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A prespecified analysis of a clinical trial in high-risk aortic stenosis patients found no differences in health status at 5 years among patients undergoing SAVR vs TAVR.
New data from an analysis of the CoreValve High-Risk Trial is detailing the effects of transcatheter and surgical aortic valve replacement (SAVR) in patients with severe aortic stenosis.
Results from the 5-year follow-up in the study suggest high-risk patients saw early benefit from transcatheter aortic valve replacement (TAVR) but identified no long-term differences in health status between SAVR and TAVR.
With TAVR proving to be one of the most impactful advances in cardiovascular medicine in recent decades, many have been waiting anxiously to see how this approach might benefit patients with severe symptomatic aortic stenosis. While the results of the CoreValve High-Risk Trial suggest those undergoing TAVR had greater rates of survival, data that has been published since the original results were released suggests this effect dissipates by 5 years.
CoreValve High-Risk was designed as a randomized clinical trial of 795 high-risk aortic stenosis patients randomized to TAVR or SAVR. In the trial, patients randomized to SAVR were treated using conventional open-heart techniques with the use of cardiopulmonary bypass and were administered aspirin at a dose of at least 81 mg daily indefinitely following the procedure.
Those randomized to TAVR received the CoreValve self-expanding prosthesis. Patients randomized to TAVR were recommended to dual antiplatelet therapy with aspirin and clopidogrel before the procedure and for 3 months following the procedure. Following the 3-month period, trial design recommended TAVR patients receive aspirin or clopidogrel monotherapy at the same dose indefinitely. At 1 year, results of the original trial indicated a significantly lower rate of all-cause mortality (14.2% vs 19.1%) among patients randomized to TAVR than those randomized to SAVR.
Of the 795 included in CoreValve High-Risk, 713 patients had baseline health status data available and were included in the current analysis. Of the 713 included in the study, 53% were men, the mean age of the group was 83 (7) years, and the mean Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary (OS) score was 46.7 (22.8). In total, 377 patients in the current analysis were randomized to TAVR and 336 were randomized to SAVR—investigators pointed out these groups were well-matched other than an increased prevalence of diabetes in the SAVR arm.
At 1-month, investigators noted TAVR was associated with greater improvements in health status compared to SAVR with results indicating a mean 1-month difference in KCCQ OS score of 16.8 points (95% CI, 12.4-21.2). At 6 months, this difference was no longer evident and there were no significant differences in health status between study arms after that point. When assessing data at 5 years, investigators found 44% (134 of 305) of the patients who underwent TAVR and 39% (105 of 266) of the patients who underwent SAVR were still alive.
Of those who survived and had health status data available, 61% (48 of 79) in the TAVR group and 65% (46 of 71) in the SAVR group had a KCCQ overall summary score greater than 60 (P=.61). Investigators also pointed out there were no significant differences between TAVR and SAVR among noniliofemoral patients included in the study.
“In light of concerns about potential deleterious effects of TAVR-related complications, including paravalvular leak, need for permanent pacing, leaflet thrombosis, or structural valve deterioration (each of which could adversely affect health status), our findings are reassuring that there were no long-term differences in health status by treatment, despite differential rates of complications,” wrote study investigators.
This study, “Five-Year Health Status After Self-expanding Transcatheter or Surgical Aortic Valve Replacement in High-risk Patients With Severe Aortic Stenosis,” was published in JAMA Cardiology.