Safety and efficacy of Direct Oral Anticoagulants (DOACs) in very elderly patients (≥ 85 years old) with non-valvular atrial fibrillation. The Experience of an Italian tertiary care center.

BACKGROUND Limited real-world data are available regarding the comparison about safety and efficacy of DOACs prescription in very elderly patients (≥85 years) with non-valvular atrial fibrillation (NVAF). Concern about the risk of bleeding with anticoagulation in very older patients still represents an important challenge for clinicians. OBJECTIVE To evaluate the different prevalence of major bleeding and thromboembolic events between very elderly NVAF patients (≥85 years) compared to those non very elderly (<85 years). METHODS Single center multidisciplinary registry including NVAF patients treated with DOACs. Primary safety endpoint was 2-year rate of major bleeding. Primary efficacy endpoint was 2-year rate of thromboembolic events. Event-free survival curves among groups were compared using Cox-Mantel test. RESULTS 908 NVAF consecutive patients were included, of these, 805 patients were <85 years (89%) and 103 patients were very elderly patients with ≥85 years (11%). Compared to patients <85 years, those very elderly have higher CHA2DS2-VASc score (p=0.001), higher rate of hypertension (p=0.001), diabetes mellitus (p=0.030), previous bleeding events (p<0.001), previous stroke/TIA/SE (p=<0.001), heart failure (p=<0.001), and lower creatinine clearance (p<0.001). In terms of safety endpoints (overall ISTH-major bleeding) no significative difference between two groups (p=0.952) were observed up to 2-year follow-up. Systemic thromboembolic event (primary efficacy endpoint) was significantly higher in patients with ≥85 years (p=0.027). The incidence of all-cause death was significantly higher in very elderly patients (p<0.001). CONCLUSIONS This single center registry, showed that the use of DOACs in very elderly NVAF was safe and is a therapeutic option to be pursued for stroke prevention especially for those who are at high risk of ischemic events.