The Lead Episode 23: A Discussion of Anticoagulation with Edoxaban in Patients with Atrial High-Rate Episodes-New England Journal of Medicine

New England Journal of Medicine

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The NOAH-AFNET 6 trial investigated the use of oral anticoagulation therapy with edoxaban for patients with atrial high-rate episodes (AHREs) but without clinically diagnosed atrial fibrillation (AF). The trial enrolled 2,608 patients and randomly assigned them to receive either edoxaban or placebo. The primary efficacy outcome, which was a composite of cardiovascular death, stroke, or systemic embolism, did not show a significant difference between the two groups. The incidence of stroke was low in both groups. However, the safety outcome, which was a composite of major bleeding or death, occurred more frequently in the edoxaban group. The trial concluded that anticoagulation therapy with edoxaban did not significantly reduce the incidence of cardiovascular death, stroke, or systemic embolism compared to placebo. It also resulted in a higher incidence of major bleeding. The trial suggested that AHREs without clinically diagnosed AF may not require anticoagulation therapy. The trial has limitations such as premature termination and limited diversity in patient population. In summary, the trial did not find a significant benefit of anticoagulation therapy in patients with AHREs but without clinically diagnosed AF and raised concerns about the increased risk of major bleeding with edoxaban.

Keywords

NOAH-AFNET 6 trial

oral anticoagulation therapy

edoxaban

atrial high-rate episodes

clinically diagnosed atrial fibrillation

cardiovascular death

stroke

systemic embolism

placebo

major bleeding