Anticoagulation in Patients With Device‐Detected Atrial Fibrillation With and Without a Prior Stroke or Transient Ischemic Attack: The NOAH‐AFNET 6 Trial

Author:

Diener Hans Christoph1ORCID,Becher Nina23ORCID,Sehner Susanne4ORCID,Toennis Tobias23ORCID,Bertaglia Emanuele5ORCID,Blomstrom‐Lundqvist Carina67ORCID,Brandes Axel89ORCID,Beuger Vincent9ORCID,Calvert Melanie1011ORCID,Camm A. John12ORCID,Chlouverakis Gregory13ORCID,Dan Gheorghe‐Andrei14ORCID,Dichtl Wolfgang15ORCID,Fierenz Alexander4ORCID,Goette Andreas91617ORCID,de Groot Joris R.18ORCID,Hermans Astrid19ORCID,Lip Gregory Y. H.2021ORCID,Lubinski Andrzej22ORCID,Marijon Eloi23ORCID,Merkely Béla24ORCID,Mont Lluís252627ORCID,Nikorowitsch Julius23ORCID,Ozga Ann‐Kathrin4ORCID,Rajappan Kim28ORCID,Sarkozy Andrea29ORCID,Scherr Daniel30,Schnabel Renate B.239ORCID,Schotten Ulrich919ORCID,Simantirakis Emmanuel31ORCID,Vardas Panos3132ORCID,Wichterle Dan33ORCID,Zapf Antonia49ORCID,Kirchhof Paulus239ORCID,

Affiliation:

1. Department of Neuroepidemiology Institute for Medical Informatics, Biometry and Epidemiology (IMIBE), University Duisburg‐Essen Essen Germany

2. Department of Cardiology University Heart & Vascular Center Hamburg, University Medical Center Hamburg‐Eppendorf Hamburg Germany

3. German Center for Cardiovascular Research (DZHK) Partner Site Hamburg/Kiel/Luebeck Hamburg Germany

4. Institute of Medical Biometry and Epidemiology University Medical Centre Hamburg‐Eppendorf Hamburg Germany

5. Cardiology Unit Camposampiero Hospital – AULSS Euganea Padua Italy

6. Department of Medical Science Uppsala University Uppsala Sweden

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

8. Department of Cardiology Esbjerg Hospital, University Hospital of Southern Denmark Esbjerg Denmark

9. Atrial Fibrillation Network (AFNET) Muenster Germany

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

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

12. Cardiovascular and Cell Sciences Research Institute, St. George’s University of London London United Kingdom

13. Biostatistics Laboratory, School of Medicine University of Crete Crete Greece

14. Medicine University “Carol Davila” Colentina University Hospital Bucharest Romania

15. Department of Internal Medicine III, Cardiology and Angiology Innsbruck Medical University Innsbruck Austria

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

17. Otto‐von‐Guericke Universität Magdeburg Magdeburg Germany

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

19. Department of Cardiology and Physiology Maastricht University Maastricht the Netherlands

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

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

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

23. Cardiology Division European Georges Pompidou Hospital Paris France

24. Heart and Vascular Center Semmelweis University Budapest Hungary

25. Hospital Clínic Universitat de Barcelona Barcelona Catalonia Spain

26. Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS) Barcelona Catalonia Spain

27. Centro de Investigación Biomédica en Red Enfermedades Cardiovasculares (CIBERCV) Madrid Spain

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

29. HRMC University Hospital Brussels, VUB Brussels Belgium Belgium

30. Department of Cardiology Medical University of Graz Graz Austria

31. Department of Cardiology Heraklion University Hospital Heraklion Greece

32. Biomedical Research Foundation Academy of Athens (BRFAA) Greece and Hygeia Hospitals Group Athens Greece

33. Department of Cardiology Institute for Clinical and Experimental Medicine Prague Czechia

Abstract

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.

Publisher

Ovid Technologies (Wolters Kluwer Health)

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