@article{d50477a52cfa4277a2484d7c9d0bccfd,
title = "2-Year Outcomes After Transcatheter Versus Surgical Aortic Valve Replacement in Low-Risk Patients",
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.",
keywords = "aortic stenosis, low surgical risk, self-expanding supra-annular valve, transcatheter aortic valve replacement",
author = "Forrest, {John K.} and Deeb, {G. Michael} and Yakubov, {Steven J.} and Rovin, {Joshua D.} and Mubashir Mumtaz and Hemal Gada and Daniel O'Hair and Tanvir Bajwa and Paul Sorajja and Heiser, {John C.} and William Merhi and Abeel Mangi and Spriggs, {Douglas J.} and Kleiman, {Neal S.} and Chetcuti, {Stanley J.} and Teirstein, {Paul S.} and Zorn, {George L.} and Peter Tadros and Didier Tch{\'e}tch{\'e} and Resar, {Jon R.} and Antony Walton and Gleason, {Thomas G.} and Basel Ramlawi and Ayman Iskander and Ronald Caputo and Oh, {Jae K.} and Jian Huang and Reardon, {Michael J.}",
note = "Funding Information: This study was funded by Medtronic, Minneapolis, Minnesota, USA. Dr Forrest has received grant support/research contracts and consultant fees/honoraria/Speakers Bureau fees from Edwards Lifesciences and Medtronic. Dr Deeb receives institutional research grants from Medtronic and Edwards LifeSciences; serves as a consultant and research investigator for Edwards Lifesciences; serves as a consultant and proctor for Terumo; serves as a research investigator for Gore Medical; and receives no personal remunerations. Dr Yakubov has received institutional research grants from Boston Scientific and Medtronic. Dr Rovin serves as a consultant, proctor, and speaker for Abbott and Medtronic. Dr Mumtaz serves as a consultant to and receives honoraria and research grants from Edwards Lifesciences, the Japanese Organization for Medical Device Development, Medtronic, and Z-Medical. Dr Gada is a consultant to Abbott, Bard, Edwards Lifesciences, and Medtronic. Dr O{\textquoteright}Hair has received grant support from Edwards Lifesciences and Medtronic; and serves as a proctor for Medtronic. Dr Bajwa serves as a consultant and proctor for Medtronic. Dr Sorajja serves as a consultant to Abbott, Anteris, Baylis, Boston Scientific, Evolution MedVenture, Half Moon Medical, Medtronic, Neovasc, Shifamed, TriFlo, WL Gore, and vDyne; and receives institutional grants from Abbott, Boston Scientific, and Medtronic. Dr Mangi has received grant support/research contracts and consultant fees/honoraria/proctoring fees and Speakers Bureau fees from Thoratec Corporation, Edwards Lifesciences, and Medtronic. Dr Kleiman has received educational and research grants from Medtronic. Dr Chetcuti serves as a proctor for, and receives grant support from Medtronic. Dr Teirstein has received research grant and honoraria from Abbott, Boston Scientific, Cordis, and Medtronic; and serves on an advisory board for Boston Scientific and Medtronic. Dr Zorn serves as a consultant for Medtronic. Dr Tadros serves as a consultant for Medtronic and Abbott. Dr Tch{\'e}tch{\'e} has received honoraria or consultation fees from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr Resar has received proctoring fees from Medtronic. Dr Walton serves as an advisor and proctor for Medtronic. Dr Gleason serves on a medical advisory board for Abbott but receives no remuneration. Dr Ramlawi has received grants, personal fees, and nonfinancial support from Medtronic, Liva Nova, and AtriCure. Dr Iskander serves as a proctor for Edwards Lifesciences. Dr Caputo serves as a consultant for Medtronic and Cordis. Dr Oh is the Director of the Echocardiography Core Laboratory and is a consultant for Medtronic; and has received research grants from REDNVIA Co. Ltd. Dr Huang is an employee and shareholder of Medtronic, plc. Dr Reardon has received fees to his institution from Medtronic for consulting and providing educational services. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Publisher Copyright: {\textcopyright} 2022",
year = "2022",
month = mar,
day = "8",
doi = "10.1016/j.jacc.2021.11.062",
language = "English (US)",
volume = "79",
pages = "882--896",
journal = "Journal of the American College of Cardiology.",
issn = "0735-1097",
publisher = "Elsevier",
number = "9",
}