N Engl J Med 2021 Aug 28. Epub 2021 Aug 28.
From the Department of Cardiology, Erasmus University Medical Center, Thoraxcenter, Rotterdam, the Netherlands (N.M.V.M., E.B.); Daiichi Sankyo, Basking Ridge, NJ (M.U., J.J., A.D., C.C.); the Department of Internal Medicine II, Division of Cardiology, Vienna General Hospital, Medical University, Vienna (C.H., I.L.); the Department of Internal Medicine, St. Johannes Hospital, Dortmund (H.M.), the Department of Internal Medicine I, University Hospital Würzburg, Würzburg (P.N.), the Department of Internal Medicine-Cardiology, Heart Center Leipzig at University of Leipzig, Leipzig (H.T.), Bremer Institute for Heart and Circulation Research at Klinikum Links der Weser, Bremen (R.H.), the Department of Cardiology, Asklepios Klinik St. Georg, Hamburg (F.M.), Daiichi Sankyo Europe, Munich (P.L., H.L.), the Department of Neurology, Alfried Krupp Krankenhaus, Essen (R.V.), and the Department of Neurology, University Hospital Heidelberg, Heidelberg (R.V.) - all in Germany; Zena and Michael A. Wiener Cardiovascular Institute, Mount Sinai Hospital, New York (R. Mehran, G.D.D.); the Department of Cardiology, Centro de Investigación Biomédica en Red Enfermedades Cardiovasculares, Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela (D.L.-O.), the Cardiovascular Institute, Hospital Clínico San Carlos, Instituto de Investigación Sanitaria San Carlos (L.N.-F.), the Department of Cardiology, University Hospital La Paz (R. Moreno), and the Department of Cardiology, University Hospital Ramon y Cajal (J.L.Z.), Madrid - all in Spain; the Department of Cardiology, Washington Adventist Hospital, Takoma Park, MD (F.S.); the Department of Cardiology, Toyohashi Heart Center, Toyohashi (M.Y.), the Department of Cardiology, Teikyo University School of Medicine (Y.W.), and the Department of Cardiology, Keio University School of Medicine (K.H.), Tokyo, and the Division of Cardiology and Catheterization Laboratories, Shonan Kamakura General Hospital, Kamakura (S.S.) - all in Japan; the Department of Cardiology, Jessa Hospital, Hasselt, Belgium (P.V.); Quebec Heart and Lung Institute, Laval University, Quebec, QC, Canada (J.R.-C.); the Division of Cardiovascular Medicine, University Hospital of Strasbourg, Strasbourg, France (P.O.); the Division of Cardiology, Policlinico Hospital, University of Catania, Catania, Italy (P.C.); the Department of Internal Medicine, Cardiovascular Center, Seoul National University Hospital, Seoul, South Korea (H.-S.K.); the Department of Cardiology, University of Bern, Bern (T.P.), and Cardiocentro Ticino Institute and Department of Biomedical Sciences, University of Italian Switzerland, Lugano (M.V.) - both in Switzerland; the Department of Cardiology, University Hospital of Wales, Cardiff (R.A.), and the Division of Brain Sciences, Imperial College London, London (R.V.) - both in the United Kingdom; the Cardiology Section, University of Oklahoma Health Sciences Center, Oklahoma City (U.B.); and National and Kapodistrian University of Athens, School of Medicine, Athens (G.D.D.).
Background: The role of direct oral anticoagulants as compared with vitamin K antagonists for atrial fibrillation after successful transcatheter aortic-valve replacement (TAVR) has not been well studied.
Methods: We conducted a multicenter, prospective, randomized, open-label, adjudicator-masked trial comparing edoxaban with vitamin K antagonists in patients with prevalent or incident atrial fibrillation as the indication for oral anticoagulation after successful TAVR. The primary efficacy outcome was a composite of adverse events consisting of death from any cause, myocardial infarction, ischemic stroke, systemic thromboembolism, valve thrombosis, or major bleeding. Read More