5-Year Outcomes After Transcatheter or Surgical Aortic Valve Replacement in Low-Risk Patients With Aortic Stenosis
- PMID: 40158212
- DOI: 10.1016/j.jacc.2025.03.004
5-Year Outcomes After Transcatheter or Surgical Aortic Valve Replacement in Low-Risk Patients With Aortic Stenosis
Abstract
Background: The Evolut Low Risk trial demonstrated that transcatheter aortic valve replacement (TAVR) was noninferior to surgery for the primary endpoint of all-cause mortality or disabling stroke at 2 years. Outcomes at 5 years have not been reported.
Objectives: This study sought to evaluate 5-year clinical and hemodynamic outcomes with TAVR vs surgery in patients from the Evolut Low Risk trial.
Methods: We randomly assigned low-risk patients with severe aortic stenosis to TAVR or surgery. The primary endpoint was a composite of all-cause mortality or disabling stroke. Secondary endpoints included clinical, echocardiographic, and quality-of-life outcomes through 5 years.
Results: A total of 1,414 patients underwent an attempted implant (n = 730 TAVR, n = 684 surgery). The mean age was 74 years (range 51-88 years), and women accounted for 35% of patients. At 5 years the Kaplan-Meier estimate for the primary endpoint of all-cause mortality or disabling stroke was 15.5% for the TAVR group and 16.4% for the surgery group (P = 0.47). The Kaplan-Meier estimates in the TAVR and surgery groups for all-cause mortality were 13.5% and 14.9% (P = 0.39) and for disabling stroke were 3.6% and 4.0% (P = 0.57). Cardiovascular mortality was 7.2% in the TAVR group and 9.3% in the surgery group (P = 0.15). Noncardiovascular mortality in the TAVR group was 6.8% and 6.2% in the surgery group (P = 0.73). A site-level vital status sweep was performed for patients who were lost to follow-up or withdrew from the study. With the addition of these patients, the all-cause mortality rate at 5 years for patients undergoing TAVR was 14.7% and for surgery was 15.2% (P = 0.74). Over 5 years, valve reintervention rate was 3.3% for TAVR and 2.5% for surgery (P = 0.44). A sustained improvement in quality of life was observed in both treatment arms with mean Kansas City Cardiomyopathy Questionnaire summary score of 88.3 ± 15.8 in TAVR and 88.5 ± 15.8 in surgery.
Conclusions: At 5 years, patients with severe aortic stenosis who were treated with either TAVR or surgery had comparable rates of all-cause mortality or disabling stroke. Valve durability and performance were excellent in both arms. This midterm evaluation reinforces the position of TAVR as noninferior to surgery in patients with severe aortic stenosis at low surgical risk (Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients; NCT02701283).
Keywords: TAVR; aortic stenosis; low-risk; supra-annular self-expanding; surgery.
Copyright © 2025 The Authors. Published by Elsevier Inc. All rights reserved.
Conflict of interest statement
Funding Support and Author Disclosures Funded by Medtronic; Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients, NCT02701283. Dr Forrest has received grant support/research contracts and consultant fees/honoraria/speakers bureau fees from Edwards Lifesciences and Medtronic. Dr Yakubov has received grants and personal fees from Medtronic and Boston Scientific. Dr Deeb has served on an advisory board for Medtronic; has received institutional grant support from Boston Scientific, Edwards Lifesciences, and Medtronic; and has received fees as a proctor for the Medtronic-sponsored SMART Trial. Dr Gada has received personal fees from Medtronic, Abbott Vascular, Edwards Lifesciences, Boston Scientific, PiCardia, and Innovative Cardiovascular Solutions. Dr Mumtaz has served as a consultant to and received honoraria and research grants from Edwards Lifesciences, the Japanese Organization for Medical Device Development, Medtronic, and Z-Medical. Dr Ramlawi has received grants, personal fees and nonfinancial support from Medtronic, Boston Scientific, Shockwave, Corcym, and AtriCure. Dr Bajwa has received fees for consulting and proctoring from Medtronic. Dr Kleiman has received research grants from Medtronic, Abbott, Edwards Lifesciences, and Boston Scientific. Dr Sorajja has served as a consultant to 4C Medical, Abbott Structural, Adona, Boston Scientific, ConKay, Coramaze, CroiValve, Cultiv8, Edwards Lifesciences, Egg Medical, EvolutionMed, Foldax, GE Medical, Haemonetics, InQ8, Laguna Tech, LAZA, Medtronic, Phillips, Polares, WL Gore, vDyne, Unorthodox Ventures, Valcare, and xDot. Dr Tchétché has received honoraria or consultation fees from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr Horlick has served as a consultant for Medtronic, Edwards, and Abbott; and has received research support from Abbott and Occlutech. Dr Saito has served as a TAVR proctor for Medtronic, Abbott, and Edwards. Dr Oh has served as the director of the Echocardiography Core Laboratory and has served as a consultant for Medtronic; and has received research grants from REDNVIA. Dr Jung is a full-time employee and shareholder of Medtronic. Dr Reardon has received research grants from Abbott, Boston Scientific, WL Gore Medical, and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.