Today, Professor Ken Okumura (Saiseikai Kumamoto Hospital, Japan) presented results from ELDERCARE-AF, a phase 3 double-blind trial that compared the safety and efficacy of once-daily edoxaban 15 mg vs. placebo in 984 Japanese patients with AF aged ≥80 years and with CHADS2 score ≥2. All patients were considered ineligible for standard OACs based on low creatinine clearance (15–30 mL/minute), low body weight (≤45 kg), history of bleeding from critical organs or concomitant non-steroidal anti-inflammatory drugs or antiplatelet therapy.
Over a median study duration of 466 days, the primary efficacy endpoint of stroke and systemic embolic events was significantly lower with edoxaban 15 mg (2.3%/year) compared with placebo (6.7%/year; hazard ratio 0.34; 95% confidence interval 0.19–0.61; p<0.001). Importantly, the primary safety endpoint of major bleeding defined by the International Society on Thrombosis and Haemostasis was nonsignificantly increased with edoxaban vs. placebo (3.3%/year vs. 1.8%/year; p=0.09). Edoxaban did not increase intracranial haemorrhage (0.3%/year vs. 0.6%/year) or fatal bleeding, but caused more gastrointestinal bleeding. The rate of all-cause mortality was not different between edoxaban (9.9%/year) and placebo (10.2%/year).
These results suggest that once-daily edoxaban 15 mg may address an important unmet need in AF, potentially providing very elderly patients ineligible for standard OACs with an effective option for thromboprophylaxis while showing a nonsignificant increase in major bleeding.