Low-dose edoxaban effective for stroke prevention for elderly patients with atrial fibrillation

Référence

Okumura K, Akao M, Yoshida T, et al, for the ELDERCARE-AF Committees and Investigators. Low-dose edoxaban in very elderly patients with atrial fibrillation. N Engl J Med 2020;383(18):1735-1745.

Sommaire

Many elderly patients with atrial fibrillation may not be prescribed standard doses of anticoagulation for stroke prevention because of a perceived higher risk of bleeding. In this Japanese study, investigators enrolled patients 80 years and older with nonvalvular atrial fibrillation and a CHADS2 score of 2 or more for whom standard doses of oral anticoagulants were considered inappropriate (eg, those with a history of critical bleeding, severe renal impairment, low body weight, continuous nonsteroidal anti-inflammatory drug use, or antiplatelet drug use). A total of 984 patients were randomized to receive either edoxaban 15 mg daily (standard dose is 60 mg or 30 mg daily) or a matched placebo. The 2 groups had similar baseline characteristics: mean age of 86.6 years, mean body weight of 50.6 kg, and a mean CHADS2 score of 3. The annualized rate of stroke or systemic embolism was lower in the edoxaban group than in the placebo group (2.3% vs 6.7%; hazard ratio [HR] 0.34; 95% CI 0.19 - 0.61; P < .001). As expected, the incidence of major bleeding was higher in the edoxaban group, although this difference did not reach significance (3.3% for edoxaban vs 1.8% for placebo; P = .09). The edoxaban group did have statistically significant higher rates of gastrointestinal bleeding (2.3% vs 0.8%; HR 2.85; 1.03 - 7.88) and clinically relevant nonmajor bleeding (14.5% vs 8.9%; HR 1.62; 1.14 - 2.30).