Pulse Brain · Growing Health Evidence Index
Peer-reviewed

Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients

Michael J. Mack, Martin B. Leon, Vinod H. Thourani, Raj Makkar, Susheel Kodali, Mark J. Russo, Samir Kapadia, S. Chris Malaisrie, David J. Cohen, Philippe Pîbarot, Jonathon Leipsic, Rebecca T. Hahn, Philipp Blanke, Mathew Williams, James M. McCabe, David L. Brown, Vasilis Babaliaros, Scott Goldman, Wilson Y. Szeto, Philippe Généreux, Ashish Pershad, Stuart Pocock, Maria Alu, John G. Webb, Craig R. Smith

New England Journal of Medicine · 2019

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Summary

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 underw

Source type
Peer-reviewed study
DOI
10.1056/nejmoa1814052
Catalogue ID
SNmojad75a-8mvdzg
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