The following is a summary of “3-Year Outcomes After Transcatheter or Surgical Aortic Valve Replacement in Low-Risk Patients With Aortic Stenosis,” published in the May 2023 issue of Cardiology by Forrest, et al.
The available randomized data comparing transcatheter aortic valve replacement (TAVR) with surgery in low-surgical risk patients beyond 2 years is limited. The need for more information posed challenges for physicians in educating patients as part of the shared decision-making process. For a study, researchers sought to evaluate the clinical and echocardiographic outcomes at 3 years from the Evolut Low-Risk trial, focusing on low-risk patients undergoing TAVR or surgery.
Low-risk patients were randomly assigned to undergo TAVR with a self-expanding, supra-annular valve or surgery. The study assessed the primary endpoint of all-cause mortality or disabling stroke and several secondary endpoints at the 3-year mark.
A total of 1,414 implantations were attempted, with 730 patients undergoing TAVR and 684 patients undergoing surgery. The mean age of the patients was 74 years, and 35% of the participants were women. At the 3-year follow-up, the primary endpoint occurred in 7.4% of TAVR patients and 10.4% of surgery patients (hazard ratio: 0.70; 95% CI: 0.49-1.00; P = 0.051). The difference between the two treatment groups for all-cause mortality or disabling stroke remained consistent: -1.8% at year 1, -2.0% at year 2, and -2.9% at year 3. The incidence of mild paravalvular regurgitation (20.3% TAVR vs. 2.5% surgery) and pacemaker placement (23.2% TAVR vs. 9.1% surgery; P < 0.001) was lower in the surgery group. The moderate or greater paravalvular regurgitation rates were <1% for both groups and were not significantly different. Patients who underwent TAVR showed significantly improved valve hemodynamics (mean gradient 9.1 mm Hg TAVR vs. 12.1 mm Hg surgery; P < 0.001) at 3 years.
In the Evolut Low-Risk study, TAVR at 3 years demonstrated durable benefits compared to surgery regarding all-cause mortality or disabling stroke. The findings provided important insights for physicians and patients in making informed decisions regarding treatment options.