar Z. Khan, of Cambridge (U.K.) University, who reported the results of TARGET on April 5 at the annual meeting of the American College of Cardiology.

Lower rates were also seen with STE for the combined end point of all-cause mortality and heart failure hospitalization. The difference was primarily driven by fewer heart failure hospitalizations. Looking at mortality alone at a mean follow-up of 400 days, the two groups did not significantly differ.

"This is a well-designed, well-conducted study with impressive differences in clinical outcomes," said Dr. Byron Kwock Lee, who is with the University of California, San Francisco, and chaired the session where the TARGET results were presented. "Other studies have shown echocardiographic outcomes but have had difficulty showing clinical differences."

"I am impressed that the modest echocardiographic changes translated to dramatic clinical effects," commented Dr. Michael Crawford, also of the University of California, San Francisco, and a panelist at the presentation of the study results.

Up to 40% of patients fail to gain significant clinical benefit from cardiac resynchronization therapy, Dr. Khan noted. The position of the left ventricular lead has emerged as an important determinant of response, with better results achieved when pacing at the latest site of contraction and lesser responses noted when pacing areas of scar.

Speckle tracking radial strain imaging correlates with delayed enhanced cardiac MRI for determination of scar, Dr. Khan said. In patients undergoing cardiac resynchronization therapy, less than 10% amplitude of radial strain at the left ventricular pacing site has a high negative predictive value (91%) for response.

Using STE, "we found that concordant lead placement, baseline dyssynchrony, and pacing away from areas of scar are strongly related to improved outcomes," he said.

The single blinded, randomized, controlled trial enrolled 220 patients recruited from three different hospitals in the U.K. Participants were in sinus rhythm, had severe heart failure (NYHA Class III/IV), left ventricular ejection fractions less than 35%, and QRS intervals greater than 120 msec. Patients were randomized in a 1:1 ratio to receive either standard lead placement without the benefit of echocardiographic guidance or targeted lead placement using STE to position the lead at the latest site of contraction and away from areas of scar. Following implantation, all devices were optimized using echocardiography.

Concordant lead placement was achieved in 61% of the STE group vs. 45% of control group. Placement was adjacent in 25% of the STE group and 28% of the control group, and was remote in 10% and 24%, respectively.

At baseline, both groups were comparable in demographic and disease characteristics. Mean age was about 70 years, about 86% were male, about 94% had NYHA Class III heart failure, and 56% had underlying ischemic cardiomyopathy.

Both groups had a 14% rate of implant-related complications. Procedural length of time was similar for both groups.

In addition to the primary end point improvements in echocardiographic response at 6-month follow-up, the STE group also had significantly improved clinical end points, compared with the standard placement group. Statistically significant differences from baseline to follow-up for the STE group vs. the standard placement group included improvement in heart failure class (P = .002), 6-mile walk test results (P = .01), and quality-of-life scores. (P = .02).

Patients in the study will continue to have ongoing follow-up.

"STE software can be applied to any existing echocardiographic image at no additional risk to the patient," Dr. Khan said. "STE makes targeting of the lead feasible at any facility that performs echocardiography and has the software available to analyze their images, so it is widely accessible at smaller centers and nonacademic hospitals where more and more pacemakers are being implanted. That being said, it requires training and experience."

Dr. Khan had no relevant financial disclosures.

NEW ORLEANS – Using speckle tracking echocardiography to guide pacemaker lead placement improved the outcomes of cardiac resynchronization therapy for patients with severe heart failure in TARGET, said to be the first randomized clinical trial to study the feasibility and outcomes of a targeted approach to left ventricular lead placement.

When speckle-tracking echocardiography (STE) was used to identify target sites for pacemaker lead placement for individual patients, leads were more likely to be placed at concordant sites. The result was improved echocardiographic response at 6 months – defined as a greater than 15% change in left ventricular end systolic volume (LVESV) from baseline to 6-month follow-up. The STE group had a 70% response as compared with a 55% response in the group with conventional lead placement without echocardiography guidance (P = .031), reported Dr. Fakhar Z. Khan, of Cambridge (U.K.) University, who reported the results of TARGET on April 5 at the annual meeting of the American College of Cardiology.

Lower rates were also seen with STE for the combined end point of all-cause mortality and heart failure hospitalization. The difference was primarily driven by fewer heart failure hospitalizations. Looking at mortality alone at a mean follow-up of 400 days, the two groups did not significantly differ.

"This is a well-designed, well-conducted study with impressive differences in clinical outcomes," said Dr. Byron Kwock Lee, who is with the University of California, San Francisco, and chaired the session where the TARGET results were presented. "Other studies have shown echocardiographic outcomes but have had difficulty showing clinical differences."

"I am impressed that the modest echocardiographic changes translated to dramatic clinical effects," commented Dr. Michael Crawford, also of the University of California, San Francisco, and a panelist at the presentation of the study results.

Up to 40% of patients fail to gain significant clinical benefit from cardiac resynchronization therapy, Dr. Khan noted. The position of the left ventricular lead has emerged as an important determinant of response, with better results achieved when pacing at the latest site of contraction and lesser responses noted when pacing areas of scar.

Speckle tracking radial strain imaging correlates with delayed enhanced cardiac MRI for determination of scar, Dr. Khan said. In patients undergoing cardiac resynchronization therapy, less than 10% amplitude of radial strain at the left ventricular pacing site has a high negative predictive value (91%) for response.

Using STE, "we found that concordant lead placement, baseline dyssynchrony, and pacing away from areas of scar are strongly related to improved outcomes," he said.

The single blinded, randomized, controlled trial enrolled 220 patients recruited from three different hospitals in the U.K. Participants were in sinus rhythm, had severe heart failure (NYHA Class III/IV), left ventricular ejection fractions less than 35%, and QRS intervals greater than 120 msec. Patients were randomized in a 1:1 ratio to receive either standard lead placement without the benefit of echocardiographic guidance or targeted lead placement using STE to position the lead at the latest site of contraction and away from areas of scar. Following implantation, all devices were optimized using echocardiography.

Concordant lead placement was achieved in 61% of the STE group vs. 45% of control group. Placement was adjacent in 25% of the STE group and 28% of the control group, and was remote in 10% and 24%, respectively.

At baseline, both groups were comparable in demographic and disease characteristics. Mean age was about 70 years, about 86% were male, about 94% had NYHA Class III heart failure, and 56% had underlying ischemic cardiomyopathy.

Both groups had a 14% rate of implant-related complications. Procedural length of time was similar for both groups.

In addition to the primary end point improvements in echocardiographic response at 6-month follow-up, the STE group also had significantly improved clinical end points, compared with the standard placement group. Statistically significant differences from baseline to follow-up for the STE group vs. the standard placement group included improvement in heart failure class (P = .002), 6-mile walk test results (P = .01), and quality-of-life scores. (P = .02).

Patients in the study will continue to have ongoing follow-up.

"STE software can be applied to any existing echocardiographic image at no additional risk to the patient," Dr. Khan said. "STE makes targeting of the lead feasible at any facility that performs echocardiography and has the software available to analyze their images, so it is widely accessible at smaller centers and nonacademic hospitals where more and more pacemakers are being implanted. That being said, it requires training and experience."

Dr. Khan had no relevant financial disclosures.

NEW ORLEANS – Using speckle tracking echocardiography to guide pacemaker lead placement improved the outcomes of cardiac resynchronization therapy for patients with severe heart failure in TARGET, said to be the first randomized clinical trial to study the feasibility and outcomes of a targeted approach to left ventricular lead placement.

When speckle-tracking echocardiography (STE) was used to identify target sites for pacemaker lead placement for individual patients, leads were more likely to be placed at concordant sites. The result was improved echocardiographic response at 6 months – defined as a greater than 15% change in left ventricular end systolic volume (LVESV) from baseline to 6-month follow-up. The STE group had a 70% response as compared with a 55% response in the group with conventional lead placement without echocardiography guidance (P = .031), reported Dr. Fakhar Z. Khan, of Cambridge (U.K.) University, who reported the results of TARGET on April 5 at the annual meeting of the American College of Cardiology.

Lower rates were also seen with STE for the combined end point of all-cause mortality and heart failure hospitalization. The difference was primarily driven by fewer heart failure hospitalizations. Looking at mortality alone at a mean follow-up of 400 days, the two groups did not significantly differ.

"This is a well-designed, well-conducted study with impressive differences in clinical outcomes," said Dr. Byron Kwock Lee, who is with the University of California, San Francisco, and chaired the session where the TARGET results were presented. "Other studies have shown echocardiographic outcomes but have had difficulty showing clinical differences."

"I am impressed that the modest echocardiographic changes translated to dramatic clinical effects," commented Dr. Michael Crawford, also of the University of California, San Francisco, and a panelist at the presentation of the study results.

Up to 40% of patients fail to gain significant clinical benefit from cardiac resynchronization therapy, Dr. Khan noted. The position of the left ventricular lead has emerged as an important determinant of response, with better results achieved when pacing at the latest site of contraction and lesser responses noted when pacing areas of scar.

Speckle tracking radial strain imaging correlates with delayed enhanced cardiac MRI for determination of scar, Dr. Khan said. In patients undergoing cardiac resynchronization therapy, less than 10% amplitude of radial strain at the left ventricular pacing site has a high negative predictive value (91%) for response.

Using STE, "we found that concordant lead placement, baseline dyssynchrony, and pacing away from areas of scar are strongly related to improved outcomes," he said.

The single blinded, randomized, controlled trial enrolled 220 patients recruited from three different hospitals in the U.K. Participants were in sinus rhythm, had severe heart failure (NYHA Class III/IV), left ventricular ejection fractions less than 35%, and QRS intervals greater than 120 msec. Patients were randomized in a 1:1 ratio to receive either standard lead placement without the benefit of echocardiographic guidance or targeted lead placement using STE to position the lead at the latest site of contraction and away from areas of scar. Following implantation, all devices were optimized using echocardiography.

Concordant lead placement was achieved in 61% of the STE group vs. 45% of control group. Placement was adjacent in 25% of the STE group and 28% of the control group, and was remote in 10% and 24%, respectively.

At baseline, both groups were comparable in demographic and disease characteristics. Mean age was about 70 years, about 86% were male, about 94% had NYHA Class III heart failure, and 56% had underlying ischemic cardiomyopathy.

Both groups had a 14% rate of implant-related complications. Procedural length of time was similar for both groups.

In addition to the primary end point improvements in echocardiographic response at 6-month follow-up, the STE group also had significantly improved clinical end points, compared with the standard placement group. Statistically significant differences from baseline to follow-up for the STE group vs. the standard placement group included improvement in heart failure class (P = .002), 6-mile walk test results (P = .01), and quality-of-life scores. (P = .02).

Patients in the study will continue to have ongoing follow-up.

"STE software can be applied to any existing echocardiographic image at no additional risk to the patient," Dr. Khan said. "STE makes targeting of the lead feasible at any facility that performs echocardiography and has the software available to analyze their images, so it is widely accessible at smaller centers and nonacademic hospitals where more and more pacemakers are being implanted. That being said, it requires training and experience."

Dr. Khan had no relevant financial disclosures.

NEW ORLEANS – Using speckle tracking echocardiography to guide pacemaker lead placement improved the outcomes of cardiac resynchronization therapy for patients with severe heart failure in TARGET, said to be the first randomized clinical trial to study the feasibility and outcomes of a targeted approach to left ventricular lead placement.

When speckle-tracking echocardiography (STE) was used to identify target sites for pacemaker lead placement for individual patients, leads were more likely to be placed at concordant sites. The result was improved echocardiographic response at 6 months – defined as a greater than 15% change in left ventricular end systolic volume (LVESV) from baseline to 6-month follow-up. The STE group had a 70% response as compared with a 55% response in the group with conventional lead placement without echocardiography guidance (P = .031), reported Dr. Fakhar Z. Khan, of Cambridge (U.K.) University, who reported the results of TARGET on April 5 at the annual meeting of the American College of Cardiology.

Lower rates were also seen with STE for the combined end point of all-cause mortality and heart failure hospitalization. The difference was primarily driven by fewer heart failure hospitalizations. Looking at mortality alone at a mean follow-up of 400 days, the two groups did not significantly differ.

"This is a well-designed, well-conducted study with impressive differences in clinical outcomes," said Dr. Byron Kwock Lee, who is with the University of California, San Francisco, and chaired the session where the TARGET results were presented. "Other studies have shown echocardiographic outcomes but have had difficulty showing clinical differences."

"I am impressed that the modest echocardiographic changes translated to dramatic clinical effects," commented Dr. Michael Crawford, also of the University of California, San Francisco, and a panelist at the presentation of the study results.

Up to 40% of patients fail to gain significant clinical benefit from cardiac resynchronization therapy, Dr. Khan noted. The position of the left ventricular lead has emerged as an important determinant of response, with better results achieved when pacing at the latest site of contraction and lesser responses noted when pacing areas of scar.

Speckle tracking radial strain imaging correlates with delayed enhanced cardiac MRI for determination of scar, Dr. Khan said. In patients undergoing cardiac resynchronization therapy, less than 10% amplitude of radial strain at the left ventricular pacing site has a high negative predictive value (91%) for response.

Using STE, "we found that concordant lead placement, baseline dyssynchrony, and pacing away from areas of scar are strongly related to improved outcomes," he said.

The single blinded, randomized, controlled trial enrolled 220 patients recruited from three different hospitals in the U.K. Participants were in sinus rhythm, had severe heart failure (NYHA Class III/IV), left ventricular ejection fractions less than 35%, and QRS intervals greater than 120 msec. Patients were randomized in a 1:1 ratio to receive either standard lead placement without the benefit of echocardiographic guidance or targeted lead placement using STE to position the lead at the latest site of contraction and away from areas of scar. Following implantation, all devices were optimized using echocardiography.

Concordant lead placement was achieved in 61% of the STE group vs. 45% of control group. Placement was adjacent in 25% of the STE group and 28% of the control group, and was remote in 10% and 24%, respectively.

At baseline, both groups were comparable in demographic and disease characteristics. Mean age was about 70 years, about 86% were male, about 94% had NYHA Class III heart failure, and 56% had underlying ischemic cardiomyopathy.

Both groups had a 14% rate of implant-related complications. Procedural length of time was similar for both groups.

In addition to the primary end point improvements in echocardiographic response at 6-month follow-up, the STE group also had significantly improved clinical end points, compared with the standard placement group. Statistically significant differences from baseline to follow-up for the STE group vs. the standard placement group included improvement in heart failure class (P = .002), 6-mile walk test results (P = .01), and quality-of-life scores. (P = .02).

Patients in the study will continue to have ongoing follow-up.

"STE software can be applied to any existing echocardiographic image at no additional risk to the patient," Dr. Khan said. "STE makes targeting of the lead feasible at any facility that performs echocardiography and has the software available to analyze their images, so it is widely accessible at smaller centers and nonacademic hospitals where more and more pacemakers are being implanted. That being said, it requires training and experience."

Dr. Khan had no relevant financial disclosures.

NEW ORLEANS – Using speckle tracking echocardiography to guide pacemaker lead placement improved the outcomes of cardiac resynchronization therapy for patients with severe heart failure in TARGET, said to be the first randomized clinical trial to study the feasibility and outcomes of a targeted approach to left ventricular lead placement.

When speckle-tracking echocardiography (STE) was used to identify target sites for pacemaker lead placement for individual patients, leads were more likely to be placed at concordant sites. The result was improved echocardiographic response at 6 months – defined as a greater than 15% change in left ventricular end systolic volume (LVESV) from baseline to 6-month follow-up. The STE group had a 70% response as compared with a 55% response in the group with conventional lead placement without echocardiography guidance (P = .031), reported Dr. Fakhar Z. Khan, of Cambridge (U.K.) University, who reported the results of TARGET on April 5 at the annual meeting of the American College of Cardiology.

Lower rates were also seen with STE for the combined end point of all-cause mortality and heart failure hospitalization. The difference was primarily driven by fewer heart failure hospitalizations. Looking at mortality alone at a mean follow-up of 400 days, the two groups did not significantly differ.

"This is a well-designed, well-conducted study with impressive differences in clinical outcomes," said Dr. Byron Kwock Lee, who is with the University of California, San Francisco, and chaired the session where the TARGET results were presented. "Other studies have shown echocardiographic outcomes but have had difficulty showing clinical differences."

"I am impressed that the modest echocardiographic changes translated to dramatic clinical effects," commented Dr. Michael Crawford, also of the University of California, San Francisco, and a panelist at the presentation of the study results.

Up to 40% of patients fail to gain significant clinical benefit from cardiac resynchronization therapy, Dr. Khan noted. The position of the left ventricular lead has emerged as an important determinant of response, with better results achieved when pacing at the latest site of contraction and lesser responses noted when pacing areas of scar.

Speckle tracking radial strain imaging correlates with delayed enhanced cardiac MRI for determination of scar, Dr. Khan said. In patients undergoing cardiac resynchronization therapy, less than 10% amplitude of radial strain at the left ventricular pacing site has a high negative predictive value (91%) for response.

Using STE, "we found that concordant lead placement, baseline dyssynchrony, and pacing away from areas of scar are strongly related to improved outcomes," he said.

The single blinded, randomized, controlled trial enrolled 220 patients recruited from three different hospitals in the U.K. Participants were in sinus rhythm, had severe heart failure (NYHA Class III/IV), left ventricular ejection fractions less than 35%, and QRS intervals greater than 120 msec. Patients were randomized in a 1:1 ratio to receive either standard lead placement without the benefit of echocardiographic guidance or targeted lead placement using STE to position the lead at the latest site of contraction and away from areas of scar. Following implantation, all devices were optimized using echocardiography.

Concordant lead placement was achieved in 61% of the STE group vs. 45% of control group. Placement was adjacent in 25% of the STE group and 28% of the control group, and was remote in 10% and 24%, respectively.

At baseline, both groups were comparable in demographic and disease characteristics. Mean age was about 70 years, about 86% were male, about 94% had NYHA Class III heart failure, and 56% had underlying ischemic cardiomyopathy.

Both groups had a 14% rate of implant-related complications. Procedural length of time was similar for both groups.

In addition to the primary end point improvements in echocardiographic response at 6-month follow-up, the STE group also had significantly improved clinical end points, compared with the standard placement group. Statistically significant differences from baseline to follow-up for the STE group vs. the standard placement group included improvement in heart failure class (P = .002), 6-mile walk test results (P = .01), and quality-of-life scores. (P = .02).

Patients in the study will continue to have ongoing follow-up.

"STE software can be applied to any existing echocardiographic image at no additional risk to the patient," Dr. Khan said. "STE makes targeting of the lead feasible at any facility that performs echocardiography and has the software available to analyze their images, so it is widely accessible at smaller centers and nonacademic hospitals where more and more pacemakers are being implanted. That being said, it requires training and experience."

Dr. Khan had no relevant financial disclosures.

NEW ORLEANS – A yet-to-be approved platinum chromium everolimus-eluting stent was found to be noninferior to the cobalt chromium everolimus-eluting stent – the most widely used stent in the United States, according to results of the large, randomized PLATINUM trial presented April 4 at the annual meeting of the American College of Cardiology.

At 1 year following implantation, both stents were associated with similar rates of cardiac death, myocardial infarction, and ischemia-driven target lesion revascularization.

Prior to this study, the cobalt chromium everolimus-eluting stent (XSCIENCE V PROMUS) set a new standard for safety and efficacy. The new platinum chromium everolimus-eluting stent (PROMUS Element) incorporates the same concentration of active antiproliferative drug and the same polymer, but uses a different metallic stent backbone whereby platinum replaces cobalt, explained lead author Dr. Gregg W. Stone, professor of medicine and director of cardiovascular research at New York Presbyterian Hospital/Columbia University Medical Center in New York City.

Theoretical advantages of the new backbone include improved deployment, vessel conformability, side branch access, radiopacity, radial strength, and functional resistance, Dr. Stone noted.

"On the basis of this study, I would expect the [Food and Drug Administration] to approve this device in the U.S., giving physicians another option of an excellent stent to use," he added.

The international study was conducted at 132 sites and included 1,530 patients undergoing angioplasty in one or two native coronary arteries with de novo target lesions. Patients were enrolled in the trial between January and September of 2009, and were randomized in a 1:1 ratio to receive either the new platinum chromium stent or the control cobalt chromium stent. Participants are being evaluated at months 1, 6, 12, and 18, and then yearly at years 2-5. At the meeting, Dr. Stone presented 1-year results of the ongoing trial.

Both groups had similar baseline demographic characteristics. Mean age was about 63 years, 71% were male, 72% had hypertension, 77% had hyperlipidemia, 23% had diabetes, 20% were current smokers, 21% had prior myocardial infarction, and 24% had unstable angina. Target lesion characteristics were similar between groups at baseline, including number of lesions treated, diameter, and lesion length. Procedural characteristics also were similar between groups, including the number of stents per patient and per target lesion, maximum stent diameter and length per lesion, and fluoroscopy time.

Technical success, as well as clinical procedural success, was achieved in more than 98% of both groups. Unplanned bail-out stenting was needed in twice as many procedures with the older stent compared with the platinum chromium stent: 9.8% versus 5.9% (P = .004). Inadequate lesion coverage occurred in 3.4% versus 1.4%, respectively (P = .01). Procedural and angiographic outcomes and antiplatelet use were similar for both groups.

For the primary end point of target lesion failure at 12 months, the platinum-chromium stent was noninferior; 2.9% of the cobalt chromium stent versus 3.4% of the platinum chromium stent met the primary end point in a per-protocol analysis. According to an intent-to-treat analysis, 3.2% and 3.5%, respectively, met the primary end point. The incidence of death or myocardial infarction was similar for both groups. Need for ischemia-driven target vessel revascularization was also quite low (around 2.8%) and similar between the groups. Stent thrombosis occurred in 0.4% of each group.

"In this study, 1 in 33 patients had an adverse event at 1 year of follow-up and 1 in 50 had recurrent ischemia with restenosis necessitating revascularization. These are excellent results," Dr. Stone emphasized.

He cautioned, however, that patients included in the trial had simpler coronary lesions, and that experience in a much larger number of patients is needed to be able to tease out true differences between the platinum and the cobalt stents.

Dr. Edward McNulty, an interventional cardiologist at Kaiser Permanente in San Francisco, agreed. At a press conference, he noted that "the different nuances between available stents do not come to light until these devices are used in thousands of patients. This will become evident from large registries and feedback from operators."

"These results are hard to beat," said Dr. Martin Leon, an interventional cardiologist at New York Presbyterian Hospital/Columbia University Medical Center. "The rate of repeat revascularization was really low."

When asked how interventionalists would choose between available drug-eluting stents, Dr. Leon commented, "It’s like the difference between a BMW and an Audi. Subtle differences may appeal more to one person than another. It is going to be very hard to distinguish between them."

Dr. Stone disclosed financial ties with Boston Scientific, which funded the study, Abbott Vascular, and Medtronic. Dr. McNulty had no financial disclosures, and Dr. Leon is an unpaid adviser to several device companies.

NEW ORLEANS – A yet-to-be approved platinum chromium everolimus-eluting stent was found to be noninferior to the cobalt chromium everolimus-eluting stent – the most widely used stent in the United States, according to results of the large, randomized PLATINUM trial presented April 4 at the annual meeting of the American College of Cardiology.

At 1 year following implantation, both stents were associated with similar rates of cardiac death, myocardial infarction, and ischemia-driven target lesion revascularization.

Prior to this study, the cobalt chromium everolimus-eluting stent (XSCIENCE V PROMUS) set a new standard for safety and efficacy. The new platinum chromium everolimus-eluting stent (PROMUS Element) incorporates the same concentration of active antiproliferative drug and the same polymer, but uses a different metallic stent backbone whereby platinum replaces cobalt, explained lead author Dr. Gregg W. Stone, professor of medicine and director of cardiovascular research at New York Presbyterian Hospital/Columbia University Medical Center in New York City.

Theoretical advantages of the new backbone include improved deployment, vessel conformability, side branch access, radiopacity, radial strength, and functional resistance, Dr. Stone noted.

"On the basis of this study, I would expect the [Food and Drug Administration] to approve this device in the U.S., giving physicians another option of an excellent stent to use," he added.

The international study was conducted at 132 sites and included 1,530 patients undergoing angioplasty in one or two native coronary arteries with de novo target lesions. Patients were enrolled in the trial between January and September of 2009, and were randomized in a 1:1 ratio to receive either the new platinum chromium stent or the control cobalt chromium stent. Participants are being evaluated at months 1, 6, 12, and 18, and then yearly at years 2-5. At the meeting, Dr. Stone presented 1-year results of the ongoing trial.

Both groups had similar baseline demographic characteristics. Mean age was about 63 years, 71% were male, 72% had hypertension, 77% had hyperlipidemia, 23% had diabetes, 20% were current smokers, 21% had prior myocardial infarction, and 24% had unstable angina. Target lesion characteristics were similar between groups at baseline, including number of lesions treated, diameter, and lesion length. Procedural characteristics also were similar between groups, including the number of stents per patient and per target lesion, maximum stent diameter and length per lesion, and fluoroscopy time.

Technical success, as well as clinical procedural success, was achieved in more than 98% of both groups. Unplanned bail-out stenting was needed in twice as many procedures with the older stent compared with the platinum chromium stent: 9.8% versus 5.9% (P = .004). Inadequate lesion coverage occurred in 3.4% versus 1.4%, respectively (P = .01). Procedural and angiographic outcomes and antiplatelet use were similar for both groups.

For the primary end point of target lesion failure at 12 months, the platinum-chromium stent was noninferior; 2.9% of the cobalt chromium stent versus 3.4% of the platinum chromium stent met the primary end point in a per-protocol analysis. According to an intent-to-treat analysis, 3.2% and 3.5%, respectively, met the primary end point. The incidence of death or myocardial infarction was similar for both groups. Need for ischemia-driven target vessel revascularization was also quite low (around 2.8%) and similar between the groups. Stent thrombosis occurred in 0.4% of each group.

"In this study, 1 in 33 patients had an adverse event at 1 year of follow-up and 1 in 50 had recurrent ischemia with restenosis necessitating revascularization. These are excellent results," Dr. Stone emphasized.

He cautioned, however, that patients included in the trial had simpler coronary lesions, and that experience in a much larger number of patients is needed to be able to tease out true differences between the platinum and the cobalt stents.

Dr. Edward McNulty, an interventional cardiologist at Kaiser Permanente in San Francisco, agreed. At a press conference, he noted that "the different nuances between available stents do not come to light until these devices are used in thousands of patients. This will become evident from large registries and feedback from operators."

"These results are hard to beat," said Dr. Martin Leon, an interventional cardiologist at New York Presbyterian Hospital/Columbia University Medical Center. "The rate of repeat revascularization was really low."

When asked how interventionalists would choose between available drug-eluting stents, Dr. Leon commented, "It’s like the difference between a BMW and an Audi. Subtle differences may appeal more to one person than another. It is going to be very hard to distinguish between them."

Dr. Stone disclosed financial ties with Boston Scientific, which funded the study, Abbott Vascular, and Medtronic. Dr. McNulty had no financial disclosures, and Dr. Leon is an unpaid adviser to several device companies.

NEW ORLEANS – A yet-to-be approved platinum chromium everolimus-eluting stent was found to be noninferior to the cobalt chromium everolimus-eluting stent – the most widely used stent in the United States, according to results of the large, randomized PLATINUM trial presented April 4 at the annual meeting of the American College of Cardiology.

At 1 year following implantation, both stents were associated with similar rates of cardiac death, myocardial infarction, and ischemia-driven target lesion revascularization.

Prior to this study, the cobalt chromium everolimus-eluting stent (XSCIENCE V PROMUS) set a new standard for safety and efficacy. The new platinum chromium everolimus-eluting stent (PROMUS Element) incorporates the same concentration of active antiproliferative drug and the same polymer, but uses a different metallic stent backbone whereby platinum replaces cobalt, explained lead author Dr. Gregg W. Stone, professor of medicine and director of cardiovascular research at New York Presbyterian Hospital/Columbia University Medical Center in New York City.

Theoretical advantages of the new backbone include improved deployment, vessel conformability, side branch access, radiopacity, radial strength, and functional resistance, Dr. Stone noted.

"On the basis of this study, I would expect the [Food and Drug Administration] to approve this device in the U.S., giving physicians another option of an excellent stent to use," he added.

The international study was conducted at 132 sites and included 1,530 patients undergoing angioplasty in one or two native coronary arteries with de novo target lesions. Patients were enrolled in the trial between January and September of 2009, and were randomized in a 1:1 ratio to receive either the new platinum chromium stent or the control cobalt chromium stent. Participants are being evaluated at months 1, 6, 12, and 18, and then yearly at years 2-5. At the meeting, Dr. Stone presented 1-year results of the ongoing trial.

Both groups had similar baseline demographic characteristics. Mean age was about 63 years, 71% were male, 72% had hypertension, 77% had hyperlipidemia, 23% had diabetes, 20% were current smokers, 21% had prior myocardial infarction, and 24% had unstable angina. Target lesion characteristics were similar between groups at baseline, including number of lesions treated, diameter, and lesion length. Procedural characteristics also were similar between groups, including the number of stents per patient and per target lesion, maximum stent diameter and length per lesion, and fluoroscopy time.

Technical success, as well as clinical procedural success, was achieved in more than 98% of both groups. Unplanned bail-out stenting was needed in twice as many procedures with the older stent compared with the platinum chromium stent: 9.8% versus 5.9% (P = .004). Inadequate lesion coverage occurred in 3.4% versus 1.4%, respectively (P = .01). Procedural and angiographic outcomes and antiplatelet use were similar for both groups.

For the primary end point of target lesion failure at 12 months, the platinum-chromium stent was noninferior; 2.9% of the cobalt chromium stent versus 3.4% of the platinum chromium stent met the primary end point in a per-protocol analysis. According to an intent-to-treat analysis, 3.2% and 3.5%, respectively, met the primary end point. The incidence of death or myocardial infarction was similar for both groups. Need for ischemia-driven target vessel revascularization was also quite low (around 2.8%) and similar between the groups. Stent thrombosis occurred in 0.4% of each group.

"In this study, 1 in 33 patients had an adverse event at 1 year of follow-up and 1 in 50 had recurrent ischemia with restenosis necessitating revascularization. These are excellent results," Dr. Stone emphasized.

He cautioned, however, that patients included in the trial had simpler coronary lesions, and that experience in a much larger number of patients is needed to be able to tease out true differences between the platinum and the cobalt stents.

Dr. Edward McNulty, an interventional cardiologist at Kaiser Permanente in San Francisco, agreed. At a press conference, he noted that "the different nuances between available stents do not come to light until these devices are used in thousands of patients. This will become evident from large registries and feedback from operators."

"These results are hard to beat," said Dr. Martin Leon, an interventional cardiologist at New York Presbyterian Hospital/Columbia University Medical Center. "The rate of repeat revascularization was really low."

When asked how interventionalists would choose between available drug-eluting stents, Dr. Leon commented, "It’s like the difference between a BMW and an Audi. Subtle differences may appeal more to one person than another. It is going to be very hard to distinguish between them."

Dr. Stone disclosed financial ties with Boston Scientific, which funded the study, Abbott Vascular, and Medtronic. Dr. McNulty had no financial disclosures, and Dr. Leon is an unpaid adviser to several device companies.

NEW ORLEANS – A yet-to-be approved platinum chromium everolimus-eluting stent was found to be noninferior to the cobalt chromium everolimus-eluting stent – the most widely used stent in the United States, according to results of the large, randomized PLATINUM trial presented April 4 at the annual meeting of the American College of Cardiology.

At 1 year following implantation, both stents were associated with similar rates of cardiac death, myocardial infarction, and ischemia-driven target lesion revascularization.

Prior to this study, the cobalt chromium everolimus-eluting stent (XSCIENCE V PROMUS) set a new standard for safety and efficacy. The new platinum chromium everolimus-eluting stent (PROMUS Element) incorporates the same concentration of active antiproliferative drug and the same polymer, but uses a different metallic stent backbone whereby platinum replaces cobalt, explained lead author Dr. Gregg W. Stone, professor of medicine and director of cardiovascular research at New York Presbyterian Hospital/Columbia University Medical Center in New York City.

Theoretical advantages of the new backbone include improved deployment, vessel conformability, side branch access, radiopacity, radial strength, and functional resistance, Dr. Stone noted.

"On the basis of this study, I would expect the [Food and Drug Administration] to approve this device in the U.S., giving physicians another option of an excellent stent to use," he added.

The international study was conducted at 132 sites and included 1,530 patients undergoing angioplasty in one or two native coronary arteries with de novo target lesions. Patients were enrolled in the trial between January and September of 2009, and were randomized in a 1:1 ratio to receive either the new platinum chromium stent or the control cobalt chromium stent. Participants are being evaluated at months 1, 6, 12, and 18, and then yearly at years 2-5. At the meeting, Dr. Stone presented 1-year results of the ongoing trial.

Both groups had similar baseline demographic characteristics. Mean age was about 63 years, 71% were male, 72% had hypertension, 77% had hyperlipidemia, 23% had diabetes, 20% were current smokers, 21% had prior myocardial infarction, and 24% had unstable angina. Target lesion characteristics were similar between groups at baseline, including number of lesions treated, diameter, and lesion length. Procedural characteristics also were similar between groups, including the number of stents per patient and per target lesion, maximum stent diameter and length per lesion, and fluoroscopy time.

Technical success, as well as clinical procedural success, was achieved in more than 98% of both groups. Unplanned bail-out stenting was needed in twice as many procedures with the older stent compared with the platinum chromium stent: 9.8% versus 5.9% (P = .004). Inadequate lesion coverage occurred in 3.4% versus 1.4%, respectively (P = .01). Procedural and angiographic outcomes and antiplatelet use were similar for both groups.

For the primary end point of target lesion failure at 12 months, the platinum-chromium stent was noninferior; 2.9% of the cobalt chromium stent versus 3.4% of the platinum chromium stent met the primary end point in a per-protocol analysis. According to an intent-to-treat analysis, 3.2% and 3.5%, respectively, met the primary end point. The incidence of death or myocardial infarction was similar for both groups. Need for ischemia-driven target vessel revascularization was also quite low (around 2.8%) and similar between the groups. Stent thrombosis occurred in 0.4% of each group.

"In this study, 1 in 33 patients had an adverse event at 1 year of follow-up and 1 in 50 had recurrent ischemia with restenosis necessitating revascularization. These are excellent results," Dr. Stone emphasized.

He cautioned, however, that patients included in the trial had simpler coronary lesions, and that experience in a much larger number of patients is needed to be able to tease out true differences between the platinum and the cobalt stents.

Dr. Edward McNulty, an interventional cardiologist at Kaiser Permanente in San Francisco, agreed. At a press conference, he noted that "the different nuances between available stents do not come to light until these devices are used in thousands of patients. This will become evident from large registries and feedback from operators."

"These results are hard to beat," said Dr. Martin Leon, an interventional cardiologist at New York Presbyterian Hospital/Columbia University Medical Center. "The rate of repeat revascularization was really low."

When asked how interventionalists would choose between available drug-eluting stents, Dr. Leon commented, "It’s like the difference between a BMW and an Audi. Subtle differences may appeal more to one person than another. It is going to be very hard to distinguish between them."

Dr. Stone disclosed financial ties with Boston Scientific, which funded the study, Abbott Vascular, and Medtronic. Dr. McNulty had no financial disclosures, and Dr. Leon is an unpaid adviser to several device companies.

NEW ORLEANS – A yet-to-be approved platinum chromium everolimus-eluting stent was found to be noninferior to the cobalt chromium everolimus-eluting stent – the most widely used stent in the United States, according to results of the large, randomized PLATINUM trial presented April 4 at the annual meeting of the American College of Cardiology.

At 1 year following implantation, both stents were associated with similar rates of cardiac death, myocardial infarction, and ischemia-driven target lesion revascularization.

Prior to this study, the cobalt chromium everolimus-eluting stent (XSCIENCE V PROMUS) set a new standard for safety and efficacy. The new platinum chromium everolimus-eluting stent (PROMUS Element) incorporates the same concentration of active antiproliferative drug and the same polymer, but uses a different metallic stent backbone whereby platinum replaces cobalt, explained lead author Dr. Gregg W. Stone, professor of medicine and director of cardiovascular research at New York Presbyterian Hospital/Columbia University Medical Center in New York City.

Theoretical advantages of the new backbone include improved deployment, vessel conformability, side branch access, radiopacity, radial strength, and functional resistance, Dr. Stone noted.

"On the basis of this study, I would expect the [Food and Drug Administration] to approve this device in the U.S., giving physicians another option of an excellent stent to use," he added.

The international study was conducted at 132 sites and included 1,530 patients undergoing angioplasty in one or two native coronary arteries with de novo target lesions. Patients were enrolled in the trial between January and September of 2009, and were randomized in a 1:1 ratio to receive either the new platinum chromium stent or the control cobalt chromium stent. Participants are being evaluated at months 1, 6, 12, and 18, and then yearly at years 2-5. At the meeting, Dr. Stone presented 1-year results of the ongoing trial.

Both groups had similar baseline demographic characteristics. Mean age was about 63 years, 71% were male, 72% had hypertension, 77% had hyperlipidemia, 23% had diabetes, 20% were current smokers, 21% had prior myocardial infarction, and 24% had unstable angina. Target lesion characteristics were similar between groups at baseline, including number of lesions treated, diameter, and lesion length. Procedural characteristics also were similar between groups, including the number of stents per patient and per target lesion, maximum stent diameter and length per lesion, and fluoroscopy time.

Technical success, as well as clinical procedural success, was achieved in more than 98% of both groups. Unplanned bail-out stenting was needed in twice as many procedures with the older stent compared with the platinum chromium stent: 9.8% versus 5.9% (P = .004). Inadequate lesion coverage occurred in 3.4% versus 1.4%, respectively (P = .01). Procedural and angiographic outcomes and antiplatelet use were similar for both groups.

For the primary end point of target lesion failure at 12 months, the platinum-chromium stent was noninferior; 2.9% of the cobalt chromium stent versus 3.4% of the platinum chromium stent met the primary end point in a per-protocol analysis. According to an intent-to-treat analysis, 3.2% and 3.5%, respectively, met the primary end point. The incidence of death or myocardial infarction was similar for both groups. Need for ischemia-driven target vessel revascularization was also quite low (around 2.8%) and similar between the groups. Stent thrombosis occurred in 0.4% of each group.

"In this study, 1 in 33 patients had an adverse event at 1 year of follow-up and 1 in 50 had recurrent ischemia with restenosis necessitating revascularization. These are excellent results," Dr. Stone emphasized.

He cautioned, however, that patients included in the trial had simpler coronary lesions, and that experience in a much larger number of patients is needed to be able to tease out true differences between the platinum and the cobalt stents.

Dr. Edward McNulty, an interventional cardiologist at Kaiser Permanente in San Francisco, agreed. At a press conference, he noted that "the different nuances between available stents do not come to light until these devices are used in thousands of patients. This will become evident from large registries and feedback from operators."

"These results are hard to beat," said Dr. Martin Leon, an interventional cardiologist at New York Presbyterian Hospital/Columbia University Medical Center. "The rate of repeat revascularization was really low."

When asked how interventionalists would choose between available drug-eluting stents, Dr. Leon commented, "It’s like the difference between a BMW and an Audi. Subtle differences may appeal more to one person than another. It is going to be very hard to distinguish between them."

Dr. Stone disclosed financial ties with Boston Scientific, which funded the study, Abbott Vascular, and Medtronic. Dr. McNulty had no financial disclosures, and Dr. Leon is an unpaid adviser to several device companies.

NEW ORLEANS – A yet-to-be approved platinum chromium everolimus-eluting stent was found to be noninferior to the cobalt chromium everolimus-eluting stent – the most widely used stent in the United States, according to results of the large, randomized PLATINUM trial presented April 4 at the annual meeting of the American College of Cardiology.

At 1 year following implantation, both stents were associated with similar rates of cardiac death, myocardial infarction, and ischemia-driven target lesion revascularization.

Prior to this study, the cobalt chromium everolimus-eluting stent (XSCIENCE V PROMUS) set a new standard for safety and efficacy. The new platinum chromium everolimus-eluting stent (PROMUS Element) incorporates the same concentration of active antiproliferative drug and the same polymer, but uses a different metallic stent backbone whereby platinum replaces cobalt, explained lead author Dr. Gregg W. Stone, professor of medicine and director of cardiovascular research at New York Presbyterian Hospital/Columbia University Medical Center in New York City.

Theoretical advantages of the new backbone include improved deployment, vessel conformability, side branch access, radiopacity, radial strength, and functional resistance, Dr. Stone noted.

"On the basis of this study, I would expect the [Food and Drug Administration] to approve this device in the U.S., giving physicians another option of an excellent stent to use," he added.

The international study was conducted at 132 sites and included 1,530 patients undergoing angioplasty in one or two native coronary arteries with de novo target lesions. Patients were enrolled in the trial between January and September of 2009, and were randomized in a 1:1 ratio to receive either the new platinum chromium stent or the control cobalt chromium stent. Participants are being evaluated at months 1, 6, 12, and 18, and then yearly at years 2-5. At the meeting, Dr. Stone presented 1-year results of the ongoing trial.

Both groups had similar baseline demographic characteristics. Mean age was about 63 years, 71% were male, 72% had hypertension, 77% had hyperlipidemia, 23% had diabetes, 20% were current smokers, 21% had prior myocardial infarction, and 24% had unstable angina. Target lesion characteristics were similar between groups at baseline, including number of lesions treated, diameter, and lesion length. Procedural characteristics also were similar between groups, including the number of stents per patient and per target lesion, maximum stent diameter and length per lesion, and fluoroscopy time.

Technical success, as well as clinical procedural success, was achieved in more than 98% of both groups. Unplanned bail-out stenting was needed in twice as many procedures with the older stent compared with the platinum chromium stent: 9.8% versus 5.9% (P = .004). Inadequate lesion coverage occurred in 3.4% versus 1.4%, respectively (P = .01). Procedural and angiographic outcomes and antiplatelet use were similar for both groups.

For the primary end point of target lesion failure at 12 months, the platinum-chromium stent was noninferior; 2.9% of the cobalt chromium stent versus 3.4% of the platinum chromium stent met the primary end point in a per-protocol analysis. According to an intent-to-treat analysis, 3.2% and 3.5%, respectively, met the primary end point. The incidence of death or myocardial infarction was similar for both groups. Need for ischemia-driven target vessel revascularization was also quite low (around 2.8%) and similar between the groups. Stent thrombosis occurred in 0.4% of each group.

"In this study, 1 in 33 patients had an adverse event at 1 year of follow-up and 1 in 50 had recurrent ischemia with restenosis necessitating revascularization. These are excellent results," Dr. Stone emphasized.

He cautioned, however, that patients included in the trial had simpler coronary lesions, and that experience in a much larger number of patients is needed to be able to tease out true differences between the platinum and the cobalt stents.

Dr. Edward McNulty, an interventional cardiologist at Kaiser Permanente in San Francisco, agreed. At a press conference, he noted that "the different nuances between available stents do not come to light until these devices are used in thousands of patients. This will become evident from large registries and feedback from operators."

"These results are hard to beat," said Dr. Martin Leon, an interventional cardiologist at New York Presbyterian Hospital/Columbia University Medical Center. "The rate of repeat revascularization was really low."

When asked how interventionalists would choose between available drug-eluting stents, Dr. Leon commented, "It’s like the difference between a BMW and an Audi. Subtle differences may appeal more to one person than another. It is going to be very hard to distinguish between them."

Dr. Stone disclosed financial ties with Boston Scientific, which funded the study, Abbott Vascular, and Medtronic. Dr. McNulty had no financial disclosures, and Dr. Leon is an unpaid adviser to several device companies.

NEW ORLEANS – A yet-to-be approved platinum chromium everolimus-eluting stent was found to be noninferior to the cobalt chromium everolimus-eluting stent – the most widely used stent in the United States, according to results of the large, randomized PLATINUM trial presented April 4 at the annual meeting of the American College of Cardiology.

At 1 year following implantation, both stents were associated with similar rates of cardiac death, myocardial infarction, and ischemia-driven target lesion revascularization.

Prior to this study, the cobalt chromium everolimus-eluting stent (XSCIENCE V PROMUS) set a new standard for safety and efficacy. The new platinum chromium everolimus-eluting stent (PROMUS Element) incorporates the same concentration of active antiproliferative drug and the same polymer, but uses a different metallic stent backbone whereby platinum replaces cobalt, explained lead author Dr. Gregg W. Stone, professor of medicine and director of cardiovascular research at New York Presbyterian Hospital/Columbia University Medical Center in New York City.

Theoretical advantages of the new backbone include improved deployment, vessel conformability, side branch access, radiopacity, radial strength, and functional resistance, Dr. Stone noted.

"On the basis of this study, I would expect the [Food and Drug Administration] to approve this device in the U.S., giving physicians another option of an excellent stent to use," he added.

The international study was conducted at 132 sites and included 1,530 patients undergoing angioplasty in one or two native coronary arteries with de novo target lesions. Patients were enrolled in the trial between January and September of 2009, and were randomized in a 1:1 ratio to receive either the new platinum chromium stent or the control cobalt chromium stent. Participants are being evaluated at months 1, 6, 12, and 18, and then yearly at years 2-5. At the meeting, Dr. Stone presented 1-year results of the ongoing trial.

Both groups had similar baseline demographic characteristics. Mean age was about 63 years, 71% were male, 72% had hypertension, 77% had hyperlipidemia, 23% had diabetes, 20% were current smokers, 21% had prior myocardial infarction, and 24% had unstable angina. Target lesion characteristics were similar between groups at baseline, including number of lesions treated, diameter, and lesion length. Procedural characteristics also were similar between groups, including the number of stents per patient and per target lesion, maximum stent diameter and length per lesion, and fluoroscopy time.

Technical success, as well as clinical procedural success, was achieved in more than 98% of both groups. Unplanned bail-out stenting was needed in twice as many procedures with the older stent compared with the platinum chromium stent: 9.8% versus 5.9% (P = .004). Inadequate lesion coverage occurred in 3.4% versus 1.4%, respectively (P = .01). Procedural and angiographic outcomes and antiplatelet use were similar for both groups.

For the primary end point of target lesion failure at 12 months, the platinum-chromium stent was noninferior; 2.9% of the cobalt chromium stent versus 3.4% of the platinum chromium stent met the primary end point in a per-protocol analysis. According to an intent-to-treat analysis, 3.2% and 3.5%, respectively, met the primary end point. The incidence of death or myocardial infarction was similar for both groups. Need for ischemia-driven target vessel revascularization was also quite low (around 2.8%) and similar between the groups. Stent thrombosis occurred in 0.4% of each group.

"In this study, 1 in 33 patients had an adverse event at 1 year of follow-up and 1 in 50 had recurrent ischemia with restenosis necessitating revascularization. These are excellent results," Dr. Stone emphasized.

He cautioned, however, that patients included in the trial had simpler coronary lesions, and that experience in a much larger number of patients is needed to be able to tease out true differences between the platinum and the cobalt stents.

Dr. Edward McNulty, an interventional cardiologist at Kaiser Permanente in San Francisco, agreed. At a press conference, he noted that "the different nuances between available stents do not come to light until these devices are used in thousands of patients. This will become evident from large registries and feedback from operators."

"These results are hard to beat," said Dr. Martin Leon, an interventional cardiologist at New York Presbyterian Hospital/Columbia University Medical Center. "The rate of repeat revascularization was really low."

When asked how interventionalists would choose between available drug-eluting stents, Dr. Leon commented, "It’s like the difference between a BMW and an Audi. Subtle differences may appeal more to one person than another. It is going to be very hard to distinguish between them."

Dr. Stone disclosed financial ties with Boston Scientific, which funded the study, Abbott Vascular, and Medtronic. Dr. McNulty had no financial disclosures, and Dr. Leon is an unpaid adviser to several device companies.

NEW ORLEANS – A yet-to-be approved platinum chromium everolimus-eluting stent was found to be noninferior to the cobalt chromium everolimus-eluting stent – the most widely used stent in the United States, according to results of the large, randomized PLATINUM trial presented April 4 at the annual meeting of the American College of Cardiology.

At 1 year following implantation, both stents were associated with similar rates of cardiac death, myocardial infarction, and ischemia-driven target lesion revascularization.

Prior to this study, the cobalt chromium everolimus-eluting stent (XSCIENCE V PROMUS) set a new standard for safety and efficacy. The new platinum chromium everolimus-eluting stent (PROMUS Element) incorporates the same concentration of active antiproliferative drug and the same polymer, but uses a different metallic stent backbone whereby platinum replaces cobalt, explained lead author Dr. Gregg W. Stone, professor of medicine and director of cardiovascular research at New York Presbyterian Hospital/Columbia University Medical Center in New York City.

Theoretical advantages of the new backbone include improved deployment, vessel conformability, side branch access, radiopacity, radial strength, and functional resistance, Dr. Stone noted.

"On the basis of this study, I would expect the [Food and Drug Administration] to approve this device in the U.S., giving physicians another option of an excellent stent to use," he added.

The international study was conducted at 132 sites and included 1,530 patients undergoing angioplasty in one or two native coronary arteries with de novo target lesions. Patients were enrolled in the trial between January and September of 2009, and were randomized in a 1:1 ratio to receive either the new platinum chromium stent or the control cobalt chromium stent. Participants are being evaluated at months 1, 6, 12, and 18, and then yearly at years 2-5. At the meeting, Dr. Stone presented 1-year results of the ongoing trial.

Both groups had similar baseline demographic characteristics. Mean age was about 63 years, 71% were male, 72% had hypertension, 77% had hyperlipidemia, 23% had diabetes, 20% were current smokers, 21% had prior myocardial infarction, and 24% had unstable angina. Target lesion characteristics were similar between groups at baseline, including number of lesions treated, diameter, and lesion length. Procedural characteristics also were similar between groups, including the number of stents per patient and per target lesion, maximum stent diameter and length per lesion, and fluoroscopy time.

Technical success, as well as clinical procedural success, was achieved in more than 98% of both groups. Unplanned bail-out stenting was needed in twice as many procedures with the older stent compared with the platinum chromium stent: 9.8% versus 5.9% (P = .004). Inadequate lesion coverage occurred in 3.4% versus 1.4%, respectively (P = .01). Procedural and angiographic outcomes and antiplatelet use were similar for both groups.

For the primary end point of target lesion failure at 12 months, the platinum-chromium stent was noninferior; 2.9% of the cobalt chromium stent versus 3.4% of the platinum chromium stent met the primary end point in a per-protocol analysis. According to an intent-to-treat analysis, 3.2% and 3.5%, respectively, met the primary end point. The incidence of death or myocardial infarction was similar for both groups. Need for ischemia-driven target vessel revascularization was also quite low (around 2.8%) and similar between the groups. Stent thrombosis occurred in 0.4% of each group.

"In this study, 1 in 33 patients had an adverse event at 1 year of follow-up and 1 in 50 had recurrent ischemia with restenosis necessitating revascularization. These are excellent results," Dr. Stone emphasized.

He cautioned, however, that patients included in the trial had simpler coronary lesions, and that experience in a much larger number of patients is needed to be able to tease out true differences between the platinum and the cobalt stents.

Dr. Edward McNulty, an interventional cardiologist at Kaiser Permanente in San Francisco, agreed. At a press conference, he noted that "the different nuances between available stents do not come to light until these devices are used in thousands of patients. This will become evident from large registries and feedback from operators."

"These results are hard to beat," said Dr. Martin Leon, an interventional cardiologist at New York Presbyterian Hospital/Columbia University Medical Center. "The rate of repeat revascularization was really low."

When asked how interventionalists would choose between available drug-eluting stents, Dr. Leon commented, "It’s like the difference between a BMW and an Audi. Subtle differences may appeal more to one person than another. It is going to be very hard to distinguish between them."

Dr. Stone disclosed financial ties with Boston Scientific, which funded the study, Abbott Vascular, and Medtronic. Dr. McNulty had no financial disclosures, and Dr. Leon is an unpaid adviser to several device companies.

NEW ORLEANS – A yet-to-be approved platinum chromium everolimus-eluting stent was found to be noninferior to the cobalt chromium everolimus-eluting stent – the most widely used stent in the United States, according to results of the large, randomized PLATINUM trial presented April 4 at the annual meeting of the American College of Cardiology.

At 1 year following implantation, both stents were associated with similar rates of cardiac death, myocardial infarction, and ischemia-driven target lesion revascularization.

Prior to this study, the cobalt chromium everolimus-eluting stent (XSCIENCE V PROMUS) set a new standard for safety and efficacy. The new platinum chromium everolimus-eluting stent (PROMUS Element) incorporates the same concentration of active antiproliferative drug and the same polymer, but uses a different metallic stent backbone whereby platinum replaces cobalt, explained lead author Dr. Gregg W. Stone, professor of medicine and director of cardiovascular research at New York Presbyterian Hospital/Columbia University Medical Center in New York City.

Theoretical advantages of the new backbone include improved deployment, vessel conformability, side branch access, radiopacity, radial strength, and functional resistance, Dr. Stone noted.

"On the basis of this study, I would expect the [Food and Drug Administration] to approve this device in the U.S., giving physicians another option of an excellent stent to use," he added.

The international study was conducted at 132 sites and included 1,530 patients undergoing angioplasty in one or two native coronary arteries with de novo target lesions. Patients were enrolled in the trial between January and September of 2009, and were randomized in a 1:1 ratio to receive either the new platinum chromium stent or the control cobalt chromium stent. Participants are being evaluated at months 1, 6, 12, and 18, and then yearly at years 2-5. At the meeting, Dr. Stone presented 1-year results of the ongoing trial.

Both groups had similar baseline demographic characteristics. Mean age was about 63 years, 71% were male, 72% had hypertension, 77% had hyperlipidemia, 23% had diabetes, 20% were current smokers, 21% had prior myocardial infarction, and 24% had unstable angina. Target lesion characteristics were similar between groups at baseline, including number of lesions treated, diameter, and lesion length. Procedural characteristics also were similar between groups, including the number of stents per patient and per target lesion, maximum stent diameter and length per lesion, and fluoroscopy time.

Technical success, as well as clinical procedural success, was achieved in more than 98% of both groups. Unplanned bail-out stenting was needed in twice as many procedures with the older stent compared with the platinum chromium stent: 9.8% versus 5.9% (P = .004). Inadequate lesion coverage occurred in 3.4% versus 1.4%, respectively (P = .01). Procedural and angiographic outcomes and antiplatelet use were similar for both groups.

For the primary end point of target lesion failure at 12 months, the platinum-chromium stent was noninferior; 2.9% of the cobalt chromium stent versus 3.4% of the platinum chromium stent met the primary end point in a per-protocol analysis. According to an intent-to-treat analysis, 3.2% and 3.5%, respectively, met the primary end point. The incidence of death or myocardial infarction was similar for both groups. Need for ischemia-driven target vessel revascularization was also quite low (around 2.8%) and similar between the groups. Stent thrombosis occurred in 0.4% of each group.

"In this study, 1 in 33 patients had an adverse event at 1 year of follow-up and 1 in 50 had recurrent ischemia with restenosis necessitating revascularization. These are excellent results," Dr. Stone emphasized.

He cautioned, however, that patients included in the trial had simpler coronary lesions, and that experience in a much larger number of patients is needed to be able to tease out true differences between the platinum and the cobalt stents.

Dr. Edward McNulty, an interventional cardiologist at Kaiser Permanente in San Francisco, agreed. At a press conference, he noted that "the different nuances between available stents do not come to light until these devices are used in thousands of patients. This will become evident from large registries and feedback from operators."

"These results are hard to beat," said Dr. Martin Leon, an interventional cardiologist at New York Presbyterian Hospital/Columbia University Medical Center. "The rate of repeat revascularization was really low."

When asked how interventionalists would choose between available drug-eluting stents, Dr. Leon commented, "It’s like the difference between a BMW and an Audi. Subtle differences may appeal more to one person than another. It is going to be very hard to distinguish between them."

Dr. Stone disclosed financial ties with Boston Scientific, which funded the study, Abbott Vascular, and Medtronic. Dr. McNulty had no financial disclosures, and Dr. Leon is an unpaid adviser to several device companies.

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 – 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 – 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.