作者
Michael J Mack, Martin B Leon, Vinod H Thourani, Raj Makkar, Susheel K Kodali, Mark Russo, Samir R Kapadia, S Chris Malaisrie, David J Cohen, Philippe Pibarot, Jonathon Leipsic, Rebecca T Hahn, Philipp Blanke, Mathew R Williams, James M McCabe, David L Brown, Vasilis Babaliaros, Scott Goldman, Wilson Y Szeto, Philippe Genereux, Ashish Pershad, Stuart J Pocock, Maria C Alu, John G Webb, Craig R Smith
发表日期
2019/5/2
期刊
New England Journal of Medicine
卷号
380
期号
18
页码范围
1695-1705
出版商
Massachusetts Medical Society
简介
Background
Among patients with aortic stenosis who are at intermediate or high risk for death with surgery, major outcomes are similar with transcatheter aortic-valve replacement (TAVR) and surgical aortic-valve replacement. There is insufficient evidence regarding the comparison of the two procedures in patients who are at low risk.
Methods
We randomly assigned patients with severe aortic stenosis and low surgical risk to undergo either TAVR with transfemoral placement of a balloon-expandable valve or surgery. The primary end point was a composite of death, stroke, or rehospitalization at 1 year. Both noninferiority testing (with a prespecified margin of 6 percentage points) and superiority testing were performed in the as-treated population.
Results
At 71 centers, 1000 patients underwent randomization. The mean age of the patients was 73 years, and the mean Society of Thoracic Surgeons risk score was …
引用总数
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