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

Hans Christoph Diener, Nina Becher, Susanne Sehner, Tobias Toennis, Emanuele Bertaglia, Carina Blomstrom-Lundqvist, Axel Brandes, Vincent Beuger, Melanie Calvert, A John Camm, Gregory Chlouverakis, Gheorghe-Andrei Dan, Wolfgang Dichtl, Alexander Fierenz, Andreas Goette, Joris R de Groot, Astrid Hermans, Gregory Y H Lip, Andrzej Lubinski, Eloi MarijonBéla Merkely, Lluís Mont, Julius Nikorowitsch, Ann-Kathrin Ozga, Kim Rajappan, Andrea Sarkozy, Daniel Scherr, Renate B Schnabel, Ulrich Schotten, Emmanuel Simantirakis, Panos Vardas, Dan Wichterle, Antonia Zapf, Paulus Kirchhof*, NOAH-AFNET 6 investigators

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

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.
Original languageEnglish
Article numbere036429
JournalJournal of the American Heart Association
Volume13
Issue number17
DOIs
Publication statusPublished - 27 Aug 2024

Keywords

  • CHA2DS2-VASc score
  • NOAH-AFNET 6
  • anticoagulation
  • atrial fibrillation
  • device-detected atrial fibrillation
  • recurrent stroke

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