Edoxaban for stroke prevention in patients with atrial fibrillation: Of randomized and real-world evidence

Atrial fibrillation (AF) is the most common chronic arrhythmia worldwide. AF related complications include ischemic stroke, which can be prevented for largely by the use of direct oral anticoagulants. This review focuses on the randomized trial and large registries on edoxaban, a direct factor Xa inhibitor. The ENGAGE-AF TIMI 48 study demonstrated that edoxaban 60/30 mg was non-inferior to warfarin for stroke or systemic embolism (SEE) prevention, while superior with regard to major bleeding. In ELDERCARE-AF, the non-approved dose of edoxaban 15 mg versus placebo resulted in a lower risk of stroke/SEE and a numerically higher major bleeding risk in elderly patients from Japan with a contraindication for anticoagulation. These results are echoed in many sub analyses, generally showing preserved efficacy and safety of edoxaban versus warfarin, in patients with varying absolute risk for clinical outcomes. Asian patients with AF, who have a different risk profile than non-Asian patients, and edoxaban proved an effective and safe anticoagulant in Asian patients too. In the ETNA-AF Global registry, comprising patients from Europe and Asia, as well as in other non-randomized real-world studies, the efficacy and safety of edoxaban was confirmed. In conclusion, edoxaban is an effective and safe direct anticoagulant for stroke prevention in AF. The large evidence base in Asian patients, in patients with cardiovascular and non-cardiovascular comorbidities and with different dosing regimens provide clinicians with a valuable option for stroke prevention in their patients with AF.