Edoxaban (15 mg/once daily) was superior to placebo in preventing stroke or systemic embolism in very elderly Japanese patients with nonvalvular atrial fibrillation (AFib) who were not appropriate candidates for standard doses of oral anticoagulants, according to findings from the ELDERCARE-AF trial presented at ESC Congress 2020 and simultaneously published in the New England Journal of Medicine.

Researchers led by Ken Okumura, MD, PhD, randomly assigned a total of 984 Japanese patients (≥80 years of age) with nonvalvular AFib to either a once-daily 15-mg dose of edoxaban or placebo. The primary efficacy endpoint was the composite of stroke or systemic embolism. The primary safety endpoint was major bleeding.

Results found the annualized rate of stroke or systemic embolism was 2.3% in the edoxaban group and 6.7% in the placebo group. The rate of major bleeding was 3.3% in the edoxaban group and 1.8% in the placebo group. Patients in the edoxaban group also experienced more gastrointestinal bleeding (14 events vs. 5 events) than those in the placebo group. No substantial difference was observed in death from any cause between the two groups (9.9% in the edoxaban group and 10.2% in the placebo group).

One of the limitations to the trial was the larger number of patients who discontinued participation. Of the 303 who didn't finish the trial, 158 withdrew and 135 died. The number of patients who discontinued were similar across both groups. "Most patients who withdrew did so because of adverse events unrelated to bleeding or because they were no longer capable of participation, the authors said.

Additionally, because the trial only involved Japanese AFib patients, the results may not be applicable to other populations. For example, results from the ENGAGE AF-TIMI 48 found Asian AFib patients treated with the lower-dose regimen of edoxaban showed higher rates of stroke or systemic embolism and higher rates of overt bleeding of any kind than patients who were not East Asian.

"This study adds to the large body of knowledge suggesting benefit over risk of anticoagulating elderly patients with AFib," said ACC.org Editor in Chief Kim A. Eagle, MD, MACC. "Age alone should not stop the use of effective agents to prevent embolic stroke."

Clinical Topics: Arrhythmias and Clinical EP, Geriatric Cardiology, Implantable Devices, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias

Keywords: ESC Congress, ESC20, Geriatrics, Arrhythmias, Cardiac, Atrial Fibrillation

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