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Late-Breaking Science: Is edoxaban 15 mg a suitable treatment option for stroke prevention in the elderly?

Thromboprophylaxis with oral anticoagulants (OACs) for stroke prevention is challenging in elderly patients with atrial fibrillation (AF), with bleeding risk factors often cited as reasons to withhold OACs. Until a Late-Breaking Science presentation at ESC Congress 2020, there were no data available from phase 3 clinical trials that specifically evaluated the use of non-vitamin K antagonist OACs in elderly patients with AF, especially those considered ineligible for available OACs.

Pharmacology and Pharmacotherapy
Cardiovascular Disease in Special Populations

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. 

The content of this article reflects the personal opinion of the author/s and is not necessarily the official position of the European Society of Cardiology.