• Oussama M Wazni, Walid I Saliba, Devi G Nair, Eloi Marijon, Boris Schmidt, Troy Hounshell, Henning Ebelt, Carsten Skurk, Saumil Oza, Chinmay Patel, Arvindh Kanagasundram, Ashish Sadhu, Sri Sundaram, Jose Osorio, George Mark, Madhukar Gupta, David B DeLurgio, Jeffrey Olson, Jens Erik Nielsen-Kudsk, BoersmaLucas V ALVAFrom Cleveland Clinic, Cleveland (O.M.W., W.I.S., K.W.); St. Bernards Medical Center and Arrhythmia Research Group, Jonesboro, AR (D.G.N.); the Cardiology Department, European Georges Pompidou Hospital, Paris (E.M.); Cardioangiologische, Jeff S Healey, Karen P Phillips, Federico M Asch, Katherine Wolski, Kristine Roy, Thomas Christen, Brad S Sutton, Kenneth M Stein, Vivek Y Reddy, and OPTION Trial Investigators.
• From Cleveland Clinic, Cleveland (O.M.W., W.I.S., K.W.); St. Bernards Medical Center and Arrhythmia Research Group, Jonesboro, AR (D.G.N.); the Cardiology Department, European Georges Pompidou Hospital, Paris (E.M.); Cardioangiologisches Centrum Bethanien, Agaplesion Markus Krankenhaus, Frankfurt am Main (B.S.), Catholic Hospital, Sankt Johann Nepomuk, Erfurt (H.E.), and Deutsches Herzzentrum der Charité (DHZC), Campus Benjamin Franklin, Berlin (C.S.) - all in Germany; Iowa Heart Center, West Des Moines (T.H.); Ascension St. Vincent's Medical Center, Jacksonville, FL (S.O.); UPMC Pinnacle, Harrisburg, PA (C.P.); Vanderbilt University, Nashville (A.K.); Phoenix Cardiovascular Research Group, Phoenix AZ (A.S.); South Denver Cardiology, Littleton, CO (S.S.); Grandview Medical Center, Birmingham, AL (J. Osorio); Heart House-Cooper University, Camden, NJ (G.M.); Lindner Center for Research and Education at Christ Hospital, Cincinnati (M.G.); Emory University, Medicine, Atlanta (D.B.D.); St. Vincent Heart Center of Indiana, Indianapolis (J. Olson); the Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark (J.E.N.-K.); St. Antonius Hospital, Nieuwegein, the Netherlands (L.V.A.B.); the Population Health Research Institute, Hamilton, ON, Canada (J.S.H.); Brisbane AF Clinic, Greenslopes Private Hospital, Brisbane, QLD, Australia (K.P.P.); Medstar Health Research Institute, Medstar Washington Hospital Center, Washington, DC (F.M.A.); Boston Scientific, Marlborough, MA (K.R., T.C., B.S.S., K.M.S.); and Cardiac Electrophysiology, Mount Sinai Fuster Heart Hospital School of Medicine, New York (V.Y.R.).
• N. Engl. J. Med. 2024 Nov 16.

BackgroundOral anticoagulation is recommended after ablation for atrial fibrillation among patients at high risk for stroke. Left atrial appendage closure is a mechanical alternative to anticoagulation, but data regarding its use after atrial fibrillation ablation are lacking.MethodsWe conducted an international randomized trial involving 1600 patients with atrial fibrillation who had an elevated score (≥2 in men and ≥3 in women) on the CHA2DS2-VASc scale (range, 0 to 9, with higher scores indicating a greater risk of stroke) and who underwent catheter ablation. Patients were randomly assigned in a 1:1 ratio to undergo left atrial appendage closure or receive oral anticoagulation. The primary safety end point, tested for superiority, was non-procedure-related major bleeding or clinically relevant nonmajor bleeding. The primary efficacy end point, tested for noninferiority, was a composite of death from any cause, stroke, or systemic embolism at 36 months. The secondary end point, tested for noninferiority, was major bleeding, including procedure-related bleeding, through 36 months.ResultsA total of 803 patients were assigned to undergo left atrial appendage closure, and 797 to receive anticoagulant therapy. The mean (±SD) age of the patients was 69.6±7.7 years, 34.1% of the patients were women, and the mean CHA2DS2-VASc score was 3.5±1.3. At 36 months, a primary safety end-point event had occurred in 65 patients (8.5%) in the left atrial appendage closure group (device group) and in 137 patients (18.1%) in the anticoagulation group (P<0.001 for superiority); a primary efficacy end-point event had occurred in 41 patients (5.3%) and 44 patients (5.8%), respectively (P<0.001 for noninferiority); and a secondary end-point event had occurred in 3.9% and 5.0% (P<0.001 for noninferiority). Complications related to the appendage closure device or procedure occurred in 23 patients.ConclusionsAmong patients who underwent catheter-based atrial fibrillation ablation, left atrial appendage closure was associated with a lower risk of non-procedure-related major or clinically relevant nonmajor bleeding than oral anticoagulation and was noninferior to oral anticoagulation with respect to a composite of death from any cause, stroke, or systemic embolism at 36 months. (Funded by Boston Scientific; OPTION ClinicalTrials.gov number, NCT03795298.).Copyright © 2024 Massachusetts Medical Society.

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