Anticoagulation with Edoxaban in Patients with Atrial High-Rate Episodes

This multicenter, double-blind, randomized NOAH-AFNET 6 trial evaluated whether oral anticoagulation with edoxaban benefits patients 65 or older who had device-detected atrial high-rate episodes (AHREs) lasting ≥6 minutes but no ECG-documented atrial fibrillation. Among 2536 patients with ≥1 stroke risk factor, edoxaban did not significantly reduce the composite of cardiovascular death, stroke, or systemic embolism compared to placebo (HR 0.81; P=0.15), though systemic embolism was numerically lower. Stroke incidence was low (~1% per patient-year) in both groups. However, edoxaban increased the composite safety outcome of death or major bleeding (HR 1.31; P=0.03). Trial enrollment was completed but ended early due to safety concerns and lack of efficacy. Authors conclude anticoagulation should not be routinely used in AHRE patients without confirmed atrial fibrillation, given low stroke risk and elevated bleeding risk. Data support refraining from anticoagulation unless ECG-documented atrial fibrillation develops.

This multicenter, double-blind, randomized NOAH-AFNET 6 trial evaluated whether oral anticoagulation with edoxaban benefits patients 65 or older who had device-detected atrial high-rate episodes (AHREs) lasting ≥6 minutes but no ECG-documented atrial fibrillation. Among 2536 patients with ≥1 stroke risk factor, edoxaban did not significantly reduce the composite of cardiovascular death, stroke, or systemic embolism compared to placebo (HR 0.81; P=0.15), though systemic embolism was numerically lower. Stroke incidence was low (~1% per patient-year) in both groups. However, edoxaban increased the composite safety outcome of death or major bleeding (HR 1.31; P=0.03). Trial enrollment was completed but ended early due to safety concerns and lack of efficacy. Authors conclude anticoagulation should not be routinely used in AHRE patients without confirmed atrial fibrillation, given low stroke risk and elevated bleeding risk. Data support refraining from anticoagulation unless ECG-documented atrial fibrillation develops.