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

Abstract

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.