Transcatheter or Surgical Aortic-Valve Replacement in Low-Risk Patients at 7 Years

作者：Martin B. Leon, Michael Mack, Philippe Pîbarot, Rebecca T. Hahn, Vinod H. Thourani, S. Kodali, Philippe Généreux, Samir Kapadia, David J. Cohen, Stuart Pocock, Yiran Zhang, Molly Szerlip, Julien Ternacle, S. Chris Malaisrie, Howard C. Herrmann, Wilson Y. Szeto, Mark J. Russo, Vasilis Babaliaros, Tamim Nazif, John G. Webb, Raj Makkar · 发表于：New England Journal of Medicine · 年份：2025 · DOI：10.1056/nejmoa2509766 · 被引用次数：69 · 研究领域：Cardiac Valve Diseases and Treatments、Aortic Disease and Treatment Approaches、Cardiovascular Function and Risk Factors

BACKGROUND: Five-year data from the PARTNER 3 trial showed that among low-risk patients with severe, symptomatic aortic stenosis, outcomes were similar among patients who had undergone transcatheter aortic-valve replacement (TAVR) and those who had undergone surgical aortic-valve replacement. Longer-term assessments of clinical outcomes and valve durability are needed. METHODS: Patients were randomly assigned in a 1:1 ratio to undergo transfemoral TAVR or surgery. The first primary end point was a nonhierarchical composite of death, stroke, or rehospitalization related to the procedure, the valve, or heart failure. The second primary end point was a hierarchical composite of death, disabling stroke, nondisabling stroke, and the number of rehospitalization days related to the procedure, the valve, or heart failure, analyzed with the use of a win ratio analysis. Clinical, echocardiographic, valve-durability, and health-status end points were assessed through 7 years. RESULTS: A total of 1000 patients underwent randomization. In the analysis of the first primary end point, the Kaplan-Meier estimate of the incidence of an end-point event was 34.6% with TAVR and 37.2% with surgery (difference, -2.6 percentage points; 95% confidence interval [CI], -9.0 to 3.7). The win ratio for the second primary end point was 1.04 (95% CI, 0.84 to 1.30). In the TAVR and surgery groups, respectively, the Kaplan-Meier estimates for the incidence of components of the first primary end point were as ...