Isolated Transcatheter and Surgical Aortic Valve Replacement in the Evolut Low-Risk Trial: 5-Year Comparative Outcomes.

Abstract

This study aimed to compare the 5-year outcomes of patients who underwent isolated transcatheter aortic valve replacement (TAVR) vs patients who underwent isolated surgical aortic valve replacement (SAVR) from the Evolut Low Risk trial. In the Evolut Low Risk trial, 1414 low-risk patients with severe aortic stenosis underwent TAVR using a self-expanding, supraannular CoreValve, Evolut R, or PRO bioprosthesis (Medtronic) or SAVR. This post hoc analysis excluded 250 patients, those with concomitant procedures (eg, percutaneous coronary intervention and coronary artery bypass grafting) and those who experienced crossover between treatment arms. The 5-year clinical and echocardiographic outcomes are reported. A total of 1164 patients underwent an isolated procedure (667 TAVR, 497 SAVR). At 5 years, the composite of all-cause mortality or disabling stroke was similar between the isolated groups (15.5% TAVR, 14.6% SAVR; P = .84). All-cause mortality (13.5% TAVR, 12.8% SAVR; P = .85) and cardiovascular mortality (6.9% TAVR, 8.3% SAVR; P = .36) were also comparable. New permanent pacemaker implantation was higher with TAVR (27.3% vs 8.9%; P < .001). The 5-year rate of aortic valve reintervention was 3.0% for TAVR and 2.2% for SAVR (P = .51). Moderate or greater paravalvular regurgitation occurred in 0.5% of TAVR patients and none of the SAVR patients (P = .52) at 5 years. This post hoc analysis of the Evolut Low Risk trial in patients undergoing isolated TAVR or SAVR demonstrates similar rates of all-cause mortality, reintervention, and moderate or greater paravalvular regurgitation at 5 years, supporting Evolut TAVR as a suitable treatment option in carefully selected low-risk patients undergoing isolated valve replacement.