BACKGROUND: Short and rare episodes of atrial fibrillation (AF) are commonly detected using implanted devices (device-detected AF) in patients with prior stroke or transient ischemic attack (TIA). The effectiveness and safety of oral anticoagulation in patients with prior stroke or TIA and device-detected AF but with no ECG-documented AF is unclear. METHODS AND RESULTS: This prespecified analysis of the NOAH-AFNET 6 (Non-Vitamin K Antagonist Oral Anticoagulants in Patients With Atrial High Rate Episodes) trial with post hoc elements assessed the effect of oral anticoagulation in patients with device-detected AF with and without a prior stroke or TIA in the randomized, double-blind, double-dummy NOAH-AFNET 6 trial. Outcomes were stroke, systemic embolism, and cardiovascular death (primary outcome) and major bleeding and death (safety outcome). A prior stroke or TIA was found in 253 patients with device-detected AF randomized in the NOAH-AFNET 6 (mean age, 78 years; 36.4% women). There was no treatment interaction with prior stroke or TIA for any of the primary and secondary time-to-event outcomes. In patients with a prior stroke or TIA, 14 out of 122 patients experienced a primary outcome event with anticoagulation (5.7% per patient-year). Without anticoagulation, there were 16 out of 131 patients with an event (6.3% per patient-year). The rate of stroke was lower than expected (anticoagulation: 4 out of 122 [1.6% per patient-year]; no anticoagulation: 6 out of 131 [2.3% per patient-year]). Numerically, there were more major bleeding events with anticoagulation in patients with prior stroke or TIA (8 out of 122 patients) than without anticoagulation (2 out of 131 patients). CONCLUSIONS: Anticoagulation appears to have ambiguous effects in patients with device-detected AF and a prior stroke or TIA in this hypothesis-generating analysis of the NOAH-AFNET 6 in the absence of ECG-documented AF, partially due to a low rate of stroke without anticoagulation.

Atrial Fibrillation Network Muenster Germany

Biomedical Research Foundation Academy of Athens Greece and Hygeia Hospitals Group Athens Greece

Biostatistics Laboratory School of Medicine University of Crete Crete Greece

Cardiac Department John Radcliffe Hospital Oxford University Hospitals NHS Foundation Trust Oxford United Kingdom

Cardiology Division European Georges Pompidou Hospital Paris France

Cardiology Unit Camposampiero Hospital AULSS Euganea Padua Italy

Cardiovascular and Cell Sciences Research Institute St George's University of London London United Kingdom

Center for Patient Reported Outcomes Research Institute of Applied Health Research University of Birmingham Birmingham United Kingdom

Centro de Investigación Biomédica en Red Enfermedades Cardiovasculares Madrid Spain

Danish Center for Health Services Research Department of Clinical Medicine Aalborg University Aalborg Denmark

Department of Cardiology and Intensive Care Medicine St Vincenz Hospital Paderborn Paderborn Germany

Department of Cardiology and Internal Diseases Medical University of Gdańsk Gdańsk Poland

Department of Cardiology and Physiology Maastricht University Maastricht the Netherlands

Department of Cardiology Esbjerg Hospital University Hospital of Southern Denmark Esbjerg Denmark

Department of Cardiology Heraklion University Hospital Heraklion Greece

Department of Cardiology Institute for Clinical and Experimental Medicine Prague Czechia

Department of Cardiology Medical University of Graz Graz Austria

Department of Cardiology School of Medical Sciences Faculty of Medicine and Health Örebro University Örebro Sweden

Department of Cardiology University Heart and Vascular Center Hamburg University Medical Center Hamburg Eppendorf Hamburg Germany

Department of Internal Medicine 3 Cardiology and Angiology Innsbruck Medical University Innsbruck Austria

Department of Medical Science Uppsala University Uppsala Sweden

Department of Neuroepidemiology Institute for Medical Informatics Biometry and Epidemiology University Duisburg Essen Essen Germany

German Center for Cardiovascular Research Partner Site Hamburg Kiel Luebeck Hamburg Germany

Heart and Vascular Center Semmelweis University Budapest Hungary

Hospital Clínic Universitat de Barcelona Barcelona Catalonia Spain

HRMC University Hospital Brussels VUB Brussels Belgium Belgium

Institut d'Investigacions Biomèdiques August Pi i Sunyer Barcelona Catalonia Spain

Institute of Medical Biometry and Epidemiology University Medical Centre Hamburg Eppendorf Hamburg Germany

Liverpool Center for Cardiovascular Science at University of Liverpool Liverpool John Moores University and Liverpool Heart and Chest Hospital Liverpool United Kingdom

Medicine University Carol Davila Colentina University Hospital Bucharest Romania

NIHR Birmingham Biomedical Research Center and NIHR Applied Research Collaboration West Midlands University of Birmingham Birmingham United Kingdom

Otto von Guericke Universität Magdeburg Magdeburg Germany

The Heart Center Department of Clinical and Experimental Cardiology Amsterdam Cardiovascular Sciences Amsterdam University Medical Centers University of Amsterdam Amsterdam the Netherlands

J Am Heart Assoc. 2024 Sep 3;13(17):e037124. doi: 10.1161/JAHA.124.037124. PubMed

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