LB-469807-05 OUTCOMES WITH AND WITHOUT ORAL ANTICOAGULATION IN PATIENTS WITH PRIOR STROKE AND DEVICE-DETECTED ATRIAL FIBRILLATION: THE NOAH-AFNET 6 TRIAL
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LB-469807-05 OUTCOMES WITH AND WITHOUT ORAL ANTICOAGULATION IN PATIENTS WITH PRIOR STROKE AND DEVICE-DETECTED ATRIAL FIBRILLATION: THE NOAH-AFNET 6 TRIAL. / Diener, Hans; Lip, Gregory; Nikorowitsch, Julius; Becher, Nina; Blomstrom, Carina; Camm, Alan; Chlouverakis, Gregory; Goette, Andreas; Schotten, Ulrich; Simantirakis, Emmanuel; Toennis, Tobias; Vardas, Panos; Zapf, Antonia; Sehner, Susanne; Schnabel, Renate; Scherr, Daniel; Ozga, Ann-Kathrin; Bertaglia, Emanuele; Brandes, Axel; Kirchhof, Paulus.
In: HEART RHYTHM, Vol. 21, No. 7, P1207, 01.05.2024.Research output: SCORING: Contribution to journal › Other (editorial matter etc.) › Research
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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 -