TBD Meeting (3309-18)

 

WASHINGTON – There were no deaths among 125 symptomatic low-risk aortic stenosis patients in the first 30 days after transcatheter aortic valve replacement (TAVR), according to results of the first U.S. study to evaluate mortality in a low-risk population.

Other complications were also low relative to those seen in previously published studies with higher-risk populations. The preliminary results are “reassuring,” Ronald Waksman, MD, associate director of the division of cardiology, Medstar Health Institute, Washington, DC, reported at CRT 2018 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.

Ted Bosworth/MDedge News

The full enrollment of 200 patients has been reached in the main arm of the Low Risk TAVR study, which is evaluating tricuspid TAVR. A second study arm evaluating bicuspid TAVR is still enrolling. The 30-day outcomes data presented at the CRT meeting were restricted to the first 125 patients enrolled.

In this study, a low-risk eligibility criterion is a Society of Thoracic Surgeons score of 3% or less. The mean score in the first 125 patients was 1.9%.

At 30 days, there were no myocardial infarctions, no acute kidney injuries of stage II or greater, and no transient ischemic attacks. There was one nondisabling stroke, one paravalvular leak, and one coronary obstruction that required a coronary artery bypass graft. The rates of new onset atrial fibrillation, major vascular complications, and life-threatening or major bleeding events were lower than 5%.

Surgical atrial valve replacement (SAVR) currently has a IB recommendation for the treatment of symptomatic low-risk aortic stenosis, but TAVR is not currently indicated in this population, according to 2017 American Heart Association/American College of Cardiology guidelines. There is, however, substantial interest in extending TAVR to a low-risk population, according to Dr. Waksman.

“We know that there are potential benefits for TAVR versus SAVR that include reduced ICU and hospital length of stay, more rapid quality of life recovery, lower risk of bleeding, and lower risk of postprocedure AF [atrial fibrillation],” said Dr. Waksman in explaining the rationale for this and other ongoing studies testing TAVR in low-risk patients.

 

In this investigator-initiated study, which was conducted without industry support, 11 sites participated. Most were relatively low-volume centers with fewer than 150 TAVR procedures performed annually, according to Dr. Waksman. The choice of TAVR device was left to the discretion of the operator.

Reflecting a lower-risk population, the mean age of 74.6 years is younger than that of participants in previous TAVR trials. The mean left ventricular ejection fraction was 62.9%. Only 4.8% had a prior MI and 19.2% had a prior coronary artery bypass graft. Most procedures were performed under conscious sedation with fewer than 20% receiving general anesthesia. The mean fluoroscopy time was 16 minutes.

The degree of improvement in hemodynamics following TAVR in this population was called “excellent,” but Dr. Waksman did report a 12.5% incidence of hypo-attenuating leaflet thickening (HALT), an 11% incidence of reduced leaflet motion, and a 9.3% incidence of hypo-attenuation affecting motion. All were subclinical effects.

In a closer analysis of HALT, the rate was 14.4% in the 80.8% of patients who received antiplatelet therapy versus 4.8% in the 17.5% who received oral anticoagulation (some received neither). Dr. Waksman called the greater association of HALT with antiplatelet therapy “a potential signal” that deserves further study.

 

Full results from all 200 patients are expected in the fall of 2018.

Jeffrey Popma, MD, director of the interventional cardiology clinical service, Beth Israel Deaconess Hospital, Boston, and moderator of the session where the data were presented, called for a direct comparison with SAVR in low-risk patients to place the relative role of these options into context.

Neil Moat, a consultant cardiac surgeon at Royal Brompton & Harefield Hospital, London, agreed. Although he is also encouraged by the evidence of safety in low-risk patients, he labeled the rate of HALT in this study “a concern.”

Dr. Waksman reported financial relationships with Abbott Vascular, Amgen, AstraZeneca, Life Technologies, Med Alliance, Medtronic Vascular, and Symetis, among other companies.

 

WASHINGTON – There were no deaths among 125 symptomatic low-risk aortic stenosis patients in the first 30 days after transcatheter aortic valve replacement (TAVR), according to results of the first U.S. study to evaluate mortality in a low-risk population.

Other complications were also low relative to those seen in previously published studies with higher-risk populations. The preliminary results are “reassuring,” Ronald Waksman, MD, associate director of the division of cardiology, Medstar Health Institute, Washington, DC, reported at CRT 2018 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.

Ted Bosworth/MDedge News

The full enrollment of 200 patients has been reached in the main arm of the Low Risk TAVR study, which is evaluating tricuspid TAVR. A second study arm evaluating bicuspid TAVR is still enrolling. The 30-day outcomes data presented at the CRT meeting were restricted to the first 125 patients enrolled.

In this study, a low-risk eligibility criterion is a Society of Thoracic Surgeons score of 3% or less. The mean score in the first 125 patients was 1.9%.

At 30 days, there were no myocardial infarctions, no acute kidney injuries of stage II or greater, and no transient ischemic attacks. There was one nondisabling stroke, one paravalvular leak, and one coronary obstruction that required a coronary artery bypass graft. The rates of new onset atrial fibrillation, major vascular complications, and life-threatening or major bleeding events were lower than 5%.

Surgical atrial valve replacement (SAVR) currently has a IB recommendation for the treatment of symptomatic low-risk aortic stenosis, but TAVR is not currently indicated in this population, according to 2017 American Heart Association/American College of Cardiology guidelines. There is, however, substantial interest in extending TAVR to a low-risk population, according to Dr. Waksman.

“We know that there are potential benefits for TAVR versus SAVR that include reduced ICU and hospital length of stay, more rapid quality of life recovery, lower risk of bleeding, and lower risk of postprocedure AF [atrial fibrillation],” said Dr. Waksman in explaining the rationale for this and other ongoing studies testing TAVR in low-risk patients.

 

In this investigator-initiated study, which was conducted without industry support, 11 sites participated. Most were relatively low-volume centers with fewer than 150 TAVR procedures performed annually, according to Dr. Waksman. The choice of TAVR device was left to the discretion of the operator.

Reflecting a lower-risk population, the mean age of 74.6 years is younger than that of participants in previous TAVR trials. The mean left ventricular ejection fraction was 62.9%. Only 4.8% had a prior MI and 19.2% had a prior coronary artery bypass graft. Most procedures were performed under conscious sedation with fewer than 20% receiving general anesthesia. The mean fluoroscopy time was 16 minutes.

The degree of improvement in hemodynamics following TAVR in this population was called “excellent,” but Dr. Waksman did report a 12.5% incidence of hypo-attenuating leaflet thickening (HALT), an 11% incidence of reduced leaflet motion, and a 9.3% incidence of hypo-attenuation affecting motion. All were subclinical effects.

In a closer analysis of HALT, the rate was 14.4% in the 80.8% of patients who received antiplatelet therapy versus 4.8% in the 17.5% who received oral anticoagulation (some received neither). Dr. Waksman called the greater association of HALT with antiplatelet therapy “a potential signal” that deserves further study.

 

Full results from all 200 patients are expected in the fall of 2018.

Jeffrey Popma, MD, director of the interventional cardiology clinical service, Beth Israel Deaconess Hospital, Boston, and moderator of the session where the data were presented, called for a direct comparison with SAVR in low-risk patients to place the relative role of these options into context.

Neil Moat, a consultant cardiac surgeon at Royal Brompton & Harefield Hospital, London, agreed. Although he is also encouraged by the evidence of safety in low-risk patients, he labeled the rate of HALT in this study “a concern.”

Dr. Waksman reported financial relationships with Abbott Vascular, Amgen, AstraZeneca, Life Technologies, Med Alliance, Medtronic Vascular, and Symetis, among other companies.

 

WASHINGTON – There were no deaths among 125 symptomatic low-risk aortic stenosis patients in the first 30 days after transcatheter aortic valve replacement (TAVR), according to results of the first U.S. study to evaluate mortality in a low-risk population.

Other complications were also low relative to those seen in previously published studies with higher-risk populations. The preliminary results are “reassuring,” Ronald Waksman, MD, associate director of the division of cardiology, Medstar Health Institute, Washington, DC, reported at CRT 2018 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.

Ted Bosworth/MDedge News

The full enrollment of 200 patients has been reached in the main arm of the Low Risk TAVR study, which is evaluating tricuspid TAVR. A second study arm evaluating bicuspid TAVR is still enrolling. The 30-day outcomes data presented at the CRT meeting were restricted to the first 125 patients enrolled.

In this study, a low-risk eligibility criterion is a Society of Thoracic Surgeons score of 3% or less. The mean score in the first 125 patients was 1.9%.

At 30 days, there were no myocardial infarctions, no acute kidney injuries of stage II or greater, and no transient ischemic attacks. There was one nondisabling stroke, one paravalvular leak, and one coronary obstruction that required a coronary artery bypass graft. The rates of new onset atrial fibrillation, major vascular complications, and life-threatening or major bleeding events were lower than 5%.

Surgical atrial valve replacement (SAVR) currently has a IB recommendation for the treatment of symptomatic low-risk aortic stenosis, but TAVR is not currently indicated in this population, according to 2017 American Heart Association/American College of Cardiology guidelines. There is, however, substantial interest in extending TAVR to a low-risk population, according to Dr. Waksman.

“We know that there are potential benefits for TAVR versus SAVR that include reduced ICU and hospital length of stay, more rapid quality of life recovery, lower risk of bleeding, and lower risk of postprocedure AF [atrial fibrillation],” said Dr. Waksman in explaining the rationale for this and other ongoing studies testing TAVR in low-risk patients.

 

In this investigator-initiated study, which was conducted without industry support, 11 sites participated. Most were relatively low-volume centers with fewer than 150 TAVR procedures performed annually, according to Dr. Waksman. The choice of TAVR device was left to the discretion of the operator.

Reflecting a lower-risk population, the mean age of 74.6 years is younger than that of participants in previous TAVR trials. The mean left ventricular ejection fraction was 62.9%. Only 4.8% had a prior MI and 19.2% had a prior coronary artery bypass graft. Most procedures were performed under conscious sedation with fewer than 20% receiving general anesthesia. The mean fluoroscopy time was 16 minutes.

The degree of improvement in hemodynamics following TAVR in this population was called “excellent,” but Dr. Waksman did report a 12.5% incidence of hypo-attenuating leaflet thickening (HALT), an 11% incidence of reduced leaflet motion, and a 9.3% incidence of hypo-attenuation affecting motion. All were subclinical effects.

In a closer analysis of HALT, the rate was 14.4% in the 80.8% of patients who received antiplatelet therapy versus 4.8% in the 17.5% who received oral anticoagulation (some received neither). Dr. Waksman called the greater association of HALT with antiplatelet therapy “a potential signal” that deserves further study.

 

Full results from all 200 patients are expected in the fall of 2018.

Jeffrey Popma, MD, director of the interventional cardiology clinical service, Beth Israel Deaconess Hospital, Boston, and moderator of the session where the data were presented, called for a direct comparison with SAVR in low-risk patients to place the relative role of these options into context.

Neil Moat, a consultant cardiac surgeon at Royal Brompton & Harefield Hospital, London, agreed. Although he is also encouraged by the evidence of safety in low-risk patients, he labeled the rate of HALT in this study “a concern.”

Dr. Waksman reported financial relationships with Abbott Vascular, Amgen, AstraZeneca, Life Technologies, Med Alliance, Medtronic Vascular, and Symetis, among other companies.

 

WASHINGTON – A novel transcatheter mitral valve replacement with a transseptally introduced docking mechanism that secures the valve with native mitral valve leaflets was found feasible and effective in an initial series of 10 patients, according to a first-in-man report at CRT 2018 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.

“All patients remained hemodynamically stable throughout the procedure, and the valve was successfully implanted in all patients,” reported John G. Webb, MD, McLeod Professor of Heart Valve Intervention at the University of British Columbia, Vancouver.

Ted Bosworth/MDedge News

The experimental Sapien M3 valve evaluated in this study has a novel design with docking and valve components. The Sapien M3 dock is comprised of a shape-memory nitinol dock that is guided to encircle the native leaflets, which is the first step in securing the system. Subsequent functional turns around the leaflets then provide a rigid landing space for placement of the M3 valve. A final atrial turn on the docking mechanism suspends the device against the mitral annulus to maintain position for valve deployment.

The docking system “is retrievable up until the point of the final release,” Dr. Webb explained. A knitted polyethylene terephthalate skirt is employed to aid in creating a seal between the leaflets and the dock. Once the docking system is in place, the procedure “then becomes a relatively standard transcatheter transseptal valve-in-valve–type procedure” that is a “fairly easy part of the procedure at centers with transcatheter valve implantation experience.”

The very first case was performed in a 75-year-old woman with severe mitral valve insufficiency. Frail with multiple comorbidities and a left ventricular ejection fraction of 30%, the patient was not a candidate for surgery. Although Dr. Webb acknowledged that the first case “was a learning process,” he reported that the patient was discharged after a 1-night hospital stay with reassuring valve placement and function based on imaging studies.

Data was available from 10 patients from five participating centers in Canada and the United States. The mean age was 74 years, and all were New York Heart Association class III or higher. The mean left ventricular ejection fraction was 37.5%. Although the average Society of Thoracic Surgery risk score was only 4.9%, Dr. Webb noted that this underestimated the vulnerability of a population in which most had compromised renal function. Half of the 10 had severe mitral valve regurgitation prior to valve replacement, and the remainder had moderate to severe regurgitation.

“At the end of 30 days, all had mild or less insufficiency,” Dr. Webb reported. Although one patient did develop significant mitral insufficiency after discharge because of a small tear attributed to probing, it was repaired with a plug. The one technical failure occurred in a patient who required a plug during the course of valve replacement; again, the plug proved effective for preventing significant valve insufficiency.

 

In this series of patients, one stroke occurred 2 days after the procedure, but there were no deaths in the initial 30-day follow-up, according to Dr. Webb. Although he noted that the procedure time in the first case was 4 hours, the procedure times became shorter with experience and the second-to-last and last cases took 2.5 and 1.3 hours, respectively.

Howard C. Herrmann, MD, director of the interventional cardiology program at the University of Pennsylvania, Philadelphia, and a panelist on the symposium where these data were presented, called the results “exciting.” However, he also noted that “this is the first time that any us have had a look at this device,” so more data will be needed to understand its clinical potential.

Edwards Lifesciences sponsored this study. Dr. Webb reported financial relationships with Abbott Vascular, Edwards Lifesciences, Essential Medical, and Vivitro.

 

WASHINGTON – A novel transcatheter mitral valve replacement with a transseptally introduced docking mechanism that secures the valve with native mitral valve leaflets was found feasible and effective in an initial series of 10 patients, according to a first-in-man report at CRT 2018 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.

“All patients remained hemodynamically stable throughout the procedure, and the valve was successfully implanted in all patients,” reported John G. Webb, MD, McLeod Professor of Heart Valve Intervention at the University of British Columbia, Vancouver.

Ted Bosworth/MDedge News

The experimental Sapien M3 valve evaluated in this study has a novel design with docking and valve components. The Sapien M3 dock is comprised of a shape-memory nitinol dock that is guided to encircle the native leaflets, which is the first step in securing the system. Subsequent functional turns around the leaflets then provide a rigid landing space for placement of the M3 valve. A final atrial turn on the docking mechanism suspends the device against the mitral annulus to maintain position for valve deployment.

The docking system “is retrievable up until the point of the final release,” Dr. Webb explained. A knitted polyethylene terephthalate skirt is employed to aid in creating a seal between the leaflets and the dock. Once the docking system is in place, the procedure “then becomes a relatively standard transcatheter transseptal valve-in-valve–type procedure” that is a “fairly easy part of the procedure at centers with transcatheter valve implantation experience.”

The very first case was performed in a 75-year-old woman with severe mitral valve insufficiency. Frail with multiple comorbidities and a left ventricular ejection fraction of 30%, the patient was not a candidate for surgery. Although Dr. Webb acknowledged that the first case “was a learning process,” he reported that the patient was discharged after a 1-night hospital stay with reassuring valve placement and function based on imaging studies.

Data was available from 10 patients from five participating centers in Canada and the United States. The mean age was 74 years, and all were New York Heart Association class III or higher. The mean left ventricular ejection fraction was 37.5%. Although the average Society of Thoracic Surgery risk score was only 4.9%, Dr. Webb noted that this underestimated the vulnerability of a population in which most had compromised renal function. Half of the 10 had severe mitral valve regurgitation prior to valve replacement, and the remainder had moderate to severe regurgitation.

“At the end of 30 days, all had mild or less insufficiency,” Dr. Webb reported. Although one patient did develop significant mitral insufficiency after discharge because of a small tear attributed to probing, it was repaired with a plug. The one technical failure occurred in a patient who required a plug during the course of valve replacement; again, the plug proved effective for preventing significant valve insufficiency.

 

In this series of patients, one stroke occurred 2 days after the procedure, but there were no deaths in the initial 30-day follow-up, according to Dr. Webb. Although he noted that the procedure time in the first case was 4 hours, the procedure times became shorter with experience and the second-to-last and last cases took 2.5 and 1.3 hours, respectively.

Howard C. Herrmann, MD, director of the interventional cardiology program at the University of Pennsylvania, Philadelphia, and a panelist on the symposium where these data were presented, called the results “exciting.” However, he also noted that “this is the first time that any us have had a look at this device,” so more data will be needed to understand its clinical potential.

Edwards Lifesciences sponsored this study. Dr. Webb reported financial relationships with Abbott Vascular, Edwards Lifesciences, Essential Medical, and Vivitro.

 

WASHINGTON – A novel transcatheter mitral valve replacement with a transseptally introduced docking mechanism that secures the valve with native mitral valve leaflets was found feasible and effective in an initial series of 10 patients, according to a first-in-man report at CRT 2018 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.

“All patients remained hemodynamically stable throughout the procedure, and the valve was successfully implanted in all patients,” reported John G. Webb, MD, McLeod Professor of Heart Valve Intervention at the University of British Columbia, Vancouver.

Ted Bosworth/MDedge News

The experimental Sapien M3 valve evaluated in this study has a novel design with docking and valve components. The Sapien M3 dock is comprised of a shape-memory nitinol dock that is guided to encircle the native leaflets, which is the first step in securing the system. Subsequent functional turns around the leaflets then provide a rigid landing space for placement of the M3 valve. A final atrial turn on the docking mechanism suspends the device against the mitral annulus to maintain position for valve deployment.

The docking system “is retrievable up until the point of the final release,” Dr. Webb explained. A knitted polyethylene terephthalate skirt is employed to aid in creating a seal between the leaflets and the dock. Once the docking system is in place, the procedure “then becomes a relatively standard transcatheter transseptal valve-in-valve–type procedure” that is a “fairly easy part of the procedure at centers with transcatheter valve implantation experience.”

The very first case was performed in a 75-year-old woman with severe mitral valve insufficiency. Frail with multiple comorbidities and a left ventricular ejection fraction of 30%, the patient was not a candidate for surgery. Although Dr. Webb acknowledged that the first case “was a learning process,” he reported that the patient was discharged after a 1-night hospital stay with reassuring valve placement and function based on imaging studies.

Data was available from 10 patients from five participating centers in Canada and the United States. The mean age was 74 years, and all were New York Heart Association class III or higher. The mean left ventricular ejection fraction was 37.5%. Although the average Society of Thoracic Surgery risk score was only 4.9%, Dr. Webb noted that this underestimated the vulnerability of a population in which most had compromised renal function. Half of the 10 had severe mitral valve regurgitation prior to valve replacement, and the remainder had moderate to severe regurgitation.

“At the end of 30 days, all had mild or less insufficiency,” Dr. Webb reported. Although one patient did develop significant mitral insufficiency after discharge because of a small tear attributed to probing, it was repaired with a plug. The one technical failure occurred in a patient who required a plug during the course of valve replacement; again, the plug proved effective for preventing significant valve insufficiency.

 

In this series of patients, one stroke occurred 2 days after the procedure, but there were no deaths in the initial 30-day follow-up, according to Dr. Webb. Although he noted that the procedure time in the first case was 4 hours, the procedure times became shorter with experience and the second-to-last and last cases took 2.5 and 1.3 hours, respectively.

Howard C. Herrmann, MD, director of the interventional cardiology program at the University of Pennsylvania, Philadelphia, and a panelist on the symposium where these data were presented, called the results “exciting.” However, he also noted that “this is the first time that any us have had a look at this device,” so more data will be needed to understand its clinical potential.

Edwards Lifesciences sponsored this study. Dr. Webb reported financial relationships with Abbott Vascular, Edwards Lifesciences, Essential Medical, and Vivitro.

WASHINGTON – On the basis of a large randomized trial called ATTRACT, many clinicians have concluded that pharmacomechanical intervention is ineffective for preventing postthrombotic syndrome (PTS) in patients with deep venous thrombosis (DVT). But weaknesses in the study design challenge this conclusion, according to several experts in a DVT symposium at the 2018 Cardiovascular Research Technologies (CRT) meeting.

“The diagnosis and evaluation of DVT must be performed with IVUS [intravascular ultrasound], not with venography,” said Peter A. Soukas, MD, director of vascular medicine at Miriam Hospital in Providence, R.I. “You cannot know whether you successfully treated the clot if you cannot see it.”

Ted Bosworth/MDedge News

The ATTRACT (Acute Venous Thrombosis: Thrombus Removal With Adjunctive Catheter-Directed Thrombolysis) trial was a recently published phase 3 multicenter trial that randomized 692 patients with acute proximal DVT to pharmacomechanical thrombolysis or anticoagulation alone (Vedantham S et al. N Engl J Med. 2017 Dec 7;377(23):2240-52). The results of the trial, sponsored by the National Heart, Lung, and Blood Institute, were negative for the primary outcome of a difference in the rate of PTS within 24 months of follow-up, but Dr. Soukas said the study does not resolve the issue.

“There were lots of limitations to that study. Here are some,” said Dr. Soukas, who then listed on a list of several considerations, including the fact that venograms – rather than IVUS, which Dr. Soukas labeled the “current gold standard” – were taken to evaluate procedure success. Another was that only half of patients had a moderate to severe DVT based on a Villalta score.

“If you look at the subgroup with a Villalta score of 10 or greater, the benefit [of pharmacomechanical intervention] was statistically significant,” he said.

In addition, the study enrolled a substantial number of patients with femoral-popliteal DVTs even though iliofemoral DVTs pose the greatest risk of postthrombotic syndrome. Dr. Soukas suggested these would have been a more appropriate focus of a study exploring the benefits of an intervention.

 

The limitations of the ATTRACT trial, which was conceived more than 5 years ago, have arisen primarily from advances in the field rather than problems with the design, Dr. Soukas explained. IVUS was not the preferred method for deep vein thrombosis evaluation then as it is now, and there have been several advances in current models of pharmacomechanical devices, which involve catheter-directed delivery of fibrinolytic therapy into the thrombus along with mechanical destruction of the clot.

Although further steps beyond clot lysis, such as stenting, were encouraged in ATTRACT to maintain venous patency, Dr. Soukas questioned whether these were employed sufficiently. For example, the rate of stenting in the experimental arm was 28%, a rate that “is not what we currently do” for patients at high risk of PTS, Dr. Soukas said.

In ATTRACT, major bleeding events were significantly higher in the experimental group (1.7% vs. 0.3%; P = .049). The authors cited this finding when they concluded that the experimental intervention was ineffective. Dr. Soukas acknowledged that bleeding risk is an important factor to consider, but he also emphasized the serious risks for failing to treat patients at high risk for PTS.

 

“PTS is devastating for patients, both functionally and economically,” Dr. Soukas said. He called the morbidity of deep vein thrombosis “staggering,” with in-hospital mortality in some series exceeding 10% and a risk of late development of postthrombotic syndrome persisting for up to 5 years. For those with proximal iliofemoral DVT, the PTS rate can reach 90%, about 15% of which can develop claudication with ulcerations, according to Dr. Soukas.

A large trial that was published in a prominent journal, ATTRACT has the potential to dissuade clinicians from considering pharmacomechanical intervention in high-risk patients who could benefit, Dr. Soukas said. Others speaking during the same symposium about advances in this field, such as John Fritz Angle, MD, director of the division of vascular and interventional radiology at the University of Virginia, Charlottesville, agreed with this assessment. Although other studies underway will reexamine this issue, there was consensus from several speakers at the CRT symposium that the results of ATTRACT should not preclude intervention in patients at high risk of PTS.

“I believe there is a role for DVT intervention for symptomatic patients with an extensive [proximal iliofemoral] clot provided they have a low bleeding risk,” Dr. Soukas said.

Dr. Soukas reported no potential conflicts of interest.

WASHINGTON – On the basis of a large randomized trial called ATTRACT, many clinicians have concluded that pharmacomechanical intervention is ineffective for preventing postthrombotic syndrome (PTS) in patients with deep venous thrombosis (DVT). But weaknesses in the study design challenge this conclusion, according to several experts in a DVT symposium at the 2018 Cardiovascular Research Technologies (CRT) meeting.

“The diagnosis and evaluation of DVT must be performed with IVUS [intravascular ultrasound], not with venography,” said Peter A. Soukas, MD, director of vascular medicine at Miriam Hospital in Providence, R.I. “You cannot know whether you successfully treated the clot if you cannot see it.”

Ted Bosworth/MDedge News

The ATTRACT (Acute Venous Thrombosis: Thrombus Removal With Adjunctive Catheter-Directed Thrombolysis) trial was a recently published phase 3 multicenter trial that randomized 692 patients with acute proximal DVT to pharmacomechanical thrombolysis or anticoagulation alone (Vedantham S et al. N Engl J Med. 2017 Dec 7;377(23):2240-52). The results of the trial, sponsored by the National Heart, Lung, and Blood Institute, were negative for the primary outcome of a difference in the rate of PTS within 24 months of follow-up, but Dr. Soukas said the study does not resolve the issue.

“There were lots of limitations to that study. Here are some,” said Dr. Soukas, who then listed on a list of several considerations, including the fact that venograms – rather than IVUS, which Dr. Soukas labeled the “current gold standard” – were taken to evaluate procedure success. Another was that only half of patients had a moderate to severe DVT based on a Villalta score.

“If you look at the subgroup with a Villalta score of 10 or greater, the benefit [of pharmacomechanical intervention] was statistically significant,” he said.

In addition, the study enrolled a substantial number of patients with femoral-popliteal DVTs even though iliofemoral DVTs pose the greatest risk of postthrombotic syndrome. Dr. Soukas suggested these would have been a more appropriate focus of a study exploring the benefits of an intervention.

 

The limitations of the ATTRACT trial, which was conceived more than 5 years ago, have arisen primarily from advances in the field rather than problems with the design, Dr. Soukas explained. IVUS was not the preferred method for deep vein thrombosis evaluation then as it is now, and there have been several advances in current models of pharmacomechanical devices, which involve catheter-directed delivery of fibrinolytic therapy into the thrombus along with mechanical destruction of the clot.

Although further steps beyond clot lysis, such as stenting, were encouraged in ATTRACT to maintain venous patency, Dr. Soukas questioned whether these were employed sufficiently. For example, the rate of stenting in the experimental arm was 28%, a rate that “is not what we currently do” for patients at high risk of PTS, Dr. Soukas said.

In ATTRACT, major bleeding events were significantly higher in the experimental group (1.7% vs. 0.3%; P = .049). The authors cited this finding when they concluded that the experimental intervention was ineffective. Dr. Soukas acknowledged that bleeding risk is an important factor to consider, but he also emphasized the serious risks for failing to treat patients at high risk for PTS.

 

“PTS is devastating for patients, both functionally and economically,” Dr. Soukas said. He called the morbidity of deep vein thrombosis “staggering,” with in-hospital mortality in some series exceeding 10% and a risk of late development of postthrombotic syndrome persisting for up to 5 years. For those with proximal iliofemoral DVT, the PTS rate can reach 90%, about 15% of which can develop claudication with ulcerations, according to Dr. Soukas.

A large trial that was published in a prominent journal, ATTRACT has the potential to dissuade clinicians from considering pharmacomechanical intervention in high-risk patients who could benefit, Dr. Soukas said. Others speaking during the same symposium about advances in this field, such as John Fritz Angle, MD, director of the division of vascular and interventional radiology at the University of Virginia, Charlottesville, agreed with this assessment. Although other studies underway will reexamine this issue, there was consensus from several speakers at the CRT symposium that the results of ATTRACT should not preclude intervention in patients at high risk of PTS.

“I believe there is a role for DVT intervention for symptomatic patients with an extensive [proximal iliofemoral] clot provided they have a low bleeding risk,” Dr. Soukas said.

Dr. Soukas reported no potential conflicts of interest.

WASHINGTON – On the basis of a large randomized trial called ATTRACT, many clinicians have concluded that pharmacomechanical intervention is ineffective for preventing postthrombotic syndrome (PTS) in patients with deep venous thrombosis (DVT). But weaknesses in the study design challenge this conclusion, according to several experts in a DVT symposium at the 2018 Cardiovascular Research Technologies (CRT) meeting.

“The diagnosis and evaluation of DVT must be performed with IVUS [intravascular ultrasound], not with venography,” said Peter A. Soukas, MD, director of vascular medicine at Miriam Hospital in Providence, R.I. “You cannot know whether you successfully treated the clot if you cannot see it.”

Ted Bosworth/MDedge News

The ATTRACT (Acute Venous Thrombosis: Thrombus Removal With Adjunctive Catheter-Directed Thrombolysis) trial was a recently published phase 3 multicenter trial that randomized 692 patients with acute proximal DVT to pharmacomechanical thrombolysis or anticoagulation alone (Vedantham S et al. N Engl J Med. 2017 Dec 7;377(23):2240-52). The results of the trial, sponsored by the National Heart, Lung, and Blood Institute, were negative for the primary outcome of a difference in the rate of PTS within 24 months of follow-up, but Dr. Soukas said the study does not resolve the issue.

“There were lots of limitations to that study. Here are some,” said Dr. Soukas, who then listed on a list of several considerations, including the fact that venograms – rather than IVUS, which Dr. Soukas labeled the “current gold standard” – were taken to evaluate procedure success. Another was that only half of patients had a moderate to severe DVT based on a Villalta score.

“If you look at the subgroup with a Villalta score of 10 or greater, the benefit [of pharmacomechanical intervention] was statistically significant,” he said.

In addition, the study enrolled a substantial number of patients with femoral-popliteal DVTs even though iliofemoral DVTs pose the greatest risk of postthrombotic syndrome. Dr. Soukas suggested these would have been a more appropriate focus of a study exploring the benefits of an intervention.

 

The limitations of the ATTRACT trial, which was conceived more than 5 years ago, have arisen primarily from advances in the field rather than problems with the design, Dr. Soukas explained. IVUS was not the preferred method for deep vein thrombosis evaluation then as it is now, and there have been several advances in current models of pharmacomechanical devices, which involve catheter-directed delivery of fibrinolytic therapy into the thrombus along with mechanical destruction of the clot.

Although further steps beyond clot lysis, such as stenting, were encouraged in ATTRACT to maintain venous patency, Dr. Soukas questioned whether these were employed sufficiently. For example, the rate of stenting in the experimental arm was 28%, a rate that “is not what we currently do” for patients at high risk of PTS, Dr. Soukas said.

In ATTRACT, major bleeding events were significantly higher in the experimental group (1.7% vs. 0.3%; P = .049). The authors cited this finding when they concluded that the experimental intervention was ineffective. Dr. Soukas acknowledged that bleeding risk is an important factor to consider, but he also emphasized the serious risks for failing to treat patients at high risk for PTS.

 

“PTS is devastating for patients, both functionally and economically,” Dr. Soukas said. He called the morbidity of deep vein thrombosis “staggering,” with in-hospital mortality in some series exceeding 10% and a risk of late development of postthrombotic syndrome persisting for up to 5 years. For those with proximal iliofemoral DVT, the PTS rate can reach 90%, about 15% of which can develop claudication with ulcerations, according to Dr. Soukas.

A large trial that was published in a prominent journal, ATTRACT has the potential to dissuade clinicians from considering pharmacomechanical intervention in high-risk patients who could benefit, Dr. Soukas said. Others speaking during the same symposium about advances in this field, such as John Fritz Angle, MD, director of the division of vascular and interventional radiology at the University of Virginia, Charlottesville, agreed with this assessment. Although other studies underway will reexamine this issue, there was consensus from several speakers at the CRT symposium that the results of ATTRACT should not preclude intervention in patients at high risk of PTS.

“I believe there is a role for DVT intervention for symptomatic patients with an extensive [proximal iliofemoral] clot provided they have a low bleeding risk,” Dr. Soukas said.

Dr. Soukas reported no potential conflicts of interest.

WASHINGTON – An all-comer observational study associated endovascular treatment of lower limb peripheral artery disease (PAD) with low event rates and substantial improvements in quality of life at 18 months, even in Rutherford stage 6 patients.

Although the proportion of patients with Rutherford stage 6 PAD was relatively small, the study results showed that peripheral vascular intervention “can be successful in this patient population as evidenced by a high freedom from major amputation,” reported William Gray, MD, system chief of the division of cardiovascular disease at the Lankenau Heart Group, Wynnewood, Pa., at CRT 2018, sponsored by the Cardiovascular Research Institute at Washington Hospital Center.

Ted Bosworth/MDedge News

After 18 months of follow-up in the LIBERTY 360 study, 82% of patients with Rutherford stage 6 disease, which is the most severe stage of PAD, were free from major amputation. The figure for a combined endpoint of freedom from amputation and death was 64%. The mortality at 18 months in the Rutherford stage 6 patients, reflective of a very-high-risk population, was 24%.

“Many of the patients in this trial, particularly the Rutherford 6 patients, would never be included in the pivotal trial for endovascular devices,” Dr. Gray said. He called this “a unique study” in that it had almost no exclusions.

The study enrolled 1,204 patients with peripheral artery disease at 51 participating sites. After 18 months, follow-up data were available on 793 patients. These were divided by Rutherford classifications into three groups: 374 patients in the combined Rutherford 2 and 3 classifications (R2/3); 371 in the combined Rutherford 4 and 5 classifications (R4/5); and 48 in the Rutherford 6 classification (R6). Patients treated with any Food and Drug Administration–approved technology for treatment of claudication and critical limb ischemia for PAD were eligible.

The endpoints considered at 18 months included procedural and lesion success, major adverse events, and quality of life. Four core laboratories were responsible for an independent analysis of outcomes. A follow-up of 5 years is planned and will include an economic analysis.

 

The procedural success rates for were 84.4% for the R2/3 group, 76.9% for the R4/5 group, and 70.2% for the R6 group. Almost all of those in the R2/3 and R4/5 groups were discharged immediately after treatment. In the R6 group, approximately 25% of patients were held for complications or additional care.

At 18 months of follow-up, freedom from major adverse events, defined as death, major amputation, or a target vessel revascularization, was achieved by 76.9% of those in the R2/3 group, 68.2% of those in the R4/5 group, and 52.8% of those in the R6 group. The analysis also looked at specific events: The rates for freedom from amputation were 99.3%, 95.3%, and 81.7% in the R2/3, R4/5, and R6 groups, respectively; the freedom from death was 93.9%, 85.5%, and 76.2%; and the freedom from target vessel revascularization was 77.5%, 70.6%, ad 65.7%.

Those in R2/3 maintained the improvement in Rutherford classification observed at 30 days for the subsequent 12 months. Those in R2/3 and R4/5 showed continued improvement in Rutherford classification. For example, R4 represented approximately 50% of the patients in R3/4 classification at baseline but less than 20% of this group at 18 months.

The change in Rutherford classification was reflected in quality of life (QOL) analyses. As far as total QOL scores, the R6 group, which had lower scores at baseline, was no longer significantly different at 18 months from the R4/5 group. On the pain subdomain QOL score, which was incrementally worse at baseline for increased PAD severity, there were no differences at 18 months after improvements in all groups.

 

Overall, the LIBERTY 360 study “supports aggressive management” with endovascular procedures in symptomatic patients with PAD. This is important because PAD often is inadequately treated or left untreated, according to Dr. Gray. He cited data suggesting that up to 50% of patients who undergo amputation because of lower limb claudication never even undergo a vascular evaluation.

Although there was no control group to evaluate outcomes in patients not treated or treated with another intervention, such as surgery, Dr. Gray suggested that there are encouraging results in a study that was conducted to enroll patients “with as many confounders as possible.”

Dr. Gray reported financial relationships with Abbott Vascular, Cordis, Medtronic, WL Gore, and a number of other device manufacturers.

WASHINGTON – An all-comer observational study associated endovascular treatment of lower limb peripheral artery disease (PAD) with low event rates and substantial improvements in quality of life at 18 months, even in Rutherford stage 6 patients.

Although the proportion of patients with Rutherford stage 6 PAD was relatively small, the study results showed that peripheral vascular intervention “can be successful in this patient population as evidenced by a high freedom from major amputation,” reported William Gray, MD, system chief of the division of cardiovascular disease at the Lankenau Heart Group, Wynnewood, Pa., at CRT 2018, sponsored by the Cardiovascular Research Institute at Washington Hospital Center.

Ted Bosworth/MDedge News

After 18 months of follow-up in the LIBERTY 360 study, 82% of patients with Rutherford stage 6 disease, which is the most severe stage of PAD, were free from major amputation. The figure for a combined endpoint of freedom from amputation and death was 64%. The mortality at 18 months in the Rutherford stage 6 patients, reflective of a very-high-risk population, was 24%.

“Many of the patients in this trial, particularly the Rutherford 6 patients, would never be included in the pivotal trial for endovascular devices,” Dr. Gray said. He called this “a unique study” in that it had almost no exclusions.

The study enrolled 1,204 patients with peripheral artery disease at 51 participating sites. After 18 months, follow-up data were available on 793 patients. These were divided by Rutherford classifications into three groups: 374 patients in the combined Rutherford 2 and 3 classifications (R2/3); 371 in the combined Rutherford 4 and 5 classifications (R4/5); and 48 in the Rutherford 6 classification (R6). Patients treated with any Food and Drug Administration–approved technology for treatment of claudication and critical limb ischemia for PAD were eligible.

The endpoints considered at 18 months included procedural and lesion success, major adverse events, and quality of life. Four core laboratories were responsible for an independent analysis of outcomes. A follow-up of 5 years is planned and will include an economic analysis.

 

The procedural success rates for were 84.4% for the R2/3 group, 76.9% for the R4/5 group, and 70.2% for the R6 group. Almost all of those in the R2/3 and R4/5 groups were discharged immediately after treatment. In the R6 group, approximately 25% of patients were held for complications or additional care.

At 18 months of follow-up, freedom from major adverse events, defined as death, major amputation, or a target vessel revascularization, was achieved by 76.9% of those in the R2/3 group, 68.2% of those in the R4/5 group, and 52.8% of those in the R6 group. The analysis also looked at specific events: The rates for freedom from amputation were 99.3%, 95.3%, and 81.7% in the R2/3, R4/5, and R6 groups, respectively; the freedom from death was 93.9%, 85.5%, and 76.2%; and the freedom from target vessel revascularization was 77.5%, 70.6%, ad 65.7%.

Those in R2/3 maintained the improvement in Rutherford classification observed at 30 days for the subsequent 12 months. Those in R2/3 and R4/5 showed continued improvement in Rutherford classification. For example, R4 represented approximately 50% of the patients in R3/4 classification at baseline but less than 20% of this group at 18 months.

The change in Rutherford classification was reflected in quality of life (QOL) analyses. As far as total QOL scores, the R6 group, which had lower scores at baseline, was no longer significantly different at 18 months from the R4/5 group. On the pain subdomain QOL score, which was incrementally worse at baseline for increased PAD severity, there were no differences at 18 months after improvements in all groups.

 

Overall, the LIBERTY 360 study “supports aggressive management” with endovascular procedures in symptomatic patients with PAD. This is important because PAD often is inadequately treated or left untreated, according to Dr. Gray. He cited data suggesting that up to 50% of patients who undergo amputation because of lower limb claudication never even undergo a vascular evaluation.

Although there was no control group to evaluate outcomes in patients not treated or treated with another intervention, such as surgery, Dr. Gray suggested that there are encouraging results in a study that was conducted to enroll patients “with as many confounders as possible.”

Dr. Gray reported financial relationships with Abbott Vascular, Cordis, Medtronic, WL Gore, and a number of other device manufacturers.

WASHINGTON – An all-comer observational study associated endovascular treatment of lower limb peripheral artery disease (PAD) with low event rates and substantial improvements in quality of life at 18 months, even in Rutherford stage 6 patients.

Although the proportion of patients with Rutherford stage 6 PAD was relatively small, the study results showed that peripheral vascular intervention “can be successful in this patient population as evidenced by a high freedom from major amputation,” reported William Gray, MD, system chief of the division of cardiovascular disease at the Lankenau Heart Group, Wynnewood, Pa., at CRT 2018, sponsored by the Cardiovascular Research Institute at Washington Hospital Center.

Ted Bosworth/MDedge News

After 18 months of follow-up in the LIBERTY 360 study, 82% of patients with Rutherford stage 6 disease, which is the most severe stage of PAD, were free from major amputation. The figure for a combined endpoint of freedom from amputation and death was 64%. The mortality at 18 months in the Rutherford stage 6 patients, reflective of a very-high-risk population, was 24%.

“Many of the patients in this trial, particularly the Rutherford 6 patients, would never be included in the pivotal trial for endovascular devices,” Dr. Gray said. He called this “a unique study” in that it had almost no exclusions.

The study enrolled 1,204 patients with peripheral artery disease at 51 participating sites. After 18 months, follow-up data were available on 793 patients. These were divided by Rutherford classifications into three groups: 374 patients in the combined Rutherford 2 and 3 classifications (R2/3); 371 in the combined Rutherford 4 and 5 classifications (R4/5); and 48 in the Rutherford 6 classification (R6). Patients treated with any Food and Drug Administration–approved technology for treatment of claudication and critical limb ischemia for PAD were eligible.

The endpoints considered at 18 months included procedural and lesion success, major adverse events, and quality of life. Four core laboratories were responsible for an independent analysis of outcomes. A follow-up of 5 years is planned and will include an economic analysis.

 

The procedural success rates for were 84.4% for the R2/3 group, 76.9% for the R4/5 group, and 70.2% for the R6 group. Almost all of those in the R2/3 and R4/5 groups were discharged immediately after treatment. In the R6 group, approximately 25% of patients were held for complications or additional care.

At 18 months of follow-up, freedom from major adverse events, defined as death, major amputation, or a target vessel revascularization, was achieved by 76.9% of those in the R2/3 group, 68.2% of those in the R4/5 group, and 52.8% of those in the R6 group. The analysis also looked at specific events: The rates for freedom from amputation were 99.3%, 95.3%, and 81.7% in the R2/3, R4/5, and R6 groups, respectively; the freedom from death was 93.9%, 85.5%, and 76.2%; and the freedom from target vessel revascularization was 77.5%, 70.6%, ad 65.7%.

Those in R2/3 maintained the improvement in Rutherford classification observed at 30 days for the subsequent 12 months. Those in R2/3 and R4/5 showed continued improvement in Rutherford classification. For example, R4 represented approximately 50% of the patients in R3/4 classification at baseline but less than 20% of this group at 18 months.

The change in Rutherford classification was reflected in quality of life (QOL) analyses. As far as total QOL scores, the R6 group, which had lower scores at baseline, was no longer significantly different at 18 months from the R4/5 group. On the pain subdomain QOL score, which was incrementally worse at baseline for increased PAD severity, there were no differences at 18 months after improvements in all groups.

 

Overall, the LIBERTY 360 study “supports aggressive management” with endovascular procedures in symptomatic patients with PAD. This is important because PAD often is inadequately treated or left untreated, according to Dr. Gray. He cited data suggesting that up to 50% of patients who undergo amputation because of lower limb claudication never even undergo a vascular evaluation.

Although there was no control group to evaluate outcomes in patients not treated or treated with another intervention, such as surgery, Dr. Gray suggested that there are encouraging results in a study that was conducted to enroll patients “with as many confounders as possible.”

Dr. Gray reported financial relationships with Abbott Vascular, Cordis, Medtronic, WL Gore, and a number of other device manufacturers.

 

WASHINGTON – Consistent with experimental and recent clinical studies, a meta-analysis of 69 randomized controlled trials found that increasing strut thickness correlated with increasing risk of stent thrombosis as well as risk of myocardial infarction.

The report was presented at CRT 2018, sponsored by the Cardiovascular Research Institute at Medstar Washington (D.C.) Hospital Center.

In the meta-analysis, which compared four categories of strut thickness, the relationship between strut thickness and rates of stent thrombosis was almost linear, according to Micaela Iantorno, MD, a clinical fellow in interventional cardiology at the hospital center.

Ted Bosworth/MDedge News

The four categories of strut thickness were characterized as ultrathin, defined as less than 81 mcg; thin, defined as 81-100 mcg; intermediate, defined as 101-120 mcg; or thick, defined as at least 121 mcg. The meta-analysis of 69 trials included data on 74,980 patients.

Thirty-six of the studies compared devices with thin struts to those with thick struts, 15 studies compared devices with ultrathin struts to devices with thin struts, and 11 compared devices with thin struts to devices with struts in the intermediate category. The remaining seven studies compared other strut thicknesses, such as ultrathin to intermediate.

When compared to devices with the thickest struts, there was a stepwise reduction in risk of strut thrombosis for each grade reduction in thickness. Expressed as an odds ratio, devices with intermediate struts were associated with 33% risk reduction, devices with thin struts were associated with a 42% risk reduction, and devices with ultrathin struts were associated with a 57% risk reduction. Each was statistically significant based on the 95% confidence interval, although P values were not reported.

When devices with ultrathin struts were compared to those with thin struts or to those with intermediate thickness struts, the differences in stent thrombosis were not statistically significant, but there were trends favoring the devices with thinner struts. However, the lower risk of stent thrombosis for devices with thin struts relative to those with intermediate thickness was modest and did not approach significance.

 

For risk of MI, the same type of gradient was observed. Relative to devices with thick struts, devices with ultrathin struts were associated with a 27% reduction, devices with thin struts were associated with a 21% reduction, and devices with struts of intermediate thickness were associated with a 15% reduction. Only the difference for the intermediate-thickness devices fell short of statistical significance.

There were 22 different stent devices represented in this analysis. Bare metal stents and stents with bioresorbable scaffolds were excluded, but devices from all three generations of drug-eluting stents, including devices with bioabsorbable polymers, were included.

Other outcomes, including mortality, cardiovascular mortality, and major adverse cardiovascular events, were evaluated, but a gradient relationship between strut thickness and these outcomes was less apparent. For example, when devices with thick struts were compared to devices with thinner struts, only the ultrathin devices achieved a significant, 15%, reduction in cardiovascular mortality. The 10% reduction in all-cause mortality fell short of statistical significance.

Emphasizing that other factors, such as stent geometry, polymer type, and type of eluting drug, were not considered in this analysis, Dr. Iantorno acknowledged that there are important limitations of this study, but the data are consistent with the hypothesis that “reducing strut thickness might be the key to improving the efficacy and safety profile of coronary stents.”

 

Sachin Kumar, MD, an interventional cardiologist at the University of Texas Health Science Center at Houston, cautioned that strut thickness “is just one side of the story.” Moderator of the session in which these data were presented, Dr. Kumar said that other factors Dr. Iantorno listed as potentially important, including polymer type and eluting drug, should not be discounted. However, he conceded that in the context of other recent evidence that strut thickness may be important to outcomes, particularly risk of stent thrombosis, this variable has become a focus of design improvements.

SOURCE: Iantorno M. Abstract CRT-100.87.

 

WASHINGTON – Consistent with experimental and recent clinical studies, a meta-analysis of 69 randomized controlled trials found that increasing strut thickness correlated with increasing risk of stent thrombosis as well as risk of myocardial infarction.

The report was presented at CRT 2018, sponsored by the Cardiovascular Research Institute at Medstar Washington (D.C.) Hospital Center.

In the meta-analysis, which compared four categories of strut thickness, the relationship between strut thickness and rates of stent thrombosis was almost linear, according to Micaela Iantorno, MD, a clinical fellow in interventional cardiology at the hospital center.

Ted Bosworth/MDedge News

The four categories of strut thickness were characterized as ultrathin, defined as less than 81 mcg; thin, defined as 81-100 mcg; intermediate, defined as 101-120 mcg; or thick, defined as at least 121 mcg. The meta-analysis of 69 trials included data on 74,980 patients.

Thirty-six of the studies compared devices with thin struts to those with thick struts, 15 studies compared devices with ultrathin struts to devices with thin struts, and 11 compared devices with thin struts to devices with struts in the intermediate category. The remaining seven studies compared other strut thicknesses, such as ultrathin to intermediate.

When compared to devices with the thickest struts, there was a stepwise reduction in risk of strut thrombosis for each grade reduction in thickness. Expressed as an odds ratio, devices with intermediate struts were associated with 33% risk reduction, devices with thin struts were associated with a 42% risk reduction, and devices with ultrathin struts were associated with a 57% risk reduction. Each was statistically significant based on the 95% confidence interval, although P values were not reported.

When devices with ultrathin struts were compared to those with thin struts or to those with intermediate thickness struts, the differences in stent thrombosis were not statistically significant, but there were trends favoring the devices with thinner struts. However, the lower risk of stent thrombosis for devices with thin struts relative to those with intermediate thickness was modest and did not approach significance.

 

For risk of MI, the same type of gradient was observed. Relative to devices with thick struts, devices with ultrathin struts were associated with a 27% reduction, devices with thin struts were associated with a 21% reduction, and devices with struts of intermediate thickness were associated with a 15% reduction. Only the difference for the intermediate-thickness devices fell short of statistical significance.

There were 22 different stent devices represented in this analysis. Bare metal stents and stents with bioresorbable scaffolds were excluded, but devices from all three generations of drug-eluting stents, including devices with bioabsorbable polymers, were included.

Other outcomes, including mortality, cardiovascular mortality, and major adverse cardiovascular events, were evaluated, but a gradient relationship between strut thickness and these outcomes was less apparent. For example, when devices with thick struts were compared to devices with thinner struts, only the ultrathin devices achieved a significant, 15%, reduction in cardiovascular mortality. The 10% reduction in all-cause mortality fell short of statistical significance.

Emphasizing that other factors, such as stent geometry, polymer type, and type of eluting drug, were not considered in this analysis, Dr. Iantorno acknowledged that there are important limitations of this study, but the data are consistent with the hypothesis that “reducing strut thickness might be the key to improving the efficacy and safety profile of coronary stents.”

 

Sachin Kumar, MD, an interventional cardiologist at the University of Texas Health Science Center at Houston, cautioned that strut thickness “is just one side of the story.” Moderator of the session in which these data were presented, Dr. Kumar said that other factors Dr. Iantorno listed as potentially important, including polymer type and eluting drug, should not be discounted. However, he conceded that in the context of other recent evidence that strut thickness may be important to outcomes, particularly risk of stent thrombosis, this variable has become a focus of design improvements.

SOURCE: Iantorno M. Abstract CRT-100.87.

 

WASHINGTON – Consistent with experimental and recent clinical studies, a meta-analysis of 69 randomized controlled trials found that increasing strut thickness correlated with increasing risk of stent thrombosis as well as risk of myocardial infarction.

The report was presented at CRT 2018, sponsored by the Cardiovascular Research Institute at Medstar Washington (D.C.) Hospital Center.

In the meta-analysis, which compared four categories of strut thickness, the relationship between strut thickness and rates of stent thrombosis was almost linear, according to Micaela Iantorno, MD, a clinical fellow in interventional cardiology at the hospital center.

Ted Bosworth/MDedge News

The four categories of strut thickness were characterized as ultrathin, defined as less than 81 mcg; thin, defined as 81-100 mcg; intermediate, defined as 101-120 mcg; or thick, defined as at least 121 mcg. The meta-analysis of 69 trials included data on 74,980 patients.

Thirty-six of the studies compared devices with thin struts to those with thick struts, 15 studies compared devices with ultrathin struts to devices with thin struts, and 11 compared devices with thin struts to devices with struts in the intermediate category. The remaining seven studies compared other strut thicknesses, such as ultrathin to intermediate.

When compared to devices with the thickest struts, there was a stepwise reduction in risk of strut thrombosis for each grade reduction in thickness. Expressed as an odds ratio, devices with intermediate struts were associated with 33% risk reduction, devices with thin struts were associated with a 42% risk reduction, and devices with ultrathin struts were associated with a 57% risk reduction. Each was statistically significant based on the 95% confidence interval, although P values were not reported.

When devices with ultrathin struts were compared to those with thin struts or to those with intermediate thickness struts, the differences in stent thrombosis were not statistically significant, but there were trends favoring the devices with thinner struts. However, the lower risk of stent thrombosis for devices with thin struts relative to those with intermediate thickness was modest and did not approach significance.

 

For risk of MI, the same type of gradient was observed. Relative to devices with thick struts, devices with ultrathin struts were associated with a 27% reduction, devices with thin struts were associated with a 21% reduction, and devices with struts of intermediate thickness were associated with a 15% reduction. Only the difference for the intermediate-thickness devices fell short of statistical significance.

There were 22 different stent devices represented in this analysis. Bare metal stents and stents with bioresorbable scaffolds were excluded, but devices from all three generations of drug-eluting stents, including devices with bioabsorbable polymers, were included.

Other outcomes, including mortality, cardiovascular mortality, and major adverse cardiovascular events, were evaluated, but a gradient relationship between strut thickness and these outcomes was less apparent. For example, when devices with thick struts were compared to devices with thinner struts, only the ultrathin devices achieved a significant, 15%, reduction in cardiovascular mortality. The 10% reduction in all-cause mortality fell short of statistical significance.

Emphasizing that other factors, such as stent geometry, polymer type, and type of eluting drug, were not considered in this analysis, Dr. Iantorno acknowledged that there are important limitations of this study, but the data are consistent with the hypothesis that “reducing strut thickness might be the key to improving the efficacy and safety profile of coronary stents.”

 

Sachin Kumar, MD, an interventional cardiologist at the University of Texas Health Science Center at Houston, cautioned that strut thickness “is just one side of the story.” Moderator of the session in which these data were presented, Dr. Kumar said that other factors Dr. Iantorno listed as potentially important, including polymer type and eluting drug, should not be discounted. However, he conceded that in the context of other recent evidence that strut thickness may be important to outcomes, particularly risk of stent thrombosis, this variable has become a focus of design improvements.

SOURCE: Iantorno M. Abstract CRT-100.87.

 

WASHINGTON – For antithrombotic therapy after transcatheter aortic valve implantation (TAVI), ticagrelor plus aspirin may be a better strategy than clopidogrel plus aspirin even though the latter combination is guideline recommended, according to a late-breaking, randomized study presented at CRT 2018 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.

Unlike the ticagrelor regimen, which did deliver the goal antiplatelet effect for all 3 months of the study, “clopidogrel did not achieve adequate platelet inhibition before or after TAVI in most patients,” reported Victor A. Jimenez Diaz, MD, a cardiologist at University Hospital, Vigo, Spain.

Ted Bosworth/MDedge News

This investigator-initiated, multicenter study, called the REAC TAVI trial, was relatively small and was limited to an evaluation of platelet reactivity, but the data suggest that a “large, randomized trial powered for clinical endpoints is urgently needed,” according to Dr. Jimenez Diaz.

The current American Heart Association/American College of Cardiology guidelines label the clopidogrel/aspirin combination for the first 6 months after TAVI “reasonable,” but Dr. Jimenez Diaz said that the value of this combination over other antiplatelet strategies has not been supported by a randomized clinical trial. The known variability in response to clopidogrel is among the reasons such data are needed.

Thrombotic and hemorrhagic complications are frequent after TAVI, making choice of antithrombotic treatment an important consideration for improving outcomes, according to Dr. Jimenez Diaz. The aim of the REAC TAVI trial was to evaluate whether ticagrelor provides a more consistent antiplatelet effect than clopidogrel for TAVI patients, which was undertaken at seven participating centers in Spain.

A total of 65 candidates for TAVI were enrolled in this study. The key exclusion criterion was chronic oral anticoagulation therapy. In a baseline assessment, patients in the study, all of whom were on 75 mg clopidogrel plus aspirin, were evaluated for high on-treatment platelet reactivity (HTPR), defined as a score of at least 208 platelet reaction units (PRU) on a standard assay.

The 46 (71%) patients found to have HTPR were randomized to 90 mg ticagrelor twice daily plus aspirin or to remain on the clopidogrel/aspirin combination. Unlike those with HTPR, in whom the mean PRU was 274 units, all of the patients without HTPR, who had a mean PRU of 134 units, remained on the baseline dual antiplatelet therapy. The study was open label.

 

The primary endpoint was adequate platelet antiaggregation, defined as absence of HTPR (less than 208 PRU), which was greater in the ticagrelor-treated group than the clopidogrel-treated group at 6 hours (91% vs. 4%), 5 days (100% vs. 10%), and 3 months (100% vs. 21%). In the patients without HTPR, the proportion with adequate platelet antiaggregation at these three time points were 73%, 64%, and 78%, respectively.

“The net difference in the randomized arms over the course of the study was 79%,” reported Dr. Jimenez Diaz, emphasizing that the study verified the hypothesis that ticagrelor would provide a more consistent antiplatelet effect than clopidogrel.

Although in-hospital bleeding complications were numerically higher in the clopidogrel-treated group (25% vs. 4%), this difference did not reach significance, and there were no significant differences in bleeding complications at any other time points or overall. There were two deaths in the clopidogrel-treated group, two deaths in the group without baseline HTPR, but no deaths in the ticagrelor-treated group.

While acknowledging that this study was small and not powered to show a difference in clinical events, Dr. Jimenez Diaz said it is important to emphasize that two-thirds of patients had HTPR at baseline. The high rate of HTPR among TAVI patients on clopidogrel and aspirin at baseline was identified as an important message from this study. However, a study is now needed to determine whether a ticagrelor strategy improves clinical outcomes when compared with a clopidogrel strategy.

 

A panel of experts at the CRT late-breaker session where these results were presented offered mixed reactions. While Jeffrey Popma, MD, director of interventional cardiology at Beth Israel Deaconess Hospital, Boston, called the results both “intriguing” and “provocative,” Ron Waksman, MD, associate director of the division of cardiology at the Medstar Health Institute, Washington, offered a note of caution, commenting that this application of ticagrelor “is off label, and then you would have to be concerned about the bleeding risk.”

However, all agreed that the optimal antithrombotic therapy for TAVI remains poorly defined and that randomized trials are needed to explore this issue.

This investigator-initiated study had no commercial sponsor. Dr. Jimenez Diaz reported no relevant financial relationships.

SOURCE: Jimenez Diaz VA. CRT 2018, Abstract LBT-10.

 

WASHINGTON – For antithrombotic therapy after transcatheter aortic valve implantation (TAVI), ticagrelor plus aspirin may be a better strategy than clopidogrel plus aspirin even though the latter combination is guideline recommended, according to a late-breaking, randomized study presented at CRT 2018 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.

Unlike the ticagrelor regimen, which did deliver the goal antiplatelet effect for all 3 months of the study, “clopidogrel did not achieve adequate platelet inhibition before or after TAVI in most patients,” reported Victor A. Jimenez Diaz, MD, a cardiologist at University Hospital, Vigo, Spain.

Ted Bosworth/MDedge News

This investigator-initiated, multicenter study, called the REAC TAVI trial, was relatively small and was limited to an evaluation of platelet reactivity, but the data suggest that a “large, randomized trial powered for clinical endpoints is urgently needed,” according to Dr. Jimenez Diaz.

The current American Heart Association/American College of Cardiology guidelines label the clopidogrel/aspirin combination for the first 6 months after TAVI “reasonable,” but Dr. Jimenez Diaz said that the value of this combination over other antiplatelet strategies has not been supported by a randomized clinical trial. The known variability in response to clopidogrel is among the reasons such data are needed.

Thrombotic and hemorrhagic complications are frequent after TAVI, making choice of antithrombotic treatment an important consideration for improving outcomes, according to Dr. Jimenez Diaz. The aim of the REAC TAVI trial was to evaluate whether ticagrelor provides a more consistent antiplatelet effect than clopidogrel for TAVI patients, which was undertaken at seven participating centers in Spain.

A total of 65 candidates for TAVI were enrolled in this study. The key exclusion criterion was chronic oral anticoagulation therapy. In a baseline assessment, patients in the study, all of whom were on 75 mg clopidogrel plus aspirin, were evaluated for high on-treatment platelet reactivity (HTPR), defined as a score of at least 208 platelet reaction units (PRU) on a standard assay.

The 46 (71%) patients found to have HTPR were randomized to 90 mg ticagrelor twice daily plus aspirin or to remain on the clopidogrel/aspirin combination. Unlike those with HTPR, in whom the mean PRU was 274 units, all of the patients without HTPR, who had a mean PRU of 134 units, remained on the baseline dual antiplatelet therapy. The study was open label.

 

The primary endpoint was adequate platelet antiaggregation, defined as absence of HTPR (less than 208 PRU), which was greater in the ticagrelor-treated group than the clopidogrel-treated group at 6 hours (91% vs. 4%), 5 days (100% vs. 10%), and 3 months (100% vs. 21%). In the patients without HTPR, the proportion with adequate platelet antiaggregation at these three time points were 73%, 64%, and 78%, respectively.

“The net difference in the randomized arms over the course of the study was 79%,” reported Dr. Jimenez Diaz, emphasizing that the study verified the hypothesis that ticagrelor would provide a more consistent antiplatelet effect than clopidogrel.

Although in-hospital bleeding complications were numerically higher in the clopidogrel-treated group (25% vs. 4%), this difference did not reach significance, and there were no significant differences in bleeding complications at any other time points or overall. There were two deaths in the clopidogrel-treated group, two deaths in the group without baseline HTPR, but no deaths in the ticagrelor-treated group.

While acknowledging that this study was small and not powered to show a difference in clinical events, Dr. Jimenez Diaz said it is important to emphasize that two-thirds of patients had HTPR at baseline. The high rate of HTPR among TAVI patients on clopidogrel and aspirin at baseline was identified as an important message from this study. However, a study is now needed to determine whether a ticagrelor strategy improves clinical outcomes when compared with a clopidogrel strategy.

 

A panel of experts at the CRT late-breaker session where these results were presented offered mixed reactions. While Jeffrey Popma, MD, director of interventional cardiology at Beth Israel Deaconess Hospital, Boston, called the results both “intriguing” and “provocative,” Ron Waksman, MD, associate director of the division of cardiology at the Medstar Health Institute, Washington, offered a note of caution, commenting that this application of ticagrelor “is off label, and then you would have to be concerned about the bleeding risk.”

However, all agreed that the optimal antithrombotic therapy for TAVI remains poorly defined and that randomized trials are needed to explore this issue.

This investigator-initiated study had no commercial sponsor. Dr. Jimenez Diaz reported no relevant financial relationships.

SOURCE: Jimenez Diaz VA. CRT 2018, Abstract LBT-10.

 

WASHINGTON – For antithrombotic therapy after transcatheter aortic valve implantation (TAVI), ticagrelor plus aspirin may be a better strategy than clopidogrel plus aspirin even though the latter combination is guideline recommended, according to a late-breaking, randomized study presented at CRT 2018 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.

Unlike the ticagrelor regimen, which did deliver the goal antiplatelet effect for all 3 months of the study, “clopidogrel did not achieve adequate platelet inhibition before or after TAVI in most patients,” reported Victor A. Jimenez Diaz, MD, a cardiologist at University Hospital, Vigo, Spain.

Ted Bosworth/MDedge News

This investigator-initiated, multicenter study, called the REAC TAVI trial, was relatively small and was limited to an evaluation of platelet reactivity, but the data suggest that a “large, randomized trial powered for clinical endpoints is urgently needed,” according to Dr. Jimenez Diaz.

The current American Heart Association/American College of Cardiology guidelines label the clopidogrel/aspirin combination for the first 6 months after TAVI “reasonable,” but Dr. Jimenez Diaz said that the value of this combination over other antiplatelet strategies has not been supported by a randomized clinical trial. The known variability in response to clopidogrel is among the reasons such data are needed.

Thrombotic and hemorrhagic complications are frequent after TAVI, making choice of antithrombotic treatment an important consideration for improving outcomes, according to Dr. Jimenez Diaz. The aim of the REAC TAVI trial was to evaluate whether ticagrelor provides a more consistent antiplatelet effect than clopidogrel for TAVI patients, which was undertaken at seven participating centers in Spain.

A total of 65 candidates for TAVI were enrolled in this study. The key exclusion criterion was chronic oral anticoagulation therapy. In a baseline assessment, patients in the study, all of whom were on 75 mg clopidogrel plus aspirin, were evaluated for high on-treatment platelet reactivity (HTPR), defined as a score of at least 208 platelet reaction units (PRU) on a standard assay.

The 46 (71%) patients found to have HTPR were randomized to 90 mg ticagrelor twice daily plus aspirin or to remain on the clopidogrel/aspirin combination. Unlike those with HTPR, in whom the mean PRU was 274 units, all of the patients without HTPR, who had a mean PRU of 134 units, remained on the baseline dual antiplatelet therapy. The study was open label.

 

The primary endpoint was adequate platelet antiaggregation, defined as absence of HTPR (less than 208 PRU), which was greater in the ticagrelor-treated group than the clopidogrel-treated group at 6 hours (91% vs. 4%), 5 days (100% vs. 10%), and 3 months (100% vs. 21%). In the patients without HTPR, the proportion with adequate platelet antiaggregation at these three time points were 73%, 64%, and 78%, respectively.

“The net difference in the randomized arms over the course of the study was 79%,” reported Dr. Jimenez Diaz, emphasizing that the study verified the hypothesis that ticagrelor would provide a more consistent antiplatelet effect than clopidogrel.

Although in-hospital bleeding complications were numerically higher in the clopidogrel-treated group (25% vs. 4%), this difference did not reach significance, and there were no significant differences in bleeding complications at any other time points or overall. There were two deaths in the clopidogrel-treated group, two deaths in the group without baseline HTPR, but no deaths in the ticagrelor-treated group.

While acknowledging that this study was small and not powered to show a difference in clinical events, Dr. Jimenez Diaz said it is important to emphasize that two-thirds of patients had HTPR at baseline. The high rate of HTPR among TAVI patients on clopidogrel and aspirin at baseline was identified as an important message from this study. However, a study is now needed to determine whether a ticagrelor strategy improves clinical outcomes when compared with a clopidogrel strategy.

 

A panel of experts at the CRT late-breaker session where these results were presented offered mixed reactions. While Jeffrey Popma, MD, director of interventional cardiology at Beth Israel Deaconess Hospital, Boston, called the results both “intriguing” and “provocative,” Ron Waksman, MD, associate director of the division of cardiology at the Medstar Health Institute, Washington, offered a note of caution, commenting that this application of ticagrelor “is off label, and then you would have to be concerned about the bleeding risk.”

However, all agreed that the optimal antithrombotic therapy for TAVI remains poorly defined and that randomized trials are needed to explore this issue.

This investigator-initiated study had no commercial sponsor. Dr. Jimenez Diaz reported no relevant financial relationships.

SOURCE: Jimenez Diaz VA. CRT 2018, Abstract LBT-10.

 

WASHINGTON – Transcatheter heart valves (THV) developed for the treatment of symptomatic aortic stenosis have been used off label for the treatment of native aortic valve regurgitation (NAVR), but registry data suggest that outcomes have been disappointing, according to a presentation at CRT 2018 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.

“Although significant improvement was seen with newer-generation THV devices, TAVR [transcatheter aortic valve replacement] for NAVR is a challenging approach associated with limited procedural efficacy,” reported Danny Dvir, MD, a prosthetic heart valve specialist and assistant professor of cardiology at the University of Washington, Seattle.

Ted Bosworth/Frontline Medical News

He based these remarks on data generated by 254 patients in the Valve in Valve International Data Registry who underwent TAVR for the treatment of NAVR. The outcomes were stratified by device generation. Of those in the registry, 109 received a first-generation device, including a device that is now considered obsolete, and 145 were implanted with a second-generation device.

Results improved substantially with second-generation devices. For example, Dr. Dvir reported that the rate of device success climbed from 47% to 82% while correct positioning climbed from 67% to 91%. The proportion of patients without moderate or severe aortic regurgitation after placement of the THV climbed from 69% to 96%.

These improvements were reflected in clinical outcomes at 30 days. When second-generation devices were compared with first-generation devices, there was a reduction in all cause mortality (8% vs. 17%) and cardiac mortality (7% vs. 12%). There were also reductions from first- to second-generation devices in noncardiac mortality (1% vs. 5%), valve-related dysfunction (10% vs. 29%), and proportion of patients in New York Heart Association class III or IV (13% vs. 18%).

The improvement in outcomes from first- to second-generation devices is encouraging, but Dr. Dvir indicated that the main message is that TAVR for NAVR is producing success rates that “are suboptimal” and “not comparable to those being achieved when the indication is aortic stenosis.” The reasons cannot be derived from these data, but he suggested that optimal sizing of the device for NAVR might be different than it is for aortic stenosis.

“I wonder if we should have better devices designed specifically for aortic regurgitation,” Dr. Dvir said.

 

Despite the improved results with second-generation THV, receipt of a first-generation device was not a significant predictor of mortality at 1 year. Rather, in an analysis of predictors, mortality was significantly increased in those with moderate or worse aortic regurgitation, Society of Thoracic Surgeons risk score of 8% or greater, and acute kidney injury of grade 2 or higher. There was also a trend for increased mortality in those with pulmonary hypertension.

Most of the devices (76%) were placed with a transfemoral approach. No difference in mortality was observed when a transfemoral approach was compared with a nontransfemoral approach.

According to the registry data, a 10%-20% oversizing of the THV was associated with a reduced risk of malpositioning, relative to devices with less than 10% oversizing or greater than 20% oversizing, reinforcing Dr. Dvir’s hypothesis that sizing is a variable affecting outcome in NAVR.

Although Dr. Dvir contended that these data raise issues about the suitability of current THV designs for use in the treatment of NAVR, not all experts were convinced by these data. Jeffrey Popma, MD, director of the interventional cardiology clinical service at Beth Israel Deaconess Hospital, Boston, questioned whether more experience is placing these devices for NAVR might lead to greater success.

 

“There are two variables to consider,” Dr. Popma said. “One is the valve and one is how much we’ve evolved our procedure over the past couple of years.” He indicated that these data do not preclude advances that would improve results in NAVR even without developing new valves specific for this indication.

Dr. Dvir reported financial relationships with Edwards Lifesciences, Medtronic, Abbott, and Jena.

SOURCE: Dvir D. CRT 2018.

 

WASHINGTON – Transcatheter heart valves (THV) developed for the treatment of symptomatic aortic stenosis have been used off label for the treatment of native aortic valve regurgitation (NAVR), but registry data suggest that outcomes have been disappointing, according to a presentation at CRT 2018 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.

“Although significant improvement was seen with newer-generation THV devices, TAVR [transcatheter aortic valve replacement] for NAVR is a challenging approach associated with limited procedural efficacy,” reported Danny Dvir, MD, a prosthetic heart valve specialist and assistant professor of cardiology at the University of Washington, Seattle.

Ted Bosworth/Frontline Medical News

He based these remarks on data generated by 254 patients in the Valve in Valve International Data Registry who underwent TAVR for the treatment of NAVR. The outcomes were stratified by device generation. Of those in the registry, 109 received a first-generation device, including a device that is now considered obsolete, and 145 were implanted with a second-generation device.

Results improved substantially with second-generation devices. For example, Dr. Dvir reported that the rate of device success climbed from 47% to 82% while correct positioning climbed from 67% to 91%. The proportion of patients without moderate or severe aortic regurgitation after placement of the THV climbed from 69% to 96%.

These improvements were reflected in clinical outcomes at 30 days. When second-generation devices were compared with first-generation devices, there was a reduction in all cause mortality (8% vs. 17%) and cardiac mortality (7% vs. 12%). There were also reductions from first- to second-generation devices in noncardiac mortality (1% vs. 5%), valve-related dysfunction (10% vs. 29%), and proportion of patients in New York Heart Association class III or IV (13% vs. 18%).

The improvement in outcomes from first- to second-generation devices is encouraging, but Dr. Dvir indicated that the main message is that TAVR for NAVR is producing success rates that “are suboptimal” and “not comparable to those being achieved when the indication is aortic stenosis.” The reasons cannot be derived from these data, but he suggested that optimal sizing of the device for NAVR might be different than it is for aortic stenosis.

“I wonder if we should have better devices designed specifically for aortic regurgitation,” Dr. Dvir said.

 

Despite the improved results with second-generation THV, receipt of a first-generation device was not a significant predictor of mortality at 1 year. Rather, in an analysis of predictors, mortality was significantly increased in those with moderate or worse aortic regurgitation, Society of Thoracic Surgeons risk score of 8% or greater, and acute kidney injury of grade 2 or higher. There was also a trend for increased mortality in those with pulmonary hypertension.

Most of the devices (76%) were placed with a transfemoral approach. No difference in mortality was observed when a transfemoral approach was compared with a nontransfemoral approach.

According to the registry data, a 10%-20% oversizing of the THV was associated with a reduced risk of malpositioning, relative to devices with less than 10% oversizing or greater than 20% oversizing, reinforcing Dr. Dvir’s hypothesis that sizing is a variable affecting outcome in NAVR.

Although Dr. Dvir contended that these data raise issues about the suitability of current THV designs for use in the treatment of NAVR, not all experts were convinced by these data. Jeffrey Popma, MD, director of the interventional cardiology clinical service at Beth Israel Deaconess Hospital, Boston, questioned whether more experience is placing these devices for NAVR might lead to greater success.

 

“There are two variables to consider,” Dr. Popma said. “One is the valve and one is how much we’ve evolved our procedure over the past couple of years.” He indicated that these data do not preclude advances that would improve results in NAVR even without developing new valves specific for this indication.

Dr. Dvir reported financial relationships with Edwards Lifesciences, Medtronic, Abbott, and Jena.

SOURCE: Dvir D. CRT 2018.

 

WASHINGTON – Transcatheter heart valves (THV) developed for the treatment of symptomatic aortic stenosis have been used off label for the treatment of native aortic valve regurgitation (NAVR), but registry data suggest that outcomes have been disappointing, according to a presentation at CRT 2018 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.

“Although significant improvement was seen with newer-generation THV devices, TAVR [transcatheter aortic valve replacement] for NAVR is a challenging approach associated with limited procedural efficacy,” reported Danny Dvir, MD, a prosthetic heart valve specialist and assistant professor of cardiology at the University of Washington, Seattle.

Ted Bosworth/Frontline Medical News

He based these remarks on data generated by 254 patients in the Valve in Valve International Data Registry who underwent TAVR for the treatment of NAVR. The outcomes were stratified by device generation. Of those in the registry, 109 received a first-generation device, including a device that is now considered obsolete, and 145 were implanted with a second-generation device.

Results improved substantially with second-generation devices. For example, Dr. Dvir reported that the rate of device success climbed from 47% to 82% while correct positioning climbed from 67% to 91%. The proportion of patients without moderate or severe aortic regurgitation after placement of the THV climbed from 69% to 96%.

These improvements were reflected in clinical outcomes at 30 days. When second-generation devices were compared with first-generation devices, there was a reduction in all cause mortality (8% vs. 17%) and cardiac mortality (7% vs. 12%). There were also reductions from first- to second-generation devices in noncardiac mortality (1% vs. 5%), valve-related dysfunction (10% vs. 29%), and proportion of patients in New York Heart Association class III or IV (13% vs. 18%).

The improvement in outcomes from first- to second-generation devices is encouraging, but Dr. Dvir indicated that the main message is that TAVR for NAVR is producing success rates that “are suboptimal” and “not comparable to those being achieved when the indication is aortic stenosis.” The reasons cannot be derived from these data, but he suggested that optimal sizing of the device for NAVR might be different than it is for aortic stenosis.

“I wonder if we should have better devices designed specifically for aortic regurgitation,” Dr. Dvir said.

 

Despite the improved results with second-generation THV, receipt of a first-generation device was not a significant predictor of mortality at 1 year. Rather, in an analysis of predictors, mortality was significantly increased in those with moderate or worse aortic regurgitation, Society of Thoracic Surgeons risk score of 8% or greater, and acute kidney injury of grade 2 or higher. There was also a trend for increased mortality in those with pulmonary hypertension.

Most of the devices (76%) were placed with a transfemoral approach. No difference in mortality was observed when a transfemoral approach was compared with a nontransfemoral approach.

According to the registry data, a 10%-20% oversizing of the THV was associated with a reduced risk of malpositioning, relative to devices with less than 10% oversizing or greater than 20% oversizing, reinforcing Dr. Dvir’s hypothesis that sizing is a variable affecting outcome in NAVR.

Although Dr. Dvir contended that these data raise issues about the suitability of current THV designs for use in the treatment of NAVR, not all experts were convinced by these data. Jeffrey Popma, MD, director of the interventional cardiology clinical service at Beth Israel Deaconess Hospital, Boston, questioned whether more experience is placing these devices for NAVR might lead to greater success.

 

“There are two variables to consider,” Dr. Popma said. “One is the valve and one is how much we’ve evolved our procedure over the past couple of years.” He indicated that these data do not preclude advances that would improve results in NAVR even without developing new valves specific for this indication.

Dr. Dvir reported financial relationships with Edwards Lifesciences, Medtronic, Abbott, and Jena.

SOURCE: Dvir D. CRT 2018.

 

WASHINGTON – The published results with bioresorbable stents have been disappointing, but most interventionalists think such devices have the potential to prevail over drug-eluting stents by addressing unmet needs, judging from a debate on this topic that took place at CRT 2018 sponsored by the Cardiovascular Research Institute at Washington Hospital Center..

“There is a clinical need for bioresorbable stents [BRS] unless drug-eluting stents [DES] are perfect, and I think we agree that they are not perfect,” argued Gregg Stone, MD, director of cardiovascular research and education at Columbia University Medical Center, New York.

Ted Bosworth/Frontline Medical News

As the proponent of a debate premise that “there is an unmet need for BRS technology in the era of improved DES technology,” Dr. Stone focused on the persistent late target-lesion failure (TLF) rate with DES. He previewed data he and his coauthors are now preparing for publication that found that the risk of TLF is about 2% per year for every year of follow-up, extending out to 20 years.

“It does not matter what device you evaluate,” Dr. Stone said. Whether caused by late polymer sensitivity reactions, late strut fractures, or neoatherosclerosis formation, failure can occur suddenly after a decade or more in DES that were performing well up until that point, according to data cited by Dr. Stone. This is one of the key risks that BRS technology was designed to address.

“We now know that the bioresorbable scaffold is replaced by normal tissue at 3 years,” Dr. Stone said. He reported that he is encouraged by the absence of any scaffold thrombosis after 3 years in a recent series of 501 patients with a BRS that have been followed at least 4 years. “This is the first time that we have seen that,” he asserted, adding, “The concept is there.”

His debate opponent, Stephan Windecker, MD, director of invasive cardiology at the Swiss Cardiovascular Center in Bern, cited numerous studies to conclude that “there is clear inferiority” of BRS relative to DES for most important clinical outcomes, including TLF. Although he acknowledged late TLF does occur with DES devices, he contended that new design changes are at least as likely to mitigate risk in DES as improvements in BRS.

Ted Bosworth/Frontline Medical News

“One of the shortcomings [of DES devices] has been scaffold thrombosis, but this may be related to strut thickness,” Dr. Windecker said. “As we move from early devices to new-generation DES [with thinner struts], there is evidence this risk is diminishing.” So far, there is no published evidence to support the premise that BRS will provide better long-term outcomes than DES, according to Dr. Windecker, who said that the higher rates of early TLF relative to DES devices is a hurdle for BRS devices even if risk of late TLF proves to be lower.

 

However, Dr. Stone suggested that reductions in strut thickness might be the answer for reduced TLF for both BRS and DES devices. If so, there are several reasons to believe that this would ultimately favor BRS as the dominant technology.

“We did not get there with the 150-mcm strut thickness scaffold, but now we have struts as thin as 80 mcm. I’m pretty confident that with smaller struts we will see great results,” countered Dr. Stone.

Returning to the theme that BRS devices address an unmet need, Dr. Stone contended that BRS is the preferred strategy if advances render BRS and drug-eluting stents equally safe and effective. Not least of the reasons is patient preference. “It is an undeniable fact that based on cultural, religious, or personal beliefs, many patients prefer not to live their lives with a permanently implanted device,” he said.

The audience agreed. Asked for a show of hands regarding whether bioresorbable stents technology has the potential to address an unmet need, the majority vote was overwhelmingly in favor of Dr. Stone’s position. Based on a visual vote count that seemed to clearly affirm that BRS addresses and unmet need, Dr. Stone contended that a statistical analysis would have had a P value “with about eight zeros after the decimal point.”

Dr. Stone reports a financial relationship with Reva Medical. Dr. Windecker reports financial relationships with Abbott, Boston Scientific, Biotronik, Edwards Lifesciences, Medtronic, and St. Jude.

 

WASHINGTON – The published results with bioresorbable stents have been disappointing, but most interventionalists think such devices have the potential to prevail over drug-eluting stents by addressing unmet needs, judging from a debate on this topic that took place at CRT 2018 sponsored by the Cardiovascular Research Institute at Washington Hospital Center..

“There is a clinical need for bioresorbable stents [BRS] unless drug-eluting stents [DES] are perfect, and I think we agree that they are not perfect,” argued Gregg Stone, MD, director of cardiovascular research and education at Columbia University Medical Center, New York.

Ted Bosworth/Frontline Medical News

As the proponent of a debate premise that “there is an unmet need for BRS technology in the era of improved DES technology,” Dr. Stone focused on the persistent late target-lesion failure (TLF) rate with DES. He previewed data he and his coauthors are now preparing for publication that found that the risk of TLF is about 2% per year for every year of follow-up, extending out to 20 years.

“It does not matter what device you evaluate,” Dr. Stone said. Whether caused by late polymer sensitivity reactions, late strut fractures, or neoatherosclerosis formation, failure can occur suddenly after a decade or more in DES that were performing well up until that point, according to data cited by Dr. Stone. This is one of the key risks that BRS technology was designed to address.

“We now know that the bioresorbable scaffold is replaced by normal tissue at 3 years,” Dr. Stone said. He reported that he is encouraged by the absence of any scaffold thrombosis after 3 years in a recent series of 501 patients with a BRS that have been followed at least 4 years. “This is the first time that we have seen that,” he asserted, adding, “The concept is there.”

His debate opponent, Stephan Windecker, MD, director of invasive cardiology at the Swiss Cardiovascular Center in Bern, cited numerous studies to conclude that “there is clear inferiority” of BRS relative to DES for most important clinical outcomes, including TLF. Although he acknowledged late TLF does occur with DES devices, he contended that new design changes are at least as likely to mitigate risk in DES as improvements in BRS.

Ted Bosworth/Frontline Medical News

“One of the shortcomings [of DES devices] has been scaffold thrombosis, but this may be related to strut thickness,” Dr. Windecker said. “As we move from early devices to new-generation DES [with thinner struts], there is evidence this risk is diminishing.” So far, there is no published evidence to support the premise that BRS will provide better long-term outcomes than DES, according to Dr. Windecker, who said that the higher rates of early TLF relative to DES devices is a hurdle for BRS devices even if risk of late TLF proves to be lower.

 

However, Dr. Stone suggested that reductions in strut thickness might be the answer for reduced TLF for both BRS and DES devices. If so, there are several reasons to believe that this would ultimately favor BRS as the dominant technology.

“We did not get there with the 150-mcm strut thickness scaffold, but now we have struts as thin as 80 mcm. I’m pretty confident that with smaller struts we will see great results,” countered Dr. Stone.

Returning to the theme that BRS devices address an unmet need, Dr. Stone contended that BRS is the preferred strategy if advances render BRS and drug-eluting stents equally safe and effective. Not least of the reasons is patient preference. “It is an undeniable fact that based on cultural, religious, or personal beliefs, many patients prefer not to live their lives with a permanently implanted device,” he said.

The audience agreed. Asked for a show of hands regarding whether bioresorbable stents technology has the potential to address an unmet need, the majority vote was overwhelmingly in favor of Dr. Stone’s position. Based on a visual vote count that seemed to clearly affirm that BRS addresses and unmet need, Dr. Stone contended that a statistical analysis would have had a P value “with about eight zeros after the decimal point.”

Dr. Stone reports a financial relationship with Reva Medical. Dr. Windecker reports financial relationships with Abbott, Boston Scientific, Biotronik, Edwards Lifesciences, Medtronic, and St. Jude.

 

WASHINGTON – The published results with bioresorbable stents have been disappointing, but most interventionalists think such devices have the potential to prevail over drug-eluting stents by addressing unmet needs, judging from a debate on this topic that took place at CRT 2018 sponsored by the Cardiovascular Research Institute at Washington Hospital Center..

“There is a clinical need for bioresorbable stents [BRS] unless drug-eluting stents [DES] are perfect, and I think we agree that they are not perfect,” argued Gregg Stone, MD, director of cardiovascular research and education at Columbia University Medical Center, New York.

Ted Bosworth/Frontline Medical News

As the proponent of a debate premise that “there is an unmet need for BRS technology in the era of improved DES technology,” Dr. Stone focused on the persistent late target-lesion failure (TLF) rate with DES. He previewed data he and his coauthors are now preparing for publication that found that the risk of TLF is about 2% per year for every year of follow-up, extending out to 20 years.

“It does not matter what device you evaluate,” Dr. Stone said. Whether caused by late polymer sensitivity reactions, late strut fractures, or neoatherosclerosis formation, failure can occur suddenly after a decade or more in DES that were performing well up until that point, according to data cited by Dr. Stone. This is one of the key risks that BRS technology was designed to address.

“We now know that the bioresorbable scaffold is replaced by normal tissue at 3 years,” Dr. Stone said. He reported that he is encouraged by the absence of any scaffold thrombosis after 3 years in a recent series of 501 patients with a BRS that have been followed at least 4 years. “This is the first time that we have seen that,” he asserted, adding, “The concept is there.”

His debate opponent, Stephan Windecker, MD, director of invasive cardiology at the Swiss Cardiovascular Center in Bern, cited numerous studies to conclude that “there is clear inferiority” of BRS relative to DES for most important clinical outcomes, including TLF. Although he acknowledged late TLF does occur with DES devices, he contended that new design changes are at least as likely to mitigate risk in DES as improvements in BRS.

Ted Bosworth/Frontline Medical News

“One of the shortcomings [of DES devices] has been scaffold thrombosis, but this may be related to strut thickness,” Dr. Windecker said. “As we move from early devices to new-generation DES [with thinner struts], there is evidence this risk is diminishing.” So far, there is no published evidence to support the premise that BRS will provide better long-term outcomes than DES, according to Dr. Windecker, who said that the higher rates of early TLF relative to DES devices is a hurdle for BRS devices even if risk of late TLF proves to be lower.

 

However, Dr. Stone suggested that reductions in strut thickness might be the answer for reduced TLF for both BRS and DES devices. If so, there are several reasons to believe that this would ultimately favor BRS as the dominant technology.

“We did not get there with the 150-mcm strut thickness scaffold, but now we have struts as thin as 80 mcm. I’m pretty confident that with smaller struts we will see great results,” countered Dr. Stone.

Returning to the theme that BRS devices address an unmet need, Dr. Stone contended that BRS is the preferred strategy if advances render BRS and drug-eluting stents equally safe and effective. Not least of the reasons is patient preference. “It is an undeniable fact that based on cultural, religious, or personal beliefs, many patients prefer not to live their lives with a permanently implanted device,” he said.

The audience agreed. Asked for a show of hands regarding whether bioresorbable stents technology has the potential to address an unmet need, the majority vote was overwhelmingly in favor of Dr. Stone’s position. Based on a visual vote count that seemed to clearly affirm that BRS addresses and unmet need, Dr. Stone contended that a statistical analysis would have had a P value “with about eight zeros after the decimal point.”

Dr. Stone reports a financial relationship with Reva Medical. Dr. Windecker reports financial relationships with Abbott, Boston Scientific, Biotronik, Edwards Lifesciences, Medtronic, and St. Jude.

 

WASHINGTON – Balloon pulmonary angioplasty provides meaningful improvements in functional capacity for patients with chronic thromboembolic pulmonary hypertension (CTEPH) who are not candidates for surgical pulmonary thromboendarterectomy, according to a single-center experience with 15 consecutive patients that was presented at CRT 2018 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.

The treatment of choice for CTEPH is pulmonary thromboendarterectomy (PTE), but “a huge percentage of the population with CTEPH” is not eligible or does not undergo surgical treatment, which was the impetus to initiate this intervention, reported Riyaz Bashir, MD, director of vascular and endovascular medicine at Temple University Hospital and professor of medicine at Temple University, Philadelphia.

Ted Bosworth/MDedge News

Much of the experience with balloon pulmonary angioplasty (BPA) for CTEPH comes from outside the United States, particularly Japan, where this procedure has been associated with improved survival, compared with historical untreated controls, according to Dr. Bashir. He cited registry data showing that more than 80% of CTEPH patients are not surgical candidates and up to 40% of those who are candidates still fail to undergo PTE for other reasons.

There have now been 15 CTEPH patients treated with BPA by Dr. Bashir and his team at Temple University. He reported 6-month outcome data on the first 13 patients, all of whom had a history of pulmonary embolism. Three of the patients had a prior PTE.

The primary outcome of interest in this series was functional improvement. Unlike PTE, immediate improvement in hemodynamics is not typically observed immediately after the procedure, but these measures do improve incrementally over time, Dr. Bashir reported. This is reflected in progressive improvements in the 6-minute walk test and in New York Heart Association (NYHA) functional class.

Of the 13 patients treated so far, 6 (46%) were in NYHA class IV and only 2 (15%) were in NYHA class II prior to BPA. Six months after BPA, the proportions had reversed. At that point, seven patients (54%) were in class II and two (15%) in class IV. The remaining patients at both time points were in NYHA class III. Similar improvements were seen in the 6-minute walk test, which typically tracks with NYHA class.

Describing the first case, performed about 2 years ago, Dr. Bashir explained that a tight stenosis in the right lower pulmonary artery of a 44-year-old woman was reached with a multipurpose guiding catheter through femoral access. A 5-mm balloon was used to dilate the stenosis and create a pulsatile flow.

 

“The goal is not to raise the mean arterial pressure above 35 mm Hg, because this has been associated with significant peripheral edema,” Dr. Bashir explained.

In this patient, progressive improvements in pulmonary pressure, cardiac index, and other hemodynamics were associated with progressive shrinking of the right ventricle over 6 months of follow-up. The walk test improved from 216 m prior to BPA to 421 m at her most recent evaluation.

The average age in the 13 patients treated so far was 55 years, and 75% are males. The mean left ventricular ejection fraction (LVEF) was 55%. According to Dr. Bashir, most patients required at least two treatment sessions and some have required up to four.

There have been two complications – one patient developed hemoptysis that required a brief intubation and the other involved perfusion edema – and no deaths in this series so far, he said.

The outcomes so far, which Dr. Bashir characterized as “an early experience,” provide evidence that BPA is “safe and feasible” for patients with CTEPH who are not surgical candidates. At Dr. Bashir’s institution, where PTE is commonly performed in patients with CTEPH (Dr. Bashir reported that 134 cases were performed over the period of time in which these 15 cases of BPA were performed), there is a plan to compare functional outcomes in CTEPH patients managed with these two different approaches.

Dr. Bashir reported no financial relationships relevant to this study.

 

SOURCE: Bashir R. CRT 2018

 

WASHINGTON – Balloon pulmonary angioplasty provides meaningful improvements in functional capacity for patients with chronic thromboembolic pulmonary hypertension (CTEPH) who are not candidates for surgical pulmonary thromboendarterectomy, according to a single-center experience with 15 consecutive patients that was presented at CRT 2018 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.

The treatment of choice for CTEPH is pulmonary thromboendarterectomy (PTE), but “a huge percentage of the population with CTEPH” is not eligible or does not undergo surgical treatment, which was the impetus to initiate this intervention, reported Riyaz Bashir, MD, director of vascular and endovascular medicine at Temple University Hospital and professor of medicine at Temple University, Philadelphia.

Ted Bosworth/MDedge News

Much of the experience with balloon pulmonary angioplasty (BPA) for CTEPH comes from outside the United States, particularly Japan, where this procedure has been associated with improved survival, compared with historical untreated controls, according to Dr. Bashir. He cited registry data showing that more than 80% of CTEPH patients are not surgical candidates and up to 40% of those who are candidates still fail to undergo PTE for other reasons.

There have now been 15 CTEPH patients treated with BPA by Dr. Bashir and his team at Temple University. He reported 6-month outcome data on the first 13 patients, all of whom had a history of pulmonary embolism. Three of the patients had a prior PTE.

The primary outcome of interest in this series was functional improvement. Unlike PTE, immediate improvement in hemodynamics is not typically observed immediately after the procedure, but these measures do improve incrementally over time, Dr. Bashir reported. This is reflected in progressive improvements in the 6-minute walk test and in New York Heart Association (NYHA) functional class.

Of the 13 patients treated so far, 6 (46%) were in NYHA class IV and only 2 (15%) were in NYHA class II prior to BPA. Six months after BPA, the proportions had reversed. At that point, seven patients (54%) were in class II and two (15%) in class IV. The remaining patients at both time points were in NYHA class III. Similar improvements were seen in the 6-minute walk test, which typically tracks with NYHA class.

Describing the first case, performed about 2 years ago, Dr. Bashir explained that a tight stenosis in the right lower pulmonary artery of a 44-year-old woman was reached with a multipurpose guiding catheter through femoral access. A 5-mm balloon was used to dilate the stenosis and create a pulsatile flow.

 

“The goal is not to raise the mean arterial pressure above 35 mm Hg, because this has been associated with significant peripheral edema,” Dr. Bashir explained.

In this patient, progressive improvements in pulmonary pressure, cardiac index, and other hemodynamics were associated with progressive shrinking of the right ventricle over 6 months of follow-up. The walk test improved from 216 m prior to BPA to 421 m at her most recent evaluation.

The average age in the 13 patients treated so far was 55 years, and 75% are males. The mean left ventricular ejection fraction (LVEF) was 55%. According to Dr. Bashir, most patients required at least two treatment sessions and some have required up to four.

There have been two complications – one patient developed hemoptysis that required a brief intubation and the other involved perfusion edema – and no deaths in this series so far, he said.

The outcomes so far, which Dr. Bashir characterized as “an early experience,” provide evidence that BPA is “safe and feasible” for patients with CTEPH who are not surgical candidates. At Dr. Bashir’s institution, where PTE is commonly performed in patients with CTEPH (Dr. Bashir reported that 134 cases were performed over the period of time in which these 15 cases of BPA were performed), there is a plan to compare functional outcomes in CTEPH patients managed with these two different approaches.

Dr. Bashir reported no financial relationships relevant to this study.

 

SOURCE: Bashir R. CRT 2018

 

WASHINGTON – Balloon pulmonary angioplasty provides meaningful improvements in functional capacity for patients with chronic thromboembolic pulmonary hypertension (CTEPH) who are not candidates for surgical pulmonary thromboendarterectomy, according to a single-center experience with 15 consecutive patients that was presented at CRT 2018 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.

The treatment of choice for CTEPH is pulmonary thromboendarterectomy (PTE), but “a huge percentage of the population with CTEPH” is not eligible or does not undergo surgical treatment, which was the impetus to initiate this intervention, reported Riyaz Bashir, MD, director of vascular and endovascular medicine at Temple University Hospital and professor of medicine at Temple University, Philadelphia.

Ted Bosworth/MDedge News

Much of the experience with balloon pulmonary angioplasty (BPA) for CTEPH comes from outside the United States, particularly Japan, where this procedure has been associated with improved survival, compared with historical untreated controls, according to Dr. Bashir. He cited registry data showing that more than 80% of CTEPH patients are not surgical candidates and up to 40% of those who are candidates still fail to undergo PTE for other reasons.

There have now been 15 CTEPH patients treated with BPA by Dr. Bashir and his team at Temple University. He reported 6-month outcome data on the first 13 patients, all of whom had a history of pulmonary embolism. Three of the patients had a prior PTE.

The primary outcome of interest in this series was functional improvement. Unlike PTE, immediate improvement in hemodynamics is not typically observed immediately after the procedure, but these measures do improve incrementally over time, Dr. Bashir reported. This is reflected in progressive improvements in the 6-minute walk test and in New York Heart Association (NYHA) functional class.

Of the 13 patients treated so far, 6 (46%) were in NYHA class IV and only 2 (15%) were in NYHA class II prior to BPA. Six months after BPA, the proportions had reversed. At that point, seven patients (54%) were in class II and two (15%) in class IV. The remaining patients at both time points were in NYHA class III. Similar improvements were seen in the 6-minute walk test, which typically tracks with NYHA class.

Describing the first case, performed about 2 years ago, Dr. Bashir explained that a tight stenosis in the right lower pulmonary artery of a 44-year-old woman was reached with a multipurpose guiding catheter through femoral access. A 5-mm balloon was used to dilate the stenosis and create a pulsatile flow.

 

“The goal is not to raise the mean arterial pressure above 35 mm Hg, because this has been associated with significant peripheral edema,” Dr. Bashir explained.

In this patient, progressive improvements in pulmonary pressure, cardiac index, and other hemodynamics were associated with progressive shrinking of the right ventricle over 6 months of follow-up. The walk test improved from 216 m prior to BPA to 421 m at her most recent evaluation.

The average age in the 13 patients treated so far was 55 years, and 75% are males. The mean left ventricular ejection fraction (LVEF) was 55%. According to Dr. Bashir, most patients required at least two treatment sessions and some have required up to four.

There have been two complications – one patient developed hemoptysis that required a brief intubation and the other involved perfusion edema – and no deaths in this series so far, he said.

The outcomes so far, which Dr. Bashir characterized as “an early experience,” provide evidence that BPA is “safe and feasible” for patients with CTEPH who are not surgical candidates. At Dr. Bashir’s institution, where PTE is commonly performed in patients with CTEPH (Dr. Bashir reported that 134 cases were performed over the period of time in which these 15 cases of BPA were performed), there is a plan to compare functional outcomes in CTEPH patients managed with these two different approaches.

Dr. Bashir reported no financial relationships relevant to this study.

 

SOURCE: Bashir R. CRT 2018

 

WASHINGTON – For treating de novo coronary lesions in vessels smaller than 2.75 mm, drug coated balloon angioplasty is as safe and may be as effective as drug-eluting stents, according to a multicenter randomized trial presented as a late-breaker at CRT 2018 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.

“The aim of PCI [percutaneous coronary intervention] without leaving any metal behind seems to be feasible and safe with drug coated balloons,” reported Victor A. Jimenez Diaz, MD, of the department of cardiology at University Hospital, Vigo, Spain.

Ted Bosworth/Frontline Medical News

De novo lesions in small coronary vessels are a clinical challenge, according to Dr. Jimenez Diaz. These are associated with relatively high rates of restenosis. They are also associated with a vessel thrombosis rate of 1% within 6 months, and a small but significant risk of major adverse cardiac events, variably estimated to range between 6% and 10% at 1 year. There is no uniformly accepted standard for treatment.

In this study, 94 patients with de novo coronary lesions in small diameter vessels were randomized to treatment with a paclitaxel drug coated balloon (DCB) (IN.PACT Falcon, Medtronic) or a zotarolimus drug-eluting stent (DES) (Resolute Integrity, Medtronic). Lesions in vessels between 2.0 and 2.75 mm in diameter were eligible; 137 lesions were treated in a study with seven participating centers in Spain.

 

For entry, target lesions had to have a stenosis of at least 70% by visual estimation or at least 50% by quantitative coronary angiography. Lesion length was limited to less than 25 mm, and severely calcified lesions were excluded.

The primary endpoint was a composite major adverse coronary event (MACE) endpoint of cardiac death, myocardial infarction, or revascularization at 12 months of follow-up. Crossovers by discretion of the interventional team were permitted.

At 12 months, MACE had occurred in 4.4% of those in the DCB group and 11.1% of those in the DES group. All primary endpoint events in both groups involved revascularizations. The two events in the DCB group were clinically driven target vessel revascularizations. Only one of the five events in the DES group was a clinically driven target lesion revascularization; the remaining four were revascularizations performed for nontarget vessels.

Four patients (8%) in the DCB group crossed over, each because of a dissection and managed with a bare-metal stent. There were four other dissections in the DCB group; one type F dissection resulted in a bailout and three dissections were managed conservatively. There were no crossovers in the DES group, and of the two dissections in the group, both were managed with the originally assigned stenting strategy.

 

Calling DCB a safe strategy for small de novo coronary stenosis, Dr. Jimenez Diaz said, “The procedural success rates were comparable.” However, he acknowledged that because of low enrollment, the study was “underpowered for clinical events.” The original power calculation called for a study of 200 patients.

“We can say results are encouraging,” Dr. Jimenez Diaz said.

Several discussants at the late-breaker abstracts agreed that DCB is an intriguing option for a difficult problem. They also agreed that restoring blood flow without leaving a permanent device is an attractive concept. However, they emphasized that a larger study is needed to declare that DCB and DES are equivalent strategies in regard to risk of MACE.

While agreeing that more data powered for events are needed, Cindy Grines, MD, chief of cardiology, Hofstra University, Hempstead, N.Y., was among those who suggested that this approach might be “worth a try.” She indicated that this study, which involved interventionalists at multiple centers, does provide support for the safety of DCB.

SOURCE: Jimenez Diaz VA. CRT 2018.

 

WASHINGTON – For treating de novo coronary lesions in vessels smaller than 2.75 mm, drug coated balloon angioplasty is as safe and may be as effective as drug-eluting stents, according to a multicenter randomized trial presented as a late-breaker at CRT 2018 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.

“The aim of PCI [percutaneous coronary intervention] without leaving any metal behind seems to be feasible and safe with drug coated balloons,” reported Victor A. Jimenez Diaz, MD, of the department of cardiology at University Hospital, Vigo, Spain.

Ted Bosworth/Frontline Medical News

De novo lesions in small coronary vessels are a clinical challenge, according to Dr. Jimenez Diaz. These are associated with relatively high rates of restenosis. They are also associated with a vessel thrombosis rate of 1% within 6 months, and a small but significant risk of major adverse cardiac events, variably estimated to range between 6% and 10% at 1 year. There is no uniformly accepted standard for treatment.

In this study, 94 patients with de novo coronary lesions in small diameter vessels were randomized to treatment with a paclitaxel drug coated balloon (DCB) (IN.PACT Falcon, Medtronic) or a zotarolimus drug-eluting stent (DES) (Resolute Integrity, Medtronic). Lesions in vessels between 2.0 and 2.75 mm in diameter were eligible; 137 lesions were treated in a study with seven participating centers in Spain.

 

For entry, target lesions had to have a stenosis of at least 70% by visual estimation or at least 50% by quantitative coronary angiography. Lesion length was limited to less than 25 mm, and severely calcified lesions were excluded.

The primary endpoint was a composite major adverse coronary event (MACE) endpoint of cardiac death, myocardial infarction, or revascularization at 12 months of follow-up. Crossovers by discretion of the interventional team were permitted.

At 12 months, MACE had occurred in 4.4% of those in the DCB group and 11.1% of those in the DES group. All primary endpoint events in both groups involved revascularizations. The two events in the DCB group were clinically driven target vessel revascularizations. Only one of the five events in the DES group was a clinically driven target lesion revascularization; the remaining four were revascularizations performed for nontarget vessels.

Four patients (8%) in the DCB group crossed over, each because of a dissection and managed with a bare-metal stent. There were four other dissections in the DCB group; one type F dissection resulted in a bailout and three dissections were managed conservatively. There were no crossovers in the DES group, and of the two dissections in the group, both were managed with the originally assigned stenting strategy.

 

Calling DCB a safe strategy for small de novo coronary stenosis, Dr. Jimenez Diaz said, “The procedural success rates were comparable.” However, he acknowledged that because of low enrollment, the study was “underpowered for clinical events.” The original power calculation called for a study of 200 patients.

“We can say results are encouraging,” Dr. Jimenez Diaz said.

Several discussants at the late-breaker abstracts agreed that DCB is an intriguing option for a difficult problem. They also agreed that restoring blood flow without leaving a permanent device is an attractive concept. However, they emphasized that a larger study is needed to declare that DCB and DES are equivalent strategies in regard to risk of MACE.

While agreeing that more data powered for events are needed, Cindy Grines, MD, chief of cardiology, Hofstra University, Hempstead, N.Y., was among those who suggested that this approach might be “worth a try.” She indicated that this study, which involved interventionalists at multiple centers, does provide support for the safety of DCB.

SOURCE: Jimenez Diaz VA. CRT 2018.

 

WASHINGTON – For treating de novo coronary lesions in vessels smaller than 2.75 mm, drug coated balloon angioplasty is as safe and may be as effective as drug-eluting stents, according to a multicenter randomized trial presented as a late-breaker at CRT 2018 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.

“The aim of PCI [percutaneous coronary intervention] without leaving any metal behind seems to be feasible and safe with drug coated balloons,” reported Victor A. Jimenez Diaz, MD, of the department of cardiology at University Hospital, Vigo, Spain.

Ted Bosworth/Frontline Medical News

De novo lesions in small coronary vessels are a clinical challenge, according to Dr. Jimenez Diaz. These are associated with relatively high rates of restenosis. They are also associated with a vessel thrombosis rate of 1% within 6 months, and a small but significant risk of major adverse cardiac events, variably estimated to range between 6% and 10% at 1 year. There is no uniformly accepted standard for treatment.

In this study, 94 patients with de novo coronary lesions in small diameter vessels were randomized to treatment with a paclitaxel drug coated balloon (DCB) (IN.PACT Falcon, Medtronic) or a zotarolimus drug-eluting stent (DES) (Resolute Integrity, Medtronic). Lesions in vessels between 2.0 and 2.75 mm in diameter were eligible; 137 lesions were treated in a study with seven participating centers in Spain.

 

For entry, target lesions had to have a stenosis of at least 70% by visual estimation or at least 50% by quantitative coronary angiography. Lesion length was limited to less than 25 mm, and severely calcified lesions were excluded.

The primary endpoint was a composite major adverse coronary event (MACE) endpoint of cardiac death, myocardial infarction, or revascularization at 12 months of follow-up. Crossovers by discretion of the interventional team were permitted.

At 12 months, MACE had occurred in 4.4% of those in the DCB group and 11.1% of those in the DES group. All primary endpoint events in both groups involved revascularizations. The two events in the DCB group were clinically driven target vessel revascularizations. Only one of the five events in the DES group was a clinically driven target lesion revascularization; the remaining four were revascularizations performed for nontarget vessels.

Four patients (8%) in the DCB group crossed over, each because of a dissection and managed with a bare-metal stent. There were four other dissections in the DCB group; one type F dissection resulted in a bailout and three dissections were managed conservatively. There were no crossovers in the DES group, and of the two dissections in the group, both were managed with the originally assigned stenting strategy.

 

Calling DCB a safe strategy for small de novo coronary stenosis, Dr. Jimenez Diaz said, “The procedural success rates were comparable.” However, he acknowledged that because of low enrollment, the study was “underpowered for clinical events.” The original power calculation called for a study of 200 patients.

“We can say results are encouraging,” Dr. Jimenez Diaz said.

Several discussants at the late-breaker abstracts agreed that DCB is an intriguing option for a difficult problem. They also agreed that restoring blood flow without leaving a permanent device is an attractive concept. However, they emphasized that a larger study is needed to declare that DCB and DES are equivalent strategies in regard to risk of MACE.

While agreeing that more data powered for events are needed, Cindy Grines, MD, chief of cardiology, Hofstra University, Hempstead, N.Y., was among those who suggested that this approach might be “worth a try.” She indicated that this study, which involved interventionalists at multiple centers, does provide support for the safety of DCB.

SOURCE: Jimenez Diaz VA. CRT 2018.