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Original Investigation
February 27, 2019

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

Author Affiliations
  • 1Department of Cardiovascular Surgery, Houston Methodist DeBakey Heart and Vascular Center, Houston, Texas
  • 2Evanston Hospital Cardiology Division, Northshore University Health System, Evanston, Illinois
  • 3Piedmont Heart Institute, Atlanta, Georgia
  • 4Cedars-Sinai Heart Institute, Los Angeles, California
  • 5Aurora St Luke's Medical Center, Milwaukee, Wisconsin
  • 6Heart Center Dresde, Dresden University Hospital, Dresden, Germany
  • 7The Lindner Research Center, The Christ Hospital Heart and Vascular Center, Cincinnati, Ohio
  • 8Washington Hospital Center, Washington, DC
  • 9Emory University, Emory University Hospital, Atlanta, Georgia
  • 10Baylor Heart & Vascular Hospital, Dallas, Texas
  • 11St John's Hospital, Springfield, Illinois
  • 12HonorHealth, Scottsdale-Lincoln Health Network, Scottsdale, Arizona
  • 13Gates Vascular Institute, University at Buffalo, Buffalo, New York
  • 14University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania
  • 15Department of Internal Medicine/Cardiology, Herzzentrum Dresden, Technische Universität Dresden, Dresden, Germany
  • 16Morton Plant Mease Healthcare System, Clearwater, Florida
  • 17Clinique Pasteur, Toulouse, France
  • 18Providence St Vincent Medical Center, Portland, Oregon
  • 19Boston Scientific Corp, Marlborough, Massachusetts
JAMA Cardiol. 2019;4(3):223-229. doi:10.1001/jamacardio.2019.0091
Key Points

Question  In high-risk patients with aortic stenosis, does the mechanically expanded valve continue to be as safe as a self-expanding valve at 2 years, are there differences in clinical outcomes, and does paravalvular leak remain lower?

Findings  In this analysis of the randomized clinical trial, at 2 years, mortality and all stroke were similar between valves. Disabling stroke and paravalvular leak were less while pacemaker requirement and valve thrombosis were more frequent after using the mechanically expanded valve.

Meaning  Mechanically expanded valves are an alternative to self-expanding valves in this high-risk population.

Abstract

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) age was 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 stroke was 8.4% vs 11.4% (HR, 0.75; 95% CI, 0.48-1.17; P = .21); disabling stroke was more frequent with CoreValve 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% vs 0.7%; 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] cm2 vs CoreValve, 1.76 [0.51] cm2; P < .01; valve gradient, mean [SD]: Lotus, 13.0 [6.7] mm Hg vs 8.1 [3.7] mm Hg; P < .01). Moderate or greater PVL was more frequent with CoreValve (0.3% Lotus vs 3.8% CoreValve; P < .01) at 2 years. Larger improvements in New York Heart Association (NYHA) functional class were observed with Lotus compared with CoreValve (improved by ≥1 NYHA class: Lotus, 338 of 402 [84.1%] vs CoreValve, 143 of 189 [75.7%]; P = .01; improved by ≥2 NYHA classes: 122 of 402 [37.3%] vs 65 of 305 [21.3%]).

Conclusions and Relevance  After 2 years, all-cause mortality rates, mortality or disabling stroke 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.

Trial Registration  clinicaltrials.gov Identifier: NCT02202434

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