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ACURATE neo falls short against SAPIEN 3 for severe aortic stenosis
SAN FRANCISCO – The ACURATE neo transcatheter aortic valve replacement (TAVR) device failed to meet noninferiority, compared with the SAPIEN 3 device, in terms of the primary composite safety and efficacy endpoint at 30 days, a randomized, comparative trial showed.
“TAVR has become an indispensable treatment option for patients with symptomatic severe aortic stenosis across all risk categories,” Jonas Lanz, MD, MSc, said at the Transcatheter Cardiovascular Therapeutics annual meeting. “The generalizability of outcomes observed in landmark trials comparing TAVR with SAVR [surgical aortic valve replacement] to other commercial TAVR systems is limited by differences in device properties and lack of head-to-head device comparisons. Iterations of the SAPIEN balloon-expandable TAVR system have been extensively investigated in several large-scale, high-quality, randomized trials and registries setting the current benchmark in terms of safety and efficacy.”
The ACURATE neo is a novel self-expanding TAVR system associated with favorable outcomes in nonrandomized studies. It has been available in Europe since 2014 but has not gained Food and Drug Administration approval.
Between February 2017 and February 2019, in a randomized trial known as SCOPE I, Dr. Lanz and colleagues at 20 European sites enrolled 739 patients with severe, symptomatic aortic stenosis at increased surgical risk. Of these, 372 were assigned to transfemoral TAVR with the ACURATE neo and 367 were assigned to the SAPIEN 3 system. The researchers designed the study to investigate noninferiority of the primary endpoint, which was a composite of safety and efficacy derived from the Valve Academic Research Consortium–2 criteria and included all-cause death, any stroke, life-threatening or disabling bleeding, major vascular complications, coronary artery obstruction requiring intervention, acute kidney injury stage 2 or higher, valve-related dysfunction requiring repeat procedure, rehospitalization for valve-related symptoms or heart failure, moderate or severe prosthetic valve regurgitation, or prosthetic valve stenosis at 30 days.
Clinical follow-up information at 30 days was available for 99% and ECG follow-up for about 98% of the total study population. The mean age of the study participants was 82 years, 57% were female, their median STS Risk Score was 3.5, and their mean transvalvular aortic gradient was 42.2 mm Hg. Dr. Lanz, with the department of cardiology at Bern (Switzerland) University Hospital, reported that the primary endpoint rate in the intention-to-treat cohort for ACURATE neo was 23.7%, compared with 16.5% with SAPIEN 3, falling short of the threshold for noninferiority (P for noninferiority = 0.42).
“I think this speaks to the fact of how high the bar is right now – how good the procedure is [and] how good the devices are,” invited discussant Michael J. Mack, MD, a cardiac surgeon at Baylor Scott & White Health, Dallas, said during the media briefing. “It’s an incredibly high bar to meet for any new device.”
Certain single components of the primary endpoint were similar in the ACURATE neo group, compared with the SAPIEN 3 group, including all-cause death (2.5% vs. 0.8%, respectively) and stroke (1.9% vs. 3%), but acute kidney injury was more common in the ACURATE neo group (3% vs. 0.8%, as was paravalvular aortic regurgitation (9.4% vs. 2.8%). “The differences between the two TAVR devices were mainly driven by moderate or severe paravalvular regurgitation and stage 2 or 3 acute kidney injury in favor of the SAPIEN 3 device,” Dr. Lanz said at the meeting sponsored by the Cardiovascular Research Foundation. “An early composite safety and efficacy endpoint proved useful in discriminating the performance of different TAVR systems.”
He pointed out that a trial called SCOPE II is underway in Europe, with a new iteration of the ACURATE neo designed to reduce the risk of paravalvular leak.
The results of SCOPE I were published online at the time of presentation (Lancet. 2019 Sep 27. doi: 10.1016/S0140-6736[19]32220-2). SCOPE I was an investigator-initiated and -conducted study funded by a dedicated research grant from Symetis in Ecublens, Switzerland (part of Boston Scientific). Dr. Lanz had no relevant disclosures.
SAN FRANCISCO – The ACURATE neo transcatheter aortic valve replacement (TAVR) device failed to meet noninferiority, compared with the SAPIEN 3 device, in terms of the primary composite safety and efficacy endpoint at 30 days, a randomized, comparative trial showed.
“TAVR has become an indispensable treatment option for patients with symptomatic severe aortic stenosis across all risk categories,” Jonas Lanz, MD, MSc, said at the Transcatheter Cardiovascular Therapeutics annual meeting. “The generalizability of outcomes observed in landmark trials comparing TAVR with SAVR [surgical aortic valve replacement] to other commercial TAVR systems is limited by differences in device properties and lack of head-to-head device comparisons. Iterations of the SAPIEN balloon-expandable TAVR system have been extensively investigated in several large-scale, high-quality, randomized trials and registries setting the current benchmark in terms of safety and efficacy.”
The ACURATE neo is a novel self-expanding TAVR system associated with favorable outcomes in nonrandomized studies. It has been available in Europe since 2014 but has not gained Food and Drug Administration approval.
Between February 2017 and February 2019, in a randomized trial known as SCOPE I, Dr. Lanz and colleagues at 20 European sites enrolled 739 patients with severe, symptomatic aortic stenosis at increased surgical risk. Of these, 372 were assigned to transfemoral TAVR with the ACURATE neo and 367 were assigned to the SAPIEN 3 system. The researchers designed the study to investigate noninferiority of the primary endpoint, which was a composite of safety and efficacy derived from the Valve Academic Research Consortium–2 criteria and included all-cause death, any stroke, life-threatening or disabling bleeding, major vascular complications, coronary artery obstruction requiring intervention, acute kidney injury stage 2 or higher, valve-related dysfunction requiring repeat procedure, rehospitalization for valve-related symptoms or heart failure, moderate or severe prosthetic valve regurgitation, or prosthetic valve stenosis at 30 days.
Clinical follow-up information at 30 days was available for 99% and ECG follow-up for about 98% of the total study population. The mean age of the study participants was 82 years, 57% were female, their median STS Risk Score was 3.5, and their mean transvalvular aortic gradient was 42.2 mm Hg. Dr. Lanz, with the department of cardiology at Bern (Switzerland) University Hospital, reported that the primary endpoint rate in the intention-to-treat cohort for ACURATE neo was 23.7%, compared with 16.5% with SAPIEN 3, falling short of the threshold for noninferiority (P for noninferiority = 0.42).
“I think this speaks to the fact of how high the bar is right now – how good the procedure is [and] how good the devices are,” invited discussant Michael J. Mack, MD, a cardiac surgeon at Baylor Scott & White Health, Dallas, said during the media briefing. “It’s an incredibly high bar to meet for any new device.”
Certain single components of the primary endpoint were similar in the ACURATE neo group, compared with the SAPIEN 3 group, including all-cause death (2.5% vs. 0.8%, respectively) and stroke (1.9% vs. 3%), but acute kidney injury was more common in the ACURATE neo group (3% vs. 0.8%, as was paravalvular aortic regurgitation (9.4% vs. 2.8%). “The differences between the two TAVR devices were mainly driven by moderate or severe paravalvular regurgitation and stage 2 or 3 acute kidney injury in favor of the SAPIEN 3 device,” Dr. Lanz said at the meeting sponsored by the Cardiovascular Research Foundation. “An early composite safety and efficacy endpoint proved useful in discriminating the performance of different TAVR systems.”
He pointed out that a trial called SCOPE II is underway in Europe, with a new iteration of the ACURATE neo designed to reduce the risk of paravalvular leak.
The results of SCOPE I were published online at the time of presentation (Lancet. 2019 Sep 27. doi: 10.1016/S0140-6736[19]32220-2). SCOPE I was an investigator-initiated and -conducted study funded by a dedicated research grant from Symetis in Ecublens, Switzerland (part of Boston Scientific). Dr. Lanz had no relevant disclosures.
SAN FRANCISCO – The ACURATE neo transcatheter aortic valve replacement (TAVR) device failed to meet noninferiority, compared with the SAPIEN 3 device, in terms of the primary composite safety and efficacy endpoint at 30 days, a randomized, comparative trial showed.
“TAVR has become an indispensable treatment option for patients with symptomatic severe aortic stenosis across all risk categories,” Jonas Lanz, MD, MSc, said at the Transcatheter Cardiovascular Therapeutics annual meeting. “The generalizability of outcomes observed in landmark trials comparing TAVR with SAVR [surgical aortic valve replacement] to other commercial TAVR systems is limited by differences in device properties and lack of head-to-head device comparisons. Iterations of the SAPIEN balloon-expandable TAVR system have been extensively investigated in several large-scale, high-quality, randomized trials and registries setting the current benchmark in terms of safety and efficacy.”
The ACURATE neo is a novel self-expanding TAVR system associated with favorable outcomes in nonrandomized studies. It has been available in Europe since 2014 but has not gained Food and Drug Administration approval.
Between February 2017 and February 2019, in a randomized trial known as SCOPE I, Dr. Lanz and colleagues at 20 European sites enrolled 739 patients with severe, symptomatic aortic stenosis at increased surgical risk. Of these, 372 were assigned to transfemoral TAVR with the ACURATE neo and 367 were assigned to the SAPIEN 3 system. The researchers designed the study to investigate noninferiority of the primary endpoint, which was a composite of safety and efficacy derived from the Valve Academic Research Consortium–2 criteria and included all-cause death, any stroke, life-threatening or disabling bleeding, major vascular complications, coronary artery obstruction requiring intervention, acute kidney injury stage 2 or higher, valve-related dysfunction requiring repeat procedure, rehospitalization for valve-related symptoms or heart failure, moderate or severe prosthetic valve regurgitation, or prosthetic valve stenosis at 30 days.
Clinical follow-up information at 30 days was available for 99% and ECG follow-up for about 98% of the total study population. The mean age of the study participants was 82 years, 57% were female, their median STS Risk Score was 3.5, and their mean transvalvular aortic gradient was 42.2 mm Hg. Dr. Lanz, with the department of cardiology at Bern (Switzerland) University Hospital, reported that the primary endpoint rate in the intention-to-treat cohort for ACURATE neo was 23.7%, compared with 16.5% with SAPIEN 3, falling short of the threshold for noninferiority (P for noninferiority = 0.42).
“I think this speaks to the fact of how high the bar is right now – how good the procedure is [and] how good the devices are,” invited discussant Michael J. Mack, MD, a cardiac surgeon at Baylor Scott & White Health, Dallas, said during the media briefing. “It’s an incredibly high bar to meet for any new device.”
Certain single components of the primary endpoint were similar in the ACURATE neo group, compared with the SAPIEN 3 group, including all-cause death (2.5% vs. 0.8%, respectively) and stroke (1.9% vs. 3%), but acute kidney injury was more common in the ACURATE neo group (3% vs. 0.8%, as was paravalvular aortic regurgitation (9.4% vs. 2.8%). “The differences between the two TAVR devices were mainly driven by moderate or severe paravalvular regurgitation and stage 2 or 3 acute kidney injury in favor of the SAPIEN 3 device,” Dr. Lanz said at the meeting sponsored by the Cardiovascular Research Foundation. “An early composite safety and efficacy endpoint proved useful in discriminating the performance of different TAVR systems.”
He pointed out that a trial called SCOPE II is underway in Europe, with a new iteration of the ACURATE neo designed to reduce the risk of paravalvular leak.
The results of SCOPE I were published online at the time of presentation (Lancet. 2019 Sep 27. doi: 10.1016/S0140-6736[19]32220-2). SCOPE I was an investigator-initiated and -conducted study funded by a dedicated research grant from Symetis in Ecublens, Switzerland (part of Boston Scientific). Dr. Lanz had no relevant disclosures.
REPORTING FROM TCT 2019
Health benefits of TAVR over SAVR sustained at 1 year
SAN FRANCISCO – Among patients with severe aortic stenosis at low surgical risk, both transcatheter and surgical aortic valve replacement resulted in substantial health status benefits at 1 year despite most patients having New York Heart Association class I or II symptoms at baseline.
However, when compared with surgical replacement,
The findings come from an analysis of patients enrolled in the randomized PARTNER 3 trial, which showed that transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 valve. At 1 year post procedure, the rate of the primary composite endpoint comprising death, stroke, or cardiovascular rehospitalization was 8.5% in the TAVR group and 15.1% with surgical aortic valve replacement (SAVR), for a highly significant 46% relative risk reduction (N Engl J Med 2019 May 2;380:1695-705).
“The PARTNER 3 and Evolut Low Risk trials have demonstrated that transfemoral TAVR is both safe and effective when compared with SAVR in patients with severe aortic stenosis at low surgical risk,” Suzanne J. Baron, MD, MSc, said at the Transcatheter Cardiovascular Therapeutics annual meeting. “While prior studies have demonstrated improved early health status with transfemoral TAVR, compared with SAVR in intermediate and high-risk patients, there is little evidence of any late health status benefit with TAVR.”
To address this gap in knowledge, Dr. Baron, director of interventional cardiology research at Lahey Hospital and Medical Center in Burlington, Mass., and associates performed a prospective study alongside the PARTNER 3 randomized trial to understand the impact of valve replacement strategy on early and late health status in aortic stenosis patients at low surgical risk. She reported results from 449 low-risk patients with severe aortic stenosis who were assigned to transfemoral TAVR using a balloon-expandable valve, and 449 who were assigned to surgery in PARTNER 3. At baseline, the mean age of patients was 73 years, 69% were male, and the average STS (Society of Thoracic Surgeons) Risk Score was 1.9%. Rates of other comorbidities were generally low.
Patients in both groups reported a mild baseline impairment in health status. The mean Kansas City Cardiomyopathy Questionnaire–Overall Summary (KCCQ-OS) score was 70, “which corresponds to only New York Heart Association Class II symptoms,” Dr. Baron said. “The SF-36 [Short Form 36] physical summary score was 44 for both groups, which is approximately half of a standard deviation below the population mean.”
As expected, patients who underwent TAVR showed substantially improved health status at 1 month based on the KCCQ-OS (mean difference,16 points; P less than .001). However, in contrast to prior studies, the researchers observed a persistent, although attenuated, benefit of TAVR over SAVR in disease-specific health status at 6 and 12 months (mean difference in KCCQ-OS of 2.6 and 1.8 points respectively; P less than .04 for both).
Dr. Baron said that a sustained benefit of TAVR over SAVR at 6 months and 1 year was observed on several KCCQ subscales, but a similar benefit was not noted on the generic health status measures such as the SF-36 physical summary score. “That’s likely reflective of the fact that, as a disease-specific measure, the KCCQ is much more sensitive in detecting meaningful differences in this population,” she explained. When change in health status was analyzed as an ordinal variable, with death as the worst outcome and large clinical improvement, which was defined as a 20-point or greater increase in the KCCQ-OS score, TAVR showed a significant benefit, compared with surgery at all time points (P less than .05).
In an effort to better understand the mechanism underlying this persistent albeit small late benefit in disease-specific health status with TAVR, the researchers generated cumulative distribution curves to display the proportion of patients who achieved a given change on the KCCQ-OS. A clear separation of the curves emerged, with 5.2% more patients in the TAVR group experiencing a change of at least 20 points, compared with the surgery group. “This suggests that the difference in late health status between the two groups is driven by this 5.2% absolute risk difference in the proportion of patients who experienced a large clinical improvement,” Dr. Baron said at the meeting, which was sponsored by the Cardiovascular Research Foundation.
Next, the researchers performed subgroup analyses to examine the interaction between the 1-year health status benefit of TAVR over surgery and prespecified baseline characteristics including age, gender, STS risk score, ejection fraction, atrial fibrillation, and New York Heart Association (NYHA) class. They observed a significant interaction between NYHA class and treatment effect such that patients who had NYHA class III or IV symptoms at baseline derived greater benefit from TAVR, compared with those who had NYHA class I or II symptoms at baseline.
“This finding suggests that it’s the patients with worse functional impairment at baseline who may be that subset of patients on the cumulative responder curves who gained better health status outcomes with TAVR, compared with surgery in the low-risk population,” Dr. Baron said.
Suzanne V. Arnold, MD, a cardiologist at Saint Luke’s Mid America Heart Institute, Kansas City, Mo., who was an invited discussant, said that it was “remarkable” that patients in the substudy were not particularly symptomatic and yet they still experienced close to a 20-point improvement in the KCCQ-OS score following TAVR, and asked whether frailty may have played a role in the 1.8-point adjusted difference in the KCCQ-OS score between TAVR and surgery at 1 year. Dr. Baron responded that she and her colleagues performed a subgroup analysis of patients who had two or more markers of frailty versus those who had one or less. Noting that there were only 20 patients in that subgroup, she said there was a significant signal that patients who were considered have two or more frail measures were considered to do much better with TAVR.
Dr. Baron concluded that the study’s overall findings, taken together with the clinical outcomes of the PARTNER 3 trial, “further support the use of TAVR in patients with severe [aortic stenosis] at low surgical risk. Longer-term follow up is needed (and ongoing) to determine whether the health status benefits of TAVR at 1 year are durable.”
The content of the study was published online at the time of presentation (J Am Coll Cardiol 2019 Sep 29. doi: 10.1016/j.jacc.2019.09.007). The PARTNER 3 quality of life substudy was funded by Edwards Lifesciences. Dr. Baron disclosed research funding and advisory board compensation from Boston Scientific Corp and consulting fees from Edwards Lifesciences.
SAN FRANCISCO – Among patients with severe aortic stenosis at low surgical risk, both transcatheter and surgical aortic valve replacement resulted in substantial health status benefits at 1 year despite most patients having New York Heart Association class I or II symptoms at baseline.
However, when compared with surgical replacement,
The findings come from an analysis of patients enrolled in the randomized PARTNER 3 trial, which showed that transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 valve. At 1 year post procedure, the rate of the primary composite endpoint comprising death, stroke, or cardiovascular rehospitalization was 8.5% in the TAVR group and 15.1% with surgical aortic valve replacement (SAVR), for a highly significant 46% relative risk reduction (N Engl J Med 2019 May 2;380:1695-705).
“The PARTNER 3 and Evolut Low Risk trials have demonstrated that transfemoral TAVR is both safe and effective when compared with SAVR in patients with severe aortic stenosis at low surgical risk,” Suzanne J. Baron, MD, MSc, said at the Transcatheter Cardiovascular Therapeutics annual meeting. “While prior studies have demonstrated improved early health status with transfemoral TAVR, compared with SAVR in intermediate and high-risk patients, there is little evidence of any late health status benefit with TAVR.”
To address this gap in knowledge, Dr. Baron, director of interventional cardiology research at Lahey Hospital and Medical Center in Burlington, Mass., and associates performed a prospective study alongside the PARTNER 3 randomized trial to understand the impact of valve replacement strategy on early and late health status in aortic stenosis patients at low surgical risk. She reported results from 449 low-risk patients with severe aortic stenosis who were assigned to transfemoral TAVR using a balloon-expandable valve, and 449 who were assigned to surgery in PARTNER 3. At baseline, the mean age of patients was 73 years, 69% were male, and the average STS (Society of Thoracic Surgeons) Risk Score was 1.9%. Rates of other comorbidities were generally low.
Patients in both groups reported a mild baseline impairment in health status. The mean Kansas City Cardiomyopathy Questionnaire–Overall Summary (KCCQ-OS) score was 70, “which corresponds to only New York Heart Association Class II symptoms,” Dr. Baron said. “The SF-36 [Short Form 36] physical summary score was 44 for both groups, which is approximately half of a standard deviation below the population mean.”
As expected, patients who underwent TAVR showed substantially improved health status at 1 month based on the KCCQ-OS (mean difference,16 points; P less than .001). However, in contrast to prior studies, the researchers observed a persistent, although attenuated, benefit of TAVR over SAVR in disease-specific health status at 6 and 12 months (mean difference in KCCQ-OS of 2.6 and 1.8 points respectively; P less than .04 for both).
Dr. Baron said that a sustained benefit of TAVR over SAVR at 6 months and 1 year was observed on several KCCQ subscales, but a similar benefit was not noted on the generic health status measures such as the SF-36 physical summary score. “That’s likely reflective of the fact that, as a disease-specific measure, the KCCQ is much more sensitive in detecting meaningful differences in this population,” she explained. When change in health status was analyzed as an ordinal variable, with death as the worst outcome and large clinical improvement, which was defined as a 20-point or greater increase in the KCCQ-OS score, TAVR showed a significant benefit, compared with surgery at all time points (P less than .05).
In an effort to better understand the mechanism underlying this persistent albeit small late benefit in disease-specific health status with TAVR, the researchers generated cumulative distribution curves to display the proportion of patients who achieved a given change on the KCCQ-OS. A clear separation of the curves emerged, with 5.2% more patients in the TAVR group experiencing a change of at least 20 points, compared with the surgery group. “This suggests that the difference in late health status between the two groups is driven by this 5.2% absolute risk difference in the proportion of patients who experienced a large clinical improvement,” Dr. Baron said at the meeting, which was sponsored by the Cardiovascular Research Foundation.
Next, the researchers performed subgroup analyses to examine the interaction between the 1-year health status benefit of TAVR over surgery and prespecified baseline characteristics including age, gender, STS risk score, ejection fraction, atrial fibrillation, and New York Heart Association (NYHA) class. They observed a significant interaction between NYHA class and treatment effect such that patients who had NYHA class III or IV symptoms at baseline derived greater benefit from TAVR, compared with those who had NYHA class I or II symptoms at baseline.
“This finding suggests that it’s the patients with worse functional impairment at baseline who may be that subset of patients on the cumulative responder curves who gained better health status outcomes with TAVR, compared with surgery in the low-risk population,” Dr. Baron said.
Suzanne V. Arnold, MD, a cardiologist at Saint Luke’s Mid America Heart Institute, Kansas City, Mo., who was an invited discussant, said that it was “remarkable” that patients in the substudy were not particularly symptomatic and yet they still experienced close to a 20-point improvement in the KCCQ-OS score following TAVR, and asked whether frailty may have played a role in the 1.8-point adjusted difference in the KCCQ-OS score between TAVR and surgery at 1 year. Dr. Baron responded that she and her colleagues performed a subgroup analysis of patients who had two or more markers of frailty versus those who had one or less. Noting that there were only 20 patients in that subgroup, she said there was a significant signal that patients who were considered have two or more frail measures were considered to do much better with TAVR.
Dr. Baron concluded that the study’s overall findings, taken together with the clinical outcomes of the PARTNER 3 trial, “further support the use of TAVR in patients with severe [aortic stenosis] at low surgical risk. Longer-term follow up is needed (and ongoing) to determine whether the health status benefits of TAVR at 1 year are durable.”
The content of the study was published online at the time of presentation (J Am Coll Cardiol 2019 Sep 29. doi: 10.1016/j.jacc.2019.09.007). The PARTNER 3 quality of life substudy was funded by Edwards Lifesciences. Dr. Baron disclosed research funding and advisory board compensation from Boston Scientific Corp and consulting fees from Edwards Lifesciences.
SAN FRANCISCO – Among patients with severe aortic stenosis at low surgical risk, both transcatheter and surgical aortic valve replacement resulted in substantial health status benefits at 1 year despite most patients having New York Heart Association class I or II symptoms at baseline.
However, when compared with surgical replacement,
The findings come from an analysis of patients enrolled in the randomized PARTNER 3 trial, which showed that transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 valve. At 1 year post procedure, the rate of the primary composite endpoint comprising death, stroke, or cardiovascular rehospitalization was 8.5% in the TAVR group and 15.1% with surgical aortic valve replacement (SAVR), for a highly significant 46% relative risk reduction (N Engl J Med 2019 May 2;380:1695-705).
“The PARTNER 3 and Evolut Low Risk trials have demonstrated that transfemoral TAVR is both safe and effective when compared with SAVR in patients with severe aortic stenosis at low surgical risk,” Suzanne J. Baron, MD, MSc, said at the Transcatheter Cardiovascular Therapeutics annual meeting. “While prior studies have demonstrated improved early health status with transfemoral TAVR, compared with SAVR in intermediate and high-risk patients, there is little evidence of any late health status benefit with TAVR.”
To address this gap in knowledge, Dr. Baron, director of interventional cardiology research at Lahey Hospital and Medical Center in Burlington, Mass., and associates performed a prospective study alongside the PARTNER 3 randomized trial to understand the impact of valve replacement strategy on early and late health status in aortic stenosis patients at low surgical risk. She reported results from 449 low-risk patients with severe aortic stenosis who were assigned to transfemoral TAVR using a balloon-expandable valve, and 449 who were assigned to surgery in PARTNER 3. At baseline, the mean age of patients was 73 years, 69% were male, and the average STS (Society of Thoracic Surgeons) Risk Score was 1.9%. Rates of other comorbidities were generally low.
Patients in both groups reported a mild baseline impairment in health status. The mean Kansas City Cardiomyopathy Questionnaire–Overall Summary (KCCQ-OS) score was 70, “which corresponds to only New York Heart Association Class II symptoms,” Dr. Baron said. “The SF-36 [Short Form 36] physical summary score was 44 for both groups, which is approximately half of a standard deviation below the population mean.”
As expected, patients who underwent TAVR showed substantially improved health status at 1 month based on the KCCQ-OS (mean difference,16 points; P less than .001). However, in contrast to prior studies, the researchers observed a persistent, although attenuated, benefit of TAVR over SAVR in disease-specific health status at 6 and 12 months (mean difference in KCCQ-OS of 2.6 and 1.8 points respectively; P less than .04 for both).
Dr. Baron said that a sustained benefit of TAVR over SAVR at 6 months and 1 year was observed on several KCCQ subscales, but a similar benefit was not noted on the generic health status measures such as the SF-36 physical summary score. “That’s likely reflective of the fact that, as a disease-specific measure, the KCCQ is much more sensitive in detecting meaningful differences in this population,” she explained. When change in health status was analyzed as an ordinal variable, with death as the worst outcome and large clinical improvement, which was defined as a 20-point or greater increase in the KCCQ-OS score, TAVR showed a significant benefit, compared with surgery at all time points (P less than .05).
In an effort to better understand the mechanism underlying this persistent albeit small late benefit in disease-specific health status with TAVR, the researchers generated cumulative distribution curves to display the proportion of patients who achieved a given change on the KCCQ-OS. A clear separation of the curves emerged, with 5.2% more patients in the TAVR group experiencing a change of at least 20 points, compared with the surgery group. “This suggests that the difference in late health status between the two groups is driven by this 5.2% absolute risk difference in the proportion of patients who experienced a large clinical improvement,” Dr. Baron said at the meeting, which was sponsored by the Cardiovascular Research Foundation.
Next, the researchers performed subgroup analyses to examine the interaction between the 1-year health status benefit of TAVR over surgery and prespecified baseline characteristics including age, gender, STS risk score, ejection fraction, atrial fibrillation, and New York Heart Association (NYHA) class. They observed a significant interaction between NYHA class and treatment effect such that patients who had NYHA class III or IV symptoms at baseline derived greater benefit from TAVR, compared with those who had NYHA class I or II symptoms at baseline.
“This finding suggests that it’s the patients with worse functional impairment at baseline who may be that subset of patients on the cumulative responder curves who gained better health status outcomes with TAVR, compared with surgery in the low-risk population,” Dr. Baron said.
Suzanne V. Arnold, MD, a cardiologist at Saint Luke’s Mid America Heart Institute, Kansas City, Mo., who was an invited discussant, said that it was “remarkable” that patients in the substudy were not particularly symptomatic and yet they still experienced close to a 20-point improvement in the KCCQ-OS score following TAVR, and asked whether frailty may have played a role in the 1.8-point adjusted difference in the KCCQ-OS score between TAVR and surgery at 1 year. Dr. Baron responded that she and her colleagues performed a subgroup analysis of patients who had two or more markers of frailty versus those who had one or less. Noting that there were only 20 patients in that subgroup, she said there was a significant signal that patients who were considered have two or more frail measures were considered to do much better with TAVR.
Dr. Baron concluded that the study’s overall findings, taken together with the clinical outcomes of the PARTNER 3 trial, “further support the use of TAVR in patients with severe [aortic stenosis] at low surgical risk. Longer-term follow up is needed (and ongoing) to determine whether the health status benefits of TAVR at 1 year are durable.”
The content of the study was published online at the time of presentation (J Am Coll Cardiol 2019 Sep 29. doi: 10.1016/j.jacc.2019.09.007). The PARTNER 3 quality of life substudy was funded by Edwards Lifesciences. Dr. Baron disclosed research funding and advisory board compensation from Boston Scientific Corp and consulting fees from Edwards Lifesciences.
REPORTING FROM TCT 2019
Transseptal access for MViV replacement cuts mortality
SAN FRANCISCO – and was an independent predictor of lower mortality at 1 year, in a review of 1,529 cases in the Society of Thoracic Surgeons transcatheter valve therapy registry.
Also, transcatheter mitral valve-in-valve (MViV) replacement, in general, is “preferable to redo mitral surgery and should be the standard of care for patients with failed surgical bioprosthesis who have favorable anatomy,” said lead investigator Mayra Guerrero, MD, an interventional cardiologist at the Mayo Clinic in Rochester, Minn, at the annual Transcatheter Cardiovascular Therapeutics meeting.
MViV replacement is a catheter-based alternative to a second open procedure for high-risk patients whose first surgically implanted mitral valve fails. The 30-day mortality tops 10% in most studies of redo operations, so the field’s been moving towards catheter treatment with the Edward Lifesciences Sapien 3 valve, which carries an indication for the procedure.
There’s been a lingering question, however, about whether it’s better to deliver the device through a hole in the atrial septum or the apex of the heart. The issue may now be resolved: “For the first time, we have found a statistical difference between the two access types” in favor of transseptal, Dr. Guerrero said at the meeting sponsored by the Cardiovascular Research Foundation.
The team compared outcomes from the 1,326 transseptal Sapien 3 cases in the registry with 203 cases that used the transapical approach from June 2015 and August 2019, linking cases with Centers of Medicare & Medicaid Services data to get a better idea of outcomes. Baseline characteristics were similar between the groups, but transapical cases tended to come earlier in the series because the field is also moving to the transseptal approach.
The procedures were technically successful – the primary safety endpoint – in 97.1% of transseptal and 94.6% of transapical patients. All-cause mortality at 1 year – the primary efficacy endpoint – was 15.8% transseptally and 21.7% transapically (hazard ratio, 0.67; 95% confidence interval, 0.47-0.97; P = .03).
Transapical cases were more likely to be converted to open surgery, and on multivariate analysis, transseptal access was an independent predictor of lower 1-year mortality.
There was good maintenance of valve performance and ejection fraction in both groups at 1 year, and similar improvements in heart failure symptoms and quality of life.
Transseptal 30-day mortality was 5% with an observed/expected ratio of 0.45 versus 8.1% transapical with an observed/expected ratio of 0.69.
“I don’t think any surgeon will disagree with this: If we don’t have to do another redo mitral valve operation, that’s a good thing. It’s one of the highest-risk procedures we do in cardiac surgery. To have an alternative that cuts that 30-day mortality down to 5% is very much positive. I think this clearly answers that this is the preferred therapy,” said cardiothoracic surgeon Michael Mack, MD, director of the cardiovascular service line at Baylor Scott & White Health System, Dallas.
The 1-year transseptal mortality of 16% is at least as good as transcatheter aortic valve replacement, but Dr. Mack and other panelists agreed that longer follow-up is needed to get a more complete picture of the procedure’s durability, especially as it begins to be used in patients who are at lower surgical risk.
For low-risk patients or patients that have, for instance, a small hypertrophic left ventricle and a surgical valve that already projects into the outflow tract, MViV replacement “could be very problematic, so there might need to be anatomic selection criteria we need to be thinking about,” said panelist Vinay Badhwar, MD, a cardiac surgeon at West Virginia University, Morgantown.
Subjects were aged an average of 73 years and 60% were women. The primary pathology was mitral stenosis followed by mitral regurgitation. The baseline mitral valve pressure gradient was about 13 mm Hg, which fell to 7 mm Hg in both groups at 1 year.
The work was funded by Edward Lifesciences, which did the statistical analysis. Dr. Guerrero disclosed research funding from the company.
SAN FRANCISCO – and was an independent predictor of lower mortality at 1 year, in a review of 1,529 cases in the Society of Thoracic Surgeons transcatheter valve therapy registry.
Also, transcatheter mitral valve-in-valve (MViV) replacement, in general, is “preferable to redo mitral surgery and should be the standard of care for patients with failed surgical bioprosthesis who have favorable anatomy,” said lead investigator Mayra Guerrero, MD, an interventional cardiologist at the Mayo Clinic in Rochester, Minn, at the annual Transcatheter Cardiovascular Therapeutics meeting.
MViV replacement is a catheter-based alternative to a second open procedure for high-risk patients whose first surgically implanted mitral valve fails. The 30-day mortality tops 10% in most studies of redo operations, so the field’s been moving towards catheter treatment with the Edward Lifesciences Sapien 3 valve, which carries an indication for the procedure.
There’s been a lingering question, however, about whether it’s better to deliver the device through a hole in the atrial septum or the apex of the heart. The issue may now be resolved: “For the first time, we have found a statistical difference between the two access types” in favor of transseptal, Dr. Guerrero said at the meeting sponsored by the Cardiovascular Research Foundation.
The team compared outcomes from the 1,326 transseptal Sapien 3 cases in the registry with 203 cases that used the transapical approach from June 2015 and August 2019, linking cases with Centers of Medicare & Medicaid Services data to get a better idea of outcomes. Baseline characteristics were similar between the groups, but transapical cases tended to come earlier in the series because the field is also moving to the transseptal approach.
The procedures were technically successful – the primary safety endpoint – in 97.1% of transseptal and 94.6% of transapical patients. All-cause mortality at 1 year – the primary efficacy endpoint – was 15.8% transseptally and 21.7% transapically (hazard ratio, 0.67; 95% confidence interval, 0.47-0.97; P = .03).
Transapical cases were more likely to be converted to open surgery, and on multivariate analysis, transseptal access was an independent predictor of lower 1-year mortality.
There was good maintenance of valve performance and ejection fraction in both groups at 1 year, and similar improvements in heart failure symptoms and quality of life.
Transseptal 30-day mortality was 5% with an observed/expected ratio of 0.45 versus 8.1% transapical with an observed/expected ratio of 0.69.
“I don’t think any surgeon will disagree with this: If we don’t have to do another redo mitral valve operation, that’s a good thing. It’s one of the highest-risk procedures we do in cardiac surgery. To have an alternative that cuts that 30-day mortality down to 5% is very much positive. I think this clearly answers that this is the preferred therapy,” said cardiothoracic surgeon Michael Mack, MD, director of the cardiovascular service line at Baylor Scott & White Health System, Dallas.
The 1-year transseptal mortality of 16% is at least as good as transcatheter aortic valve replacement, but Dr. Mack and other panelists agreed that longer follow-up is needed to get a more complete picture of the procedure’s durability, especially as it begins to be used in patients who are at lower surgical risk.
For low-risk patients or patients that have, for instance, a small hypertrophic left ventricle and a surgical valve that already projects into the outflow tract, MViV replacement “could be very problematic, so there might need to be anatomic selection criteria we need to be thinking about,” said panelist Vinay Badhwar, MD, a cardiac surgeon at West Virginia University, Morgantown.
Subjects were aged an average of 73 years and 60% were women. The primary pathology was mitral stenosis followed by mitral regurgitation. The baseline mitral valve pressure gradient was about 13 mm Hg, which fell to 7 mm Hg in both groups at 1 year.
The work was funded by Edward Lifesciences, which did the statistical analysis. Dr. Guerrero disclosed research funding from the company.
SAN FRANCISCO – and was an independent predictor of lower mortality at 1 year, in a review of 1,529 cases in the Society of Thoracic Surgeons transcatheter valve therapy registry.
Also, transcatheter mitral valve-in-valve (MViV) replacement, in general, is “preferable to redo mitral surgery and should be the standard of care for patients with failed surgical bioprosthesis who have favorable anatomy,” said lead investigator Mayra Guerrero, MD, an interventional cardiologist at the Mayo Clinic in Rochester, Minn, at the annual Transcatheter Cardiovascular Therapeutics meeting.
MViV replacement is a catheter-based alternative to a second open procedure for high-risk patients whose first surgically implanted mitral valve fails. The 30-day mortality tops 10% in most studies of redo operations, so the field’s been moving towards catheter treatment with the Edward Lifesciences Sapien 3 valve, which carries an indication for the procedure.
There’s been a lingering question, however, about whether it’s better to deliver the device through a hole in the atrial septum or the apex of the heart. The issue may now be resolved: “For the first time, we have found a statistical difference between the two access types” in favor of transseptal, Dr. Guerrero said at the meeting sponsored by the Cardiovascular Research Foundation.
The team compared outcomes from the 1,326 transseptal Sapien 3 cases in the registry with 203 cases that used the transapical approach from June 2015 and August 2019, linking cases with Centers of Medicare & Medicaid Services data to get a better idea of outcomes. Baseline characteristics were similar between the groups, but transapical cases tended to come earlier in the series because the field is also moving to the transseptal approach.
The procedures were technically successful – the primary safety endpoint – in 97.1% of transseptal and 94.6% of transapical patients. All-cause mortality at 1 year – the primary efficacy endpoint – was 15.8% transseptally and 21.7% transapically (hazard ratio, 0.67; 95% confidence interval, 0.47-0.97; P = .03).
Transapical cases were more likely to be converted to open surgery, and on multivariate analysis, transseptal access was an independent predictor of lower 1-year mortality.
There was good maintenance of valve performance and ejection fraction in both groups at 1 year, and similar improvements in heart failure symptoms and quality of life.
Transseptal 30-day mortality was 5% with an observed/expected ratio of 0.45 versus 8.1% transapical with an observed/expected ratio of 0.69.
“I don’t think any surgeon will disagree with this: If we don’t have to do another redo mitral valve operation, that’s a good thing. It’s one of the highest-risk procedures we do in cardiac surgery. To have an alternative that cuts that 30-day mortality down to 5% is very much positive. I think this clearly answers that this is the preferred therapy,” said cardiothoracic surgeon Michael Mack, MD, director of the cardiovascular service line at Baylor Scott & White Health System, Dallas.
The 1-year transseptal mortality of 16% is at least as good as transcatheter aortic valve replacement, but Dr. Mack and other panelists agreed that longer follow-up is needed to get a more complete picture of the procedure’s durability, especially as it begins to be used in patients who are at lower surgical risk.
For low-risk patients or patients that have, for instance, a small hypertrophic left ventricle and a surgical valve that already projects into the outflow tract, MViV replacement “could be very problematic, so there might need to be anatomic selection criteria we need to be thinking about,” said panelist Vinay Badhwar, MD, a cardiac surgeon at West Virginia University, Morgantown.
Subjects were aged an average of 73 years and 60% were women. The primary pathology was mitral stenosis followed by mitral regurgitation. The baseline mitral valve pressure gradient was about 13 mm Hg, which fell to 7 mm Hg in both groups at 1 year.
The work was funded by Edward Lifesciences, which did the statistical analysis. Dr. Guerrero disclosed research funding from the company.
REPORTING FROM TCT 2019
Volume directly tied to mitral valve procedure success
SAN FRANCISCO – Volume matters when it comes to mitral valve repair/replacement for primary mitral regurgitation. in the Society of Thoracic Surgeons Adult Cardiac Surgery Database.
Investigators “found a clear inflection point at approximately 75 cases” for hospitals and 35 cases for individual surgeons when the curves for successful mitral repair and 30-day operative mortality start to level out. Nationwide, 148 hospitals (14%) in the analysis did 75 or more mitral cases a year, and 303 surgeons (13%) did at least 35.
Lead investigator Vinay Badhwar, MD, professor and chair of cardiovascular and thoracic surgery at West Virginia University, Morgantown, estimated that about 90% of Americans have access to a regional hospital that does at least 25 mitral procedures annually, and about 82% can use a regional hospital that does at least 40. Meanwhile, the rate of mitral valve repair for primary mitral regurgitation was 81% (44,692/55,311) in the study, up from about 60% a decade ago.
“We are getting there; we are getting better,” Dr. Badhwar said at the Transcatheter Cardiovascular Therapeutics annual meeting. By defining volume cut points, he said the findings could be useful in future guidelines to steer referrals to higher-volume centers.
“We really needed these data, because we’ve had so many other pieces pointing to the volume repair rates and technical success, which clearly is related to volume. Now we have the outcome data we’ve been looking for; this ties it together. There really is an impact on patient outcomes,” Robert Bonow, MD, a professor of cardiology at Northwestern University, Chicago, commented.
The team divided annual case volume into quartiles. The lowest hospital quartile did fewer than 11 cases a year, and the highest more than 46. The lowest-quartile surgeons did fewer than 6 cases a year, and the highest more than 20. Lowest-quartile surgeons and hospitals, versus the highest, had higher operative mortality and 30-day morbidity and mortality, and lower 1-year survival.
Patients in the lowest quartile were also more likely to be black or Hispanic (14.8% versus 10.2%); have no insurance (4.0% versus 2.4%); and more severe symptom presentation (31.9% versus 23.8% class III or IV heart failure). The differences were highly statistically significant.
Study moderator Ajay Kirtane, MD, an interventional cardiologist and associate professor of medicine at Columbia University, New York, said there’s a role for advocacy to get more people to high-volume centers. “Just because you live in an area that has a good program doesn’t mean that you are actually going to get referred to that program. We find a lot that it’s advocacy that is important,” especially with the disparities noted in the study. “Not everybody has an advocate who says, ‘Don’t do it here; do it someplace else,’ ” he said at the meeting sponsored by the Cardiovascular Research Foundation.
And not everyone has an advocate to get them to the right surgeon, even if they get to the right program. “There are cardiac procedures that most surgeons can do well. Mitral valve surgery is one of those that should be super specialized,” said cardiothoracic surgeon Michael Mack, MD, director of the cardiovascular service line at Baylor Scott and White Health System, Dallas.
No industry funding was reported. Dr. Badhwar had no relevant disclosures.
SOURCE: Badhwar V et al. TCT 2019.
SAN FRANCISCO – Volume matters when it comes to mitral valve repair/replacement for primary mitral regurgitation. in the Society of Thoracic Surgeons Adult Cardiac Surgery Database.
Investigators “found a clear inflection point at approximately 75 cases” for hospitals and 35 cases for individual surgeons when the curves for successful mitral repair and 30-day operative mortality start to level out. Nationwide, 148 hospitals (14%) in the analysis did 75 or more mitral cases a year, and 303 surgeons (13%) did at least 35.
Lead investigator Vinay Badhwar, MD, professor and chair of cardiovascular and thoracic surgery at West Virginia University, Morgantown, estimated that about 90% of Americans have access to a regional hospital that does at least 25 mitral procedures annually, and about 82% can use a regional hospital that does at least 40. Meanwhile, the rate of mitral valve repair for primary mitral regurgitation was 81% (44,692/55,311) in the study, up from about 60% a decade ago.
“We are getting there; we are getting better,” Dr. Badhwar said at the Transcatheter Cardiovascular Therapeutics annual meeting. By defining volume cut points, he said the findings could be useful in future guidelines to steer referrals to higher-volume centers.
“We really needed these data, because we’ve had so many other pieces pointing to the volume repair rates and technical success, which clearly is related to volume. Now we have the outcome data we’ve been looking for; this ties it together. There really is an impact on patient outcomes,” Robert Bonow, MD, a professor of cardiology at Northwestern University, Chicago, commented.
The team divided annual case volume into quartiles. The lowest hospital quartile did fewer than 11 cases a year, and the highest more than 46. The lowest-quartile surgeons did fewer than 6 cases a year, and the highest more than 20. Lowest-quartile surgeons and hospitals, versus the highest, had higher operative mortality and 30-day morbidity and mortality, and lower 1-year survival.
Patients in the lowest quartile were also more likely to be black or Hispanic (14.8% versus 10.2%); have no insurance (4.0% versus 2.4%); and more severe symptom presentation (31.9% versus 23.8% class III or IV heart failure). The differences were highly statistically significant.
Study moderator Ajay Kirtane, MD, an interventional cardiologist and associate professor of medicine at Columbia University, New York, said there’s a role for advocacy to get more people to high-volume centers. “Just because you live in an area that has a good program doesn’t mean that you are actually going to get referred to that program. We find a lot that it’s advocacy that is important,” especially with the disparities noted in the study. “Not everybody has an advocate who says, ‘Don’t do it here; do it someplace else,’ ” he said at the meeting sponsored by the Cardiovascular Research Foundation.
And not everyone has an advocate to get them to the right surgeon, even if they get to the right program. “There are cardiac procedures that most surgeons can do well. Mitral valve surgery is one of those that should be super specialized,” said cardiothoracic surgeon Michael Mack, MD, director of the cardiovascular service line at Baylor Scott and White Health System, Dallas.
No industry funding was reported. Dr. Badhwar had no relevant disclosures.
SOURCE: Badhwar V et al. TCT 2019.
SAN FRANCISCO – Volume matters when it comes to mitral valve repair/replacement for primary mitral regurgitation. in the Society of Thoracic Surgeons Adult Cardiac Surgery Database.
Investigators “found a clear inflection point at approximately 75 cases” for hospitals and 35 cases for individual surgeons when the curves for successful mitral repair and 30-day operative mortality start to level out. Nationwide, 148 hospitals (14%) in the analysis did 75 or more mitral cases a year, and 303 surgeons (13%) did at least 35.
Lead investigator Vinay Badhwar, MD, professor and chair of cardiovascular and thoracic surgery at West Virginia University, Morgantown, estimated that about 90% of Americans have access to a regional hospital that does at least 25 mitral procedures annually, and about 82% can use a regional hospital that does at least 40. Meanwhile, the rate of mitral valve repair for primary mitral regurgitation was 81% (44,692/55,311) in the study, up from about 60% a decade ago.
“We are getting there; we are getting better,” Dr. Badhwar said at the Transcatheter Cardiovascular Therapeutics annual meeting. By defining volume cut points, he said the findings could be useful in future guidelines to steer referrals to higher-volume centers.
“We really needed these data, because we’ve had so many other pieces pointing to the volume repair rates and technical success, which clearly is related to volume. Now we have the outcome data we’ve been looking for; this ties it together. There really is an impact on patient outcomes,” Robert Bonow, MD, a professor of cardiology at Northwestern University, Chicago, commented.
The team divided annual case volume into quartiles. The lowest hospital quartile did fewer than 11 cases a year, and the highest more than 46. The lowest-quartile surgeons did fewer than 6 cases a year, and the highest more than 20. Lowest-quartile surgeons and hospitals, versus the highest, had higher operative mortality and 30-day morbidity and mortality, and lower 1-year survival.
Patients in the lowest quartile were also more likely to be black or Hispanic (14.8% versus 10.2%); have no insurance (4.0% versus 2.4%); and more severe symptom presentation (31.9% versus 23.8% class III or IV heart failure). The differences were highly statistically significant.
Study moderator Ajay Kirtane, MD, an interventional cardiologist and associate professor of medicine at Columbia University, New York, said there’s a role for advocacy to get more people to high-volume centers. “Just because you live in an area that has a good program doesn’t mean that you are actually going to get referred to that program. We find a lot that it’s advocacy that is important,” especially with the disparities noted in the study. “Not everybody has an advocate who says, ‘Don’t do it here; do it someplace else,’ ” he said at the meeting sponsored by the Cardiovascular Research Foundation.
And not everyone has an advocate to get them to the right surgeon, even if they get to the right program. “There are cardiac procedures that most surgeons can do well. Mitral valve surgery is one of those that should be super specialized,” said cardiothoracic surgeon Michael Mack, MD, director of the cardiovascular service line at Baylor Scott and White Health System, Dallas.
No industry funding was reported. Dr. Badhwar had no relevant disclosures.
SOURCE: Badhwar V et al. TCT 2019.
REPORTING FROM TCT 2019
Transcatheter TR repair tops medical management
SAN FRANCISCO – Survival after 12 months was more likely with transcatheter repair of tricuspid regurgitation instead of guideline-directed medical therapy, and patients were less likely to be rehospitalized with heart failure, in a propensity-matched case-control study presented at the Transcatheter Cardiovascular Therapeutics annual meeting.
Tricuspid regurgitation carries a substantial burden of morbidity and mortality, but there hasn’t been great success with surgical approaches, so several trials are underway assessing transcatheter repair. It’s unclear at the moment whether it will beat medical management, which generally includes diuretics and symptom relief, said lead investigator Maurizio Taramasso, MD, PhD, a cardiac surgeon and interventional cardiologist at the University Hospital of Zürich.
Dr. Taramasso and colleagues wanted to take a look at the issue pending results of the randomized trials. “There’s still a lot of uncertainty in regard to what we can do for the patient by reducing tricuspid regurgitation. [There are] no data showing that reducing tricuspid regurgitation improves survival,” he said at the meeting.
The investigators matched 268 patients from the international Transcatheter Tricuspid Valve Therapies registry treated during 2016-2018 with 268 medical-management patients from the Mayo Clinic in Rochester, Minn., and Leiden (the Netherlands) University, based on age, European System for Cardiac Operative Risk Evaluation II scores, and systolic pulmonary artery pressure, the major predictor of poor outcomes in tricuspid regurgitation.
Even with matching, transcatheter patients were worse off, which is probably why they had valve repair in the first place, Dr. Taramasso said at the meeting sponsored by the Cardiovascular Research Foundation. The baseline burden of right ventricular dysfunction, heart failure, mitral regurgitation, atrial fibrillation, and pacemaker placement were all significantly higher in the transcatheter group.
Even so, transcatheter patients had lower 1-year mortality (23% vs. 36%; P = .001) and fewer heart failure rehospitalizations (32% vs. 49%, P less than .0001). Transcatheter repair was associated with greater survival and freedom from heart failure rehospitalization (HR, 0.60; 95% CI, 0.46-0.79; P = .003), which remained significant after adjusting for sex, New York Heart Association functional class, right ventricular dysfunction, and atrial fibrillation (HR, 0.39; 95% CI, 0.26-0.59; P less than .0001), and after further adjustment for mitral regurgitation and pacemaker/defibrillator placement (HR, 0.35; 95% CI, 0.23-0.54; P less than .0001). Subgroup analyses based on mitral regurgitation severity, pulmonary artery pressure, and other factors all favored repair.
“This is an important set of data to show that, indeed, fixing the tricuspid valve does lead to better outcomes, and perhaps we can do that with a transcatheter approach,” said Robert Bonow, MD, a professor of cardiology at Northwestern University, Chicago, after hearing the presentation.
The fact that transcatheter patients were sicker when they were treated is reassuring, added moderator Ajay Kirtane, MD, an interventional cardiologist and associate professor of medicine at Columbia University, New York.
The success rate for the procedure, which was to be alive at the end of it, with the device successfully implanted, the delivery system retrieved, and residual tricuspid regurgitation (TR) less than 3+, was 86%, and 85% of patients were treated with MitraClip, most with two or three clips. Outcomes were similar, but not worse, than medical management when TR wasn’t significantly reduced.
Operators were highly experienced, there were no emergent conversions to surgery, and patients tolerated the approach “pretty well,” Dr. Taramasso said. The lesson is that “we should really try to reduce TR, but just a little bit is not enough.” Overall, “we probably need better devices and better patient selection. With the data we are collecting, we’ll be able soon to known when late is too late, which patients should not be treated,” he said.
The study didn’t address postprocedure medications, but it’s been noted in the registry that medication use generally declines after a few months. Subjects tended to be aged in their mid-70s, and there were slightly more women than men.
The results were published online concurrently with Dr. Taramasso’s report in the Journal of the American College of Cardiology.
No company funding was reported. Dr. Taramasso is a consultant for Abbott Vascular, Boston Scientific, 4TECH, and CoreMedic; and has received speaker fees from Edwards Lifesciences.
SOURCE: Taramasso M et al. J Am Coll Cardiol. 2019 Sep 24. doi: 10.1016/j.jacc.2019.09.028.
SAN FRANCISCO – Survival after 12 months was more likely with transcatheter repair of tricuspid regurgitation instead of guideline-directed medical therapy, and patients were less likely to be rehospitalized with heart failure, in a propensity-matched case-control study presented at the Transcatheter Cardiovascular Therapeutics annual meeting.
Tricuspid regurgitation carries a substantial burden of morbidity and mortality, but there hasn’t been great success with surgical approaches, so several trials are underway assessing transcatheter repair. It’s unclear at the moment whether it will beat medical management, which generally includes diuretics and symptom relief, said lead investigator Maurizio Taramasso, MD, PhD, a cardiac surgeon and interventional cardiologist at the University Hospital of Zürich.
Dr. Taramasso and colleagues wanted to take a look at the issue pending results of the randomized trials. “There’s still a lot of uncertainty in regard to what we can do for the patient by reducing tricuspid regurgitation. [There are] no data showing that reducing tricuspid regurgitation improves survival,” he said at the meeting.
The investigators matched 268 patients from the international Transcatheter Tricuspid Valve Therapies registry treated during 2016-2018 with 268 medical-management patients from the Mayo Clinic in Rochester, Minn., and Leiden (the Netherlands) University, based on age, European System for Cardiac Operative Risk Evaluation II scores, and systolic pulmonary artery pressure, the major predictor of poor outcomes in tricuspid regurgitation.
Even with matching, transcatheter patients were worse off, which is probably why they had valve repair in the first place, Dr. Taramasso said at the meeting sponsored by the Cardiovascular Research Foundation. The baseline burden of right ventricular dysfunction, heart failure, mitral regurgitation, atrial fibrillation, and pacemaker placement were all significantly higher in the transcatheter group.
Even so, transcatheter patients had lower 1-year mortality (23% vs. 36%; P = .001) and fewer heart failure rehospitalizations (32% vs. 49%, P less than .0001). Transcatheter repair was associated with greater survival and freedom from heart failure rehospitalization (HR, 0.60; 95% CI, 0.46-0.79; P = .003), which remained significant after adjusting for sex, New York Heart Association functional class, right ventricular dysfunction, and atrial fibrillation (HR, 0.39; 95% CI, 0.26-0.59; P less than .0001), and after further adjustment for mitral regurgitation and pacemaker/defibrillator placement (HR, 0.35; 95% CI, 0.23-0.54; P less than .0001). Subgroup analyses based on mitral regurgitation severity, pulmonary artery pressure, and other factors all favored repair.
“This is an important set of data to show that, indeed, fixing the tricuspid valve does lead to better outcomes, and perhaps we can do that with a transcatheter approach,” said Robert Bonow, MD, a professor of cardiology at Northwestern University, Chicago, after hearing the presentation.
The fact that transcatheter patients were sicker when they were treated is reassuring, added moderator Ajay Kirtane, MD, an interventional cardiologist and associate professor of medicine at Columbia University, New York.
The success rate for the procedure, which was to be alive at the end of it, with the device successfully implanted, the delivery system retrieved, and residual tricuspid regurgitation (TR) less than 3+, was 86%, and 85% of patients were treated with MitraClip, most with two or three clips. Outcomes were similar, but not worse, than medical management when TR wasn’t significantly reduced.
Operators were highly experienced, there were no emergent conversions to surgery, and patients tolerated the approach “pretty well,” Dr. Taramasso said. The lesson is that “we should really try to reduce TR, but just a little bit is not enough.” Overall, “we probably need better devices and better patient selection. With the data we are collecting, we’ll be able soon to known when late is too late, which patients should not be treated,” he said.
The study didn’t address postprocedure medications, but it’s been noted in the registry that medication use generally declines after a few months. Subjects tended to be aged in their mid-70s, and there were slightly more women than men.
The results were published online concurrently with Dr. Taramasso’s report in the Journal of the American College of Cardiology.
No company funding was reported. Dr. Taramasso is a consultant for Abbott Vascular, Boston Scientific, 4TECH, and CoreMedic; and has received speaker fees from Edwards Lifesciences.
SOURCE: Taramasso M et al. J Am Coll Cardiol. 2019 Sep 24. doi: 10.1016/j.jacc.2019.09.028.
SAN FRANCISCO – Survival after 12 months was more likely with transcatheter repair of tricuspid regurgitation instead of guideline-directed medical therapy, and patients were less likely to be rehospitalized with heart failure, in a propensity-matched case-control study presented at the Transcatheter Cardiovascular Therapeutics annual meeting.
Tricuspid regurgitation carries a substantial burden of morbidity and mortality, but there hasn’t been great success with surgical approaches, so several trials are underway assessing transcatheter repair. It’s unclear at the moment whether it will beat medical management, which generally includes diuretics and symptom relief, said lead investigator Maurizio Taramasso, MD, PhD, a cardiac surgeon and interventional cardiologist at the University Hospital of Zürich.
Dr. Taramasso and colleagues wanted to take a look at the issue pending results of the randomized trials. “There’s still a lot of uncertainty in regard to what we can do for the patient by reducing tricuspid regurgitation. [There are] no data showing that reducing tricuspid regurgitation improves survival,” he said at the meeting.
The investigators matched 268 patients from the international Transcatheter Tricuspid Valve Therapies registry treated during 2016-2018 with 268 medical-management patients from the Mayo Clinic in Rochester, Minn., and Leiden (the Netherlands) University, based on age, European System for Cardiac Operative Risk Evaluation II scores, and systolic pulmonary artery pressure, the major predictor of poor outcomes in tricuspid regurgitation.
Even with matching, transcatheter patients were worse off, which is probably why they had valve repair in the first place, Dr. Taramasso said at the meeting sponsored by the Cardiovascular Research Foundation. The baseline burden of right ventricular dysfunction, heart failure, mitral regurgitation, atrial fibrillation, and pacemaker placement were all significantly higher in the transcatheter group.
Even so, transcatheter patients had lower 1-year mortality (23% vs. 36%; P = .001) and fewer heart failure rehospitalizations (32% vs. 49%, P less than .0001). Transcatheter repair was associated with greater survival and freedom from heart failure rehospitalization (HR, 0.60; 95% CI, 0.46-0.79; P = .003), which remained significant after adjusting for sex, New York Heart Association functional class, right ventricular dysfunction, and atrial fibrillation (HR, 0.39; 95% CI, 0.26-0.59; P less than .0001), and after further adjustment for mitral regurgitation and pacemaker/defibrillator placement (HR, 0.35; 95% CI, 0.23-0.54; P less than .0001). Subgroup analyses based on mitral regurgitation severity, pulmonary artery pressure, and other factors all favored repair.
“This is an important set of data to show that, indeed, fixing the tricuspid valve does lead to better outcomes, and perhaps we can do that with a transcatheter approach,” said Robert Bonow, MD, a professor of cardiology at Northwestern University, Chicago, after hearing the presentation.
The fact that transcatheter patients were sicker when they were treated is reassuring, added moderator Ajay Kirtane, MD, an interventional cardiologist and associate professor of medicine at Columbia University, New York.
The success rate for the procedure, which was to be alive at the end of it, with the device successfully implanted, the delivery system retrieved, and residual tricuspid regurgitation (TR) less than 3+, was 86%, and 85% of patients were treated with MitraClip, most with two or three clips. Outcomes were similar, but not worse, than medical management when TR wasn’t significantly reduced.
Operators were highly experienced, there were no emergent conversions to surgery, and patients tolerated the approach “pretty well,” Dr. Taramasso said. The lesson is that “we should really try to reduce TR, but just a little bit is not enough.” Overall, “we probably need better devices and better patient selection. With the data we are collecting, we’ll be able soon to known when late is too late, which patients should not be treated,” he said.
The study didn’t address postprocedure medications, but it’s been noted in the registry that medication use generally declines after a few months. Subjects tended to be aged in their mid-70s, and there were slightly more women than men.
The results were published online concurrently with Dr. Taramasso’s report in the Journal of the American College of Cardiology.
No company funding was reported. Dr. Taramasso is a consultant for Abbott Vascular, Boston Scientific, 4TECH, and CoreMedic; and has received speaker fees from Edwards Lifesciences.
SOURCE: Taramasso M et al. J Am Coll Cardiol. 2019 Sep 24. doi: 10.1016/j.jacc.2019.09.028.
REPORTING FROM TCT 2019
Strong showing for TAVR after 5 years in PARTNER 2A
SAN FRANCISCO – At 5 years, the rates of disabling stroke or death were similar among patients with severe aortic stenosis and intermediate surgical risk who underwent transcatheter aortic valve replacement or surgical aortic valve replacement.
At the same time, patients who underwent TAVR using a transthoracic approach had poorer outcomes, compared with their counterparts who underwent SAVR, Vinod H. Thourani, MD, reported at the Transcatheter Cardiovascular Therapeutics annual meeting. The findings come from an analysis of the PARTNER 2A trial, the largest randomized study ever conducted in the field of TAVR and SAVR.
In an effort to compare the key clinical outcomes, bioprosthetic valve function, and quality-of-life measures at 5 years for TAVR versus surgery, Dr. Thourani and his colleagues used data from 2,032 intermediate-risk patients with severe AS assigned to either TAVR or SAVR at 57 centers in the PARTNER 2A trial. Their mean age was 82 years, and their average Society of Thoracic Surgery risk score was 5.8%. The 2-year primary endpoint was all-cause death or disabling stroke in the intention-to-treat (ITT) population. At 5 years, the researchers analyzed all primary and secondary clinical and echo endpoints in both ITT and prespecified as-treated populations.
At 5 years, the primary endpoint of death and disabling stroke at 5 years was 47.9% in the TAVR group and 43.4% in the surgery group, a difference that did not reach statistical significance (hazard ratio, 1.09; P = .21). In the transfemoral cohort, rates of the primary endpoint were also similar between TAVR and SAVR (44.5% vs. 42%, respectively; HR, 1.02; P = .80). In the transthoracic cohort, however, the researchers observed a divergence in the primary outcome starting at year 1, such that it was higher with TAVR at 5 years, compared with SAVR (59.3% vs. 48.3%; P = .03), reported Dr. Thourani, chair of cardiac surgery at Medstar Heart and Vascular Institute, Washington.
When he and his colleagues examined freedom from aortic valve reintervention at 5 years, the hazard ratios showed some difference between TAVR and SAVR (HR, 3.93; P = .003), yet clinically the freedom from reintervention rate was very high (96.8% vs. 99.4%, respectively). “The other issue we’ve been interested in is the difference between mean aortic valve gradients between the groups,” Dr. Thourani said at the meeting. “There was no difference in mean aortic valve gradients between TAVR and SAVR at 5 years (a mean of 11.4 mm Hg vs. 10.8 mm Hg, respectively; P = .23).”
Paravalvular regurgitation (PVR) was more common in the TAVR vs. SAVR group at all follow-up times (P less than .001 in all categories). By year 5, the proportion of patients with moderate to severe PVR was 6.5% in the TAVR group vs. 0.4% in the SAVR group, respectively, while the proportion of those with mild PVR was 26.8%, compared with 5.9%.
In other findings, no difference in mortality was seen in the TAVR cohort between those with mild PVR and no or trace PVR (48.7% vs. 41.1%; P = .07). However, those with moderate to severe PVR at the end of the procedure had an increased mortality at the end of 5 years (64.8%; P = .007). “If you had none or trace PVR at baseline, there was no major difference in mortality between the two groups at 2 years,” Dr. Thourani said. “That difference was maintained at 5 years.”
The overall findings, he continued, support the notion that TAVR should be considered as an alternative to surgery in intermediate-risk patients with severe aortic stenosis. “However, in patients without acceptable transfemoral access, surgery may be the preferred alternative,” he said.
Roxana Mehran, MD,, director of interventional cardiovascular research and clinical trials at Mount Sinai School of Medicine, New York, commented that the reassurance of the same outcomes at 5 years between the two approaches “makes TAVR superior. It’s a less invasive and durable result. One of the things we have yet to figure out is the need for anticoagulation to prevent stroke in these patients. We have very little data and understanding about that.”
The PARTNER 2A study was funded by Edwards Lifesciences. Dr. Thourani has received grant or research support from and participation in steering committees for Edwards Lifesciences, Abbott Vascular, Boston Scientific, Gore Vascular, JenaValve, and Cryolife.
SAN FRANCISCO – At 5 years, the rates of disabling stroke or death were similar among patients with severe aortic stenosis and intermediate surgical risk who underwent transcatheter aortic valve replacement or surgical aortic valve replacement.
At the same time, patients who underwent TAVR using a transthoracic approach had poorer outcomes, compared with their counterparts who underwent SAVR, Vinod H. Thourani, MD, reported at the Transcatheter Cardiovascular Therapeutics annual meeting. The findings come from an analysis of the PARTNER 2A trial, the largest randomized study ever conducted in the field of TAVR and SAVR.
In an effort to compare the key clinical outcomes, bioprosthetic valve function, and quality-of-life measures at 5 years for TAVR versus surgery, Dr. Thourani and his colleagues used data from 2,032 intermediate-risk patients with severe AS assigned to either TAVR or SAVR at 57 centers in the PARTNER 2A trial. Their mean age was 82 years, and their average Society of Thoracic Surgery risk score was 5.8%. The 2-year primary endpoint was all-cause death or disabling stroke in the intention-to-treat (ITT) population. At 5 years, the researchers analyzed all primary and secondary clinical and echo endpoints in both ITT and prespecified as-treated populations.
At 5 years, the primary endpoint of death and disabling stroke at 5 years was 47.9% in the TAVR group and 43.4% in the surgery group, a difference that did not reach statistical significance (hazard ratio, 1.09; P = .21). In the transfemoral cohort, rates of the primary endpoint were also similar between TAVR and SAVR (44.5% vs. 42%, respectively; HR, 1.02; P = .80). In the transthoracic cohort, however, the researchers observed a divergence in the primary outcome starting at year 1, such that it was higher with TAVR at 5 years, compared with SAVR (59.3% vs. 48.3%; P = .03), reported Dr. Thourani, chair of cardiac surgery at Medstar Heart and Vascular Institute, Washington.
When he and his colleagues examined freedom from aortic valve reintervention at 5 years, the hazard ratios showed some difference between TAVR and SAVR (HR, 3.93; P = .003), yet clinically the freedom from reintervention rate was very high (96.8% vs. 99.4%, respectively). “The other issue we’ve been interested in is the difference between mean aortic valve gradients between the groups,” Dr. Thourani said at the meeting. “There was no difference in mean aortic valve gradients between TAVR and SAVR at 5 years (a mean of 11.4 mm Hg vs. 10.8 mm Hg, respectively; P = .23).”
Paravalvular regurgitation (PVR) was more common in the TAVR vs. SAVR group at all follow-up times (P less than .001 in all categories). By year 5, the proportion of patients with moderate to severe PVR was 6.5% in the TAVR group vs. 0.4% in the SAVR group, respectively, while the proportion of those with mild PVR was 26.8%, compared with 5.9%.
In other findings, no difference in mortality was seen in the TAVR cohort between those with mild PVR and no or trace PVR (48.7% vs. 41.1%; P = .07). However, those with moderate to severe PVR at the end of the procedure had an increased mortality at the end of 5 years (64.8%; P = .007). “If you had none or trace PVR at baseline, there was no major difference in mortality between the two groups at 2 years,” Dr. Thourani said. “That difference was maintained at 5 years.”
The overall findings, he continued, support the notion that TAVR should be considered as an alternative to surgery in intermediate-risk patients with severe aortic stenosis. “However, in patients without acceptable transfemoral access, surgery may be the preferred alternative,” he said.
Roxana Mehran, MD,, director of interventional cardiovascular research and clinical trials at Mount Sinai School of Medicine, New York, commented that the reassurance of the same outcomes at 5 years between the two approaches “makes TAVR superior. It’s a less invasive and durable result. One of the things we have yet to figure out is the need for anticoagulation to prevent stroke in these patients. We have very little data and understanding about that.”
The PARTNER 2A study was funded by Edwards Lifesciences. Dr. Thourani has received grant or research support from and participation in steering committees for Edwards Lifesciences, Abbott Vascular, Boston Scientific, Gore Vascular, JenaValve, and Cryolife.
SAN FRANCISCO – At 5 years, the rates of disabling stroke or death were similar among patients with severe aortic stenosis and intermediate surgical risk who underwent transcatheter aortic valve replacement or surgical aortic valve replacement.
At the same time, patients who underwent TAVR using a transthoracic approach had poorer outcomes, compared with their counterparts who underwent SAVR, Vinod H. Thourani, MD, reported at the Transcatheter Cardiovascular Therapeutics annual meeting. The findings come from an analysis of the PARTNER 2A trial, the largest randomized study ever conducted in the field of TAVR and SAVR.
In an effort to compare the key clinical outcomes, bioprosthetic valve function, and quality-of-life measures at 5 years for TAVR versus surgery, Dr. Thourani and his colleagues used data from 2,032 intermediate-risk patients with severe AS assigned to either TAVR or SAVR at 57 centers in the PARTNER 2A trial. Their mean age was 82 years, and their average Society of Thoracic Surgery risk score was 5.8%. The 2-year primary endpoint was all-cause death or disabling stroke in the intention-to-treat (ITT) population. At 5 years, the researchers analyzed all primary and secondary clinical and echo endpoints in both ITT and prespecified as-treated populations.
At 5 years, the primary endpoint of death and disabling stroke at 5 years was 47.9% in the TAVR group and 43.4% in the surgery group, a difference that did not reach statistical significance (hazard ratio, 1.09; P = .21). In the transfemoral cohort, rates of the primary endpoint were also similar between TAVR and SAVR (44.5% vs. 42%, respectively; HR, 1.02; P = .80). In the transthoracic cohort, however, the researchers observed a divergence in the primary outcome starting at year 1, such that it was higher with TAVR at 5 years, compared with SAVR (59.3% vs. 48.3%; P = .03), reported Dr. Thourani, chair of cardiac surgery at Medstar Heart and Vascular Institute, Washington.
When he and his colleagues examined freedom from aortic valve reintervention at 5 years, the hazard ratios showed some difference between TAVR and SAVR (HR, 3.93; P = .003), yet clinically the freedom from reintervention rate was very high (96.8% vs. 99.4%, respectively). “The other issue we’ve been interested in is the difference between mean aortic valve gradients between the groups,” Dr. Thourani said at the meeting. “There was no difference in mean aortic valve gradients between TAVR and SAVR at 5 years (a mean of 11.4 mm Hg vs. 10.8 mm Hg, respectively; P = .23).”
Paravalvular regurgitation (PVR) was more common in the TAVR vs. SAVR group at all follow-up times (P less than .001 in all categories). By year 5, the proportion of patients with moderate to severe PVR was 6.5% in the TAVR group vs. 0.4% in the SAVR group, respectively, while the proportion of those with mild PVR was 26.8%, compared with 5.9%.
In other findings, no difference in mortality was seen in the TAVR cohort between those with mild PVR and no or trace PVR (48.7% vs. 41.1%; P = .07). However, those with moderate to severe PVR at the end of the procedure had an increased mortality at the end of 5 years (64.8%; P = .007). “If you had none or trace PVR at baseline, there was no major difference in mortality between the two groups at 2 years,” Dr. Thourani said. “That difference was maintained at 5 years.”
The overall findings, he continued, support the notion that TAVR should be considered as an alternative to surgery in intermediate-risk patients with severe aortic stenosis. “However, in patients without acceptable transfemoral access, surgery may be the preferred alternative,” he said.
Roxana Mehran, MD,, director of interventional cardiovascular research and clinical trials at Mount Sinai School of Medicine, New York, commented that the reassurance of the same outcomes at 5 years between the two approaches “makes TAVR superior. It’s a less invasive and durable result. One of the things we have yet to figure out is the need for anticoagulation to prevent stroke in these patients. We have very little data and understanding about that.”
The PARTNER 2A study was funded by Edwards Lifesciences. Dr. Thourani has received grant or research support from and participation in steering committees for Edwards Lifesciences, Abbott Vascular, Boston Scientific, Gore Vascular, JenaValve, and Cryolife.
AT TCT 2019
Investigative device cut risk of contrast-induced AKI
SAN FRANCISCO – A urine flow rate (UFR)–guided approach was superior to the left ventricular end-diastolic pressure (LVEDP)-guided hydration regimen in preventing contrast-induced acute kidney injury and acute pulmonary edema in high-risk patients.
The results come from a randomized, multicenter, investigator-initiated trial designed to compare two hydration strategies for reducing the risk of acute kidney injury that Carlo Briguori, MD, PhD, presented at the Transcatheter Cardiovascular Therapeutics annual meeting.
Between July 15, 2015 and June 6, 2019, Dr. Briguori, chief of the laboratory of interventional cardiology at the Mediterranea Cardiocentro in Naples, Italy, and his colleagues enrolled 708 patients with an estimated glomerular filtration rate of 45 mL/min per 1.73 m2 or less and/or with a Mehran’s score greater of at least 11 and/or a Gurm’s score greater than 7. Of these, 355 were assigned to LVEDP-guided hydration with normal saline, while 353 were assigned to UFR-guided hydration controlled by the RenalGuard system. Iobitridol, a low-osmolar, nonionic contrast agent, was administered in all cases.
The primary endpoint for the trial, known as Renal Insufficiency Following Contrast Media Administration Trial III (REMEDIAL III), was the composite of contrast-induced acute kidney injury (defined as a serum creatinine increase of at least 25% and/or at least 0.5 mg/dL from baseline to 48 hours) and/or acute pulmonary edema. That endpoint occurred in 5.7% of patients in the UFR-guided group and in 10.3% of patients in the LVEDP-guided group (relative risk, 0.56; P = .036). As for side effects, three patients in the UFR-guided group (0.8%) experienced complications related to Foley insertion, including one case of hematuria and two cases of pain on micturition. No patients developed a urinary tract infection, Dr. Briguori reported at the meeting, which was sponsored by the Cardiovascular Research Foundation.
Hypokalemia occurred in 6.2% of patients in the UFR-guided group and 2.3% of patients in the LVEDP-guided group (RR, 2.70; P = .013), while potassium replacement was required in 5.1% of patients in the UFR-guided group, compared with 1.4% of LVEDP-guided patients (RR, 3.74; P = .009). Meanwhile, hypernatremia was observed in 1.2% of patients in both groups (P = 1.00).
“For the longest time, the interventional field has been trying to find ways to minimize acute kidney injury related to interventional procedures,” Juan F. Granada, MD, president and CEO of the Cardiovascular Research Foundation said in a media briefing. “We have a lot of data with multiple approaches with different results – mostly negative. This is important because, as procedures get more complex, longer, and contrast media is used, there is continuous interest in minimizing the potential kidney injury.”
A discussant at the briefing, Gary S. Mintz, MD, a senior medical adviser for the CRF, suggested a different approach to preventing contrast-induced nephropathy. “If you do imaging-guided zero-contrast percutaneous coronary intervention, you do not get contrast-induced nephropathy, period,” he said. “If you get rid of contrast, you get rid of contrast nephropathy. Anybody who has worked with patients who transition to dialysis understands that once you go on dialysis, your life changes for the worse no matter what you do. There has been no improvement in dialysis therapy in decades. But to me, the solution is to get rid of contrast, which can be done if you think differently and plan differently.”
For his part, Dr. Briguori said that he and his colleagues in REMEDIAL III “tried to use the least amount of contrast possible. The mean volume of contrast media in this trial was 70 mL, which is very low.”
The RenalGuard device (RenalGuard Solutions) is CE-marked for sale in Europe and is under investigation in the United States. The REMEDIAL III study was supported by an unrestricted grant from Guerbet (Villepinte, France) provided to the Mediterranea Cardiocentro. Dr. Briguori reported having no relevant disclosures.
SOURCE: Briguori C. TCT 2019, Late Breaking Trials 4 Session.
SAN FRANCISCO – A urine flow rate (UFR)–guided approach was superior to the left ventricular end-diastolic pressure (LVEDP)-guided hydration regimen in preventing contrast-induced acute kidney injury and acute pulmonary edema in high-risk patients.
The results come from a randomized, multicenter, investigator-initiated trial designed to compare two hydration strategies for reducing the risk of acute kidney injury that Carlo Briguori, MD, PhD, presented at the Transcatheter Cardiovascular Therapeutics annual meeting.
Between July 15, 2015 and June 6, 2019, Dr. Briguori, chief of the laboratory of interventional cardiology at the Mediterranea Cardiocentro in Naples, Italy, and his colleagues enrolled 708 patients with an estimated glomerular filtration rate of 45 mL/min per 1.73 m2 or less and/or with a Mehran’s score greater of at least 11 and/or a Gurm’s score greater than 7. Of these, 355 were assigned to LVEDP-guided hydration with normal saline, while 353 were assigned to UFR-guided hydration controlled by the RenalGuard system. Iobitridol, a low-osmolar, nonionic contrast agent, was administered in all cases.
The primary endpoint for the trial, known as Renal Insufficiency Following Contrast Media Administration Trial III (REMEDIAL III), was the composite of contrast-induced acute kidney injury (defined as a serum creatinine increase of at least 25% and/or at least 0.5 mg/dL from baseline to 48 hours) and/or acute pulmonary edema. That endpoint occurred in 5.7% of patients in the UFR-guided group and in 10.3% of patients in the LVEDP-guided group (relative risk, 0.56; P = .036). As for side effects, three patients in the UFR-guided group (0.8%) experienced complications related to Foley insertion, including one case of hematuria and two cases of pain on micturition. No patients developed a urinary tract infection, Dr. Briguori reported at the meeting, which was sponsored by the Cardiovascular Research Foundation.
Hypokalemia occurred in 6.2% of patients in the UFR-guided group and 2.3% of patients in the LVEDP-guided group (RR, 2.70; P = .013), while potassium replacement was required in 5.1% of patients in the UFR-guided group, compared with 1.4% of LVEDP-guided patients (RR, 3.74; P = .009). Meanwhile, hypernatremia was observed in 1.2% of patients in both groups (P = 1.00).
“For the longest time, the interventional field has been trying to find ways to minimize acute kidney injury related to interventional procedures,” Juan F. Granada, MD, president and CEO of the Cardiovascular Research Foundation said in a media briefing. “We have a lot of data with multiple approaches with different results – mostly negative. This is important because, as procedures get more complex, longer, and contrast media is used, there is continuous interest in minimizing the potential kidney injury.”
A discussant at the briefing, Gary S. Mintz, MD, a senior medical adviser for the CRF, suggested a different approach to preventing contrast-induced nephropathy. “If you do imaging-guided zero-contrast percutaneous coronary intervention, you do not get contrast-induced nephropathy, period,” he said. “If you get rid of contrast, you get rid of contrast nephropathy. Anybody who has worked with patients who transition to dialysis understands that once you go on dialysis, your life changes for the worse no matter what you do. There has been no improvement in dialysis therapy in decades. But to me, the solution is to get rid of contrast, which can be done if you think differently and plan differently.”
For his part, Dr. Briguori said that he and his colleagues in REMEDIAL III “tried to use the least amount of contrast possible. The mean volume of contrast media in this trial was 70 mL, which is very low.”
The RenalGuard device (RenalGuard Solutions) is CE-marked for sale in Europe and is under investigation in the United States. The REMEDIAL III study was supported by an unrestricted grant from Guerbet (Villepinte, France) provided to the Mediterranea Cardiocentro. Dr. Briguori reported having no relevant disclosures.
SOURCE: Briguori C. TCT 2019, Late Breaking Trials 4 Session.
SAN FRANCISCO – A urine flow rate (UFR)–guided approach was superior to the left ventricular end-diastolic pressure (LVEDP)-guided hydration regimen in preventing contrast-induced acute kidney injury and acute pulmonary edema in high-risk patients.
The results come from a randomized, multicenter, investigator-initiated trial designed to compare two hydration strategies for reducing the risk of acute kidney injury that Carlo Briguori, MD, PhD, presented at the Transcatheter Cardiovascular Therapeutics annual meeting.
Between July 15, 2015 and June 6, 2019, Dr. Briguori, chief of the laboratory of interventional cardiology at the Mediterranea Cardiocentro in Naples, Italy, and his colleagues enrolled 708 patients with an estimated glomerular filtration rate of 45 mL/min per 1.73 m2 or less and/or with a Mehran’s score greater of at least 11 and/or a Gurm’s score greater than 7. Of these, 355 were assigned to LVEDP-guided hydration with normal saline, while 353 were assigned to UFR-guided hydration controlled by the RenalGuard system. Iobitridol, a low-osmolar, nonionic contrast agent, was administered in all cases.
The primary endpoint for the trial, known as Renal Insufficiency Following Contrast Media Administration Trial III (REMEDIAL III), was the composite of contrast-induced acute kidney injury (defined as a serum creatinine increase of at least 25% and/or at least 0.5 mg/dL from baseline to 48 hours) and/or acute pulmonary edema. That endpoint occurred in 5.7% of patients in the UFR-guided group and in 10.3% of patients in the LVEDP-guided group (relative risk, 0.56; P = .036). As for side effects, three patients in the UFR-guided group (0.8%) experienced complications related to Foley insertion, including one case of hematuria and two cases of pain on micturition. No patients developed a urinary tract infection, Dr. Briguori reported at the meeting, which was sponsored by the Cardiovascular Research Foundation.
Hypokalemia occurred in 6.2% of patients in the UFR-guided group and 2.3% of patients in the LVEDP-guided group (RR, 2.70; P = .013), while potassium replacement was required in 5.1% of patients in the UFR-guided group, compared with 1.4% of LVEDP-guided patients (RR, 3.74; P = .009). Meanwhile, hypernatremia was observed in 1.2% of patients in both groups (P = 1.00).
“For the longest time, the interventional field has been trying to find ways to minimize acute kidney injury related to interventional procedures,” Juan F. Granada, MD, president and CEO of the Cardiovascular Research Foundation said in a media briefing. “We have a lot of data with multiple approaches with different results – mostly negative. This is important because, as procedures get more complex, longer, and contrast media is used, there is continuous interest in minimizing the potential kidney injury.”
A discussant at the briefing, Gary S. Mintz, MD, a senior medical adviser for the CRF, suggested a different approach to preventing contrast-induced nephropathy. “If you do imaging-guided zero-contrast percutaneous coronary intervention, you do not get contrast-induced nephropathy, period,” he said. “If you get rid of contrast, you get rid of contrast nephropathy. Anybody who has worked with patients who transition to dialysis understands that once you go on dialysis, your life changes for the worse no matter what you do. There has been no improvement in dialysis therapy in decades. But to me, the solution is to get rid of contrast, which can be done if you think differently and plan differently.”
For his part, Dr. Briguori said that he and his colleagues in REMEDIAL III “tried to use the least amount of contrast possible. The mean volume of contrast media in this trial was 70 mL, which is very low.”
The RenalGuard device (RenalGuard Solutions) is CE-marked for sale in Europe and is under investigation in the United States. The REMEDIAL III study was supported by an unrestricted grant from Guerbet (Villepinte, France) provided to the Mediterranea Cardiocentro. Dr. Briguori reported having no relevant disclosures.
SOURCE: Briguori C. TCT 2019, Late Breaking Trials 4 Session.
REPORTING FROM TCT 2019
Portico system safe, effective for high-risk TAVR patients
SAN FRANCISCO – An investigational device exemption trial of the Portico valve with FlexNav delivery system showed 1-year clinical results on par with commercially available valves, Gregory P. Fontana, MD, reported at the Transcatheter Cardiovascular Therapeutics annual meeting.
In a prospective, open-label study conducted at 52 sites known as PORTICO, Dr. Fontana and colleagues conducted a noninferiority intention-to-treat evaluation of the safety and effectiveness of the self-expanding Portico transcatheter aortic valve replacement system, compared with Food and Drug Administration–approved and commercially available TAVR systems for patients with severe aortic stenosis at high or extreme risk for surgery. Between May 2014 and June 2019, 750 patients from 69 sites were randomized 1:1 to each group. The prespecified primary safety composite endpoint was all-cause mortality, disabling stroke, life-threatening bleeding requiring blood transfusion, acute kidney injury requiring dialysis, or major vascular complications at 30 days, while the primary effectiveness composite endpoint was all-cause mortality or disabling stroke at 1 year.
The mean baseline age of patients was 83 years, 53% were female, and their mean Society of Thoracic Surgeons score was 6.5%. Dr. Fontana, director and chairman of cardiothoracic surgery at the CardioVascular Institute of Los Robles Regional Medical Center, Thousand Oaks, Calif., reported at the meeting sponsored by the Cardiovascular Research Foundation that procedural success was comparable between groups (96.5% for Portico vs, 98.3% for commercially available TAVR, respectively). In addition, patients in both groups met the prespecified primary safety composite endpoint (13.8% vs. 9.6%; P for noninferiority = .03) and the primary effectiveness composite endpoint (14.9% vs. 13.4%, P for noninferiority = .006).
However, the rate of moderate to severe paravalvular leak at 30 days was 6.3% among patients in the Portico valve group, compared with 2.1% of their counterparts in the commercially available TAVR group, a difference that did not reach noninferiority. Dr. Fontana said that a next-generation valve with design modifications to reduce paravalvular leak is being tested in clinical trials.
PORTICO included a separate cohort of 100 patients who underwent Portico valve implantation using the FlexNav Delivery System, which became available after the trial had launched. The primary safety endpoint for the FlexNav cohort was major vascular complication rate at 30 days. This cohort demonstrated no deaths or strokes, low rates of major vascular complications (7.0%) and new permanent pacemaker implants (14.6%), as well as a safety profile comparable with the commercially available valve group in the randomized study (8.0% vs. 9.6%).
“My sense of this device is that presumably it will be another valve we have available to us in the United States,” Pinak B. Shah, MD, a cardiologist at Brigham and Women’s Hospital, Boston, said during a media briefing. “The challenge to all of us is to figure out where it fits in our armamentarium. Is it going to be worth individuals to learn a whole new device when at this point it’s hard to say if there’s a major difference compared to the other self-expanding devices we have now?”
With the new FlexNav delivery system, the Portico valve is characterized by “a very calm, slow delivery,” said Dr. Fontana, who was the study’s coprincipal investigator, along with Raj R. Makkar, MD, director of interventional cardiology at Cedars-Sinai Medical Center, Los Angeles. “The operator can land the valve exactly where they want it. If they’re not happy, they can make some adjustments. I haven’t yet a system in my hands that is as stable as this. The option of having excellent hemodynamics and large cells to engage the coronary system is a unique combination for us in the United States.”
The Portico valve is not currently FDA approved. The PORTICO study was funded by Abbott. Dr. Fontana disclosed grant/research support from Abbott and Medtronic and consulting fees/honoraria from Abbott, Medtronic, and LivaNova.
SAN FRANCISCO – An investigational device exemption trial of the Portico valve with FlexNav delivery system showed 1-year clinical results on par with commercially available valves, Gregory P. Fontana, MD, reported at the Transcatheter Cardiovascular Therapeutics annual meeting.
In a prospective, open-label study conducted at 52 sites known as PORTICO, Dr. Fontana and colleagues conducted a noninferiority intention-to-treat evaluation of the safety and effectiveness of the self-expanding Portico transcatheter aortic valve replacement system, compared with Food and Drug Administration–approved and commercially available TAVR systems for patients with severe aortic stenosis at high or extreme risk for surgery. Between May 2014 and June 2019, 750 patients from 69 sites were randomized 1:1 to each group. The prespecified primary safety composite endpoint was all-cause mortality, disabling stroke, life-threatening bleeding requiring blood transfusion, acute kidney injury requiring dialysis, or major vascular complications at 30 days, while the primary effectiveness composite endpoint was all-cause mortality or disabling stroke at 1 year.
The mean baseline age of patients was 83 years, 53% were female, and their mean Society of Thoracic Surgeons score was 6.5%. Dr. Fontana, director and chairman of cardiothoracic surgery at the CardioVascular Institute of Los Robles Regional Medical Center, Thousand Oaks, Calif., reported at the meeting sponsored by the Cardiovascular Research Foundation that procedural success was comparable between groups (96.5% for Portico vs, 98.3% for commercially available TAVR, respectively). In addition, patients in both groups met the prespecified primary safety composite endpoint (13.8% vs. 9.6%; P for noninferiority = .03) and the primary effectiveness composite endpoint (14.9% vs. 13.4%, P for noninferiority = .006).
However, the rate of moderate to severe paravalvular leak at 30 days was 6.3% among patients in the Portico valve group, compared with 2.1% of their counterparts in the commercially available TAVR group, a difference that did not reach noninferiority. Dr. Fontana said that a next-generation valve with design modifications to reduce paravalvular leak is being tested in clinical trials.
PORTICO included a separate cohort of 100 patients who underwent Portico valve implantation using the FlexNav Delivery System, which became available after the trial had launched. The primary safety endpoint for the FlexNav cohort was major vascular complication rate at 30 days. This cohort demonstrated no deaths or strokes, low rates of major vascular complications (7.0%) and new permanent pacemaker implants (14.6%), as well as a safety profile comparable with the commercially available valve group in the randomized study (8.0% vs. 9.6%).
“My sense of this device is that presumably it will be another valve we have available to us in the United States,” Pinak B. Shah, MD, a cardiologist at Brigham and Women’s Hospital, Boston, said during a media briefing. “The challenge to all of us is to figure out where it fits in our armamentarium. Is it going to be worth individuals to learn a whole new device when at this point it’s hard to say if there’s a major difference compared to the other self-expanding devices we have now?”
With the new FlexNav delivery system, the Portico valve is characterized by “a very calm, slow delivery,” said Dr. Fontana, who was the study’s coprincipal investigator, along with Raj R. Makkar, MD, director of interventional cardiology at Cedars-Sinai Medical Center, Los Angeles. “The operator can land the valve exactly where they want it. If they’re not happy, they can make some adjustments. I haven’t yet a system in my hands that is as stable as this. The option of having excellent hemodynamics and large cells to engage the coronary system is a unique combination for us in the United States.”
The Portico valve is not currently FDA approved. The PORTICO study was funded by Abbott. Dr. Fontana disclosed grant/research support from Abbott and Medtronic and consulting fees/honoraria from Abbott, Medtronic, and LivaNova.
SAN FRANCISCO – An investigational device exemption trial of the Portico valve with FlexNav delivery system showed 1-year clinical results on par with commercially available valves, Gregory P. Fontana, MD, reported at the Transcatheter Cardiovascular Therapeutics annual meeting.
In a prospective, open-label study conducted at 52 sites known as PORTICO, Dr. Fontana and colleagues conducted a noninferiority intention-to-treat evaluation of the safety and effectiveness of the self-expanding Portico transcatheter aortic valve replacement system, compared with Food and Drug Administration–approved and commercially available TAVR systems for patients with severe aortic stenosis at high or extreme risk for surgery. Between May 2014 and June 2019, 750 patients from 69 sites were randomized 1:1 to each group. The prespecified primary safety composite endpoint was all-cause mortality, disabling stroke, life-threatening bleeding requiring blood transfusion, acute kidney injury requiring dialysis, or major vascular complications at 30 days, while the primary effectiveness composite endpoint was all-cause mortality or disabling stroke at 1 year.
The mean baseline age of patients was 83 years, 53% were female, and their mean Society of Thoracic Surgeons score was 6.5%. Dr. Fontana, director and chairman of cardiothoracic surgery at the CardioVascular Institute of Los Robles Regional Medical Center, Thousand Oaks, Calif., reported at the meeting sponsored by the Cardiovascular Research Foundation that procedural success was comparable between groups (96.5% for Portico vs, 98.3% for commercially available TAVR, respectively). In addition, patients in both groups met the prespecified primary safety composite endpoint (13.8% vs. 9.6%; P for noninferiority = .03) and the primary effectiveness composite endpoint (14.9% vs. 13.4%, P for noninferiority = .006).
However, the rate of moderate to severe paravalvular leak at 30 days was 6.3% among patients in the Portico valve group, compared with 2.1% of their counterparts in the commercially available TAVR group, a difference that did not reach noninferiority. Dr. Fontana said that a next-generation valve with design modifications to reduce paravalvular leak is being tested in clinical trials.
PORTICO included a separate cohort of 100 patients who underwent Portico valve implantation using the FlexNav Delivery System, which became available after the trial had launched. The primary safety endpoint for the FlexNav cohort was major vascular complication rate at 30 days. This cohort demonstrated no deaths or strokes, low rates of major vascular complications (7.0%) and new permanent pacemaker implants (14.6%), as well as a safety profile comparable with the commercially available valve group in the randomized study (8.0% vs. 9.6%).
“My sense of this device is that presumably it will be another valve we have available to us in the United States,” Pinak B. Shah, MD, a cardiologist at Brigham and Women’s Hospital, Boston, said during a media briefing. “The challenge to all of us is to figure out where it fits in our armamentarium. Is it going to be worth individuals to learn a whole new device when at this point it’s hard to say if there’s a major difference compared to the other self-expanding devices we have now?”
With the new FlexNav delivery system, the Portico valve is characterized by “a very calm, slow delivery,” said Dr. Fontana, who was the study’s coprincipal investigator, along with Raj R. Makkar, MD, director of interventional cardiology at Cedars-Sinai Medical Center, Los Angeles. “The operator can land the valve exactly where they want it. If they’re not happy, they can make some adjustments. I haven’t yet a system in my hands that is as stable as this. The option of having excellent hemodynamics and large cells to engage the coronary system is a unique combination for us in the United States.”
The Portico valve is not currently FDA approved. The PORTICO study was funded by Abbott. Dr. Fontana disclosed grant/research support from Abbott and Medtronic and consulting fees/honoraria from Abbott, Medtronic, and LivaNova.
REPORTING FROM TCT 2019
5-year outcomes similar between PCI and CABG for left main CAD
SAN FRANCISCO – Among patients with left main coronary artery disease and low or intermediate coronary disease complexity, no significant differences were observed between percutaneous coronary intervention and coronary artery bypass graft surgery with respect to the composite rate of death, stroke, or myocardial infarction at 5 years.
The findings come from an analysis of data from the EXCEL trial, which lead investigator Gregg W. Stone, MD, presented at the Transcatheter Cardiovascular Therapeutics annual meeting.
“PCI may be considered an acceptable revascularization modality for selected patients with left main coronary artery disease, a decision which should be made after heart team discussion, taking into account each patient’s individual risk factors and preferences,” said Dr. Stone, professor of medicine and professor of population health sciences and policy at the Icahn School of Medicine at Mount Sinai, New York.
Between September 2010 and March 2014, Dr. Stone and his colleagues at 126 sites in 17 countries enrolled 1,905 patients with left main CAD and site-assessed low or intermediate CAD complexity (SYNTAX score of up to 32) for randomization into one of two arms: 948 to revascularization with the Xience everolimus-eluting stent and 957 to coronary artery bypass graft surgery (CABG). The primary outcome was the composite of death, stroke, or myocardial infarction at 5 years. Long-term additional secondary outcomes included their components at 5 years, as well as therapy failure (definite stent thrombosis or symptomatic graft stenosis or occlusion), all revascularizations, and all cerebrovascular events (stroke or transient ischemic attack).
Dr. Stone reported that at 5 years, the primary composite of death, stroke, or MI occurred in 22.0% of patients in the PCI group and 19.2% of patients in the CABG group, a nonsignificant difference at P = 0.13).
However, when the researchers broke the results into three distinct risk periods within the 5-year time frame, they found that, with longer follow-up, came more of an advantage for CABG. The relative risk of PCI vs. CABG for the primary outcome favored PCI over CABG in the first 30 days (4.9% vs. 8%; hazard ratio, 0.61; P = .008), was neutral at 30 days to 1 year (4.1 vs. 3.8%; HR, 1.07; P = .76), and reversed at 1-5 years (15.1% vs. 9.7%; HR, 1.61; P less than .001). Using restricted mean survival time analysis, Dr. Stone and his colleagues found that, at the end of the 5-year follow-up period, event-free survival time was 5.2 days longer after PCI, compared with CABG. This translates into “a very similar event-free survival of a burden of disease from these two therapies at the end of 5 years,” he said.
In their analysis of secondary endpoints, some differences were noted, including an elevated risk of all-cause mortality in the PCI group, compared with the CABG group (13% vs. 9.9%, respectively; odds ratio, 1.38), yet no differences in definite cardiovascular mortality (5% vs. 4.5%; OR, 1.13) or in MI (10.6% vs. 9.1%; OR 1.14). In addition, there were fewer cerebrovascular events in the PCI vs. CABG groups (3.3% vs. 5.2%; OR, 0.61). “Overall, all of these differences were relatively small given the 5-year perspective,” Dr. Stone said at the meeting sponsored by the Cardiovascular Research Foundation. He concluded that the early benefits of PCI attributable to reduced periprocedural risk “were attenuated by the greater number of events occurring during follow-up with CABG, such that at 5 years the cumulative mean time free from adverse events was similar with both treatments.” He noted that a 10-year or longer follow-up is required to characterize the very late safety profile of PCI and CABG as both stents and bypass grafts progressively fail over time.
Discussant Dharam Kumbhani, MD, an interventional cardiologist at UT Southwestern Medical Center, Dallas, said that the findings from EXCEL “help us move the field forward and help us understand this concept of risk with PCI versus CABG. It really does help inform shared decision-making with patients.”
Results of the study were published online at the time of presentation (N Engl J Med. 2019 Sep 28. doi: 10.1056/NEJMoa1909406). The EXCEL trial was funded by Abbott Vascular. Dr. Stone disclosed having relationships with numerous device and pharmaceutical companies but had no relevant disclosures for this study.
SOURCE: Stone G et al. TCT 2019. N Engl J Med. 2019 Sep 28. doi: 10.1056/NEJMoa1909406.
SAN FRANCISCO – Among patients with left main coronary artery disease and low or intermediate coronary disease complexity, no significant differences were observed between percutaneous coronary intervention and coronary artery bypass graft surgery with respect to the composite rate of death, stroke, or myocardial infarction at 5 years.
The findings come from an analysis of data from the EXCEL trial, which lead investigator Gregg W. Stone, MD, presented at the Transcatheter Cardiovascular Therapeutics annual meeting.
“PCI may be considered an acceptable revascularization modality for selected patients with left main coronary artery disease, a decision which should be made after heart team discussion, taking into account each patient’s individual risk factors and preferences,” said Dr. Stone, professor of medicine and professor of population health sciences and policy at the Icahn School of Medicine at Mount Sinai, New York.
Between September 2010 and March 2014, Dr. Stone and his colleagues at 126 sites in 17 countries enrolled 1,905 patients with left main CAD and site-assessed low or intermediate CAD complexity (SYNTAX score of up to 32) for randomization into one of two arms: 948 to revascularization with the Xience everolimus-eluting stent and 957 to coronary artery bypass graft surgery (CABG). The primary outcome was the composite of death, stroke, or myocardial infarction at 5 years. Long-term additional secondary outcomes included their components at 5 years, as well as therapy failure (definite stent thrombosis or symptomatic graft stenosis or occlusion), all revascularizations, and all cerebrovascular events (stroke or transient ischemic attack).
Dr. Stone reported that at 5 years, the primary composite of death, stroke, or MI occurred in 22.0% of patients in the PCI group and 19.2% of patients in the CABG group, a nonsignificant difference at P = 0.13).
However, when the researchers broke the results into three distinct risk periods within the 5-year time frame, they found that, with longer follow-up, came more of an advantage for CABG. The relative risk of PCI vs. CABG for the primary outcome favored PCI over CABG in the first 30 days (4.9% vs. 8%; hazard ratio, 0.61; P = .008), was neutral at 30 days to 1 year (4.1 vs. 3.8%; HR, 1.07; P = .76), and reversed at 1-5 years (15.1% vs. 9.7%; HR, 1.61; P less than .001). Using restricted mean survival time analysis, Dr. Stone and his colleagues found that, at the end of the 5-year follow-up period, event-free survival time was 5.2 days longer after PCI, compared with CABG. This translates into “a very similar event-free survival of a burden of disease from these two therapies at the end of 5 years,” he said.
In their analysis of secondary endpoints, some differences were noted, including an elevated risk of all-cause mortality in the PCI group, compared with the CABG group (13% vs. 9.9%, respectively; odds ratio, 1.38), yet no differences in definite cardiovascular mortality (5% vs. 4.5%; OR, 1.13) or in MI (10.6% vs. 9.1%; OR 1.14). In addition, there were fewer cerebrovascular events in the PCI vs. CABG groups (3.3% vs. 5.2%; OR, 0.61). “Overall, all of these differences were relatively small given the 5-year perspective,” Dr. Stone said at the meeting sponsored by the Cardiovascular Research Foundation. He concluded that the early benefits of PCI attributable to reduced periprocedural risk “were attenuated by the greater number of events occurring during follow-up with CABG, such that at 5 years the cumulative mean time free from adverse events was similar with both treatments.” He noted that a 10-year or longer follow-up is required to characterize the very late safety profile of PCI and CABG as both stents and bypass grafts progressively fail over time.
Discussant Dharam Kumbhani, MD, an interventional cardiologist at UT Southwestern Medical Center, Dallas, said that the findings from EXCEL “help us move the field forward and help us understand this concept of risk with PCI versus CABG. It really does help inform shared decision-making with patients.”
Results of the study were published online at the time of presentation (N Engl J Med. 2019 Sep 28. doi: 10.1056/NEJMoa1909406). The EXCEL trial was funded by Abbott Vascular. Dr. Stone disclosed having relationships with numerous device and pharmaceutical companies but had no relevant disclosures for this study.
SOURCE: Stone G et al. TCT 2019. N Engl J Med. 2019 Sep 28. doi: 10.1056/NEJMoa1909406.
SAN FRANCISCO – Among patients with left main coronary artery disease and low or intermediate coronary disease complexity, no significant differences were observed between percutaneous coronary intervention and coronary artery bypass graft surgery with respect to the composite rate of death, stroke, or myocardial infarction at 5 years.
The findings come from an analysis of data from the EXCEL trial, which lead investigator Gregg W. Stone, MD, presented at the Transcatheter Cardiovascular Therapeutics annual meeting.
“PCI may be considered an acceptable revascularization modality for selected patients with left main coronary artery disease, a decision which should be made after heart team discussion, taking into account each patient’s individual risk factors and preferences,” said Dr. Stone, professor of medicine and professor of population health sciences and policy at the Icahn School of Medicine at Mount Sinai, New York.
Between September 2010 and March 2014, Dr. Stone and his colleagues at 126 sites in 17 countries enrolled 1,905 patients with left main CAD and site-assessed low or intermediate CAD complexity (SYNTAX score of up to 32) for randomization into one of two arms: 948 to revascularization with the Xience everolimus-eluting stent and 957 to coronary artery bypass graft surgery (CABG). The primary outcome was the composite of death, stroke, or myocardial infarction at 5 years. Long-term additional secondary outcomes included their components at 5 years, as well as therapy failure (definite stent thrombosis or symptomatic graft stenosis or occlusion), all revascularizations, and all cerebrovascular events (stroke or transient ischemic attack).
Dr. Stone reported that at 5 years, the primary composite of death, stroke, or MI occurred in 22.0% of patients in the PCI group and 19.2% of patients in the CABG group, a nonsignificant difference at P = 0.13).
However, when the researchers broke the results into three distinct risk periods within the 5-year time frame, they found that, with longer follow-up, came more of an advantage for CABG. The relative risk of PCI vs. CABG for the primary outcome favored PCI over CABG in the first 30 days (4.9% vs. 8%; hazard ratio, 0.61; P = .008), was neutral at 30 days to 1 year (4.1 vs. 3.8%; HR, 1.07; P = .76), and reversed at 1-5 years (15.1% vs. 9.7%; HR, 1.61; P less than .001). Using restricted mean survival time analysis, Dr. Stone and his colleagues found that, at the end of the 5-year follow-up period, event-free survival time was 5.2 days longer after PCI, compared with CABG. This translates into “a very similar event-free survival of a burden of disease from these two therapies at the end of 5 years,” he said.
In their analysis of secondary endpoints, some differences were noted, including an elevated risk of all-cause mortality in the PCI group, compared with the CABG group (13% vs. 9.9%, respectively; odds ratio, 1.38), yet no differences in definite cardiovascular mortality (5% vs. 4.5%; OR, 1.13) or in MI (10.6% vs. 9.1%; OR 1.14). In addition, there were fewer cerebrovascular events in the PCI vs. CABG groups (3.3% vs. 5.2%; OR, 0.61). “Overall, all of these differences were relatively small given the 5-year perspective,” Dr. Stone said at the meeting sponsored by the Cardiovascular Research Foundation. He concluded that the early benefits of PCI attributable to reduced periprocedural risk “were attenuated by the greater number of events occurring during follow-up with CABG, such that at 5 years the cumulative mean time free from adverse events was similar with both treatments.” He noted that a 10-year or longer follow-up is required to characterize the very late safety profile of PCI and CABG as both stents and bypass grafts progressively fail over time.
Discussant Dharam Kumbhani, MD, an interventional cardiologist at UT Southwestern Medical Center, Dallas, said that the findings from EXCEL “help us move the field forward and help us understand this concept of risk with PCI versus CABG. It really does help inform shared decision-making with patients.”
Results of the study were published online at the time of presentation (N Engl J Med. 2019 Sep 28. doi: 10.1056/NEJMoa1909406). The EXCEL trial was funded by Abbott Vascular. Dr. Stone disclosed having relationships with numerous device and pharmaceutical companies but had no relevant disclosures for this study.
SOURCE: Stone G et al. TCT 2019. N Engl J Med. 2019 Sep 28. doi: 10.1056/NEJMoa1909406.
AT TCT 2019
Short DAPT found noninferior to longer DAPT post stent implantation
In addition, P2Y12 inhibitor monotherapy was almost equivalent to aspirin monotherapy after 3 months in terms of both bleeding and thrombotic events.
“Recent guidelines recommend short DAPT up to 3 months, only in high bleeding risk patients,” lead investigator Ken Kozuma, MD, said during a media briefing at the Transcatheter Cardiovascular Therapeutics annual meeting. “However, short-term DAPT may be beneficial for any patients. Aspirin may be more associated with bleeding complication than P2Y12 receptor inhibitors.”
In a single-arm registry trial known as MODEL U-SES, Dr. Kozuma, of Teikyo University Hospital in Tokyo, and colleagues at 65 sites in Japan prospectively evaluated the safety of 3-month DAPT after implantation of the Ultimaster bioresorbable polymer sirolimus-eluting stent (BP-SES). The secondary objective was to investigate the appropriateness of P2Y12 receptor inhibitor monotherapy compared with aspirin monotherapy after 3 months. The researchers enrolled 1,695 patients with a mean age of 70 years who were treated with U-SES and considered appropriate for 3-month DAPT after implantation.
The primary endpoint was a composite endpoint of all-cause death, myocardial infarction, stroke (ischemic and hemorrhagic), Academic Research Consortium (ARC) definite/probable stent thrombosis, and serious bleeding (Bleeding Academic Research Consortium [BARC] 3 or 5) during the 12 months after stent implantation. Major secondary endpoints included a comparison of the incidence of each event for each continued antiplatelet drug.
Of the 1,695 patients enrolled, 1,686 completed 3-month clinical follow-up while 1,616 completed 1-year clinical follow-up. Patient-level adjusted historical data from 542 subjects in the CENTURY II cohort was used as the control group. Patients in that trial received the same stent but took DAPT for 1 year.
Dr. Kozuma reported that the primary endpoint occurred in 4.3% of patients in the MODEL U-SES group, compared with 5.7% of patients in the CENTURY II BP-SES group, a difference of –3.17%, which demonstrated noninferiority of the trial (P less than .001). At 3 months, P2Y12 inhibitor monotherapy was equivalent to aspirin monotherapy in terms of both bleeding and thrombotic events (2.5% in each modality; hazard ratio, 1.14; P = 0.71).
Dr. Kozuma acknowledged certain limitations of the trial, including the fact that propensity score adjusted analysis “may not compensate the selection bias of this study sufficiently, since considerable baseline difference was observed. Also, comparison between aspirin and P2Y12 receptor inhibitors was not randomized so that the safety and efficacy of each antiplatelet monotherapy cannot be conclusive.”
Despite these limitations, he concluded that the trial “demonstrated that 3-month DAPT was noninferior to an adjusted cohort of longer DAPT after BP-SES implantation in net adverse clinical events. Direct comparison between P2Y12 inhibitor and aspirin would be necessary to confirm the efficacy and safety of P2Y12 inhibitor monotherapy in a randomized fashion.”
The meeting was sponsored by the Cardiovascular Research Foundation.
Terumo sponsored the trial. Dr. Kozuma disclosed that he serves on the scientific advisory boards for and has received honoraria from Terumo, Abbott Vascular Japan, Boston Scientific Japan, Daiichi-Sankyo, Sanofi, Bayer, Boehringer Ingelheim and Bristol-Meyers Squibb.
SOURCE: Kozuma K et al. TCT 2019, late-breaking presentation.
In addition, P2Y12 inhibitor monotherapy was almost equivalent to aspirin monotherapy after 3 months in terms of both bleeding and thrombotic events.
“Recent guidelines recommend short DAPT up to 3 months, only in high bleeding risk patients,” lead investigator Ken Kozuma, MD, said during a media briefing at the Transcatheter Cardiovascular Therapeutics annual meeting. “However, short-term DAPT may be beneficial for any patients. Aspirin may be more associated with bleeding complication than P2Y12 receptor inhibitors.”
In a single-arm registry trial known as MODEL U-SES, Dr. Kozuma, of Teikyo University Hospital in Tokyo, and colleagues at 65 sites in Japan prospectively evaluated the safety of 3-month DAPT after implantation of the Ultimaster bioresorbable polymer sirolimus-eluting stent (BP-SES). The secondary objective was to investigate the appropriateness of P2Y12 receptor inhibitor monotherapy compared with aspirin monotherapy after 3 months. The researchers enrolled 1,695 patients with a mean age of 70 years who were treated with U-SES and considered appropriate for 3-month DAPT after implantation.
The primary endpoint was a composite endpoint of all-cause death, myocardial infarction, stroke (ischemic and hemorrhagic), Academic Research Consortium (ARC) definite/probable stent thrombosis, and serious bleeding (Bleeding Academic Research Consortium [BARC] 3 or 5) during the 12 months after stent implantation. Major secondary endpoints included a comparison of the incidence of each event for each continued antiplatelet drug.
Of the 1,695 patients enrolled, 1,686 completed 3-month clinical follow-up while 1,616 completed 1-year clinical follow-up. Patient-level adjusted historical data from 542 subjects in the CENTURY II cohort was used as the control group. Patients in that trial received the same stent but took DAPT for 1 year.
Dr. Kozuma reported that the primary endpoint occurred in 4.3% of patients in the MODEL U-SES group, compared with 5.7% of patients in the CENTURY II BP-SES group, a difference of –3.17%, which demonstrated noninferiority of the trial (P less than .001). At 3 months, P2Y12 inhibitor monotherapy was equivalent to aspirin monotherapy in terms of both bleeding and thrombotic events (2.5% in each modality; hazard ratio, 1.14; P = 0.71).
Dr. Kozuma acknowledged certain limitations of the trial, including the fact that propensity score adjusted analysis “may not compensate the selection bias of this study sufficiently, since considerable baseline difference was observed. Also, comparison between aspirin and P2Y12 receptor inhibitors was not randomized so that the safety and efficacy of each antiplatelet monotherapy cannot be conclusive.”
Despite these limitations, he concluded that the trial “demonstrated that 3-month DAPT was noninferior to an adjusted cohort of longer DAPT after BP-SES implantation in net adverse clinical events. Direct comparison between P2Y12 inhibitor and aspirin would be necessary to confirm the efficacy and safety of P2Y12 inhibitor monotherapy in a randomized fashion.”
The meeting was sponsored by the Cardiovascular Research Foundation.
Terumo sponsored the trial. Dr. Kozuma disclosed that he serves on the scientific advisory boards for and has received honoraria from Terumo, Abbott Vascular Japan, Boston Scientific Japan, Daiichi-Sankyo, Sanofi, Bayer, Boehringer Ingelheim and Bristol-Meyers Squibb.
SOURCE: Kozuma K et al. TCT 2019, late-breaking presentation.
In addition, P2Y12 inhibitor monotherapy was almost equivalent to aspirin monotherapy after 3 months in terms of both bleeding and thrombotic events.
“Recent guidelines recommend short DAPT up to 3 months, only in high bleeding risk patients,” lead investigator Ken Kozuma, MD, said during a media briefing at the Transcatheter Cardiovascular Therapeutics annual meeting. “However, short-term DAPT may be beneficial for any patients. Aspirin may be more associated with bleeding complication than P2Y12 receptor inhibitors.”
In a single-arm registry trial known as MODEL U-SES, Dr. Kozuma, of Teikyo University Hospital in Tokyo, and colleagues at 65 sites in Japan prospectively evaluated the safety of 3-month DAPT after implantation of the Ultimaster bioresorbable polymer sirolimus-eluting stent (BP-SES). The secondary objective was to investigate the appropriateness of P2Y12 receptor inhibitor monotherapy compared with aspirin monotherapy after 3 months. The researchers enrolled 1,695 patients with a mean age of 70 years who were treated with U-SES and considered appropriate for 3-month DAPT after implantation.
The primary endpoint was a composite endpoint of all-cause death, myocardial infarction, stroke (ischemic and hemorrhagic), Academic Research Consortium (ARC) definite/probable stent thrombosis, and serious bleeding (Bleeding Academic Research Consortium [BARC] 3 or 5) during the 12 months after stent implantation. Major secondary endpoints included a comparison of the incidence of each event for each continued antiplatelet drug.
Of the 1,695 patients enrolled, 1,686 completed 3-month clinical follow-up while 1,616 completed 1-year clinical follow-up. Patient-level adjusted historical data from 542 subjects in the CENTURY II cohort was used as the control group. Patients in that trial received the same stent but took DAPT for 1 year.
Dr. Kozuma reported that the primary endpoint occurred in 4.3% of patients in the MODEL U-SES group, compared with 5.7% of patients in the CENTURY II BP-SES group, a difference of –3.17%, which demonstrated noninferiority of the trial (P less than .001). At 3 months, P2Y12 inhibitor monotherapy was equivalent to aspirin monotherapy in terms of both bleeding and thrombotic events (2.5% in each modality; hazard ratio, 1.14; P = 0.71).
Dr. Kozuma acknowledged certain limitations of the trial, including the fact that propensity score adjusted analysis “may not compensate the selection bias of this study sufficiently, since considerable baseline difference was observed. Also, comparison between aspirin and P2Y12 receptor inhibitors was not randomized so that the safety and efficacy of each antiplatelet monotherapy cannot be conclusive.”
Despite these limitations, he concluded that the trial “demonstrated that 3-month DAPT was noninferior to an adjusted cohort of longer DAPT after BP-SES implantation in net adverse clinical events. Direct comparison between P2Y12 inhibitor and aspirin would be necessary to confirm the efficacy and safety of P2Y12 inhibitor monotherapy in a randomized fashion.”
The meeting was sponsored by the Cardiovascular Research Foundation.
Terumo sponsored the trial. Dr. Kozuma disclosed that he serves on the scientific advisory boards for and has received honoraria from Terumo, Abbott Vascular Japan, Boston Scientific Japan, Daiichi-Sankyo, Sanofi, Bayer, Boehringer Ingelheim and Bristol-Meyers Squibb.
SOURCE: Kozuma K et al. TCT 2019, late-breaking presentation.
AT TCT 2019