Major Bleeding Events Associated with Rivaroxaban Use in Patients Aged 75 Years and Older with Nonvalvular Atrial Fibrillation: A Review of the Literature

Atrial fibrillation (AF) is highly prevalent among older adults and is associated with a substantial risk of thromboembolic events, making oral anticoagulation a fundamental component of stroke prevention. Rivaroxaban, a direct oral factor Xa inhibitor, is widely used in patients with nonvalvular atrial fibrillation (NVAF); however, advanced age is associated with an increased susceptibility to bleeding due to age related changes in renal function, vascular integrity, comorbidity burden, polypharmacy, and the frequent coexistence of antiplatelet therapy. Patients aged 75 years and older therefore represent a clinically relevant population in which the balance between thromboembolic protection and bleeding risk requires particular consideration. This review aims to analyze the available evidence regarding major bleeding events associated with rivaroxaban use in patients aged 75 years and older with NVAF, with particular emphasis on the incidence, clinical characteristics, and determinants of major bleeding, including gastrointestinal and intracranial hemorrhage. Evidence from randomized clinical trials, observational studies, real world cohorts, and systematic reviews indicates that older patients receiving rivaroxaban have a higher absolute risk of major bleeding than younger patients, although randomized trial data suggest that the relative bleeding risk compared with warfarin is not substantially modified by age. Real world evidence, however, suggests that very elderly patients may experience higher rates of major and gastrointestinal bleeding, particularly in the presence of renal impairment, hypertension, hepatic dysfunction, previous bleeding, low body weight, or concomitant antiplatelet therapy. These findings highlight the importance of individualized anticoagulant selection, appropriate dose adjustment according to renal function, systematic assessment of modifiable bleeding risk factors, and careful monitoring in older adults. Rivaroxaban remains an effective anticoagulant for stroke prevention in elderly patients with NVAF, but its use in individuals aged 75 years and older requires a careful assessment of the individual benefit-risk profile, particularly among the very elderly and those with multiple bleeding risk factors.