2-year outcomes after transcatheter versus surgical aortic valve replacement in low-risk patients

John K. Forrest, Department of Internal Medicine (Cardiology), Yale University School of Medicine, New Haven, Connecticut, USA; Department of Surgery (Cardiac Surgery), Yale University School of Medicine, New Haven, Connecticut, USA. Electronic address: john.k.forrest@yale.edu.
G Michael Deeb, Department of Interventional Cardiology, University of Michigan Hospitals, Ann Arbor, Michigan, USA; Department of Cardiovascular Surgery, University of Michigan Hospitals, Ann Arbor, Michigan, USA.Follow
Steven J. Yakubov, Department of Interventional Cardiology, Riverside Methodist-OhioHealth, Columbus, Ohio, USA.
Joshua D. Rovin, Department of Cardiac Surgery, Morton Plant Hospital, Clearwater, Florida, USA.
Mubashir Mumtaz, Department of Interventional Cardiology, University of Pittsburgh Medical Center Pinnacle, Wormleyburg, Pennsylvania, USA; Department of Cardiovascular and Thoracic Surgery, University of Pittsburgh Medical Center Pinnacle, Wormleyburg, Pennsylvania, USA.
Hemal Gada, Department of Interventional Cardiology, University of Pittsburgh Medical Center Pinnacle, Wormleyburg, Pennsylvania, USA; Department of Cardiovascular and Thoracic Surgery, University of Pittsburgh Medical Center Pinnacle, Wormleyburg, Pennsylvania, USA.
Daniel O'Hair, Advocate Aurora Health
Tanvir Bajwa, Advocate Aurora HealthFollow
Paul Sorajja, Department of Interventional Cardiology, Minneapolis Heart Institute-Abbott Northwestern Hospital, Minneapolis, Minnesota, USA.
John C. Heiser, Department of Interventional Cardiology, Spectrum Health, Grand Rapids, Michigan, USA; Department of Cardiothoracic Surgery, Spectrum Health, Grand Rapids, Michigan, USA.
William Merhi, Department of Interventional Cardiology, Spectrum Health, Grand Rapids, Michigan, USA; Department of Cardiothoracic Surgery, Spectrum Health, Grand Rapids, Michigan, USA.
Abeel Mangi, Department of Internal Medicine (Cardiology), Yale University School of Medicine, New Haven, Connecticut, USA; Department of Surgery (Cardiac Surgery), Yale University School of Medicine, New Haven, Connecticut, USA.
Douglas J. Spriggs, Department of Cardiac Surgery, Morton Plant Hospital, Clearwater, Florida, USA.
Neal S. Kleiman, Department of Interventional Cardiology, Houston Methodist-DeBakey Heart and Vascular Center, Houston, Texas, USA; Department of Cardiothoracic Surgery, Houston Methodist-DeBakey Heart and Vascular Center, Houston, Texas, USA.
Stanley J. Chetcuti, Department of Interventional Cardiology, University of Michigan Hospitals, Ann Arbor, Michigan, USA; Department of Cardiovascular Surgery, University of Michigan Hospitals, Ann Arbor, Michigan, USA.Follow
Paul S. Teirstein, Department of Interventional Cardiology, Scripps Clinic, La Jolla, California, USA.
George L. Zorn, Department of Interventional Cardiology, University of Kansas, Kansas City, Kansas, USA; Department of Cardiac Surgery, University of Kansas, Kansas City, Kansas, USA.
Peter Tadros, Department of Interventional Cardiology, University of Kansas, Kansas City, Kansas, USA; Department of Cardiac Surgery, University of Kansas, Kansas City, Kansas, USA.
Didier Tchétché, Department of Interventional Cardiology, Clinique Pasteur, Toulouse, France.
Jon R. Resar, Department of Interventional Cardiology, Johns Hopkins Hospital, Baltimore, Maryland, USA.
Antony Walton, Department of Interventional Cardiology, Alfred Hospital, Melbourne, Victoria, Australia.
Thomas G. Gleason, Department of Cardiac Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA.
Basel Ramlawi, Department of Cardiovascular Surgery, Valley Health System, Winchester, Virginia, USA.
Ayman Iskander, Department of Interventional Cardiology, Saint Joseph's Hospital Health Center, Syracuse, New York, USA; Department of Cardiovascular Surgery, Saint Joseph's Hospital Health Center, Syracuse, New York, USA.
Ronald Caputo, Department of Interventional Cardiology, Saint Joseph's Hospital Health Center, Syracuse, New York, USA; Department of Cardiovascular Surgery, Saint Joseph's Hospital Health Center, Syracuse, New York, USA.
Jae K. Oh, Division of Cardiovascular Ultrasound, Mayo Clinic, Rochester, Minnesota, USA.
Jian Huang, Department of Statistics, Medtronic, Minneapolis, Minnesota, USA.
Michael J. Reardon, Department of Interventional Cardiology, Houston Methodist-DeBakey Heart and Vascular Center, Houston, Texas, USA; Department of Cardiothoracic Surgery, Houston Methodist-DeBakey Heart and Vascular Center, Houston, Texas, USA.

Affiliations

Aurora St. Luke's Medical Center

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).

Type

Article

PubMed ID

35241222

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