2-Year Outcomes After Transcatheter Versus Surgical Aortic Valve Replacement in Low-Risk Patients

John K. Forrest, G. Michael Deeb, Steven J. Yakubov, Joshua D. Rovin, Mubashir Mumtaz, Hemal Gada, Daniel O'Hair, Tanvir Bajwa, Paul Sorajja, John C. Heiser, William Merhi, Abeel Mangi, Douglas J. Spriggs, Neal S. Kleiman, Stanley J. Chetcuti, Paul S. Teirstein, George L. Zorn, Peter Tadros, Didier Tchétché, Jon R. ResarAntony Walton, Thomas G. Gleason, Basel Ramlawi, Ayman Iskander, Ronald Caputo, Jae K. Oh, Jian Huang, Michael J. Reardon

Research output: Contribution to journalArticlepeer-review

Abstract

Background: The Evolut Low Risk Trial (Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients) showed that transcatheter aortic valve replacement (TAVR) with a supra-annular, self-expanding valve was noninferior to surgery for the primary endpoint of all-cause mortality or disabling stroke at 2 years. This finding was based on a Bayesian analysis performed after 850 patients had reached 1 year of follow-up. Objectives: The goal of this study was to report the full 2-year clinical and echocardiographic outcomes for patients enrolled in the Evolut Low Risk Trial. Methods: A total of 1,414 low-surgical risk patients with severe aortic stenosis were randomized to receive TAVR or surgical AVR. An independent clinical events committee adjudicated adverse events, and a central echocardiographic core laboratory assessed hemodynamic endpoints. Results: An attempted implant was performed in 730 TAVR and 684 surgical patients from March 2016 to May 2019. The Kaplan-Meier rates for the complete 2-year primary endpoint of death or disabling stroke were 4.3% in the TAVR group and 6.3% in the surgery group (P = 0.084). These rates were comparable to the interim Bayesian rates of 5.3% with TAVR and 6.7% with surgery (difference: −1.4%; 95% Bayesian credible interval: −4.9% to 2.1%). All-cause mortality rates were 3.5% vs 4.4% (P = 0.366), and disabling stroke rates were 1.5% vs 2.7% (P = 0.119), respectively. Between years 1 and 2, there was no convergence of the primary outcome curves. Conclusions: The complete 2-year follow-up from the Evolut Low Risk Trial found that TAVR is noninferior to surgery for the primary endpoint of all-cause mortality or disabling stroke, with event rates that were slightly better than those predicted by using the Bayesian analysis. (Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients [Evolut Low Risk Trial]; NCT02701283)

Original languageEnglish (US)
Pages (from-to)882-896
Number of pages15
JournalJournal of the American College of Cardiology
Volume79
Issue number9
DOIs
StatePublished - Mar 8 2022

Keywords

  • aortic stenosis
  • low surgical risk
  • self-expanding supra-annular valve
  • transcatheter aortic valve replacement

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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