Three-year outcomes after transcatheter or surgical aortic valve replacement in low-risk patients with aortic stenosis
Forrest JK, Deeb GM, Yakubov SJ, et al. Three-Year Outcomes After Transcatheter or Surgical Aortic Valve Replacement in Low-Risk Patients with Aortic Stenosis [published online ahead of print, 2023 Feb 24]. J Am Coll Cardiol. 2023;S0735-1097(23)00411-4. doi:10.1016/j.jacc.2023.02.017
Background: Randomized data comparing outcomes of transcatheter aortic valve replacement (TAVR) to surgery in low surgical risk patients at time points beyond 2 years is limited. This presents an unknown for physicians striving to educate patients as part of a shared decision-making process.
Objective: We evaluated 3-year clinical and echocardiographic outcomes from the Evolut Low Risk trial.
Methods: Low-risk patients were randomized to TAVR with a self-expanding, supra-annular valve or surgery. The primary endpoint of all-cause mortality or disabling stroke and several secondary endpoints were assessed at 3 years.
Results: There were 1414 attempted implants (730 TAVR; 684 surgery). Patients had a mean age of 74 years and 35% were women. At 3 years, the primary endpoint occurred in 7.4% of TAVR patients and 10.4% of surgery patients (HR, 0.70; 95% CI, 0.49-1.00; p=0.051). The difference between treatment arms for all-cause mortality or disabling stroke remained broadly consistent over time: -1.8% at year 1; -2.0% at year 2; -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) were lower in the surgery group. Rates of moderate or greater paravalvular regurgitation for both groups were <1% and not significantly different. Patients who underwent TAVR had significantly improved valve hemodynamics (mean gradient 9.1mmHg TAVR vs. 12.1mmHg surgery; p<0.001) at 3 years.
Conclusions: Within the Evolut Low Risk study, TAVR at 3 years showed durable benefits compared to surgery with respect to all-cause mortality or disabling stroke.
Aurora St Luke's Medical Center