LB-469807-05 OUTCOMES WITH AND WITHOUT ORAL ANTICOAGULATION IN PATIENTS WITH PRIOR STROKE AND DEVICE-DETECTED ATRIAL FIBRILLATION: THE NOAH-AFNET 6 TRIAL

TY - JOUR

T1 - LB-469807-05 OUTCOMES WITH AND WITHOUT ORAL ANTICOAGULATION IN PATIENTS WITH PRIOR STROKE AND DEVICE-DETECTED ATRIAL FIBRILLATION: THE NOAH-AFNET 6 TRIAL

AU - Diener, Hans

AU - Lip, Gregory

AU - Nikorowitsch, Julius

AU - Becher, Nina

AU - Blomstrom, Carina

AU - Camm, Alan

AU - Chlouverakis, Gregory

AU - Goette, Andreas

AU - Schotten, Ulrich

AU - Simantirakis, Emmanuel

AU - Toennis, Tobias

AU - Vardas, Panos

AU - Zapf, Antonia

AU - Sehner, Susanne

AU - Schnabel, Renate

AU - Scherr, Daniel

AU - Ozga, Ann-Kathrin

AU - Bertaglia, Emanuele

AU - Brandes, Axel

AU - Kirchhof, Paulus

PY - 2024/5/1

Y1 - 2024/5/1

N2 - Introduction: Patients with a prior stroke are at high risk of recurrent strokes. In patients with ECG-documented atrial fibrillation (AF), anticoagulation reduces subsequent strokes. Detection of short and rare episodes of atrial fibrillation using implanted devices (device-detected AF, DDAF) is common in patients with a prior stroke and these patients are often treatedwith an anticoagulant when DDAF is detected. Data on the effectiveness and safety of oral anticoagulation in patients a prior stroke and DDAF but no ECG-documented AF are lacking.Methods: This prespecified secondary analysis of NOAH-AFNET 6 with post-hoc elements assessed the effects of oral anticoagulation on stroke, systemic embolism andcardiovascular death (primary outcome) and major ISTH bleeding and death (safety outcome) in patients with DDAF and a prior stroke in the randomized, double-blind, double-dummyNOAH-AFNET 6 trial.Results: The analysis population consisted of 253/2534 patients with DDAF and a prior stroke or transient ischemic attack at baseline (mean age 78 years, 36.4% women). These patientswere randomized to anticoagulation with edoxaban or no anticoagulation containing aspirin in patients with a prior stroke or TIA. Interaction analysis did not detect a treatment interactionwith prior stroke for any of the primary and secondary time-to- event outcomes. Anticoagulation did not reduce primary outcome events within this subgroup (no anticoagulation: 16/131 patientswith an event (6.3%/patient-year); anticoagulation: 14/122 patients (5.7%/patient-year), and the rate of recurrent stroke was not significantly different between treatment groups(anticoagulation: 4/122 (1.6%/patient-year); no anticoagulation: 6/131 (2.3%/patient-year)). Anticoagulation markedly increased major ISTH bleeding in patients with prior stroke compared toaspirin (adjusted hazard ratio 4.2 [0.9-19.9]; patients without prior stroke: adjusted hazard ratio 1.9 [1.2-3.2]; interaction p-value50.068).Application: In patients with a prior stroke and device-detected AF without ECG-documented AF, therapeutic decisions need to consider the effects of anticoagulation on stroke, bleeding anddeath. Based on this subgroup analysis in 253 patients in NOAH-AFNET 6, that decision will not be easy. We need better methods to estimate stroke risk in patients with device-detected AF.Next Steps/Future: The findings will help clinicians and call for validation in other data sets, including in the ARTESiA trial and in a patient-level meta analysis of both trials.

AB - Introduction: Patients with a prior stroke are at high risk of recurrent strokes. In patients with ECG-documented atrial fibrillation (AF), anticoagulation reduces subsequent strokes. Detection of short and rare episodes of atrial fibrillation using implanted devices (device-detected AF, DDAF) is common in patients with a prior stroke and these patients are often treatedwith an anticoagulant when DDAF is detected. Data on the effectiveness and safety of oral anticoagulation in patients a prior stroke and DDAF but no ECG-documented AF are lacking.Methods: This prespecified secondary analysis of NOAH-AFNET 6 with post-hoc elements assessed the effects of oral anticoagulation on stroke, systemic embolism andcardiovascular death (primary outcome) and major ISTH bleeding and death (safety outcome) in patients with DDAF and a prior stroke in the randomized, double-blind, double-dummyNOAH-AFNET 6 trial.Results: The analysis population consisted of 253/2534 patients with DDAF and a prior stroke or transient ischemic attack at baseline (mean age 78 years, 36.4% women). These patientswere randomized to anticoagulation with edoxaban or no anticoagulation containing aspirin in patients with a prior stroke or TIA. Interaction analysis did not detect a treatment interactionwith prior stroke for any of the primary and secondary time-to- event outcomes. Anticoagulation did not reduce primary outcome events within this subgroup (no anticoagulation: 16/131 patientswith an event (6.3%/patient-year); anticoagulation: 14/122 patients (5.7%/patient-year), and the rate of recurrent stroke was not significantly different between treatment groups(anticoagulation: 4/122 (1.6%/patient-year); no anticoagulation: 6/131 (2.3%/patient-year)). Anticoagulation markedly increased major ISTH bleeding in patients with prior stroke compared toaspirin (adjusted hazard ratio 4.2 [0.9-19.9]; patients without prior stroke: adjusted hazard ratio 1.9 [1.2-3.2]; interaction p-value50.068).Application: In patients with a prior stroke and device-detected AF without ECG-documented AF, therapeutic decisions need to consider the effects of anticoagulation on stroke, bleeding anddeath. Based on this subgroup analysis in 253 patients in NOAH-AFNET 6, that decision will not be easy. We need better methods to estimate stroke risk in patients with device-detected AF.Next Steps/Future: The findings will help clinicians and call for validation in other data sets, including in the ARTESiA trial and in a patient-level meta analysis of both trials.

U2 - 10.1016/j.hrthm.2024.04.020

DO - 10.1016/j.hrthm.2024.04.020

M3 - Other (editorial matter etc.)

VL - 21

JO - HEART RHYTHM

JF - HEART RHYTHM

SN - 1547-5271

IS - 7

M1 - P1207

ER -