Clinical Outcomes of Very Elderly Patients With Atrial Fibrillation Receiving On‐label Doses of Apixaban: J‐ELD AF Registry Subanalysis

BACKGROUND: Increasing age predisposes patients with atrial fibrillation to both thromboembolic and bleeding events; however, data on outcomes of very elderly patients (aged ≥85 years) receiving appropriate antithrombotic therapy are still limited. METHODS AND RESULTS: The J‐ELD AF (Multicenter Prospective Cohort Study to Investigate the Effectiveness and Safety of Apixaban in Japanese Elderly Atrial Fibrillation Patients) Registry is a multicenter prospective observational study of Japanese patients with nonvalvular atrial fibrillation aged ≥75 years taking on‐label doses (standard dose of 5 mg BID or reduced dose of 2.5 mg BID) of apixaban. The entire cohort (3031 patients from 110 institutions) was divided into 3 age groups: 75 to 79 years (n=1068, 35.2%), 80 to 84 years (n=1120, 37.0%), and ≥85 years (n=843, 27.8%). The event incidence rates (/100 person‐years) were 1.40, 1.55, and 1.95 for stroke or systemic embolism (log‐rank P=0.65); 1.70, 1.55, and 2.61 for bleeding requiring hospitalization (log‐rank P=0.33); 2.09, 2.60, and 5.29 for total deaths (log‐rank P<0.001); and 0.40, 1.06, and 1.55 for cardiovascular deaths (log‐rank P=0.045), respectively. After adjusting for confounders using a Cox regression analysis, age ≥85 years was identified as an independent risk of total death (hazard ratio, 1.89; 95% CI, 1.10–3.26 [P=0.022]), but not of stroke or systemic embolism, bleeding requiring hospitalization, or cardiovascular death. CONCLUSIONS: Although mortality increased with age, age ≥85 years was not a significant risk of stroke or systemic embolism, bleeding requiring hospitalization, or cardiovascular death in Japanese patients with nonvalvular atrial fibrillation taking on‐label doses of apixaban. REGISTRATION: URL: https://www.umin.ac.jp/ctr; Unique identifier: UMIN000017895.