TY - JOUR
T1 - Anticoagulation in Patients With Device-Detected Atrial Fibrillation With and Without a Prior Stroke or Transient Ischemic Attack
T2 - The NOAH-AFNET 6 Trial
AU - Diener, Hans Christoph
AU - Becher, Nina
AU - Sehner, Susanne
AU - Toennis, Tobias
AU - Bertaglia, Emanuele
AU - Blomstrom-Lundqvist, Carina
AU - Brandes, Axel
AU - Beuger, Vincent
AU - Calvert, Melanie
AU - Camm, A John
AU - Chlouverakis, Gregory
AU - Dan, Gheorghe-Andrei
AU - Dichtl, Wolfgang
AU - Fierenz, Alexander
AU - Goette, Andreas
AU - de Groot, Joris R
AU - Hermans, Astrid
AU - Lip, Gregory Y H
AU - Lubinski, Andrzej
AU - Marijon, Eloi
AU - Merkely, Béla
AU - Mont, Lluís
AU - Nikorowitsch, Julius
AU - Ozga, Ann-Kathrin
AU - Rajappan, Kim
AU - Sarkozy, Andrea
AU - Scherr, Daniel
AU - Schnabel, Renate B
AU - Schotten, Ulrich
AU - Simantirakis, Emmanuel
AU - Vardas, Panos
AU - Wichterle, Dan
AU - Zapf, Antonia
AU - Kirchhof, Paulus
AU - NOAH-AFNET 6 investigators
PY - 2024/8/27
Y1 - 2024/8/27
N2 - 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.
AB - 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.
KW - CHA2DS2-VASc score
KW - NOAH-AFNET 6
KW - anticoagulation
KW - atrial fibrillation
KW - device-detected atrial fibrillation
KW - recurrent stroke
U2 - 10.1161/JAHA.124.036429
DO - 10.1161/JAHA.124.036429
M3 - Article
SN - 2047-9980
VL - 13
JO - Journal of the American Heart Association
JF - Journal of the American Heart Association
IS - 17
M1 - e036429
ER -