Edoxaban was found to be superior to placebo for the prevention of stroke and systemic embolism in very elderly Japanese patients with nonvalvular atrial fibrillation, according to a study published in the New England Journal of Medicine.
A total of 984 patients (mean age, 86.6±4.2 years; 42.6% men) with nonvalvular atrial fibrillation who were not appropriate candidates to receive standard doses of oral anticoagulants were enrolled in this phase 3, multicenter, randomized, double-blind, placebo-controlled trial. The study’s primary efficacy end point was the composite of stroke or systemic embolism, and the primary safety end point was major bleeding. Participants were assigned to receive a daily dose of 15 mg of edoxaban (n=492) or placebo (n=492). A total of 681 patients completed the trial.
The annualized rate of stroke or systemic embolism was 2.3% in the edoxaban group and 6.7% in the placebo group (hazard ratio [HR], 0.34; 95% CI, 0.19-0.61; P <.001), and the annualized rate of major bleeding was 3.3% in the edoxaban group compared and 1.8% in the placebo group (HR, 1.87; 95% CI, 0.90-3.89; P =.09).
The rate of gastrointestinal bleeding was higher in the edoxaban compared with the placebo group (14 events; 2.3% per patient-year vs 5 events; 0.8% per patient-year, respectively; HR, 2.85; 95% CI, 1.03-7.88). In addition, there were 66 deaths from any cause in the edoxaban group compared with 69 in the placebo group (9.9% per patient-year vs 10.2% per patient year, respectively; HR, 0.97; 95% CI, 0.69-1.36).
Study limitations include the fact that a substantial number of patients discontinued the trial, in great part due to adverse events unrelated to bleeding.
“In very elderly Japanese patients with nonvalvular atrial fibrillation who were not appropriate candidates for a standard oral anticoagulation regimen, a once-daily 15-mg dose of edoxaban was superior to placebo in preventing stroke or systemic embolism and did not result in a significantly higher incidence of major bleeding than placebo,” concluded the investigators.
Disclosures: This study was funded by Daiichi Sankyo. Some of the study authors reported affiliations with pharmaceutical and medical device companies. Please see the original reference for a full list of disclosures.
Okumura K, Akao M, Yoshida T, et al. Low-dose edoxaban in very elderly patients with atrial fibrillation. N Engl J Med. 2020;383(18):1735-1745.