Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients

著者: Jeffrey J. Popma, G. Michael Deeb, Steven J. Yakubov, Mubashir Mumtaz, Hemal Gada, Daniel O’Hair, Tanvir Bajwa, John Heiser, William Merhi, Neal S. Kleiman, Judah Askew, Paul Sorajja, Joshua D. Rovin, Stanley Chetcuti, David Adams, Paul S. Teirstein, George L. Zorn, John K. Forrest, Didier Tchétché, Jon R. Resar, Antony Walton, Nicolò Piazza, Basel Ramlawi, N. Bryce Robinson, George Petrossian, Thomas G. Gleason, Jae K. Oh, Michael J. Boulware, Hongyan Qiao, Andrew S. Mugglin, Michael J. Reardon - New England Journal of Medicine, NEJM 2019 被引用: 3,605

BACKGROUND: Transcatheter aortic-valve replacement (TAVR) is an alternative to surgery in patients with severe aortic stenosis who are at increased risk for death from surgery; less is known about TAVR in low-risk patients. METHODS: We performed a randomized noninferiority trial in which TAVR with a self-expanding supraannular bioprosthesis was compared with surgical aortic-valve replacement in patients who had severe aortic stenosis and were at low surgical risk. When 850 patients had reached 12-month follow-up, we analyzed data regarding the primary end point, a composite of death or disabling stroke at 24 months, using Bayesian methods. RESULTS: ). CONCLUSIONS: In patients with severe aortic stenosis who were at low surgical risk, TAVR with a self-expanding supraannular bioprosthesis was noninferior to surgery with respect to the composite end point of death or disabling stroke at 24 months. (Funded by Medtronic; ClinicalTrials.gov number, NCT02701283.).