Long-term outcomes of transcatheter aortic valve replacement with the Lotus Valve vs CoreValve/EvolutR: A secondary analysis of the REPRISE III randomized clinical trial

David G. Rizik, Department of Cardiology, HonorHealth and the Scottsdale-Lincoln Health Network, Scottsdale, Arizona.
Vivek Rajagopal, Cardiology Department, Piedmont Hospital, Atlanta, Georgia.
Raj R. Makkar, Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California.
Tanvir Bajwa, Advocate Aurora HealthFollow
Neal S. Kleiman, Department of Cardiology, Houston Methodist DeBakey Heart and Vascular Center, Houston, Texas.
Axel Linke, Department of Internal Medicine and Cardiology, Technische Universität Dresden, Dresden, Germany.
Dean J. Kereiakes, The Christ Hospital Heart and Vascular Center/The Lindner Research Center Cincinnati, Cincinnati, Ohio.
Ron Waksman, Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC.
Vinod H. Thourani, Department of Cardiovascular Surgery, Marcus Valve Center, Piedmont Heart Institute, Atlanta, Georgia.
Robert C. Stoler, Baylor Heart & Vascular Hospital, Dallas, Texas.
Gregory J. Mishkel, Division of Cardiology, NorthShore University HealthSystem, University of Chicago Pritzker School of Medicine, Chicago, Illinois.
Vijay S. Iyer, Gates Vascular Institute, Interventional Cardiology, University at Buffalo, School of Medicine and Biomedical Sciences, Buffalo, New York.
Maurice Buchbinder, Department of Cardiology, Foundation for Cardiovascular Medicine, Stanford University, Stanford, California.Follow
Matthias Götberg, Department of Cardiology, Clinical Sciences, Lund University, Skane University Hospital, Lund, Sweden.
Henrik Bjursten, Department of Cardiothoracic Surgery, Skåne University Hospital, Lund, Sweden.Follow
Dominic J. Allocco, Boston Scientific Corp, Marlborough, Massachusetts.Follow
Michael J. Reardon, Department of Cardiovascular Surgery, Houston Methodist DeBakey Heart and Vascular Center, Houston, Texas.

Affiliations

Aurora St Luke's Medical Center

Abstract

Importance: Long-term follow-up after transcatheter aortic valve replacement (TAVR) is of interest given that longitudinal data on mortality and durability of transcatheter heart valves are limited. The REPRISE III (Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System-Randomized Clinical Evaluation) randomized clinical trial compared the mechanically expanded Lotus valve with the self-expanding CoreValve/EvolutR TAVR platforms.

Objective: To describe the final 5-year outcomes of the REPRISE III trial.

Design, setting, and participants: This prespecified secondary analysis assessed the final 5-year clinical, functional, and echocardiographic outcomes of 912 patients from the REPRISE III trial, which was conducted at 55 centers in North America, Europe, and Australia between September 22, 2014, and December 24, 2015. Patients had high risk for aortic stenosis or severe or symptomatic aortic stenosis. Data were analyzed from September 22, 2014, to May 21, 2021.

Intervention: Lotus valve or CoreValve/EvolutR TAVR platforms.

Main outcomes and measures: Valve Academic Research Consortium-2 end points, hemodynamic measures, functional status, and health status were examined through the 5-year follow-up.

Results: A total of 912 patients (mean [SD] age, 82.8 [7.3] years; 463 women [50.8%]) were randomized to either the Lotus valve group (n = 607) or CoreValve/EvolutR group (n = 305), with a baseline Society of Thoracic Surgeons risk score of 6.8%. Clinical follow-up data from the REPRISE III trial were available for 581 patients (95.7%) in the Lotus valve group and 285 patients (93.4%) in the CoreValve/EvolutR group. At 5 years, the cumulative event rate for all-cause mortality was 50.9% in the Lotus valve group vs 52.8% in the CoreValve/EvolutR group (P = .59). Disabling stroke was less frequent with the Lotus valve vs CoreValve/EvolutR (cumulative event rates, 8.3% vs 12.2%; P = .04), whereas the cumulative event rates for overall stroke were similar in both groups (14.1% vs 15.3%; P = .38). Insertion of a new permanent pacemaker (38.9% vs 27.3%; P < .001) and detection of prosthetic aortic valve thrombosis (5.8% vs 1.8%; P = .007) were more common in the Lotus valve group than in the CoreValve/EvolutR group. A smaller proportion of patients who received the Lotus valve experienced valve malpositioning (0% vs 2.6%; P < .001) and required the use of a second valve (1.0% vs 3.8%; P < .001) during the procedure compared with those who received the CoreValve/EvolutR. Compared with the Lotus valve group, the CoreValve/EvolutR group had a significantly lower mean (SD) aortic gradient (7.8 [4.2] mm Hg vs 12.6 [6.7] mm Hg; P < .001) and larger valve areas (1.57 [0.56] cm2 vs 1.42 [0.42] cm2; P = .10). After 5 years, the proportion of patients with moderate or greater paravalvular leak was not significantly higher with the CoreValve/EvolutR than with the Lotus valve (1.9% vs 0%; P = .31); however, the proportion of patients with mild paravalvular leak was higher in the CoreValve/EvolutR group compared with the Lotus valve group (23.1% vs 7.8%; P = .006). Long-term, similar improvements in New York Heart Association class and Kansas City Cardiomyopathy Questionnaire score were observed in both groups.

Conclusions and relevance: The REPRISE III trial found that, at 5 years, the clinical outcomes of the Lotus valve were comparable to those of the CoreValve/EvolutR and that the Lotus valve was safe and effective.

Trial registration: ClinicalTrials.gov Identifier: NCT02202434.

Type

Article

PubMed ID

36301543

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