@article{6936b137da2948088d39972af252e138,
title = "Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients",
abstract = "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 1.9% (with scores ranging from 0 to 100% and higher scores indicating a greater risk of death within 30 days after the procedure). The Kaplan–Meier estimate of the rate of the primary composite end point at 1 year was significantly lower in the TAVR group than in the surgery group (8.5% vs. 15.1%; absolute difference, −6.6 percentage points; 95% confidence interval [CI], −10.8 to −2.5; P<0.001 for noninferiority; hazard ratio, 0.54; 95% CI, 0.37 to 0.79; P=0.001 for superiority). At 30 days, TAVR resulted in a lower rate of stroke than surgery (P=0.02) and in lower rates of death or stroke (P=0.01) and new-onset atrial fibrillation (P<0.001). TAVR also resulted in a shorter index hospitalization than surgery (P<0.001) and in a lower risk of a poor treatment outcome (death or a low Kansas City Cardiomyopathy Questionnaire score) at 30 days (P<0.001). There were no significant between-group differences in major vascular complications, new permanent pacemaker insertions, or moderate or severe paravalvular regurgitation. CONCLUSIONS Among patients with severe aortic stenosis who were at low surgical risk, the rate of the composite of death, stroke, or rehospitalization at 1 year was significantly lower with TAVR than with surgery. (Funded by Edwards Lifesciences; PARTNER 3 ClinicalTrials.gov number, NCT02675114.)",
author = "Mack, {Michael J.} and Leon, {Martin B.} and Thourani, {Vinod H.} and Raj Makkar and Kodali, {Susheel K.} and Mark Russo and Kapadia, {Samir R.} and {Chris Malaisrie}, S. and Cohen, {David J.} and Philippe Pibarot and Jonathon Leipsic and Hahn, {Rebecca T.} and Philipp Blanke and Williams, {Mathew R.} and McCabe, {James M.} and Brown, {David L.} and Vasilis Babaliaros and Scott Goldman and Szeto, {Wilson Y.} and Philippe Genereux and Ashish Pershad and Pocock, {Stuart J.} and Alu, {Maria C.} and Webb, {John G.} and Smith, {Craig R.}",
note = "Funding Information: Dr. Mack reports receiving consulting fees from Gore, serving as a trial coprimary investigator for Edwards Lifesciences and Abbott, and serving as a study chair for Medtronic; Dr. Leon, receiving grant support, paid to his institution, and advisory board fees from Medtronic and Abbott, grant support, paid to his institution, advisory board fees, and equity from Boston Scientific, advisory board fees from Gore, and advisory board fees from Meril Life Sciences; Dr. Thourani, receiving grant support and serving as an advisor for Edwards Lifesciences; Dr. Makkar, receiving grant support from Abbott and Edwards Lifesciences; Dr. Kodali, receiving equity from BioTrace Medical, Funding Information: Dura Biotech, and Thubrikar Aortic Valve, grant support from Medtronic and Boston Scientific, grant support and consulting fees from Abbott Vascular, and consulting fees from Claret Medical, Admedus, and Meril Life Sciences; Dr. Russo, receiving consulting fees, lecture fees, and fees for serving as a proctor from Edwards Lifesciences, consulting fees and fees for serving as a proctor from Abbott, and consulting fees from Boston Scientific; Dr. Malaisrie, receiving consulting fees from Medtronic and lecture fees from Abbott; Dr. Cohen, receiving grant support, paid to his institution, and consulting fees from Edwards Lifesciences and Medtronic, and grant support, paid to his institution, from Boston Scientific and Abbott Vascular; Dr. Leipsic, receiving grant support from Abbott and Medtronic, and consulting fees and stock options from Circle Cardiovascular Imaging; Dr. Hahn, receiving lecture fees and consulting fees from Abbott Vascular and Siemens Healthineers, lecture fees from Boston Scientific and Bayliss, and consulting fees from Edwards Lifesciences, Philips Healthcare, 3Mensio, Medtronic, and Navigate; Dr. Blanke, receiving consulting fees from Edwards Life-sciences, Tendyne (Abbott), Circle Cardiovascular Imaging, Neovasc, and Gore; Dr. McCabe, receiving consulting fees from Edwards Lifesciences; Dr. Babaliaros, receiving lecture fees and consulting fees from Edwards Lifesciences and Abbott; Dr. Publisher Copyright: Copyright {\textcopyright} 2019 Massachusetts Medical Society.",
year = "2019",
month = may,
day = "2",
doi = "10.1056/NEJMoa1814052",
language = "English (US)",
volume = "380",
pages = "1695--1705",
journal = "New England Journal of Medicine",
issn = "0028-4793",
publisher = "Massachussetts Medical Society",
number = "18",
}