User login
Prosthesis-patient mismatch post TAVR ups death risk 19%
SAN DIEGO – Severe prosthesis-patient mismatch (PPM) after transcatheter aortic valve replacement (TAVR) increases risk of adverse outcomes and may be preventable in some cases with careful preprocedural planning, suggests a registry-based retrospective cohort study of 62,125 patients treated in the contemporary era.
The study – the largest to date of this patient population – determined that about one in every eight patients undergoing TAVR ultimately had a severe mismatch between the hemodynamics of the valve prosthesis and the requirements for cardiac output. Compared with counterparts that have moderate or no PPM, these patients with severe PPM had a 12% higher adjusted risk of heart failure rehospitalization and a 19% higher adjusted risk of death, according to results reported at the Transcatheter Cardiovascular Therapeutics annual meeting and simultaneously published online (J Am Coll Cardiol. 2018 Sep 23. doi: 10.1016/j.jacc.2018.09.001).
Notably, some of the predictors of severe PPM, such as use of smaller-diameter valves and performance of a valve-in-valve procedure, were potentially modifiable.
“Our findings suggest that efforts should be made to identify this problem and limit the risk for PPM after TAVR,” concluded lead investigator Howard C. Herrmann, MD, a professor at the University of Pennsylvania and director of the cardiac catheterization laboratories, Hospital of the University of Pennsylvania, both in Philadelphia. “Awareness is really the first step in trying to fix it.”
“We spend a lot of time in the heart-team meetings looking at the CT scans for annular dimensions and the vascular access, but we don’t really talk too much about severe PPM or the risk of that,” he elaborated. “This [study] allows us to start to predict it, based on patient factors and what prosthesis we might be choosing for a patient, and it allows us to have that conversation and think about alternatives.
“There are alternatives to try to avoid PPM, everything from which prosthesis we choose to the size of the prosthesis, to whether we fracture a patient’s valve if we are doing a valve-in-valve procedure. In the future, in some situations, we might even choose a low-risk or low-intermediate-risk patient for surgery with an enlargement operation in order to get a larger effective orifice area. So there are choices that we can make, and we should start thinking about that in the heart-team approach.”
Findings in context
The new study reinforces the message “that hemodynamics matter,” he said. “To the extent that we can get larger valves in and get better results from those valves, it will reduce the frequency of PPM. That’s something as operators we don’t spend as much time focusing on, and this will refocus our attention in trying to prevent PPM by being more diligent in terms of prosthesis choice and some operator characteristics, to try to reduce the gradients and improve the effective orifice areas as much as we can.”
Panelist Jeffrey J. Popma, MD, an interventional cardiologist at Beth Israel Deaconess Medical Center, Boston, noted that he and his colleagues have observed similar trends in their smaller studies but had difficulty teasing out contributors. “It really goes back to the preprocedural planning about what valve you can get in, and larger orifice area is certainly better,” he concurred. “So I do think that this is a phenomenal addition.”
Study details
For the study, Dr. Herrmann and his colleagues analyzed 2014-2107 data from the STS/ACC Transcatheter Valve Therapy Registry, a national surveillance and quality improvement system. They identified enrollees aged 65 years or older at the time of their TAVR procedure who had fee-for-service Medicare and linked them to Centers for Medicare & Medicaid Services claims data to assess outcomes.
Overall, 12.1% of patients had severe PPM, defined as an effective valve orifice area indexed to body surface area of less than 0.65 cm2/m2 on discharge echocardiography, and another 24.6% had moderate PPM, Dr. Herrmann reported at the meeting, sponsored by the Cardiovascular Research Foundation.
The strongest multivariate predictors of severe PPM were small prosthetic valve size (up to 23 mm in diameter) (odds ratio, 2.77), a valve-in-valve procedure (OR, 2.78), larger body surface area (OR, 1.71 per 0.2-U increase), and female sex (OR, 1.46). Odds also increased with decreasing age and were elevated for patients of nonwhite/Hispanic race and those having a lower ejection fraction, atrial fibrillation or flutter, or severe mitral or tricuspid regurgitation.
It was not possible to assess specific valves as predictors of mismatch because the registry prohibits comparisons across manufacturers, according to Dr. Herrmann.
One-year mortality, the study’s primary endpoint, was 17.2% in patients with severe PPM, compared with 15.8% in patients with moderate or no PPM (adjusted hazard ratio, 1.19; P less than .001). Findings were similar across subgroups.
The 1-year rate of heart failure rehospitalization was 14.7% in patients with severe PPM, compared with 12.2% in patients with moderate or no PPM (AHR, 1.12; P = .017).
“I would point out that these [outcome] curves are divergent at 1 year,” Dr. Herrmann noted. “So if we look at low-intermediate-risk and low-risk patients and younger patients, who may be more active and who see the effects of PPM more commonly and who are going to be living more than 1 year, we are going to have to consider this going forward in a more important way.”
Severe PPM did not significantly influence the rate of stroke (which stood at about 4% in each group) or worsen quality of life score at 1 year.
Dr. Herrmann disclosed receiving institutional grant/research support from Abbott Vascular, Bayer, Boston Scientific, Corvia Medical, Edwards Lifesciences, Medtronic, and St. Jude Medical, as well as consulting fees/honoraria from Edwards, Medtronic, and Siemens Healthineers.
SAN DIEGO – Severe prosthesis-patient mismatch (PPM) after transcatheter aortic valve replacement (TAVR) increases risk of adverse outcomes and may be preventable in some cases with careful preprocedural planning, suggests a registry-based retrospective cohort study of 62,125 patients treated in the contemporary era.
The study – the largest to date of this patient population – determined that about one in every eight patients undergoing TAVR ultimately had a severe mismatch between the hemodynamics of the valve prosthesis and the requirements for cardiac output. Compared with counterparts that have moderate or no PPM, these patients with severe PPM had a 12% higher adjusted risk of heart failure rehospitalization and a 19% higher adjusted risk of death, according to results reported at the Transcatheter Cardiovascular Therapeutics annual meeting and simultaneously published online (J Am Coll Cardiol. 2018 Sep 23. doi: 10.1016/j.jacc.2018.09.001).
Notably, some of the predictors of severe PPM, such as use of smaller-diameter valves and performance of a valve-in-valve procedure, were potentially modifiable.
“Our findings suggest that efforts should be made to identify this problem and limit the risk for PPM after TAVR,” concluded lead investigator Howard C. Herrmann, MD, a professor at the University of Pennsylvania and director of the cardiac catheterization laboratories, Hospital of the University of Pennsylvania, both in Philadelphia. “Awareness is really the first step in trying to fix it.”
“We spend a lot of time in the heart-team meetings looking at the CT scans for annular dimensions and the vascular access, but we don’t really talk too much about severe PPM or the risk of that,” he elaborated. “This [study] allows us to start to predict it, based on patient factors and what prosthesis we might be choosing for a patient, and it allows us to have that conversation and think about alternatives.
“There are alternatives to try to avoid PPM, everything from which prosthesis we choose to the size of the prosthesis, to whether we fracture a patient’s valve if we are doing a valve-in-valve procedure. In the future, in some situations, we might even choose a low-risk or low-intermediate-risk patient for surgery with an enlargement operation in order to get a larger effective orifice area. So there are choices that we can make, and we should start thinking about that in the heart-team approach.”
Findings in context
The new study reinforces the message “that hemodynamics matter,” he said. “To the extent that we can get larger valves in and get better results from those valves, it will reduce the frequency of PPM. That’s something as operators we don’t spend as much time focusing on, and this will refocus our attention in trying to prevent PPM by being more diligent in terms of prosthesis choice and some operator characteristics, to try to reduce the gradients and improve the effective orifice areas as much as we can.”
Panelist Jeffrey J. Popma, MD, an interventional cardiologist at Beth Israel Deaconess Medical Center, Boston, noted that he and his colleagues have observed similar trends in their smaller studies but had difficulty teasing out contributors. “It really goes back to the preprocedural planning about what valve you can get in, and larger orifice area is certainly better,” he concurred. “So I do think that this is a phenomenal addition.”
Study details
For the study, Dr. Herrmann and his colleagues analyzed 2014-2107 data from the STS/ACC Transcatheter Valve Therapy Registry, a national surveillance and quality improvement system. They identified enrollees aged 65 years or older at the time of their TAVR procedure who had fee-for-service Medicare and linked them to Centers for Medicare & Medicaid Services claims data to assess outcomes.
Overall, 12.1% of patients had severe PPM, defined as an effective valve orifice area indexed to body surface area of less than 0.65 cm2/m2 on discharge echocardiography, and another 24.6% had moderate PPM, Dr. Herrmann reported at the meeting, sponsored by the Cardiovascular Research Foundation.
The strongest multivariate predictors of severe PPM were small prosthetic valve size (up to 23 mm in diameter) (odds ratio, 2.77), a valve-in-valve procedure (OR, 2.78), larger body surface area (OR, 1.71 per 0.2-U increase), and female sex (OR, 1.46). Odds also increased with decreasing age and were elevated for patients of nonwhite/Hispanic race and those having a lower ejection fraction, atrial fibrillation or flutter, or severe mitral or tricuspid regurgitation.
It was not possible to assess specific valves as predictors of mismatch because the registry prohibits comparisons across manufacturers, according to Dr. Herrmann.
One-year mortality, the study’s primary endpoint, was 17.2% in patients with severe PPM, compared with 15.8% in patients with moderate or no PPM (adjusted hazard ratio, 1.19; P less than .001). Findings were similar across subgroups.
The 1-year rate of heart failure rehospitalization was 14.7% in patients with severe PPM, compared with 12.2% in patients with moderate or no PPM (AHR, 1.12; P = .017).
“I would point out that these [outcome] curves are divergent at 1 year,” Dr. Herrmann noted. “So if we look at low-intermediate-risk and low-risk patients and younger patients, who may be more active and who see the effects of PPM more commonly and who are going to be living more than 1 year, we are going to have to consider this going forward in a more important way.”
Severe PPM did not significantly influence the rate of stroke (which stood at about 4% in each group) or worsen quality of life score at 1 year.
Dr. Herrmann disclosed receiving institutional grant/research support from Abbott Vascular, Bayer, Boston Scientific, Corvia Medical, Edwards Lifesciences, Medtronic, and St. Jude Medical, as well as consulting fees/honoraria from Edwards, Medtronic, and Siemens Healthineers.
SAN DIEGO – Severe prosthesis-patient mismatch (PPM) after transcatheter aortic valve replacement (TAVR) increases risk of adverse outcomes and may be preventable in some cases with careful preprocedural planning, suggests a registry-based retrospective cohort study of 62,125 patients treated in the contemporary era.
The study – the largest to date of this patient population – determined that about one in every eight patients undergoing TAVR ultimately had a severe mismatch between the hemodynamics of the valve prosthesis and the requirements for cardiac output. Compared with counterparts that have moderate or no PPM, these patients with severe PPM had a 12% higher adjusted risk of heart failure rehospitalization and a 19% higher adjusted risk of death, according to results reported at the Transcatheter Cardiovascular Therapeutics annual meeting and simultaneously published online (J Am Coll Cardiol. 2018 Sep 23. doi: 10.1016/j.jacc.2018.09.001).
Notably, some of the predictors of severe PPM, such as use of smaller-diameter valves and performance of a valve-in-valve procedure, were potentially modifiable.
“Our findings suggest that efforts should be made to identify this problem and limit the risk for PPM after TAVR,” concluded lead investigator Howard C. Herrmann, MD, a professor at the University of Pennsylvania and director of the cardiac catheterization laboratories, Hospital of the University of Pennsylvania, both in Philadelphia. “Awareness is really the first step in trying to fix it.”
“We spend a lot of time in the heart-team meetings looking at the CT scans for annular dimensions and the vascular access, but we don’t really talk too much about severe PPM or the risk of that,” he elaborated. “This [study] allows us to start to predict it, based on patient factors and what prosthesis we might be choosing for a patient, and it allows us to have that conversation and think about alternatives.
“There are alternatives to try to avoid PPM, everything from which prosthesis we choose to the size of the prosthesis, to whether we fracture a patient’s valve if we are doing a valve-in-valve procedure. In the future, in some situations, we might even choose a low-risk or low-intermediate-risk patient for surgery with an enlargement operation in order to get a larger effective orifice area. So there are choices that we can make, and we should start thinking about that in the heart-team approach.”
Findings in context
The new study reinforces the message “that hemodynamics matter,” he said. “To the extent that we can get larger valves in and get better results from those valves, it will reduce the frequency of PPM. That’s something as operators we don’t spend as much time focusing on, and this will refocus our attention in trying to prevent PPM by being more diligent in terms of prosthesis choice and some operator characteristics, to try to reduce the gradients and improve the effective orifice areas as much as we can.”
Panelist Jeffrey J. Popma, MD, an interventional cardiologist at Beth Israel Deaconess Medical Center, Boston, noted that he and his colleagues have observed similar trends in their smaller studies but had difficulty teasing out contributors. “It really goes back to the preprocedural planning about what valve you can get in, and larger orifice area is certainly better,” he concurred. “So I do think that this is a phenomenal addition.”
Study details
For the study, Dr. Herrmann and his colleagues analyzed 2014-2107 data from the STS/ACC Transcatheter Valve Therapy Registry, a national surveillance and quality improvement system. They identified enrollees aged 65 years or older at the time of their TAVR procedure who had fee-for-service Medicare and linked them to Centers for Medicare & Medicaid Services claims data to assess outcomes.
Overall, 12.1% of patients had severe PPM, defined as an effective valve orifice area indexed to body surface area of less than 0.65 cm2/m2 on discharge echocardiography, and another 24.6% had moderate PPM, Dr. Herrmann reported at the meeting, sponsored by the Cardiovascular Research Foundation.
The strongest multivariate predictors of severe PPM were small prosthetic valve size (up to 23 mm in diameter) (odds ratio, 2.77), a valve-in-valve procedure (OR, 2.78), larger body surface area (OR, 1.71 per 0.2-U increase), and female sex (OR, 1.46). Odds also increased with decreasing age and were elevated for patients of nonwhite/Hispanic race and those having a lower ejection fraction, atrial fibrillation or flutter, or severe mitral or tricuspid regurgitation.
It was not possible to assess specific valves as predictors of mismatch because the registry prohibits comparisons across manufacturers, according to Dr. Herrmann.
One-year mortality, the study’s primary endpoint, was 17.2% in patients with severe PPM, compared with 15.8% in patients with moderate or no PPM (adjusted hazard ratio, 1.19; P less than .001). Findings were similar across subgroups.
The 1-year rate of heart failure rehospitalization was 14.7% in patients with severe PPM, compared with 12.2% in patients with moderate or no PPM (AHR, 1.12; P = .017).
“I would point out that these [outcome] curves are divergent at 1 year,” Dr. Herrmann noted. “So if we look at low-intermediate-risk and low-risk patients and younger patients, who may be more active and who see the effects of PPM more commonly and who are going to be living more than 1 year, we are going to have to consider this going forward in a more important way.”
Severe PPM did not significantly influence the rate of stroke (which stood at about 4% in each group) or worsen quality of life score at 1 year.
Dr. Herrmann disclosed receiving institutional grant/research support from Abbott Vascular, Bayer, Boston Scientific, Corvia Medical, Edwards Lifesciences, Medtronic, and St. Jude Medical, as well as consulting fees/honoraria from Edwards, Medtronic, and Siemens Healthineers.
REPORTING FROM TCT 2018
Key clinical point:
Major finding: Patients with severe PPM after TAVR had elevated risks of heart failure rehospitalization (adjusted hazard ratio, 1.12) and death (AHR, 1.19).
Study details: A retrospective cohort study of 62,125 patients aged 65 years or older who underwent TAVR and were captured in the national STS/ACC Transcatheter Valve Therapy Registry.
Disclosures: Dr. Herrmann disclosed receiving institutional grant/research support from Abbott Vascular, Bayer, Boston Scientific, Corvia Medical, Edwards Lifesciences, Medtronic, and St. Jude Medical, as well as consulting fees/honoraria from Edwards, Medtronic, and Siemens Healthineers.
Novel device improves mitral regurgitation 30% in REDUCE-FMR
SAN DIEGO – In patients with heart failure and functional mitral regurgitation, implantation of an investigational device led to reduced MR and improved left ventricular remodeling at 1 year, compared with patients who received sham treatment in the REDUCE-FMR trial.
The device showed promise in this trial, despite a small sample size, and its nature makes it possible to follow up with other procedures if the disease progresses. “The advantage of this technique is that all other options are still open,” Horst Sievert, MD, director of the CardioVascular Center in Frankfurt, said during a press conference at the Transcatheter Cardiovascular Therapeutics annual meeting.
The Carillon Mitral Counter System includes two anchors, one in the great cardiac vein and one in the coronary sinus, connected by a shaping ribbon. The tension of the ribbon bolsters the mitral annulus, which in turn reduces mitral regurgitation.
REDUCE-FMR recruited 120 patients from centers in eight countries and randomized 87 to the Carillon device (73 implanted) and 33 to a sham procedure. Sham patients were sedated and received a coronary sinus angiogram. Patients were included if they had dilated ischemic or nonischemic cardiomyopathy and moderate to severe functional MR, among other requirements. Exclusion criteria included existing coronary artery stents in the implant target zone, severe mitral annular calcification, and significant organic mitral valve pathology.
The primary endpoint was the mean reduction of regurgitant volume at 1 year. The treated patients had a 22% reduction of 7.1 mL, while the sham group on average had an 8% increase of 3.3 mL (P = .03). In the as-treated subpopulation, which comprised 45 patients in the treatment group and 13 controls, the values were –7.5 mL and +3.3 mL (P = .02). A per-protocol analysis, which excluded patients who did not meet protocol criteria, led to an amplification of the effect when the study design was adhered to (–12.5 mL vs. +1.3 mL), though this result did not achieve statistical significance owing to the small sample size.
For the safety endpoints, the researchers examined the frequency of major adverse events (MAE), including death, myocardial infarction, cardiac perforation, device embolism, and surgery or percutaneous coronary intervention related to the device at 1 year. In the treatment group, 16.1% experienced a MAE, compared with 18.2% of control patients, a statistically nonsignificant difference.
A secondary efficacy endpoint of change in left ventricular end-diastolic volume showed improvements in the treatment group at 6 months (–12.4 mL) and 12 months (–8.6 mL), compared with increases in the sham group at 6 months (+5.4 mL) and 12 months (+6.5 mL). A similar trend occurred in left ventricular end-systolic volume (–7.8 mL and –4.8 mL; +3.4 mL and +6.1 mL, respectively).
The study was conducted in a patient population similar to that of the COAPT trial, which examined implantation of Abbott’s MitraClip. That study, presented here at TCT 2018 and simultaneously published in the New England Journal of Medicine, also examined patients with heart failure and secondary MR.
However, in REDUCE-FMR, many of the patients had milder heart failure than the researchers had expected: 44.8% in the treatment group had NYHA class II, as did 48.5% in the sham group. That surprise may help identify an appropriate patient population. “I think this device may have a nice spot in between medical therapy and MitraClip implantation, because we have, by chance, a patient population with mild heart insufficiency and mild MR,” said Dr. Sievert.
The two devices also showed different physiologic effects, Michael Mack, MD, said at a press conference. “One subtle difference is that, in this trial, the difference is due to both positive left ventricular remodeling in the treatment arm and continued progression in the sham control. In COAPT, the difference in improvement that we saw was totally due to prevention of progression of disease. We just stabilized the disease to where it was at. So that’s an intriguing difference here, that you actually were able to demonstrate positive left ventricular remodeling,” noted Dr. Mack, medical director for cardiovascular surgery at Baylor Scott & White Medical Center, Plano, Tex. He was a coinvestigator in the COAPT trial.
REDUCE-FMR was funded by Cardiac Dimensions. Dr. Sievert has received consulting fees, travel expenses, and study honoraria from Cardiac Dimensions, and 35 other companies. Dr. Mack has received grant support or had a research contract with Abbott Vascular, Medtronic, and Edwards Lifesciences.
SAN DIEGO – In patients with heart failure and functional mitral regurgitation, implantation of an investigational device led to reduced MR and improved left ventricular remodeling at 1 year, compared with patients who received sham treatment in the REDUCE-FMR trial.
The device showed promise in this trial, despite a small sample size, and its nature makes it possible to follow up with other procedures if the disease progresses. “The advantage of this technique is that all other options are still open,” Horst Sievert, MD, director of the CardioVascular Center in Frankfurt, said during a press conference at the Transcatheter Cardiovascular Therapeutics annual meeting.
The Carillon Mitral Counter System includes two anchors, one in the great cardiac vein and one in the coronary sinus, connected by a shaping ribbon. The tension of the ribbon bolsters the mitral annulus, which in turn reduces mitral regurgitation.
REDUCE-FMR recruited 120 patients from centers in eight countries and randomized 87 to the Carillon device (73 implanted) and 33 to a sham procedure. Sham patients were sedated and received a coronary sinus angiogram. Patients were included if they had dilated ischemic or nonischemic cardiomyopathy and moderate to severe functional MR, among other requirements. Exclusion criteria included existing coronary artery stents in the implant target zone, severe mitral annular calcification, and significant organic mitral valve pathology.
The primary endpoint was the mean reduction of regurgitant volume at 1 year. The treated patients had a 22% reduction of 7.1 mL, while the sham group on average had an 8% increase of 3.3 mL (P = .03). In the as-treated subpopulation, which comprised 45 patients in the treatment group and 13 controls, the values were –7.5 mL and +3.3 mL (P = .02). A per-protocol analysis, which excluded patients who did not meet protocol criteria, led to an amplification of the effect when the study design was adhered to (–12.5 mL vs. +1.3 mL), though this result did not achieve statistical significance owing to the small sample size.
For the safety endpoints, the researchers examined the frequency of major adverse events (MAE), including death, myocardial infarction, cardiac perforation, device embolism, and surgery or percutaneous coronary intervention related to the device at 1 year. In the treatment group, 16.1% experienced a MAE, compared with 18.2% of control patients, a statistically nonsignificant difference.
A secondary efficacy endpoint of change in left ventricular end-diastolic volume showed improvements in the treatment group at 6 months (–12.4 mL) and 12 months (–8.6 mL), compared with increases in the sham group at 6 months (+5.4 mL) and 12 months (+6.5 mL). A similar trend occurred in left ventricular end-systolic volume (–7.8 mL and –4.8 mL; +3.4 mL and +6.1 mL, respectively).
The study was conducted in a patient population similar to that of the COAPT trial, which examined implantation of Abbott’s MitraClip. That study, presented here at TCT 2018 and simultaneously published in the New England Journal of Medicine, also examined patients with heart failure and secondary MR.
However, in REDUCE-FMR, many of the patients had milder heart failure than the researchers had expected: 44.8% in the treatment group had NYHA class II, as did 48.5% in the sham group. That surprise may help identify an appropriate patient population. “I think this device may have a nice spot in between medical therapy and MitraClip implantation, because we have, by chance, a patient population with mild heart insufficiency and mild MR,” said Dr. Sievert.
The two devices also showed different physiologic effects, Michael Mack, MD, said at a press conference. “One subtle difference is that, in this trial, the difference is due to both positive left ventricular remodeling in the treatment arm and continued progression in the sham control. In COAPT, the difference in improvement that we saw was totally due to prevention of progression of disease. We just stabilized the disease to where it was at. So that’s an intriguing difference here, that you actually were able to demonstrate positive left ventricular remodeling,” noted Dr. Mack, medical director for cardiovascular surgery at Baylor Scott & White Medical Center, Plano, Tex. He was a coinvestigator in the COAPT trial.
REDUCE-FMR was funded by Cardiac Dimensions. Dr. Sievert has received consulting fees, travel expenses, and study honoraria from Cardiac Dimensions, and 35 other companies. Dr. Mack has received grant support or had a research contract with Abbott Vascular, Medtronic, and Edwards Lifesciences.
SAN DIEGO – In patients with heart failure and functional mitral regurgitation, implantation of an investigational device led to reduced MR and improved left ventricular remodeling at 1 year, compared with patients who received sham treatment in the REDUCE-FMR trial.
The device showed promise in this trial, despite a small sample size, and its nature makes it possible to follow up with other procedures if the disease progresses. “The advantage of this technique is that all other options are still open,” Horst Sievert, MD, director of the CardioVascular Center in Frankfurt, said during a press conference at the Transcatheter Cardiovascular Therapeutics annual meeting.
The Carillon Mitral Counter System includes two anchors, one in the great cardiac vein and one in the coronary sinus, connected by a shaping ribbon. The tension of the ribbon bolsters the mitral annulus, which in turn reduces mitral regurgitation.
REDUCE-FMR recruited 120 patients from centers in eight countries and randomized 87 to the Carillon device (73 implanted) and 33 to a sham procedure. Sham patients were sedated and received a coronary sinus angiogram. Patients were included if they had dilated ischemic or nonischemic cardiomyopathy and moderate to severe functional MR, among other requirements. Exclusion criteria included existing coronary artery stents in the implant target zone, severe mitral annular calcification, and significant organic mitral valve pathology.
The primary endpoint was the mean reduction of regurgitant volume at 1 year. The treated patients had a 22% reduction of 7.1 mL, while the sham group on average had an 8% increase of 3.3 mL (P = .03). In the as-treated subpopulation, which comprised 45 patients in the treatment group and 13 controls, the values were –7.5 mL and +3.3 mL (P = .02). A per-protocol analysis, which excluded patients who did not meet protocol criteria, led to an amplification of the effect when the study design was adhered to (–12.5 mL vs. +1.3 mL), though this result did not achieve statistical significance owing to the small sample size.
For the safety endpoints, the researchers examined the frequency of major adverse events (MAE), including death, myocardial infarction, cardiac perforation, device embolism, and surgery or percutaneous coronary intervention related to the device at 1 year. In the treatment group, 16.1% experienced a MAE, compared with 18.2% of control patients, a statistically nonsignificant difference.
A secondary efficacy endpoint of change in left ventricular end-diastolic volume showed improvements in the treatment group at 6 months (–12.4 mL) and 12 months (–8.6 mL), compared with increases in the sham group at 6 months (+5.4 mL) and 12 months (+6.5 mL). A similar trend occurred in left ventricular end-systolic volume (–7.8 mL and –4.8 mL; +3.4 mL and +6.1 mL, respectively).
The study was conducted in a patient population similar to that of the COAPT trial, which examined implantation of Abbott’s MitraClip. That study, presented here at TCT 2018 and simultaneously published in the New England Journal of Medicine, also examined patients with heart failure and secondary MR.
However, in REDUCE-FMR, many of the patients had milder heart failure than the researchers had expected: 44.8% in the treatment group had NYHA class II, as did 48.5% in the sham group. That surprise may help identify an appropriate patient population. “I think this device may have a nice spot in between medical therapy and MitraClip implantation, because we have, by chance, a patient population with mild heart insufficiency and mild MR,” said Dr. Sievert.
The two devices also showed different physiologic effects, Michael Mack, MD, said at a press conference. “One subtle difference is that, in this trial, the difference is due to both positive left ventricular remodeling in the treatment arm and continued progression in the sham control. In COAPT, the difference in improvement that we saw was totally due to prevention of progression of disease. We just stabilized the disease to where it was at. So that’s an intriguing difference here, that you actually were able to demonstrate positive left ventricular remodeling,” noted Dr. Mack, medical director for cardiovascular surgery at Baylor Scott & White Medical Center, Plano, Tex. He was a coinvestigator in the COAPT trial.
REDUCE-FMR was funded by Cardiac Dimensions. Dr. Sievert has received consulting fees, travel expenses, and study honoraria from Cardiac Dimensions, and 35 other companies. Dr. Mack has received grant support or had a research contract with Abbott Vascular, Medtronic, and Edwards Lifesciences.
REPORTING FROM TCT 2018
Key clinical point: The device led to improvement in mitral regurgitation as well as ventricular remodeling.
Major finding:
Study details: REDUCE-FMR, a randomized, sham controlled trial of 120 patients from 8 countries.
Disclosures: REDUCE-FMR was funded by Cardiac Dimensions. Dr. Sievert has received consulting fees, travel expenses, and study honoraria from Cardiac Dimensions, and 35 other companies. Dr. Mack has received grant support or had a research contract with Abbott Vascular, Medtronic, and Edwards Lifesciences.
COAPT: MitraClip prolongs life in selected HF patients
SAN DIEGO – Among a carefully selected subset of heart failure patients and severe secondary mitral regurgitation, transcatheter mitral valve repair with the MitraClip reduced hospitalizations for heart failure by 47%, and death from any cause by 38% over 24 months, compared with maximal medical therapy alone.
That’s according to a randomized, open-label trial presented at the Transcatheter Cardiovascular Therapeutics annual meeting.
The number needed to treat to prevent one heart failure (HF) hospitalization within 2 years was three; the number needed to treat to save one life was six. Only about 3% of patients had a device complication within 12 months of placement in the study, dubbed COAPT (the Heart Failure Patients with Functional Mitral Regurgitation Trial).
COAPT patients had grade 3+ or 4+ secondary mitral regurgitation, with a mean effective regurgitant orifice area (EROA) of 41 mm2. Their left ventricles were dilated, but not huge, with a mean left ventricular end-diastolic volume of 101 mL/m2. “We estimate that’s about 10% of heart failure patients,” said lead investigator and interventional cardiologist Gregg W. Stone, MD, a professor of medicine at Columbia University, New York.
MitraClip placement was performed in high-volume centers by experienced operators, and patients were on maximally tolerated doses of guideline-directed medical therapy, as per the 2013 American College of Cardiology/American Heart Association heart failure management guidelines. There was very little variation in treatment regimens during the 2-year trial (J Am Coll Cardiol. 2017;70:776-803).
Those parameters matter. Among HF patients who did not fit them in the recent Mitra-FR trial in France, MitraClip did not reduce rates of death or unplanned hospitalization (N Engl J Med. 2018 Aug 27. doi: 10.1056/NEJMoa1805374).
COAPT and Mitra-FR investigators said at the meeting that the studies are complimentary, not conflicting, because together, they define secondary mitral regurgitation (MR) patients who will and will not benefit from the device.
MR was less severe in Mitra-FR, with a mean EROA of 31 mm2, but left ventricles were more dilated, with a mean left ventricular end-diastolic volume of 135 mL/m2. Patients were on more real-world drug regimens that varied over the course of the trial. Also, the lower implantation rates and higher complication rates in Mitra-FR “suggests perhaps greater experience of the COAPT operators,” said Dr. Stone, who also is the director of cardiovascular research and education at the Center for Interventional Vascular Therapy at New York-Presbyterian Hospital/Columbia University Medical Center.
In short, “they were a different patient population than were enrolled in COAPT,” he said at the meeting, sponsored by the Cardiovascular Research Foundation, which Dr. Stone also codirects.
There was great excitement at TCT about COAPT because there was a startling benefit for patients who previously had few options. But many speakers worried that the hype surrounding the trial will drown out the critically important message about patient selection and that the clip will be used in HF patients who don’t fit the COAPT profile.
They also said that the emerging picture of benefit in patients with less ventricular dilation but more mitral regurgitation needs to be fleshed out and better quantified.
COAPT randomized 302 patients to MitraClip on a background of guideline-directed therapy and 312 to guideline-directed therapy alone. Participants who had mitral regurgitation caused by left ventricular dysfunction, were not surgical candidates, and remained symptomatic despite optimal treatment.
The annualized rate of all hospitalizations for HF within 24 months was 35.8% per patient-year in the device group, as compared with 67.9% per patient-year in the control group, for a relative reduction of 47% (P less than .001).
Death from any cause within 24 months occurred in 29.1% of the patients in the device group and 46.1% in the control group, yielding a reduction of 38% (P less than .001).
“We didn’t cure patients by fixing their MR. They still had 29% 2-year mortality, but we did markedly improve their quality of life. The only subgroup that didn’t benefit were patients that had an EORA of less than 30 mm2 and end diastolic volume greater than the median” of 96 mL/m2, which was “fascinating,” Dr. Stone said, and fit the emerging picture.
Mitral regurgitation grade fell to 1+ or lower in 82% of patients after clip placement and remained there in the majority of survivors at 2 years.
For a long time, “HF experts thought MR was just a marker of severe left ventricular dysfunction. What I think we see here is that secondary MR is not just a bystander. It contributes to the abnormal pathophysiology of these patients,” he said.
The trial was sponsored by MitraClip’s maker, Abbott. The company participated in site selection, management, and data analysis. Dr. Stone disclosed that his employer, Columbia University, receives royalties from Abbott for sale of the clip. Several fellow investigators disclosed grants, fees, and other financial ties to the company.
Simultaneously with the COAPT presentation, the results were published online (N Engl J Med. 2018 Sep 23. doi: 10.1056/NEJMoa1806640).
Mitra-FR was funded by the French Ministry of Health and Research and Abbott.
This is really a blockbuster trial, because you see a statistically significant reduction in cardiovascular endpoints, which is something we almost never see in device-based trials. I think this is going to change clinical practice, but the question of generalizability is tricky. This was such a well-conducted trial; it may be difficult to generalize this to the practicing public. I was impressed by the MitraClip performance: the reduction in MR [mitral regurgitation], the lack of recurrence, and the small number of complications. Perhaps more than anything else, the difference between Mitra-FR and COAPT was the quality of the operators.
Martin B. Leon, MD , is the director of the Center for Interventional Vascular Therapy at Columbia University, N.Y., and the Cardiovascular Research Foundation’s founder and codirector of medical research and education. He was not involved in COAPT, and made his comments after the study presentation.
This is really a blockbuster trial, because you see a statistically significant reduction in cardiovascular endpoints, which is something we almost never see in device-based trials. I think this is going to change clinical practice, but the question of generalizability is tricky. This was such a well-conducted trial; it may be difficult to generalize this to the practicing public. I was impressed by the MitraClip performance: the reduction in MR [mitral regurgitation], the lack of recurrence, and the small number of complications. Perhaps more than anything else, the difference between Mitra-FR and COAPT was the quality of the operators.
Martin B. Leon, MD , is the director of the Center for Interventional Vascular Therapy at Columbia University, N.Y., and the Cardiovascular Research Foundation’s founder and codirector of medical research and education. He was not involved in COAPT, and made his comments after the study presentation.
This is really a blockbuster trial, because you see a statistically significant reduction in cardiovascular endpoints, which is something we almost never see in device-based trials. I think this is going to change clinical practice, but the question of generalizability is tricky. This was such a well-conducted trial; it may be difficult to generalize this to the practicing public. I was impressed by the MitraClip performance: the reduction in MR [mitral regurgitation], the lack of recurrence, and the small number of complications. Perhaps more than anything else, the difference between Mitra-FR and COAPT was the quality of the operators.
Martin B. Leon, MD , is the director of the Center for Interventional Vascular Therapy at Columbia University, N.Y., and the Cardiovascular Research Foundation’s founder and codirector of medical research and education. He was not involved in COAPT, and made his comments after the study presentation.
SAN DIEGO – Among a carefully selected subset of heart failure patients and severe secondary mitral regurgitation, transcatheter mitral valve repair with the MitraClip reduced hospitalizations for heart failure by 47%, and death from any cause by 38% over 24 months, compared with maximal medical therapy alone.
That’s according to a randomized, open-label trial presented at the Transcatheter Cardiovascular Therapeutics annual meeting.
The number needed to treat to prevent one heart failure (HF) hospitalization within 2 years was three; the number needed to treat to save one life was six. Only about 3% of patients had a device complication within 12 months of placement in the study, dubbed COAPT (the Heart Failure Patients with Functional Mitral Regurgitation Trial).
COAPT patients had grade 3+ or 4+ secondary mitral regurgitation, with a mean effective regurgitant orifice area (EROA) of 41 mm2. Their left ventricles were dilated, but not huge, with a mean left ventricular end-diastolic volume of 101 mL/m2. “We estimate that’s about 10% of heart failure patients,” said lead investigator and interventional cardiologist Gregg W. Stone, MD, a professor of medicine at Columbia University, New York.
MitraClip placement was performed in high-volume centers by experienced operators, and patients were on maximally tolerated doses of guideline-directed medical therapy, as per the 2013 American College of Cardiology/American Heart Association heart failure management guidelines. There was very little variation in treatment regimens during the 2-year trial (J Am Coll Cardiol. 2017;70:776-803).
Those parameters matter. Among HF patients who did not fit them in the recent Mitra-FR trial in France, MitraClip did not reduce rates of death or unplanned hospitalization (N Engl J Med. 2018 Aug 27. doi: 10.1056/NEJMoa1805374).
COAPT and Mitra-FR investigators said at the meeting that the studies are complimentary, not conflicting, because together, they define secondary mitral regurgitation (MR) patients who will and will not benefit from the device.
MR was less severe in Mitra-FR, with a mean EROA of 31 mm2, but left ventricles were more dilated, with a mean left ventricular end-diastolic volume of 135 mL/m2. Patients were on more real-world drug regimens that varied over the course of the trial. Also, the lower implantation rates and higher complication rates in Mitra-FR “suggests perhaps greater experience of the COAPT operators,” said Dr. Stone, who also is the director of cardiovascular research and education at the Center for Interventional Vascular Therapy at New York-Presbyterian Hospital/Columbia University Medical Center.
In short, “they were a different patient population than were enrolled in COAPT,” he said at the meeting, sponsored by the Cardiovascular Research Foundation, which Dr. Stone also codirects.
There was great excitement at TCT about COAPT because there was a startling benefit for patients who previously had few options. But many speakers worried that the hype surrounding the trial will drown out the critically important message about patient selection and that the clip will be used in HF patients who don’t fit the COAPT profile.
They also said that the emerging picture of benefit in patients with less ventricular dilation but more mitral regurgitation needs to be fleshed out and better quantified.
COAPT randomized 302 patients to MitraClip on a background of guideline-directed therapy and 312 to guideline-directed therapy alone. Participants who had mitral regurgitation caused by left ventricular dysfunction, were not surgical candidates, and remained symptomatic despite optimal treatment.
The annualized rate of all hospitalizations for HF within 24 months was 35.8% per patient-year in the device group, as compared with 67.9% per patient-year in the control group, for a relative reduction of 47% (P less than .001).
Death from any cause within 24 months occurred in 29.1% of the patients in the device group and 46.1% in the control group, yielding a reduction of 38% (P less than .001).
“We didn’t cure patients by fixing their MR. They still had 29% 2-year mortality, but we did markedly improve their quality of life. The only subgroup that didn’t benefit were patients that had an EORA of less than 30 mm2 and end diastolic volume greater than the median” of 96 mL/m2, which was “fascinating,” Dr. Stone said, and fit the emerging picture.
Mitral regurgitation grade fell to 1+ or lower in 82% of patients after clip placement and remained there in the majority of survivors at 2 years.
For a long time, “HF experts thought MR was just a marker of severe left ventricular dysfunction. What I think we see here is that secondary MR is not just a bystander. It contributes to the abnormal pathophysiology of these patients,” he said.
The trial was sponsored by MitraClip’s maker, Abbott. The company participated in site selection, management, and data analysis. Dr. Stone disclosed that his employer, Columbia University, receives royalties from Abbott for sale of the clip. Several fellow investigators disclosed grants, fees, and other financial ties to the company.
Simultaneously with the COAPT presentation, the results were published online (N Engl J Med. 2018 Sep 23. doi: 10.1056/NEJMoa1806640).
Mitra-FR was funded by the French Ministry of Health and Research and Abbott.
SAN DIEGO – Among a carefully selected subset of heart failure patients and severe secondary mitral regurgitation, transcatheter mitral valve repair with the MitraClip reduced hospitalizations for heart failure by 47%, and death from any cause by 38% over 24 months, compared with maximal medical therapy alone.
That’s according to a randomized, open-label trial presented at the Transcatheter Cardiovascular Therapeutics annual meeting.
The number needed to treat to prevent one heart failure (HF) hospitalization within 2 years was three; the number needed to treat to save one life was six. Only about 3% of patients had a device complication within 12 months of placement in the study, dubbed COAPT (the Heart Failure Patients with Functional Mitral Regurgitation Trial).
COAPT patients had grade 3+ or 4+ secondary mitral regurgitation, with a mean effective regurgitant orifice area (EROA) of 41 mm2. Their left ventricles were dilated, but not huge, with a mean left ventricular end-diastolic volume of 101 mL/m2. “We estimate that’s about 10% of heart failure patients,” said lead investigator and interventional cardiologist Gregg W. Stone, MD, a professor of medicine at Columbia University, New York.
MitraClip placement was performed in high-volume centers by experienced operators, and patients were on maximally tolerated doses of guideline-directed medical therapy, as per the 2013 American College of Cardiology/American Heart Association heart failure management guidelines. There was very little variation in treatment regimens during the 2-year trial (J Am Coll Cardiol. 2017;70:776-803).
Those parameters matter. Among HF patients who did not fit them in the recent Mitra-FR trial in France, MitraClip did not reduce rates of death or unplanned hospitalization (N Engl J Med. 2018 Aug 27. doi: 10.1056/NEJMoa1805374).
COAPT and Mitra-FR investigators said at the meeting that the studies are complimentary, not conflicting, because together, they define secondary mitral regurgitation (MR) patients who will and will not benefit from the device.
MR was less severe in Mitra-FR, with a mean EROA of 31 mm2, but left ventricles were more dilated, with a mean left ventricular end-diastolic volume of 135 mL/m2. Patients were on more real-world drug regimens that varied over the course of the trial. Also, the lower implantation rates and higher complication rates in Mitra-FR “suggests perhaps greater experience of the COAPT operators,” said Dr. Stone, who also is the director of cardiovascular research and education at the Center for Interventional Vascular Therapy at New York-Presbyterian Hospital/Columbia University Medical Center.
In short, “they were a different patient population than were enrolled in COAPT,” he said at the meeting, sponsored by the Cardiovascular Research Foundation, which Dr. Stone also codirects.
There was great excitement at TCT about COAPT because there was a startling benefit for patients who previously had few options. But many speakers worried that the hype surrounding the trial will drown out the critically important message about patient selection and that the clip will be used in HF patients who don’t fit the COAPT profile.
They also said that the emerging picture of benefit in patients with less ventricular dilation but more mitral regurgitation needs to be fleshed out and better quantified.
COAPT randomized 302 patients to MitraClip on a background of guideline-directed therapy and 312 to guideline-directed therapy alone. Participants who had mitral regurgitation caused by left ventricular dysfunction, were not surgical candidates, and remained symptomatic despite optimal treatment.
The annualized rate of all hospitalizations for HF within 24 months was 35.8% per patient-year in the device group, as compared with 67.9% per patient-year in the control group, for a relative reduction of 47% (P less than .001).
Death from any cause within 24 months occurred in 29.1% of the patients in the device group and 46.1% in the control group, yielding a reduction of 38% (P less than .001).
“We didn’t cure patients by fixing their MR. They still had 29% 2-year mortality, but we did markedly improve their quality of life. The only subgroup that didn’t benefit were patients that had an EORA of less than 30 mm2 and end diastolic volume greater than the median” of 96 mL/m2, which was “fascinating,” Dr. Stone said, and fit the emerging picture.
Mitral regurgitation grade fell to 1+ or lower in 82% of patients after clip placement and remained there in the majority of survivors at 2 years.
For a long time, “HF experts thought MR was just a marker of severe left ventricular dysfunction. What I think we see here is that secondary MR is not just a bystander. It contributes to the abnormal pathophysiology of these patients,” he said.
The trial was sponsored by MitraClip’s maker, Abbott. The company participated in site selection, management, and data analysis. Dr. Stone disclosed that his employer, Columbia University, receives royalties from Abbott for sale of the clip. Several fellow investigators disclosed grants, fees, and other financial ties to the company.
Simultaneously with the COAPT presentation, the results were published online (N Engl J Med. 2018 Sep 23. doi: 10.1056/NEJMoa1806640).
Mitra-FR was funded by the French Ministry of Health and Research and Abbott.
REPORTING FROM TCT 2018
Key clinical point: MitraClip reduced death and heart failure hospitalizations in certain patients, but
Major finding: Among a subset of heart failure patients with moderately dilated left ventricles and severe secondary mitral regurgitation, transcatheter mitral valve repair with the MitraClip reduced hospitalizations for heart failure within 24 months by 47%, and death from any cause within 24 months by 38%, compared with maximal medical therapy alone.
Study details: COAPT, a randomized, open-label trial with 614 subjects
Disclosures: The work was funded by MitraClip maker, Abbott. The company participated in site selection, management, and data analysis. The lead and several other investigators disclosed financial ties to the company.
Cheaper drug-eluting stent fares as well as Xience
SAN DIEGO – The Supraflex drug-eluting stent is noninferior to Abbott’s Xience stent, according to results of the TALENT trial. Supfraflex elutes sirolimus from a bioabsorbable polymer, while Xience elutes everolimus from a durable polymer coating.
Stent technology has reached a “safety plateau,” which is leading to decisions based on economic factors, said Patrick Serruys, MD, during a presentation of the results at Transcatheter Cardiovascular Therapeutics annual meeting. Dr. Serruys is a professor of cardiology at the National Heart and Lung Institute of Imperial College in London.
The Indian government’s policy also requires companies to prove that their product is noninferior to proven stents. To satisfy that requirement, researchers conducted the Thin Strut Sirolimus-Eluting Stent in All Comers Population vs Everolimus-eluting Stent (TALENT) study. In this trial (NCT02870140), 1,435 patients from 23 sites were randomized to receive either the Supraflex stent, manufactured by India-based SMT, or the Xience stent.
The population was “all comers” who had symptomatic coronary artery disease that qualified for percutaneous coronary interventions, including chronic stable angina, silent ischemia, and acute coronary syndromes. The researchers followed patients out to 3 years.
The two groups were similar in their baseline characteristics, with the exception of previous coronary artery bypass graft, which was more frequent in the Xience group (7.7% versus 4.6%).
The primary endpoint of the study was a composite of cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revascularization (CI-TLR). At 3 years, 5.3% of the Xience group experienced the composite outcome versus 4.9% of the Supraflex group, a nonsignificant difference. The result confirmed the noninferiority of Supraflex at a margin of 4% (P less than .001). When the adverse events were broken down individually in a per-protocol analysis, the only significant difference between the two groups was with respect to CI-TLR, which favored Supraflex (1.2% versus 3.1%; P = .021). There were seven deaths in the Supraflex arm versus two in the Xience group. However, there was no apparent explanation for the difference, and it may have been because of chance, according to Dr. Serruys.
“The performance of Xience was excellent in this trial, at 5.3% it had one of the lowest (adverse outcome rates) I have seen so far, but the Supraflex also did very well,” said Dr. Serruys at a press conference.
The results of the study have implications in countries with capped stent prices or where there are models for competitive pricing. “Market competitiveness may influence future decisions on which stent you use,” said Dr. Serruys.
Because the trial was designed with India’s regulatory environment in mind, it is unlikely to be applicable to marketing approval in the United States, but such inexpensive stents could be coming. They may drive down prices, but they could also have a dark side, according to Dr. Cohen. “The companies that make these kinds of stents don’t do the kind of innovation we’ve come to expect in the field. I don’t know if they can support the R&D programs that the companies that we currently use [can support],” he said.
TALENT was sponsored by SMT, which manufactures Supraflex, and by the European Clinical Research Institute. Dr. Serruys has consulted for, received honoraria from, or served on the speaker’s bureau for Abbott. Dr. Cohen has received grant support from Abbott Vascular, Boston Scientific, Edwards Lifesciences, Medtronic, Corvia Medical, and Svelte. He has consulted for, received honoraria, or served on the speaker’s bureau for Edwards Lifesciences and Medtronic.
SAN DIEGO – The Supraflex drug-eluting stent is noninferior to Abbott’s Xience stent, according to results of the TALENT trial. Supfraflex elutes sirolimus from a bioabsorbable polymer, while Xience elutes everolimus from a durable polymer coating.
Stent technology has reached a “safety plateau,” which is leading to decisions based on economic factors, said Patrick Serruys, MD, during a presentation of the results at Transcatheter Cardiovascular Therapeutics annual meeting. Dr. Serruys is a professor of cardiology at the National Heart and Lung Institute of Imperial College in London.
The Indian government’s policy also requires companies to prove that their product is noninferior to proven stents. To satisfy that requirement, researchers conducted the Thin Strut Sirolimus-Eluting Stent in All Comers Population vs Everolimus-eluting Stent (TALENT) study. In this trial (NCT02870140), 1,435 patients from 23 sites were randomized to receive either the Supraflex stent, manufactured by India-based SMT, or the Xience stent.
The population was “all comers” who had symptomatic coronary artery disease that qualified for percutaneous coronary interventions, including chronic stable angina, silent ischemia, and acute coronary syndromes. The researchers followed patients out to 3 years.
The two groups were similar in their baseline characteristics, with the exception of previous coronary artery bypass graft, which was more frequent in the Xience group (7.7% versus 4.6%).
The primary endpoint of the study was a composite of cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revascularization (CI-TLR). At 3 years, 5.3% of the Xience group experienced the composite outcome versus 4.9% of the Supraflex group, a nonsignificant difference. The result confirmed the noninferiority of Supraflex at a margin of 4% (P less than .001). When the adverse events were broken down individually in a per-protocol analysis, the only significant difference between the two groups was with respect to CI-TLR, which favored Supraflex (1.2% versus 3.1%; P = .021). There were seven deaths in the Supraflex arm versus two in the Xience group. However, there was no apparent explanation for the difference, and it may have been because of chance, according to Dr. Serruys.
“The performance of Xience was excellent in this trial, at 5.3% it had one of the lowest (adverse outcome rates) I have seen so far, but the Supraflex also did very well,” said Dr. Serruys at a press conference.
The results of the study have implications in countries with capped stent prices or where there are models for competitive pricing. “Market competitiveness may influence future decisions on which stent you use,” said Dr. Serruys.
Because the trial was designed with India’s regulatory environment in mind, it is unlikely to be applicable to marketing approval in the United States, but such inexpensive stents could be coming. They may drive down prices, but they could also have a dark side, according to Dr. Cohen. “The companies that make these kinds of stents don’t do the kind of innovation we’ve come to expect in the field. I don’t know if they can support the R&D programs that the companies that we currently use [can support],” he said.
TALENT was sponsored by SMT, which manufactures Supraflex, and by the European Clinical Research Institute. Dr. Serruys has consulted for, received honoraria from, or served on the speaker’s bureau for Abbott. Dr. Cohen has received grant support from Abbott Vascular, Boston Scientific, Edwards Lifesciences, Medtronic, Corvia Medical, and Svelte. He has consulted for, received honoraria, or served on the speaker’s bureau for Edwards Lifesciences and Medtronic.
SAN DIEGO – The Supraflex drug-eluting stent is noninferior to Abbott’s Xience stent, according to results of the TALENT trial. Supfraflex elutes sirolimus from a bioabsorbable polymer, while Xience elutes everolimus from a durable polymer coating.
Stent technology has reached a “safety plateau,” which is leading to decisions based on economic factors, said Patrick Serruys, MD, during a presentation of the results at Transcatheter Cardiovascular Therapeutics annual meeting. Dr. Serruys is a professor of cardiology at the National Heart and Lung Institute of Imperial College in London.
The Indian government’s policy also requires companies to prove that their product is noninferior to proven stents. To satisfy that requirement, researchers conducted the Thin Strut Sirolimus-Eluting Stent in All Comers Population vs Everolimus-eluting Stent (TALENT) study. In this trial (NCT02870140), 1,435 patients from 23 sites were randomized to receive either the Supraflex stent, manufactured by India-based SMT, or the Xience stent.
The population was “all comers” who had symptomatic coronary artery disease that qualified for percutaneous coronary interventions, including chronic stable angina, silent ischemia, and acute coronary syndromes. The researchers followed patients out to 3 years.
The two groups were similar in their baseline characteristics, with the exception of previous coronary artery bypass graft, which was more frequent in the Xience group (7.7% versus 4.6%).
The primary endpoint of the study was a composite of cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revascularization (CI-TLR). At 3 years, 5.3% of the Xience group experienced the composite outcome versus 4.9% of the Supraflex group, a nonsignificant difference. The result confirmed the noninferiority of Supraflex at a margin of 4% (P less than .001). When the adverse events were broken down individually in a per-protocol analysis, the only significant difference between the two groups was with respect to CI-TLR, which favored Supraflex (1.2% versus 3.1%; P = .021). There were seven deaths in the Supraflex arm versus two in the Xience group. However, there was no apparent explanation for the difference, and it may have been because of chance, according to Dr. Serruys.
“The performance of Xience was excellent in this trial, at 5.3% it had one of the lowest (adverse outcome rates) I have seen so far, but the Supraflex also did very well,” said Dr. Serruys at a press conference.
The results of the study have implications in countries with capped stent prices or where there are models for competitive pricing. “Market competitiveness may influence future decisions on which stent you use,” said Dr. Serruys.
Because the trial was designed with India’s regulatory environment in mind, it is unlikely to be applicable to marketing approval in the United States, but such inexpensive stents could be coming. They may drive down prices, but they could also have a dark side, according to Dr. Cohen. “The companies that make these kinds of stents don’t do the kind of innovation we’ve come to expect in the field. I don’t know if they can support the R&D programs that the companies that we currently use [can support],” he said.
TALENT was sponsored by SMT, which manufactures Supraflex, and by the European Clinical Research Institute. Dr. Serruys has consulted for, received honoraria from, or served on the speaker’s bureau for Abbott. Dr. Cohen has received grant support from Abbott Vascular, Boston Scientific, Edwards Lifesciences, Medtronic, Corvia Medical, and Svelte. He has consulted for, received honoraria, or served on the speaker’s bureau for Edwards Lifesciences and Medtronic.
REPORTING FROM TCT 2018
Key clinical point: Equivalent, cheaper stents could put economic pressure on choice of stent.
Major finding: At 1 year, there was no significant difference in a composite of death and cardiac events.
Study details: TALENT, a multicenter, randomized, controlled trial of 1,435 patients.
Disclosures: TALENT was sponsored by SMT, which manufactures Supraflex, and by the European Clinical Research Institute. Dr. Serruys has consulted for, received honoraria from, or served on the speaker’s bureau for Abbott. Dr. Cohen has received grant support from Abbott Vascular, Boston Scientific, Edwards Lifesciences, Medtronic, Corvia Medical, and Svelte. He has consulted for, received honoraria from, or served on the speaker’s bureau for Edwards Lifesciences and Medtronic.
Drug-coated stent bests bare metal in patients with high bleeding risk
SAN DIEGO – Positive results of the LEADERS FREE II trial in patients with high bleeding risk undergoing percutaneous coronary intervention may pave the way for approval of a new drug-coated stent in the United States and possibly spell the end for bare-metal stents.
The stent studied – a polymer-free umirolimus-coated stent – is currently marketed in Europe as BioFreedom (Biosensors International). It outperformed a very similar bare-metal stent (Gazelle, manufactured by Biosensors Interventional Technologies) in the randomized LEADERS FREE trial, which was conducted outside the United States (N Engl J Med. 2015 Nov 19;373[21]:2038-47). The single-arm LEADERS FREE II (NCT02843633) trial was undertaken to confirm those findings, assess their generalizability in a North American population, and obtain data to support regulatory approval of the stent in the United States, explained presenting author Mitchell W. Krucoff, MD, a professor of medicine and member in the Duke Clinical Research Institute, Duke University, Durham, N.C. All patients received drug-coated stents because it was considered unethical to randomize any to bare-metal stents after the preceding trial. As in that trial, all patients received 1 month of dual-antiplatelet therapy.
Compared with the 1,211 propensity-matched patients treated with bare metal stents in the LEADERS FREE trial, the 1,203 patients treated with drug-coated stents in the LEADERS FREE II trial had a 33% lower risk of primary safety events (a composite of cardiac death and myocardial infarction) and a 37% lower risk of primary efficacy events (clinically driven target lesion revascularization) at 1 year, according to the study’s main results. Secondary outcomes were all similar or better with the drug-coated stents.
“This study demonstrates reproducibility of the randomized LEADERS FREE findings showing superior safety … and superior effectiveness … of the drug-coated stent over the bare-metal stent,” Dr. Krucoff said. “This study also, by enrolling more than half of patients in North America, supports the generalizability of the findings to patients on both sides of the Atlantic.”
Parsing the findings
When asked whether the Food and Drug Administration should approve this stent and whether he would use it for his patients, Dr. Krucoff gave a “yes, but …” reply. “The but here is, we have a lot to learn in this area. These are patients who by and large have been excluded from every pivotal drug-eluting stent study and every pivotal dual-antiplatelet study,” he elaborated. It is therefore unclear, for example, how the stent will perform as more are treated and what the optimal duration of dual-antiplatelet therapy is. Nonetheless, given that these patients make up a sizable share of the PCI [percutaneous coronary intervention] population and that some centers still commonly use bare-metal stents, “I think bringing this stent forward with a label for 30 days [of dual-antiplatelet therapy] in high bleeding risk patients is a yes.”
“To me, the main driving factor for an expeditious [approval] process is, if you put a conservatively critical eye to this, you could say that LEADERS FREE alerts us to a safety signal [about] our intuitive behavior practice of putting bare-metal stents in patients who we know are at high bleeding risk, so we are only going to treat them with 30 days of dual-antiplatelet therapy. There is actually a safety signal that we are potentially doing harm, based on at least one look at this,” Dr. Krucoff added. “There is no question, I think FDA decisions are primarily driven by safety concerns. The unusual thing here is, it’s not a safety concern as a defect in the device, it’s a safety concern relative to our current practice.”
Trial details
On average, the patients enrolled in LEADERS FREE II were generally similar to counterparts enrolled in LEADERS FREE and had an average of 1.74 factors putting them at high risk for bleeding, according to Dr. Krucoff. Of note, it was an all-comers trial in that there was no restriction on coronary anatomy, lesion complexity, or clinical presentation.
Results reported at the meeting, which was sponsored by the Cardiovascular Research Foundation, showed that the rate of the primary safety endpoint – the composite of cardiac death and myocardial infarction at 1 year – was 8.6% with the drug-coated stent and 12.3% with the bare-metal stent, for an absolute risk difference of –3.7% (hazard ratio, 0.67; P for noninferiority less than .0001; P for superiority = .0025).
Findings were significant for each component individually and were generally consistent across patient subgroups, Dr. Krucoff said. Secondary safety endpoints showed “no sign of a safety signal or concern with the drug-coated stent platform with 30 days of dual-antiplatelet therapy.”
In an additional analysis, the unadjusted rates of the primary safety endpoint were was 8.6% and 9.0% with the drug-coated stent in the LEADERS FREE II and the LEADERS FREE populations, respectively, compared with 12.4% with the bare-metal stent.
The rate of the primary efficacy endpoint – clinically driven target lesion revascularization at 1 year – was 6.1% with the drug-coated stent and 9.3% with the bare-metal stent, for an absolute risk difference of –3.2% (hazard ratio, 0.63; P for superiority = .0111). Findings again were consistently in favor of the drug-coated stent across most patient subgroups, with the exception of patients having renal failure at the time of admission. Secondary efficacy endpoints all significantly favored that stent as well.
The 1-year rates of bleeding overall and by severity were statistically indistinguishable, Dr. Krucoff reported. The rate of severe bleeding – Bleeding Academic Research Consortium (BARC) type 3-5 – was 7.0% with the drug-coated stent and 7.3% with the bare metal stent.
Dr. Krucoff disclosed that he has various affiliations and financial relationships with Abbott Vascular, Biosensors, Boston Scientific, CSI, Medtronic, OrbusNeich, and Terumo. The trial was sponsored by Biosensors.
SAN DIEGO – Positive results of the LEADERS FREE II trial in patients with high bleeding risk undergoing percutaneous coronary intervention may pave the way for approval of a new drug-coated stent in the United States and possibly spell the end for bare-metal stents.
The stent studied – a polymer-free umirolimus-coated stent – is currently marketed in Europe as BioFreedom (Biosensors International). It outperformed a very similar bare-metal stent (Gazelle, manufactured by Biosensors Interventional Technologies) in the randomized LEADERS FREE trial, which was conducted outside the United States (N Engl J Med. 2015 Nov 19;373[21]:2038-47). The single-arm LEADERS FREE II (NCT02843633) trial was undertaken to confirm those findings, assess their generalizability in a North American population, and obtain data to support regulatory approval of the stent in the United States, explained presenting author Mitchell W. Krucoff, MD, a professor of medicine and member in the Duke Clinical Research Institute, Duke University, Durham, N.C. All patients received drug-coated stents because it was considered unethical to randomize any to bare-metal stents after the preceding trial. As in that trial, all patients received 1 month of dual-antiplatelet therapy.
Compared with the 1,211 propensity-matched patients treated with bare metal stents in the LEADERS FREE trial, the 1,203 patients treated with drug-coated stents in the LEADERS FREE II trial had a 33% lower risk of primary safety events (a composite of cardiac death and myocardial infarction) and a 37% lower risk of primary efficacy events (clinically driven target lesion revascularization) at 1 year, according to the study’s main results. Secondary outcomes were all similar or better with the drug-coated stents.
“This study demonstrates reproducibility of the randomized LEADERS FREE findings showing superior safety … and superior effectiveness … of the drug-coated stent over the bare-metal stent,” Dr. Krucoff said. “This study also, by enrolling more than half of patients in North America, supports the generalizability of the findings to patients on both sides of the Atlantic.”
Parsing the findings
When asked whether the Food and Drug Administration should approve this stent and whether he would use it for his patients, Dr. Krucoff gave a “yes, but …” reply. “The but here is, we have a lot to learn in this area. These are patients who by and large have been excluded from every pivotal drug-eluting stent study and every pivotal dual-antiplatelet study,” he elaborated. It is therefore unclear, for example, how the stent will perform as more are treated and what the optimal duration of dual-antiplatelet therapy is. Nonetheless, given that these patients make up a sizable share of the PCI [percutaneous coronary intervention] population and that some centers still commonly use bare-metal stents, “I think bringing this stent forward with a label for 30 days [of dual-antiplatelet therapy] in high bleeding risk patients is a yes.”
“To me, the main driving factor for an expeditious [approval] process is, if you put a conservatively critical eye to this, you could say that LEADERS FREE alerts us to a safety signal [about] our intuitive behavior practice of putting bare-metal stents in patients who we know are at high bleeding risk, so we are only going to treat them with 30 days of dual-antiplatelet therapy. There is actually a safety signal that we are potentially doing harm, based on at least one look at this,” Dr. Krucoff added. “There is no question, I think FDA decisions are primarily driven by safety concerns. The unusual thing here is, it’s not a safety concern as a defect in the device, it’s a safety concern relative to our current practice.”
Trial details
On average, the patients enrolled in LEADERS FREE II were generally similar to counterparts enrolled in LEADERS FREE and had an average of 1.74 factors putting them at high risk for bleeding, according to Dr. Krucoff. Of note, it was an all-comers trial in that there was no restriction on coronary anatomy, lesion complexity, or clinical presentation.
Results reported at the meeting, which was sponsored by the Cardiovascular Research Foundation, showed that the rate of the primary safety endpoint – the composite of cardiac death and myocardial infarction at 1 year – was 8.6% with the drug-coated stent and 12.3% with the bare-metal stent, for an absolute risk difference of –3.7% (hazard ratio, 0.67; P for noninferiority less than .0001; P for superiority = .0025).
Findings were significant for each component individually and were generally consistent across patient subgroups, Dr. Krucoff said. Secondary safety endpoints showed “no sign of a safety signal or concern with the drug-coated stent platform with 30 days of dual-antiplatelet therapy.”
In an additional analysis, the unadjusted rates of the primary safety endpoint were was 8.6% and 9.0% with the drug-coated stent in the LEADERS FREE II and the LEADERS FREE populations, respectively, compared with 12.4% with the bare-metal stent.
The rate of the primary efficacy endpoint – clinically driven target lesion revascularization at 1 year – was 6.1% with the drug-coated stent and 9.3% with the bare-metal stent, for an absolute risk difference of –3.2% (hazard ratio, 0.63; P for superiority = .0111). Findings again were consistently in favor of the drug-coated stent across most patient subgroups, with the exception of patients having renal failure at the time of admission. Secondary efficacy endpoints all significantly favored that stent as well.
The 1-year rates of bleeding overall and by severity were statistically indistinguishable, Dr. Krucoff reported. The rate of severe bleeding – Bleeding Academic Research Consortium (BARC) type 3-5 – was 7.0% with the drug-coated stent and 7.3% with the bare metal stent.
Dr. Krucoff disclosed that he has various affiliations and financial relationships with Abbott Vascular, Biosensors, Boston Scientific, CSI, Medtronic, OrbusNeich, and Terumo. The trial was sponsored by Biosensors.
SAN DIEGO – Positive results of the LEADERS FREE II trial in patients with high bleeding risk undergoing percutaneous coronary intervention may pave the way for approval of a new drug-coated stent in the United States and possibly spell the end for bare-metal stents.
The stent studied – a polymer-free umirolimus-coated stent – is currently marketed in Europe as BioFreedom (Biosensors International). It outperformed a very similar bare-metal stent (Gazelle, manufactured by Biosensors Interventional Technologies) in the randomized LEADERS FREE trial, which was conducted outside the United States (N Engl J Med. 2015 Nov 19;373[21]:2038-47). The single-arm LEADERS FREE II (NCT02843633) trial was undertaken to confirm those findings, assess their generalizability in a North American population, and obtain data to support regulatory approval of the stent in the United States, explained presenting author Mitchell W. Krucoff, MD, a professor of medicine and member in the Duke Clinical Research Institute, Duke University, Durham, N.C. All patients received drug-coated stents because it was considered unethical to randomize any to bare-metal stents after the preceding trial. As in that trial, all patients received 1 month of dual-antiplatelet therapy.
Compared with the 1,211 propensity-matched patients treated with bare metal stents in the LEADERS FREE trial, the 1,203 patients treated with drug-coated stents in the LEADERS FREE II trial had a 33% lower risk of primary safety events (a composite of cardiac death and myocardial infarction) and a 37% lower risk of primary efficacy events (clinically driven target lesion revascularization) at 1 year, according to the study’s main results. Secondary outcomes were all similar or better with the drug-coated stents.
“This study demonstrates reproducibility of the randomized LEADERS FREE findings showing superior safety … and superior effectiveness … of the drug-coated stent over the bare-metal stent,” Dr. Krucoff said. “This study also, by enrolling more than half of patients in North America, supports the generalizability of the findings to patients on both sides of the Atlantic.”
Parsing the findings
When asked whether the Food and Drug Administration should approve this stent and whether he would use it for his patients, Dr. Krucoff gave a “yes, but …” reply. “The but here is, we have a lot to learn in this area. These are patients who by and large have been excluded from every pivotal drug-eluting stent study and every pivotal dual-antiplatelet study,” he elaborated. It is therefore unclear, for example, how the stent will perform as more are treated and what the optimal duration of dual-antiplatelet therapy is. Nonetheless, given that these patients make up a sizable share of the PCI [percutaneous coronary intervention] population and that some centers still commonly use bare-metal stents, “I think bringing this stent forward with a label for 30 days [of dual-antiplatelet therapy] in high bleeding risk patients is a yes.”
“To me, the main driving factor for an expeditious [approval] process is, if you put a conservatively critical eye to this, you could say that LEADERS FREE alerts us to a safety signal [about] our intuitive behavior practice of putting bare-metal stents in patients who we know are at high bleeding risk, so we are only going to treat them with 30 days of dual-antiplatelet therapy. There is actually a safety signal that we are potentially doing harm, based on at least one look at this,” Dr. Krucoff added. “There is no question, I think FDA decisions are primarily driven by safety concerns. The unusual thing here is, it’s not a safety concern as a defect in the device, it’s a safety concern relative to our current practice.”
Trial details
On average, the patients enrolled in LEADERS FREE II were generally similar to counterparts enrolled in LEADERS FREE and had an average of 1.74 factors putting them at high risk for bleeding, according to Dr. Krucoff. Of note, it was an all-comers trial in that there was no restriction on coronary anatomy, lesion complexity, or clinical presentation.
Results reported at the meeting, which was sponsored by the Cardiovascular Research Foundation, showed that the rate of the primary safety endpoint – the composite of cardiac death and myocardial infarction at 1 year – was 8.6% with the drug-coated stent and 12.3% with the bare-metal stent, for an absolute risk difference of –3.7% (hazard ratio, 0.67; P for noninferiority less than .0001; P for superiority = .0025).
Findings were significant for each component individually and were generally consistent across patient subgroups, Dr. Krucoff said. Secondary safety endpoints showed “no sign of a safety signal or concern with the drug-coated stent platform with 30 days of dual-antiplatelet therapy.”
In an additional analysis, the unadjusted rates of the primary safety endpoint were was 8.6% and 9.0% with the drug-coated stent in the LEADERS FREE II and the LEADERS FREE populations, respectively, compared with 12.4% with the bare-metal stent.
The rate of the primary efficacy endpoint – clinically driven target lesion revascularization at 1 year – was 6.1% with the drug-coated stent and 9.3% with the bare-metal stent, for an absolute risk difference of –3.2% (hazard ratio, 0.63; P for superiority = .0111). Findings again were consistently in favor of the drug-coated stent across most patient subgroups, with the exception of patients having renal failure at the time of admission. Secondary efficacy endpoints all significantly favored that stent as well.
The 1-year rates of bleeding overall and by severity were statistically indistinguishable, Dr. Krucoff reported. The rate of severe bleeding – Bleeding Academic Research Consortium (BARC) type 3-5 – was 7.0% with the drug-coated stent and 7.3% with the bare metal stent.
Dr. Krucoff disclosed that he has various affiliations and financial relationships with Abbott Vascular, Biosensors, Boston Scientific, CSI, Medtronic, OrbusNeich, and Terumo. The trial was sponsored by Biosensors.
REPORTING FROM TCT 2018
Key clinical point: The polymer-free umirolimus (Biolimus A9)–coated stent is superior to the bare-metal stent in patients at high bleeding risk when used with a month of dual-antiplatelet therapy.
Major finding: The drug-coated stent reduced 1-year risks of the composite of cardiac death and MI by 33% and clinically driven target lesion revascularization by 37% when compared with matched controls.
Study details: A single-arm trial of 1,203 patients at high bleeding risk undergoing PCI who were given drug-coated stents with 1 month of dual-antiplatelet therapy who were compared with 1,211 propensity-matched historical control patients given bare-metal stents (LEADERS FREE II trial).
Disclosures: Dr. Krucoff has various affiliations/financial relationships with Abbott Vascular, Biosensors, Boston Scientific, CSI, Medtronic, OrbusNeich, and Terumo. The trial was sponsored by Biosensors.
IMPERIAL: Eluvia stent tops Zilver PTX for PAD
SAN DIEGO – In the first randomized, head-to-head trial of drug-releasing stents for above-the-knee femoropopliteal peripheral artery disease (PAD), Boston Scientific’s polymer-coated, paclitaxel-eluting stent outperformed Cook Medical’s polymer-free, paclitaxel-coated stent.
At 12 months, primary patency was 86.8% (231/266) in the Eluvia group, versus 81.5% (106/130) among those randomized to Zilver PTX. About 5% of Eluvia patients (14/273) and 9% of patients in the Zilver PTX arm (12/133) had a major adverse event, defined as death within a month or target limb amputation or revascularization through 12 months. Both outcomes were statistically significant at P less than .0001. Overall, 4.5% of Eluvia patients (13/287) required target lesion revascularization, compared with 9% of Zilver PTX patients (13/145).
“These data suggest the Boston Scientific product is superior. Unless there are big differences in cost or technical aspects of the procedure, I would foresee a fairly substantial shift to” Eluvia if it’s approved, which seems likely, said interventional cardiologist David Cohen, MD, of Saint Luke’s Mid America Heart Institute, Kansas City, Mo., who comoderated the study presentation at the Transcatheter Cardiovascular Therapeutics annual meeting.
There were six cases of aneurysmal degeneration with Eluvia, but none with Zilver PTX. All six patients were patent at 1 year, without revascularization or stent thrombosis. It’s too early to know what to make of the finding. The planned 5-year follow-up should shed some light on the issue, Dr. Gray said.
At present, there’s no clear algorithm for above-the-knee PAD. Balloons and stents – both drug-releasing and bare – are all in play, and new devices are on the way. “With a head-to-head trial like this, we are staring to pare down all the noise in the market place. I think for long complicated lesions, I would be very surprised if we don’t start seeing more drug-eluting stents, because the results are so good. Drug-coated balloons are useful, but they take a little bit longer and a little more nuance,” especially when stent are used to touch up the results, he said.
“If [Boston Scientific] prices this at a premium and my doctors come to me and say ‘You’ve got to let us buy this,’ it’s going to be a hard sell for me,” said Dr. Jaff, a professor of medicine at Harvard Medical School, Boston, and president of the nearby Newton-Wellesley Hospital in Newton, Mass.
As for shifting away from drug-coated balloons, which are an increasingly popular option, a head-to-head trial is in order. If it turns out Eluvia doesn’t “have a huge advantage, I’d start off with a drug-coated balloon. You leave yourself every option going down the road if it fails. If you have a stent that fails, it’s harder to work with,” he said.
About two-thirds of the subjects were men, and the mean age was about 68 years. Most patients in both arms had marked improvements in symptoms and walking ability after stent placement. Rates of stent thrombosis were low, at about 2% with Eluvia versus 4% with Zilver PTX, a statistically nonsignificant difference.
The IMPERIAL results were published online simultaneously with Dr. Gray’s presentation (Lancet. 2018 Sep 22. doi: 10.1016/S0140-6736[18]32262-1).
The work was funded and conducted by Boston Scientific. Dr. Gray and Dr. Jaffe are advisors to the company. Most of the other investigators disclosed financial ties to company, and one was an employee. Dr. Cohen wasn’t involved in the work. The TCT meeting was sponsored by the Cardiovascular Research Foundation.
SAN DIEGO – In the first randomized, head-to-head trial of drug-releasing stents for above-the-knee femoropopliteal peripheral artery disease (PAD), Boston Scientific’s polymer-coated, paclitaxel-eluting stent outperformed Cook Medical’s polymer-free, paclitaxel-coated stent.
At 12 months, primary patency was 86.8% (231/266) in the Eluvia group, versus 81.5% (106/130) among those randomized to Zilver PTX. About 5% of Eluvia patients (14/273) and 9% of patients in the Zilver PTX arm (12/133) had a major adverse event, defined as death within a month or target limb amputation or revascularization through 12 months. Both outcomes were statistically significant at P less than .0001. Overall, 4.5% of Eluvia patients (13/287) required target lesion revascularization, compared with 9% of Zilver PTX patients (13/145).
“These data suggest the Boston Scientific product is superior. Unless there are big differences in cost or technical aspects of the procedure, I would foresee a fairly substantial shift to” Eluvia if it’s approved, which seems likely, said interventional cardiologist David Cohen, MD, of Saint Luke’s Mid America Heart Institute, Kansas City, Mo., who comoderated the study presentation at the Transcatheter Cardiovascular Therapeutics annual meeting.
There were six cases of aneurysmal degeneration with Eluvia, but none with Zilver PTX. All six patients were patent at 1 year, without revascularization or stent thrombosis. It’s too early to know what to make of the finding. The planned 5-year follow-up should shed some light on the issue, Dr. Gray said.
At present, there’s no clear algorithm for above-the-knee PAD. Balloons and stents – both drug-releasing and bare – are all in play, and new devices are on the way. “With a head-to-head trial like this, we are staring to pare down all the noise in the market place. I think for long complicated lesions, I would be very surprised if we don’t start seeing more drug-eluting stents, because the results are so good. Drug-coated balloons are useful, but they take a little bit longer and a little more nuance,” especially when stent are used to touch up the results, he said.
“If [Boston Scientific] prices this at a premium and my doctors come to me and say ‘You’ve got to let us buy this,’ it’s going to be a hard sell for me,” said Dr. Jaff, a professor of medicine at Harvard Medical School, Boston, and president of the nearby Newton-Wellesley Hospital in Newton, Mass.
As for shifting away from drug-coated balloons, which are an increasingly popular option, a head-to-head trial is in order. If it turns out Eluvia doesn’t “have a huge advantage, I’d start off with a drug-coated balloon. You leave yourself every option going down the road if it fails. If you have a stent that fails, it’s harder to work with,” he said.
About two-thirds of the subjects were men, and the mean age was about 68 years. Most patients in both arms had marked improvements in symptoms and walking ability after stent placement. Rates of stent thrombosis were low, at about 2% with Eluvia versus 4% with Zilver PTX, a statistically nonsignificant difference.
The IMPERIAL results were published online simultaneously with Dr. Gray’s presentation (Lancet. 2018 Sep 22. doi: 10.1016/S0140-6736[18]32262-1).
The work was funded and conducted by Boston Scientific. Dr. Gray and Dr. Jaffe are advisors to the company. Most of the other investigators disclosed financial ties to company, and one was an employee. Dr. Cohen wasn’t involved in the work. The TCT meeting was sponsored by the Cardiovascular Research Foundation.
SAN DIEGO – In the first randomized, head-to-head trial of drug-releasing stents for above-the-knee femoropopliteal peripheral artery disease (PAD), Boston Scientific’s polymer-coated, paclitaxel-eluting stent outperformed Cook Medical’s polymer-free, paclitaxel-coated stent.
At 12 months, primary patency was 86.8% (231/266) in the Eluvia group, versus 81.5% (106/130) among those randomized to Zilver PTX. About 5% of Eluvia patients (14/273) and 9% of patients in the Zilver PTX arm (12/133) had a major adverse event, defined as death within a month or target limb amputation or revascularization through 12 months. Both outcomes were statistically significant at P less than .0001. Overall, 4.5% of Eluvia patients (13/287) required target lesion revascularization, compared with 9% of Zilver PTX patients (13/145).
“These data suggest the Boston Scientific product is superior. Unless there are big differences in cost or technical aspects of the procedure, I would foresee a fairly substantial shift to” Eluvia if it’s approved, which seems likely, said interventional cardiologist David Cohen, MD, of Saint Luke’s Mid America Heart Institute, Kansas City, Mo., who comoderated the study presentation at the Transcatheter Cardiovascular Therapeutics annual meeting.
There were six cases of aneurysmal degeneration with Eluvia, but none with Zilver PTX. All six patients were patent at 1 year, without revascularization or stent thrombosis. It’s too early to know what to make of the finding. The planned 5-year follow-up should shed some light on the issue, Dr. Gray said.
At present, there’s no clear algorithm for above-the-knee PAD. Balloons and stents – both drug-releasing and bare – are all in play, and new devices are on the way. “With a head-to-head trial like this, we are staring to pare down all the noise in the market place. I think for long complicated lesions, I would be very surprised if we don’t start seeing more drug-eluting stents, because the results are so good. Drug-coated balloons are useful, but they take a little bit longer and a little more nuance,” especially when stent are used to touch up the results, he said.
“If [Boston Scientific] prices this at a premium and my doctors come to me and say ‘You’ve got to let us buy this,’ it’s going to be a hard sell for me,” said Dr. Jaff, a professor of medicine at Harvard Medical School, Boston, and president of the nearby Newton-Wellesley Hospital in Newton, Mass.
As for shifting away from drug-coated balloons, which are an increasingly popular option, a head-to-head trial is in order. If it turns out Eluvia doesn’t “have a huge advantage, I’d start off with a drug-coated balloon. You leave yourself every option going down the road if it fails. If you have a stent that fails, it’s harder to work with,” he said.
About two-thirds of the subjects were men, and the mean age was about 68 years. Most patients in both arms had marked improvements in symptoms and walking ability after stent placement. Rates of stent thrombosis were low, at about 2% with Eluvia versus 4% with Zilver PTX, a statistically nonsignificant difference.
The IMPERIAL results were published online simultaneously with Dr. Gray’s presentation (Lancet. 2018 Sep 22. doi: 10.1016/S0140-6736[18]32262-1).
The work was funded and conducted by Boston Scientific. Dr. Gray and Dr. Jaffe are advisors to the company. Most of the other investigators disclosed financial ties to company, and one was an employee. Dr. Cohen wasn’t involved in the work. The TCT meeting was sponsored by the Cardiovascular Research Foundation.
REPORTING FROM TCT 2018
Key clinical point: A drug-eluting stent under development for peripheral artery disease outperformed the only one currently on the market in the United States.
Major finding: At 12 months, primary patency was 86.8% in the Eluvia group versus 81.5% among those randomized to Zilver PTX.
Study details: IMPERIAL was a head-to-head randomized trial with 465 subjects comparing two stents for femoropopliteal PAD.
Disclosures: The work was funded and conducted by Boston Scientific. Most of the investigators disclosed financial ties to company; one was an employee.
DIVA results similar for drug-eluting, bare-metal stents
Drug-eluting stents (DESs) and less-expensive bare-metal stents (BMSs) performed equally well in patients with failed saphenous vein grafts after coronary artery bypass graft surgery, based on an analysis of patients in the DIVA trial.
The findings run counter to those of previous clinical trials, which had found drug-eluting stents perform better than bare-metal stents in these situations. “The study results have important economic implications in countries with high DES prices, such as the USA, because they suggest that the lower-cost BMS can be used in SVG [saphenous vein graft] lesions without compromising either safety or efficacy,” lead author Emmanouil S. Brilakis, MD, PhD, of Minneapolis Heart Institute and his coauthors said in reporting the results for the DIVA trial investigators in the Lancet.
The DIVA trial was a randomized, double-blind, controlled trial done at 25 U.S. Department of Veterans Affairs centers. Researchers randomly assigned 599 patients who had previous coronary artery bypass surgery to either the DES or BMS groups, and the study reported data from 597 patients. The combined endpoint comprised cardiac death, target vessel MI, or target vessel revascularization at 12 months and then over the entire length of follow-up, which ranged from 2 to 7 years. Operators used the DES or BMS of their choice.
While BMSs are presumed to be less expensive than DESs, the study authors did not provide prices or price ranges for the stents. Dr. Brilakis and his coauthors acknowledged that the financial implications depend on local stent pricing practices.
The cost-effectiveness of using DESs vs. BMSs has been controversial, with many studies reporting that BMS are cost-effective over the long-term because of the lower incidence of revascularization and later hospitalization. These studies did not differentiate between SVG and native vessels, however. Multiple studies have reported that the overall costs, including the cost for reintervention, are lower for DESs than for BMSs in native vessels. A Wake Forest study reported the average per procedure cost was $1,846 higher for a DES but the cost was offset after 3 years by lower revascularization rates (Circ Cardiovasc Qual Outcomes. 2011. doi: 10.1161/CIRCOUTCOMES.110.960187)
A recent Korean study found the total cost of DESs was about 5% higher (Yonsei Med J. 2014 Nov;55[6]:1533-41). A French study reported BMSs resulted in a cost reduction $217 per case (Open Heart. 2016 Aug 25;3[2]:e000445). But few, if any, studies have directly compared prices hospitals pay for DESs and BMSs.
Pricing aside, Dr. Brilakis and his coauthors reported no statistical differences in terms of outcomes between the DES and BMS groups. Baseline characteristics of both groups were similar, and the vessel failure rates were 17% in the DES group and 19% in the BMS group after 12 months of follow-up. After 2-7 years, “target vessel failure occurred in approximately one in three patients, with no difference between the bare-metal and drug-eluting stents,” Dr. Brilakis and his coauthors said.
There was no significant difference in cardiac death rates – 5% for DES patients and 4% for BMS patients – or in rates of target lesion revascularization, at 9% and 8%, respectively. Postprocedure medication rates were also similar between the two groups. For example, the rates of patients on P2Y12 inhibitors were 89% for both groups at 12 months and, among those who had follow-up at 36 months, 48% for DES and 44% for BMS.
Among the limitations of the study that Dr. Brilakis and his coauthors noted was the high proportion of men in the VA population – only two women, both in the DES group, participated in the study – and the interventionists doing the index SVG intervention were not masked to the type of stent used.
Dr. Brilakis disclosed relationships with Abbott Vascular, Amgen, Asahi, Boston Scientific, Cardinal Health, CSI, Elsevier, GE Healthcare, Medicure, Medtronic, Nitiloop, InfraRedx, and Osprey.
SOURCE: Brilakis ES et al. Lancet. 2018 May 19;391(10134);1997-2007.
The predominant use of second-generation drug-eluting stents in the DIVA study may explain why the researchers found no difference in outcomes for bare metal and drug-eluting stents.
Most patients in previous trials were treated with first-generation drug-eluting stents, but second-generation drug-eluting stents perform better than their first-generation counterparts in native coronary artery disease. One might think that this finding should also apply to saphenous vein bypass graft lesions in which atherosclerosis is more aggressive and the progress of the disease much faster, yet this was not the case in DIVA, and the study authors did not provide an explanation for this finding.
One possible reason for the comparability of outcomes in the drug-eluting stents and bare metal stents groups may be that saphenous vein bypass graft lesions may be more favorably disposed to paclitaxel, commonly used in first-generation drug-eluting stents, than the drugs found in the second-generation stents. The DIVA findings may indicate that the second-generation drug-eluting stents performed worse, not that the bare metal stents performed better.
Studies of only first-generation paclitaxel-eluting stents showed a sustained benefit. Any notion that the pathophysiology of saphenous vein grafts might make them more amenable to a bare metal stent while a drug-eluting stent is better suited for native vessels is purely speculative. Further research comparing the effect of different stent types in saphenous vein bypass graft failure is warranted.
Raban V. Jeger, MD, and Sven Möbius-Winkler, MD, made these remarks in an invited commentary. Dr. Jeger is with the University Hospital Basel (Switzerland), and Dr. Möbius-Winkler is with University Hospital Jena (Germany). Dr. Jeger disclosed he is the principal investigator of the BASKET-SAVAGE trial, which received funding from Boston Scientific Germany. Dr. Möbius-Winkler had no financial relationships to disclose.
The predominant use of second-generation drug-eluting stents in the DIVA study may explain why the researchers found no difference in outcomes for bare metal and drug-eluting stents.
Most patients in previous trials were treated with first-generation drug-eluting stents, but second-generation drug-eluting stents perform better than their first-generation counterparts in native coronary artery disease. One might think that this finding should also apply to saphenous vein bypass graft lesions in which atherosclerosis is more aggressive and the progress of the disease much faster, yet this was not the case in DIVA, and the study authors did not provide an explanation for this finding.
One possible reason for the comparability of outcomes in the drug-eluting stents and bare metal stents groups may be that saphenous vein bypass graft lesions may be more favorably disposed to paclitaxel, commonly used in first-generation drug-eluting stents, than the drugs found in the second-generation stents. The DIVA findings may indicate that the second-generation drug-eluting stents performed worse, not that the bare metal stents performed better.
Studies of only first-generation paclitaxel-eluting stents showed a sustained benefit. Any notion that the pathophysiology of saphenous vein grafts might make them more amenable to a bare metal stent while a drug-eluting stent is better suited for native vessels is purely speculative. Further research comparing the effect of different stent types in saphenous vein bypass graft failure is warranted.
Raban V. Jeger, MD, and Sven Möbius-Winkler, MD, made these remarks in an invited commentary. Dr. Jeger is with the University Hospital Basel (Switzerland), and Dr. Möbius-Winkler is with University Hospital Jena (Germany). Dr. Jeger disclosed he is the principal investigator of the BASKET-SAVAGE trial, which received funding from Boston Scientific Germany. Dr. Möbius-Winkler had no financial relationships to disclose.
The predominant use of second-generation drug-eluting stents in the DIVA study may explain why the researchers found no difference in outcomes for bare metal and drug-eluting stents.
Most patients in previous trials were treated with first-generation drug-eluting stents, but second-generation drug-eluting stents perform better than their first-generation counterparts in native coronary artery disease. One might think that this finding should also apply to saphenous vein bypass graft lesions in which atherosclerosis is more aggressive and the progress of the disease much faster, yet this was not the case in DIVA, and the study authors did not provide an explanation for this finding.
One possible reason for the comparability of outcomes in the drug-eluting stents and bare metal stents groups may be that saphenous vein bypass graft lesions may be more favorably disposed to paclitaxel, commonly used in first-generation drug-eluting stents, than the drugs found in the second-generation stents. The DIVA findings may indicate that the second-generation drug-eluting stents performed worse, not that the bare metal stents performed better.
Studies of only first-generation paclitaxel-eluting stents showed a sustained benefit. Any notion that the pathophysiology of saphenous vein grafts might make them more amenable to a bare metal stent while a drug-eluting stent is better suited for native vessels is purely speculative. Further research comparing the effect of different stent types in saphenous vein bypass graft failure is warranted.
Raban V. Jeger, MD, and Sven Möbius-Winkler, MD, made these remarks in an invited commentary. Dr. Jeger is with the University Hospital Basel (Switzerland), and Dr. Möbius-Winkler is with University Hospital Jena (Germany). Dr. Jeger disclosed he is the principal investigator of the BASKET-SAVAGE trial, which received funding from Boston Scientific Germany. Dr. Möbius-Winkler had no financial relationships to disclose.
Drug-eluting stents (DESs) and less-expensive bare-metal stents (BMSs) performed equally well in patients with failed saphenous vein grafts after coronary artery bypass graft surgery, based on an analysis of patients in the DIVA trial.
The findings run counter to those of previous clinical trials, which had found drug-eluting stents perform better than bare-metal stents in these situations. “The study results have important economic implications in countries with high DES prices, such as the USA, because they suggest that the lower-cost BMS can be used in SVG [saphenous vein graft] lesions without compromising either safety or efficacy,” lead author Emmanouil S. Brilakis, MD, PhD, of Minneapolis Heart Institute and his coauthors said in reporting the results for the DIVA trial investigators in the Lancet.
The DIVA trial was a randomized, double-blind, controlled trial done at 25 U.S. Department of Veterans Affairs centers. Researchers randomly assigned 599 patients who had previous coronary artery bypass surgery to either the DES or BMS groups, and the study reported data from 597 patients. The combined endpoint comprised cardiac death, target vessel MI, or target vessel revascularization at 12 months and then over the entire length of follow-up, which ranged from 2 to 7 years. Operators used the DES or BMS of their choice.
While BMSs are presumed to be less expensive than DESs, the study authors did not provide prices or price ranges for the stents. Dr. Brilakis and his coauthors acknowledged that the financial implications depend on local stent pricing practices.
The cost-effectiveness of using DESs vs. BMSs has been controversial, with many studies reporting that BMS are cost-effective over the long-term because of the lower incidence of revascularization and later hospitalization. These studies did not differentiate between SVG and native vessels, however. Multiple studies have reported that the overall costs, including the cost for reintervention, are lower for DESs than for BMSs in native vessels. A Wake Forest study reported the average per procedure cost was $1,846 higher for a DES but the cost was offset after 3 years by lower revascularization rates (Circ Cardiovasc Qual Outcomes. 2011. doi: 10.1161/CIRCOUTCOMES.110.960187)
A recent Korean study found the total cost of DESs was about 5% higher (Yonsei Med J. 2014 Nov;55[6]:1533-41). A French study reported BMSs resulted in a cost reduction $217 per case (Open Heart. 2016 Aug 25;3[2]:e000445). But few, if any, studies have directly compared prices hospitals pay for DESs and BMSs.
Pricing aside, Dr. Brilakis and his coauthors reported no statistical differences in terms of outcomes between the DES and BMS groups. Baseline characteristics of both groups were similar, and the vessel failure rates were 17% in the DES group and 19% in the BMS group after 12 months of follow-up. After 2-7 years, “target vessel failure occurred in approximately one in three patients, with no difference between the bare-metal and drug-eluting stents,” Dr. Brilakis and his coauthors said.
There was no significant difference in cardiac death rates – 5% for DES patients and 4% for BMS patients – or in rates of target lesion revascularization, at 9% and 8%, respectively. Postprocedure medication rates were also similar between the two groups. For example, the rates of patients on P2Y12 inhibitors were 89% for both groups at 12 months and, among those who had follow-up at 36 months, 48% for DES and 44% for BMS.
Among the limitations of the study that Dr. Brilakis and his coauthors noted was the high proportion of men in the VA population – only two women, both in the DES group, participated in the study – and the interventionists doing the index SVG intervention were not masked to the type of stent used.
Dr. Brilakis disclosed relationships with Abbott Vascular, Amgen, Asahi, Boston Scientific, Cardinal Health, CSI, Elsevier, GE Healthcare, Medicure, Medtronic, Nitiloop, InfraRedx, and Osprey.
SOURCE: Brilakis ES et al. Lancet. 2018 May 19;391(10134);1997-2007.
Drug-eluting stents (DESs) and less-expensive bare-metal stents (BMSs) performed equally well in patients with failed saphenous vein grafts after coronary artery bypass graft surgery, based on an analysis of patients in the DIVA trial.
The findings run counter to those of previous clinical trials, which had found drug-eluting stents perform better than bare-metal stents in these situations. “The study results have important economic implications in countries with high DES prices, such as the USA, because they suggest that the lower-cost BMS can be used in SVG [saphenous vein graft] lesions without compromising either safety or efficacy,” lead author Emmanouil S. Brilakis, MD, PhD, of Minneapolis Heart Institute and his coauthors said in reporting the results for the DIVA trial investigators in the Lancet.
The DIVA trial was a randomized, double-blind, controlled trial done at 25 U.S. Department of Veterans Affairs centers. Researchers randomly assigned 599 patients who had previous coronary artery bypass surgery to either the DES or BMS groups, and the study reported data from 597 patients. The combined endpoint comprised cardiac death, target vessel MI, or target vessel revascularization at 12 months and then over the entire length of follow-up, which ranged from 2 to 7 years. Operators used the DES or BMS of their choice.
While BMSs are presumed to be less expensive than DESs, the study authors did not provide prices or price ranges for the stents. Dr. Brilakis and his coauthors acknowledged that the financial implications depend on local stent pricing practices.
The cost-effectiveness of using DESs vs. BMSs has been controversial, with many studies reporting that BMS are cost-effective over the long-term because of the lower incidence of revascularization and later hospitalization. These studies did not differentiate between SVG and native vessels, however. Multiple studies have reported that the overall costs, including the cost for reintervention, are lower for DESs than for BMSs in native vessels. A Wake Forest study reported the average per procedure cost was $1,846 higher for a DES but the cost was offset after 3 years by lower revascularization rates (Circ Cardiovasc Qual Outcomes. 2011. doi: 10.1161/CIRCOUTCOMES.110.960187)
A recent Korean study found the total cost of DESs was about 5% higher (Yonsei Med J. 2014 Nov;55[6]:1533-41). A French study reported BMSs resulted in a cost reduction $217 per case (Open Heart. 2016 Aug 25;3[2]:e000445). But few, if any, studies have directly compared prices hospitals pay for DESs and BMSs.
Pricing aside, Dr. Brilakis and his coauthors reported no statistical differences in terms of outcomes between the DES and BMS groups. Baseline characteristics of both groups were similar, and the vessel failure rates were 17% in the DES group and 19% in the BMS group after 12 months of follow-up. After 2-7 years, “target vessel failure occurred in approximately one in three patients, with no difference between the bare-metal and drug-eluting stents,” Dr. Brilakis and his coauthors said.
There was no significant difference in cardiac death rates – 5% for DES patients and 4% for BMS patients – or in rates of target lesion revascularization, at 9% and 8%, respectively. Postprocedure medication rates were also similar between the two groups. For example, the rates of patients on P2Y12 inhibitors were 89% for both groups at 12 months and, among those who had follow-up at 36 months, 48% for DES and 44% for BMS.
Among the limitations of the study that Dr. Brilakis and his coauthors noted was the high proportion of men in the VA population – only two women, both in the DES group, participated in the study – and the interventionists doing the index SVG intervention were not masked to the type of stent used.
Dr. Brilakis disclosed relationships with Abbott Vascular, Amgen, Asahi, Boston Scientific, Cardinal Health, CSI, Elsevier, GE Healthcare, Medicure, Medtronic, Nitiloop, InfraRedx, and Osprey.
SOURCE: Brilakis ES et al. Lancet. 2018 May 19;391(10134);1997-2007.
FROM THE LANCET
Key clinical point: Drug-eluting and bare-metal stents had similar outcomes for saphenous vein bypass lesions.
Major finding: Target vessel failure was 17% for drug-eluting stents and 19% for bare metal stents.
Study details: The DIVA trial randomly assigned 599 patients with post-CABG saphenous vein bypass graft failure to drug-eluting or bare metal stents between Jan. 1, 2012, and Dec. 31, 2015.
Disclosures: Dr. Brilakis disclosed relationships with Abbott Vascular, Amgen, Asahi, Boston Scientific, Cardinal Health, CSI, Elsevier, GE Healthcare, Medicure, Medtronic, Nitiloop, InfraRedx, and Osprey.
Source: Brilakis ES et al. Lancet. 2018 May 19;391(10134);1997-2007.
Connecting at TCT 2018
The 30th anniversary of the Transcatheter Cardiovascular Therapeutics meeting in San Diego, sponsored by the Cardiovascular Research Foundation, will be the temporary home of more than 10,000 attendees. That’s up from about 9,400 last year.
Even so, that leaves a lot of folks who can’t be in sunny California. Keep in touch with friends near and far by using social media. Twitter hashtags for the meeting are #TCT2018 and #TCTConference.
The organizers encourage attendees to share their experiences and the educational content from the meeting, keeping in mind embargoes and some limitations, by posting photos, slides, or short video clips. Also, presentation slides will be online immediately after the sessions.
Attendees also can connect with each other using the the CRF Events app, available for free download here. But we recommend that meet outside if you can, considering the weather report.
The 30th anniversary of the Transcatheter Cardiovascular Therapeutics meeting in San Diego, sponsored by the Cardiovascular Research Foundation, will be the temporary home of more than 10,000 attendees. That’s up from about 9,400 last year.
Even so, that leaves a lot of folks who can’t be in sunny California. Keep in touch with friends near and far by using social media. Twitter hashtags for the meeting are #TCT2018 and #TCTConference.
The organizers encourage attendees to share their experiences and the educational content from the meeting, keeping in mind embargoes and some limitations, by posting photos, slides, or short video clips. Also, presentation slides will be online immediately after the sessions.
Attendees also can connect with each other using the the CRF Events app, available for free download here. But we recommend that meet outside if you can, considering the weather report.
The 30th anniversary of the Transcatheter Cardiovascular Therapeutics meeting in San Diego, sponsored by the Cardiovascular Research Foundation, will be the temporary home of more than 10,000 attendees. That’s up from about 9,400 last year.
Even so, that leaves a lot of folks who can’t be in sunny California. Keep in touch with friends near and far by using social media. Twitter hashtags for the meeting are #TCT2018 and #TCTConference.
The organizers encourage attendees to share their experiences and the educational content from the meeting, keeping in mind embargoes and some limitations, by posting photos, slides, or short video clips. Also, presentation slides will be online immediately after the sessions.
Attendees also can connect with each other using the the CRF Events app, available for free download here. But we recommend that meet outside if you can, considering the weather report.
TCT presents new, ‘massive’ integrated, hands-on learning center
pavilions devoted to specific fields.
This major innovation brings TCT back to basics, Juan F. Granada, MD, president and CEO of the Cardiovascular Research Foundation and codirector of Transcatheter Cardiovascular Therapeutics, said in an interview.
Dr. Granada was closely involved with the program and said it’s been in the works for a couple of years. The emphasis of these workshops is to teach physicians an understanding of anatomy. TCT is devoting a massive amount of space to this effort, about 60% of the exhibit hall. The eight pavilions are dedicated to training tracks, and every single tool available to interventional cardiologists will be there, he said.
If you preregistered before all 4,000 spots filled up some days ago, consider yourself lucky. But be assured that the TCT organizers are tracking the registrations, even those submitted after the limit was reached, to help them plan for next year’s meeting in San Francisco.
The workshops will run over 3 days, from Saturday through Monday, Sept. 22-24.
pavilions devoted to specific fields.
This major innovation brings TCT back to basics, Juan F. Granada, MD, president and CEO of the Cardiovascular Research Foundation and codirector of Transcatheter Cardiovascular Therapeutics, said in an interview.
Dr. Granada was closely involved with the program and said it’s been in the works for a couple of years. The emphasis of these workshops is to teach physicians an understanding of anatomy. TCT is devoting a massive amount of space to this effort, about 60% of the exhibit hall. The eight pavilions are dedicated to training tracks, and every single tool available to interventional cardiologists will be there, he said.
If you preregistered before all 4,000 spots filled up some days ago, consider yourself lucky. But be assured that the TCT organizers are tracking the registrations, even those submitted after the limit was reached, to help them plan for next year’s meeting in San Francisco.
The workshops will run over 3 days, from Saturday through Monday, Sept. 22-24.
pavilions devoted to specific fields.
This major innovation brings TCT back to basics, Juan F. Granada, MD, president and CEO of the Cardiovascular Research Foundation and codirector of Transcatheter Cardiovascular Therapeutics, said in an interview.
Dr. Granada was closely involved with the program and said it’s been in the works for a couple of years. The emphasis of these workshops is to teach physicians an understanding of anatomy. TCT is devoting a massive amount of space to this effort, about 60% of the exhibit hall. The eight pavilions are dedicated to training tracks, and every single tool available to interventional cardiologists will be there, he said.
If you preregistered before all 4,000 spots filled up some days ago, consider yourself lucky. But be assured that the TCT organizers are tracking the registrations, even those submitted after the limit was reached, to help them plan for next year’s meeting in San Francisco.
The workshops will run over 3 days, from Saturday through Monday, Sept. 22-24.
Top research at TCT 2018
The research area that rose to the top in terms of importance to practice at the upcoming Transcatheter Cardiovascular Therapeutics meeting in San Diego is in mitral valve interventions, but there’s much more potentially practice-changing original reporting as well.
Of the 155 abstracts considered for Late-Breaking Trials, only 10% were selected. That’s in addition to the other 1,650 abstracts submitted for the meeting.
The research chosen for the Late-Breaking Trial and Late-Breaking Research sessions held on Saturday, Sept. 22, through Tuesday, Sept. 25, fall into four categories, Juan F. Granada, MD, president and CEO of the Cardiovascular Research Foundation and codirector of Transcatheter Cardiovascular Therapeutics, said in an interview.
The first and most important category is mitral intervention, he said, and the studies with the most potential to change U.S. practice will be presented on Sunday morning at 10:15-11:15 in the Late-Breaking Trial session. The session kicks off with COAPT, the long-anticipated trial that randomized patients with severe mitral regurgitation secondary to heart failure to the MitraClip or to optimal medical management. The MitraClip, which doesn’t entail a concomitant annuloplasty, currently is approved by the Food and Drug Administration for patients with primary, degenerative mitral regurgitation not amenable to surgical repair only. But, if COAPT yields positive results, the role of the MitraClip may expand greatly.
Also presented in that Sunday session will be results of REDUCE-FMR, a sham-controlled trial in patients with heart failure–associated functional mitral regurgitation who received either treatment with the CARILLON Mitral Contour System, which is an indirect annuloplasty device, or optimal medical treatment.
Secondly, “we’ve got a lot to learn from two trials in the Absorb bioresorbable scaffold,” Dr. Granada said. Although the device failed commercially on the heels of news of target vessel failure and scaffold thrombosis, detailed results of ABSORB IV and COMPARE ABSORB will inform future designs, he said.The third area Dr. Granada emphasized was direct comparisons of stents. Saturday’s Late-Breaking Trials sessions offer results of several head-to-head trials. BIONYX compared the bioresorbable polymer Orsiro stent with the newer durable polymer Resolute Onyx. TALENT, unusual in its all-comers design, compared clinical outcomes at 12 months between the Supraflex ultrathin coronary stent and Xience everolimus eluting system. Whether strut thickness can make a difference in outcomes will be of great interest as the results of these and other trials are presented at the meeting.
Lastly, an endovascular trial comparing two stents in long lesion, IMPERIAL, will be of interest. It randomized patients with chronic, symptomatic superficial femoral or proximal popliteal artery lesions to treatment with either the Eluvia vascular stent or the Zilver PTX, the first drug-eluting stent approved for use in these patients.
Remember, there also are oral abstract and moderated poster sessions happening throughout the meeting, so there’s something for everyone.
The research area that rose to the top in terms of importance to practice at the upcoming Transcatheter Cardiovascular Therapeutics meeting in San Diego is in mitral valve interventions, but there’s much more potentially practice-changing original reporting as well.
Of the 155 abstracts considered for Late-Breaking Trials, only 10% were selected. That’s in addition to the other 1,650 abstracts submitted for the meeting.
The research chosen for the Late-Breaking Trial and Late-Breaking Research sessions held on Saturday, Sept. 22, through Tuesday, Sept. 25, fall into four categories, Juan F. Granada, MD, president and CEO of the Cardiovascular Research Foundation and codirector of Transcatheter Cardiovascular Therapeutics, said in an interview.
The first and most important category is mitral intervention, he said, and the studies with the most potential to change U.S. practice will be presented on Sunday morning at 10:15-11:15 in the Late-Breaking Trial session. The session kicks off with COAPT, the long-anticipated trial that randomized patients with severe mitral regurgitation secondary to heart failure to the MitraClip or to optimal medical management. The MitraClip, which doesn’t entail a concomitant annuloplasty, currently is approved by the Food and Drug Administration for patients with primary, degenerative mitral regurgitation not amenable to surgical repair only. But, if COAPT yields positive results, the role of the MitraClip may expand greatly.
Also presented in that Sunday session will be results of REDUCE-FMR, a sham-controlled trial in patients with heart failure–associated functional mitral regurgitation who received either treatment with the CARILLON Mitral Contour System, which is an indirect annuloplasty device, or optimal medical treatment.
Secondly, “we’ve got a lot to learn from two trials in the Absorb bioresorbable scaffold,” Dr. Granada said. Although the device failed commercially on the heels of news of target vessel failure and scaffold thrombosis, detailed results of ABSORB IV and COMPARE ABSORB will inform future designs, he said.The third area Dr. Granada emphasized was direct comparisons of stents. Saturday’s Late-Breaking Trials sessions offer results of several head-to-head trials. BIONYX compared the bioresorbable polymer Orsiro stent with the newer durable polymer Resolute Onyx. TALENT, unusual in its all-comers design, compared clinical outcomes at 12 months between the Supraflex ultrathin coronary stent and Xience everolimus eluting system. Whether strut thickness can make a difference in outcomes will be of great interest as the results of these and other trials are presented at the meeting.
Lastly, an endovascular trial comparing two stents in long lesion, IMPERIAL, will be of interest. It randomized patients with chronic, symptomatic superficial femoral or proximal popliteal artery lesions to treatment with either the Eluvia vascular stent or the Zilver PTX, the first drug-eluting stent approved for use in these patients.
Remember, there also are oral abstract and moderated poster sessions happening throughout the meeting, so there’s something for everyone.
The research area that rose to the top in terms of importance to practice at the upcoming Transcatheter Cardiovascular Therapeutics meeting in San Diego is in mitral valve interventions, but there’s much more potentially practice-changing original reporting as well.
Of the 155 abstracts considered for Late-Breaking Trials, only 10% were selected. That’s in addition to the other 1,650 abstracts submitted for the meeting.
The research chosen for the Late-Breaking Trial and Late-Breaking Research sessions held on Saturday, Sept. 22, through Tuesday, Sept. 25, fall into four categories, Juan F. Granada, MD, president and CEO of the Cardiovascular Research Foundation and codirector of Transcatheter Cardiovascular Therapeutics, said in an interview.
The first and most important category is mitral intervention, he said, and the studies with the most potential to change U.S. practice will be presented on Sunday morning at 10:15-11:15 in the Late-Breaking Trial session. The session kicks off with COAPT, the long-anticipated trial that randomized patients with severe mitral regurgitation secondary to heart failure to the MitraClip or to optimal medical management. The MitraClip, which doesn’t entail a concomitant annuloplasty, currently is approved by the Food and Drug Administration for patients with primary, degenerative mitral regurgitation not amenable to surgical repair only. But, if COAPT yields positive results, the role of the MitraClip may expand greatly.
Also presented in that Sunday session will be results of REDUCE-FMR, a sham-controlled trial in patients with heart failure–associated functional mitral regurgitation who received either treatment with the CARILLON Mitral Contour System, which is an indirect annuloplasty device, or optimal medical treatment.
Secondly, “we’ve got a lot to learn from two trials in the Absorb bioresorbable scaffold,” Dr. Granada said. Although the device failed commercially on the heels of news of target vessel failure and scaffold thrombosis, detailed results of ABSORB IV and COMPARE ABSORB will inform future designs, he said.The third area Dr. Granada emphasized was direct comparisons of stents. Saturday’s Late-Breaking Trials sessions offer results of several head-to-head trials. BIONYX compared the bioresorbable polymer Orsiro stent with the newer durable polymer Resolute Onyx. TALENT, unusual in its all-comers design, compared clinical outcomes at 12 months between the Supraflex ultrathin coronary stent and Xience everolimus eluting system. Whether strut thickness can make a difference in outcomes will be of great interest as the results of these and other trials are presented at the meeting.
Lastly, an endovascular trial comparing two stents in long lesion, IMPERIAL, will be of interest. It randomized patients with chronic, symptomatic superficial femoral or proximal popliteal artery lesions to treatment with either the Eluvia vascular stent or the Zilver PTX, the first drug-eluting stent approved for use in these patients.
Remember, there also are oral abstract and moderated poster sessions happening throughout the meeting, so there’s something for everyone.