• Philippe Généreux, Allan Schwartz, J Bradley Oldemeyer, Philippe Pibarot, David J Cohen, Philipp Blanke, Brian R Lindman, Vasilis Babaliaros, William F Fearon, David V Daniels, Adnan K Chhatriwalla, Clifford Kavinsky, Hemal Gada, Pinak Shah, Molly Szerlip, Thom Dahle, Kashish Goel, William O'Neill, Tej Sheth, Charles J Davidson, Raj R Makkar, Heather Prince, Yanglu Zhao, Rebecca T Hahn, Jonathon Leipsic, Björn Redfors, Stuart J Pocock, Michael Mack, Martin B Leon, and EARLY TAVR Trial Investigators.
• From Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown, NJ (P.G.); Columbia University Medical Center/New York Presbyterian Hospital (A.S., R.T.H., M.B.L.), the Cardiovascular Research Foundation (D.J.C., R.T.H., B.R., M.B.L.), and Weill Cornell Medicine (B.R.), New York, and St. Francis Hospital and Heart Center, Roslyn (D.J.C.) - all in New York; University of Colorado Health, Medical Center of the Rockies, Loveland (J.B.O.); Laval University, Quebec, QC (P.P.), St. Paul's Hospital, University of British Columbia, Vancouver (P.B., J.L.), and McMaster University, Hamilton, ON (T.S.) - all in Canada; Vanderbilt University Medical Center, Nashville (B.R.L., K.G.); Emory University, Atlanta (V.B.); the Division of Cardiovascular Medicine and Stanford Cardiovascular Institute, Stanford University, Stanford (W.F.F.), VA Palo Alto Health Care System, Palo Alto (W.F.F.), California Pacific Medical Center, San Francisco (D.V.D.), Cedars-Sinai Medical Center, Los Angeles (R.R.M.), and Edwards Lifesciences, Irvine (H.P., Y.Z.) - all in California; Saint Luke's Mid America Heart Institute, Kansas City, MO (A.K.C.); Beth Israel Deaconess Medical Center/Harvard Medical School (C.K.) and Brigham and Women's Hospital (P.S.) - both in Boston; Pinnacle Health Harrisburg, Harrisburg, PA (H.G.); Baylor Scott and White The Heart Hospital Plano, Plano, TX (M.S., M.M.); CentraCare Heart and Vascular Center, St. Cloud, MN (T.D.); Henry Ford Hospital, Detroit (W.O.); Northwestern University, Chicago (C.J.D.); Gothenburg University/Sahlgrenska University Hospital, Gothenburg, Sweden (B.R.); and London School of Hygiene and Tropical Medicine, London (S.J.P.).
• N. Engl. J. Med. 2024 Oct 28.

BackgroundFor 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.MethodsAt 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.ResultsA 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 patients assigned to clinical surveillance, stroke occurred in 4.2% and 6.7%, respectively, and unplanned hospitalization for cardiovascular causes occurred in 20.9% and 41.7%. During a median follow-up of 3.8 years, 87.0% of patients in the clinical surveillance group underwent aortic-valve replacement. There were no apparent differences in procedure-related adverse events between patients in the TAVR group and those in the clinical surveillance group who underwent aortic-valve replacement.ConclusionsAmong patients with asymptomatic severe aortic stenosis, a strategy of early TAVR was superior to clinical surveillance in reducing the incidence of death, stroke, or unplanned hospitalization for cardiovascular causes. (Funded by Edwards Lifesciences; EARLY TAVR ClinicalTrials.gov number, NCT03042104.).Copyright © 2024 Massachusetts Medical Society.

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