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

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.

Conflict of interest statement

Conflict of Interest Disclosures: Dr Makkar reported receiving grants from Abbott Vascular and Edwards Lifesciences Corporation and personal fees from Cordis, Medtronic, and Cedars-Sinai Medical Center during the conduct of the study and outside the submitted work. Dr Kleiman reported receiving grants from Medtronic, Abbott Vascular, Edwards Lifesciences Corporation, and Boston Scientific Corporation during the conduct of the study. Dr Linke reported receiving study fees from Boston Scientific Corporation during the conduct of the study; personal fees from Abbott Vascular, Medtronic, Edwards Lifesciences Corporation, AstraZeneca, Boston Scientific Corporation, Transverse Medical, Biotronik, Daiichi, Novartis, Bayer, Boehringer, Abiomed, and Pfizer; and grants from Novartis and Edwards Lifesciences Corporation outside the submitted work. Dr Waksman reported receiving personal fees from Abbott Vascular, Cordis, Pi-Cardia Ltd, Swiss Interventional Systems/SIS Medical AG, and Venous MedTech; receiving consulting fees from Biotronik, Boston Scientific Corporation, Medtronic, Philips Image Guided Therapy (IGT), and Transmural Systems Inc; serving on the advisory boards of Boston Scientific Corporation, Medtronic, and Philips IGT; holding stock or stock options in MedAlliance and Transmural Systems Inc; and receiving grants from Amgen, Biotronik, Boston Scientific Corporation, Chiesi, Medtronic, and Philips IGT outside the submitted work. Dr Thourani reported receiving personal fees from Boston Scientific Corporation outside the submitted work. Dr Stoler reported receiving personal fees from Boston Scientific Corporation and Medtronic during the conduct of the study and personal fees from Edwards Lifesciences Corporation outside the submitted work. Dr Iyer reported receiving grants from Boston Scientific Corporation during the conduct of the study. Dr Götberg reported receiving personal fees from Boston Scientific Corporation during the conduct of the study and personal fees from Medtronic and Philips Healthcare outside the submitted work. Dr Bjursten reported receiving personal fees and grants from Boston Scientific Corporation during the conduct of the study. Dr Allocco reported receiving personal fees from, being an employee of, and holding stock or stock options in Boston Scientific Corporation during the conduct of the study. Dr Reardon reported receiving consulting fees from Boston Scientific Corporation and Medtronic paid to his department outside the submitted work. No other disclosures were reported.

Figures

Figure 1.. Study Flow Diagram

VARC-2 indicates Valve Academic Research Consortium.

Figure 2.. Cumulative Event Curve for Death and Stroke

Event rates were calculated using the Kaplan-Meier method. Error bars indicate SEs.

Figure 3.. Hemodynamic Parameters From Baseline to 5 Years

Aortic regurgitation is shown only at baseline; paravalvular leak is shown at discharge to 5 years. EOA indicates effective orifice area.

Figure 4.. Symptom Status From Baseline to 5 Years

KCCQ indicates Kansas City Cardiomyopathy Questionnaire; NYHA, New York Heart Association.