DOACs for Older adults with Atrial Fibrillation and Falls: Results from the prospective single-centre DOAFF study.

Falls are one of the most fearsome events in anticoagulated older adults. The evidence concerning safety of direct oral anticoagulants (DOACs) in falling elderly patients with atrial fibrillation (AF) is still limited. We prospectively enrolled consecutive anticoagulant-naïve patients aged 65 years and older, starting anticoagulation with DOACs for AF. The study cohort was stratified in fallers vs. non-fallers, according to the occurrence of at least one fall during the 2-year follow-up and bleeding outcomes were evaluated. We enrolled 524 consecutive patients. Mean age was 80.8 years and they were mostly women (54.0%). Among the study cohort, 148 patients (28.2%) presented at least one fall episode during the study period. After the adjustment for potential confounders, no difference was found between fallers and non-fallers for all the study outcomes: major bleeding [HR: 1.04 (95%CI: 0.58–1.85)], intracranial haemorrhage [HR: 1.63 (95%CI: 0.69–3.80)], clinically relevant non-major bleeding [HR: 1.21 (95%CI: 0.83–1.76)], and all-cause death [HR: 1.51 (95%CI: 0.85–2.69)]. The presence of a prior cerebrovascular event [HR: 2.27 (95%CI: 1.12–4.62); p-value: 0.02] and polypharmacy [HR: 1.60 (95%CI: 1.08–2.39); p-value: 0.02] were the main drivers for major and clinically relevant non-major bleedings, respectively. Falls in an anticoagulant-naïve population aged 65 years and over starting a DOAC for AF do not increase the bleeding risk. Thus, the presence of falls should not discourage clinicians from prescribing DOACs also in this subset of patients. • Safety of DOACs in older adults with AF and falls was evaluated. • Falls did not increase the bleeding risk in older adults with AF on DOACs. • The presence of falls should not dissuade from prescribing DOACs in this population. • DOACs dose reduction should be adopted only when the appropriate criteria are met. • Cerebrovascular events and polypharmacy showed to be key predictors of bleeding. [ABSTRACT FROM AUTHOR]