Transcatheter Aortic-Valve Replacement in Low-Risk Patients at Five Years

作者：Michael J. Mack, Martin B. Leon, Vinod H. Thourani, Philippe Pîbarot, Rebecca T. Hahn, Philippe Généreux, Susheel Kodali, Samir Kapadia, David J. Cohen, Stuart Pocock, Michael Lu, Roseann White, Molly Szerlip, Julien Ternacle, S. Chris Malaisrie, Howard C. Herrmann, Wilson Y. Szeto, Mark J. Russo, Vasilis Babaliaros, Craig R. Smith, Philipp Blanke, John G. Webb, Raj Makkar · 发表于：New England Journal of Medicine · 年份：2023 · DOI：10.1056/nejmoa2307447 · 被引用次数：624 · 研究领域：Cardiac Valve Diseases and Treatments、Aortic Disease and Treatment Approaches、Cardiovascular Function and Risk Factors

BACKGROUND: A previous analysis in this trial showed that among patients with severe, symptomatic aortic stenosis who were at low surgical risk, the rate of the composite end point of death, stroke, or rehospitalization at 1 year was significantly lower with transcatheter aortic-valve replacement (TAVR) than with surgical aortic-valve replacement. Longer-term outcomes are unknown. METHODS: We randomly assigned patients with severe, symptomatic aortic stenosis and low surgical risk to undergo either TAVR or surgery. The first primary end point was a composite of death, stroke, or rehospitalization related to the valve, the procedure, or heart failure. The second primary end point was a hierarchical composite that included death, disabling stroke, nondisabling stroke, and the number of rehospitalization days, analyzed with the use of a win ratio analysis. Clinical, echocardiographic, and health-status outcomes were assessed through 5 years. RESULTS: A total of 1000 patients underwent randomization: 503 patients were assigned to undergo TAVR, and 497 to undergo surgery. A component of the first primary end point occurred in 111 of 496 patients in the TAVR group and in 117 of 454 patients in the surgery group (Kaplan-Meier estimates, 22.8% in the TAVR group and 27.2% in the surgery group; difference, -4.3 percentage points; 95% confidence interval [CI], -9.9 to 1.3; P = 0.07). The win ratio for the second primary end point was 1.17 (95% CI, 0.90 to 1.51; P = 0.25). The Kaplan-Mei...