Two-Year Outcomes After Transcatheter Aortic Valve Replacement With Mechanical vs Self-expanding Valves: The REPRISE III Randomized Clinical Trial.

IMPORTANCE To our knowledge, REPRISE III is the first large randomized comparison of 2 different transcatheter aortic valve replacement platforms: the mechanically expanded Lotus valve (Boston Scientific) and self-expanding CoreValve (Medtronic). OBJECTIVE To evaluate outcomes of Lotus vs CoreValve after 2 years. DESIGN, SETTING, AND PARTICIPANTS A total of 912 patients with high/extreme risk and severe, symptomatic aortic stenosis enrolled between September 22, 2014, and December 24, 2015, were randomized 2: 1 to receive Lotus (607 [66.6%]) or CoreValve (305 [33.4%] at 55 centers in North America, Europe, and Australia. The first 2-year visit occurred on October 17, 2016, and the last was conducted on April 12, 2018. Clinical and echocardiographic assessments are complete through 2 years and will continue annually through 5 years. MAIN OUTCOMES AND MEASURES All-cause mortality and all-cause mortality or disabling stroke at 2 years. Other clinical factors included overall stroke, disabling stroke, repeated procedures, rehospitalization, valve thrombosis, and pacemaker implantation. Echocardiographic analyses included effective orifice area, mean gradient, and paravalvular leaks (PVLs). RESULTS Of 912 participants, the mean (SD) agewas 82.8 (7.3) years, 465 (51%) were women, and the mean (SD) Society of Thoracic Surgeons predicted risk of mortality was 6.8%(4.0%). At 2 years, all-cause death was 21.3% with Lotus vs 22.5% with CoreValve (hazard ratio [HR], 0.94; 95% CI, 0.69-1.26; P =.67) and all-cause mortality or disabling stroke was 22.8% with Lotus and 27.0% with CoreValve (HR, 0.81; 95% CI, 0.61-1.07; P=.14). Overall strokewas 8.4% vs 11.4%(HR, 0.75; 95% CI, 0.48-1.17; P =.21); disabling stroke was more frequent with Core Valve vs Lotus (4.7% Lotus vs 8.6% CoreValve; HR, 0.53; 95% CI, 0.31-0.93; P =.02). More Lotus patients received a new permanent pacemaker (41.7% vs 26.1%; HR, 1.87; 95% CI, 1.41-2.49; P <.01) or had a valve thrombosis (3.0% vs 0.0%; P <.01) compared with CoreValve. More patients who received CoreValve experienced a repeated procedure (0.6% Lotus vs 2.9% CoreValve; HR, 0.19; 95% CI, 0.05-0.70; P <.01), valve migration (0.0% vs0.7%; P =.05), or embolization (0.0% vs 2.0%; P <.01) than Lotus. Valve areas remained significantly larger and the mean gradient was lower with CoreValve than Lotus (valve area, mean [SD]: Lotus, 1.53 [0.49] cm(2) vs CoreValve, 1.76 [0.51] cm2; P <.01; valvegradient, mean[SD]: Lotus, 13.0[6.7] mmHgvs8.1 [3.7] mmHg; P <.01). Moderate or greaterPVLwas more frequent with CoreValve (0.3% Lotus vs 3.8% CoreValve; P <.01) at 2 years. Larger improvements inNewYork Heart Association (NYHA) functional classwere observed with LotuscomparedwithCoreValve(improvedby >= 1NYHAclass: Lotus, 338of402[84.1%] vsCoreValve, 143of189[75.7%]; P =.01; improvedby >= 2NYHAclasses: 122of402[37.3%] vs65of305[21.3%]). CONCLUSIONSANDRELEVANCE After2years, all-causemortalityrates, mortalityordisablingstroke were similar between Lotus and CoreValve. Disabling stroke, functional class, valve migration, and PVL favored the Lotus arm whereas valve hemodynamics, thrombosis, and new pacemaker implantation favored the CoreValve arm.