• Paulus Kirchhof, Tobias Toennis, Andreas Goette, A John Camm, Hans Christoph Diener, Nina Becher, Emanuele Bertaglia, Carina Blomstrom Lundqvist, Martin Borlich, Axel Brandes, Nuno Cabanelas, Melanie Calvert, Gregory Chlouverakis, Gheorghe-Andrei Dan, Joris R de Groot, Wolfgang Dichtl, Borys Kravchuk, Andrzej Lubiński, Eloi Marijon, Béla Merkely, Lluís Mont, Ann-Kathrin Ozga, Kim Rajappan, Andrea Sarkozy, Daniel Scherr, Rafał Sznajder, Vasil Velchev, Dan Wichterle, Susanne Sehner, Emmanuel Simantirakis, LipGregory Y HGYHFrom the Atrial Fibrillation Network, Münster (P.K., A.G., U.S.), the Department of Cardiology, University Heart and Vascular Center Hamburg (P.K., T.T., N.B.), and the Institute of Medical Biometry and Epidemiology (A.-K.O., S.S., A.Z.),, Panos Vardas, Ulrich Schotten, Antonia Zapf, NOAH-AFNET 6 Investigators, and NOAH-AFNET6 sites and investigators.
• From the Atrial Fibrillation Network, Münster (P.K., A.G., U.S.), the Department of Cardiology, University Heart and Vascular Center Hamburg (P.K., T.T., N.B.), and the Institute of Medical Biometry and Epidemiology (A.-K.O., S.S., A.Z.), University Medical Center Hamburg-Eppendorf, and the German Center for Cardiovascular Research (DZHK) Partner Site Hamburg-Kiel-Lübeck (P.K., T.T., N.B.), Hamburg, the Department of Cardiology and Intensive Care Medicine, St. Vincenz Hospital Paderborn, Paderborn (A.G.), the Department of Neuroepidemiology, Institute for Medical Informatics, Biometry, and Epidemiology, University Duisburg-Essen, Essen (H.C.D.), and the Heart Center, Segeberger Kliniken, Bad Segeberg (M.B.) - all in Germany; the Institute of Cardiovascular Sciences (P.K.) and the Centre for Patient Reported Outcome Research, Institute of Applied Health Research, the National Institute for Health and Care Research (NIHR) Birmingham Biomedical Research Centre, and the NIHR Applied Research Collaboration West Midlands (M.C.), University of Birmingham, Birmingham, the Cardiovascular and Cell Sciences Research Institute, St. George's University of London, and Imperial College London, London (A.J.C.), the Cardiac Department, John Radcliffe Hospital, Oxford University Hospitals NHS Foundation Trust, Oxford (K.R.), and Liverpool Centre for Cardiovascular Science at University of Liverpool, John Moores University, and Liverpool Heart and Chest Hospital, Liverpool (G.Y.H.L.) - all in the United Kingdom; Unità Operativa Complessa Cardiologia-Azienda Ospedale Università di Padova, Padua, Italy (E.B.); the Department of Medical Science, Uppsala University, Uppsala, and the Department of Cardiology, School of Medical Sciences, Faculty of Medicine and Health, Örebro University, Örebro - both in Sweden (C.B.L.); the Department of Cardiology, Odense University Hospital, Odense, and the Department of Cardiology, Esbjerg Hospital-University Hospital of Southern Denmark, Esbjerg (A.B.), and the Danish Center for Health Services Research, Department of Clinical Medicine, Aalborg University, Aalborg (G.Y.H.L.) - all in Denmark; the Cardiology Department, Fernando Fonseca Hospital, Amadora, Portugal (N.C.); the Biostatistics Lab, School of Medicine, University of Crete (G.C.), and the Department of Cardiology, Heraklion University Hospital (E.S.), Heraklion, and the Biomedical Research Foundation Academy of Athens and Hygeia Hospitals Group, Athens (P.V.) - all in Greece; Medicine University Carol Davila, Colentina University Hospital, Bucharest, Romania (G.-A.D.); the Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam (J.R.G.), and the Departments of Cardiology and Physiology, Maastricht University, Maastricht (U.S.) - both in the Netherlands; the Department of Internal Medicine III, Cardiology and Angiology, Innsbruck Medical University, Innsbruck (W.D.), and the Department of Cardiology, Medical University of Graz, Graz (D.S.) - both in Austria; the National Institute of Cardiovascular Surgery, Academy of Medical Sciences of Ukraine, Kyiv (B.K.); the Department of Cardiology and Internal Disease, Medical University of Gdansk, Gdansk (A.L.), and the Department of Electrocardiology and Heart Failure, Leszek Giec Upper Silesian Medical Center, Katowice (R.S.) - both in Poland; the Cardiology Division, European Georges Pompidou Hospital, Paris (E.M.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); the Hospital Clinic, Universtitat de Barcelona, Barcelona, Institut d'Investigacions Biomèdiques August Pi Sunyer, Barcelona, and Centro de Investigacion Biomedica en Red Cardiovascular, Madrid - all in Spain (L.M.); the Department of Cardiology, University Hospital Antwerp, Edegem, Belgium (A.S.); the Cardiology Clinic, St. Anna University Hospital Sofia, Sofia Medical University, Sofia, Bulgaria (V.V.); and the Department of Cardiology, Institute for Clinical and Experimental Medicine, Prague, Czech Republic (D.W.).
• N. Engl. J. Med. 2023 Sep 28; 389 (13): 116711791167-1179.

BackgroundDevice-detected atrial high-rate episodes (AHREs) are atrial arrhythmias detected by implanted cardiac devices. AHREs resemble atrial fibrillation but are rare and brief. Whether the occurrence of AHREs in patients without atrial fibrillation (as documented on a conventional electrocardiogram [ECG]) justifies the initiation of anticoagulants is not known.MethodsWe conducted an event-driven, double-blind, double-dummy, randomized trial involving patients 65 years of age or older who had AHREs lasting for at least 6 minutes and who had at least one additional risk factor for stroke. Patients were randomly assigned in a 1:1 ratio to receive edoxaban or placebo. The primary efficacy outcome was a composite of cardiovascular death, stroke, or systemic embolism, evaluated in a time-to-event analysis. The safety outcome was a composite of death from any cause or major bleeding.ResultsThe analysis population consisted of 2536 patients (1270 in the edoxaban group and 1266 in the placebo group). The mean age was 78 years, 37.4% were women, and the median duration of AHREs was 2.8 hours. The trial was terminated early, at a median follow-up of 21 months, on the basis of safety concerns and the results of an independent, informal assessment of futility for the efficacy of edoxaban; at termination, the planned enrollment had been completed. A primary efficacy outcome event occurred in 83 patients (3.2% per patient-year) in the edoxaban group and in 101 patients (4.0% per patient-year) in the placebo group (hazard ratio, 0.81; 95% confidence interval [CI], 0.60 to 1.08; P = 0.15). The incidence of stroke was approximately 1% per patient-year in both groups. A safety outcome event occurred in 149 patients (5.9% per patient-year) in the edoxaban group and in 114 patients (4.5% per patient-year) in the placebo group (hazard ratio, 1.31; 95% CI, 1.02 to 1.67; P = 0.03). ECG-diagnosed atrial fibrillation developed in 462 of 2536 patients (18.2% total, 8.7% per patient-year).ConclusionsAmong patients with AHREs detected by implantable devices, anticoagulation with edoxaban did not significantly reduce the incidence of a composite of cardiovascular death, stroke, or systemic embolism as compared with placebo, but it led to a higher incidence of a composite of death or major bleeding. The incidence of stroke was low in both groups. (Funded by the German Center for Cardiovascular Research and others; NOAH-AFNET 6 ClinicalTrials.gov number, NCT02618577; ISRCTN number, ISRCTN17309850.).Copyright © 2023 Massachusetts Medical Society.

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