Transcatheter Aortic-Valve Replacement for Asymptomatic Severe Aortic Stenosis

作者：Philippe Généreux, Allan J. Schwartz, J. Bradley Oldemeyer, Philippe Pîbarot, David Jonathan Cohen, Philipp Blanke, Brian R. Lindman, Vasilis C. Babaliaros, William Fuller Fearon, David V. Daniels, Adnan K. Chhatriwalla, Clifford J. Kavinsky, Hemal Gada, Pinak Bipin Shah, Molly Szerlip, Thom G.A. Dahle, Kashish Goel, William W. O’Neill, Tej Sheth, Charles J. Davidson, Raj Makkar, Heather Prince, Yanglu Zhao, Rebecca Tung Hahn, Jonathon A Leipsic, Björn Redfors, Stuart Pocock, Michael J. Mack, Martin B. Leon · 发表于：New England Journal of Medicine · 年份：2024 · DOI：10.1056/nejmoa2405880 · 被引用次数：300 · 研究领域：Cardiac Valve Diseases and Treatments、Aortic Disease and Treatment Approaches、Cardiovascular Function and Risk Factors

BACKGROUND: For patients with asymptomatic severe aortic stenosis and preserved left ventricular ejection fraction, current guidelines recommend routine clinical surveillance every 6 to 12 months. Data from randomized trials examining whether early intervention with transcatheter aortic-valve replacement (TAVR) will improve outcomes in these patients are lacking. METHODS: At 75 centers in the United States and Canada, we randomly assigned, in a 1:1 ratio, patients with asymptomatic severe aortic stenosis to undergo early TAVR with transfemoral placement of a balloon-expandable valve or clinical surveillance. The primary end point was a composite of death, stroke, or unplanned hospitalization for cardiovascular causes. Superiority testing was performed in the intention-to-treat population. RESULTS: A total of 901 patients underwent randomization; 455 patients were assigned to TAVR and 446 to clinical surveillance. The mean age of the patients was 75.8 years, the mean Society of Thoracic Surgeons Predicted Risk of Mortality score was 1.8% (on a scale from 0 to 100%, with higher scores indicating a greater risk of death within 30 days after surgery), and 83.6% of patients were at low surgical risk. A primary end-point event occurred in 122 patients (26.8%) in the TAVR group and in 202 patients (45.3%) in the clinical surveillance group (hazard ratio, 0.50; 95% confidence interval, 0.40 to 0.63; P<0.001). Death occurred in 8.4% of the patients assigned to TAVR and in 9.2% of the ...