Atrial fibrillation (AF) refers to irregular and rapid heart rate resulting in poor blood flow. AF can occur at any age, but it’s risk significantly increases in older adults. This study aims to evaluate the efficacy of edoxaban, an anticoagulant medication, in the treatment of AF in very elderly patients.
This multicenter, phase 3, double-blind, randomized, event-driven, placebo-controlled trial included a total of 984 patients with nonvalvular AF. The patients were randomly assigned in a 1:1 ratio to receive edoxaban (n=492) or placebo (n=492). The primary outcome of the study was the incidents of stroke and systemic embolism, along with adverse events.
Of 984 patients who were included in the study, 158 withdrew consent, 135 died, and 10 had other reasons. Therefore, a total of 681 patients completed the trial. The annualized rate of stroke or systemic embolism in the remaining patients was 2.3% in the edoxaban group and 6.7% in the placebo group. The annualized rate of major bleeding was found to be 3.3% in the edoxaban group and 1.8% in the placebo group.
The research concluded that the use of low-dose edoxaban was associated with a lower rate of stroke and systemic embolism compared with placebo.