Direct oral
anticoagulants (DOACs), such as
rivaroxaban, reduce the risk of
stroke and systemic
embolism in patients with nonvalvular
atrial fibrillation (NVAF). However, it is still unclear whether the
stroke reduction benefit outweighs the
bleeding risk in elderly Japanese patients with NVAF. The
Xarelto Post-Authorization Safety and Effectiveness Study in Japanese Patients with
Atrial Fibrillation (XAPASS) was a real-world, prospective observational, post-marketing surveillance study on the safety and effectiveness of
rivaroxaban in Japanese clinical practice. This sub-analysis evaluated the clinical outcomes of elderly patients aged ≥ 75 years. At the 1-year follow-up, there were 4,685 (48.91%) and 4,893 (51.09%) patients aged ≥ 75 and < 75 years, respectively. Safety and effectiveness outcomes were compared between patients aged ≥ 75 years and those aged < 75 years, and among 3 elderly sub-populations (age ranges: 75-79, 80-84, and ≥ 85 years). Patients aged ≥ 75 years had higher rates of major
bleeding [2.22 vs. 1.35 events per 100 patient-years, hazard ratio (HR) 1.63, 95% confidence interval (CI) 1.17-2.28] and composite of
stroke (ischemic or hemorrhagic)/non-central nervous system (non-CNS) systemic
embolism (SE)/
myocardial infarction (MI) (2.41 vs. 1.21 events per 100 patient-years, HR 1.97, 95% CI 1.40-2.77) compared to patients aged < 75 years.
Intracranial hemorrhage rates were < 1 event per 100 patient-years in both groups (0.85 vs. 0.59 events per 100 patient-years, HR 1.43, 95% CI 0.85-2.40). Kaplan-Meier curves of major
bleeding and
stroke/non-CNS SE/MI showed that no significant differences of cumulative event rates were identified among the 3 elderly sub-populations. Stepwise Cox regression analyses revealed that
creatinine clearance (CrCl) (<50 mL/min), hepatic impairment, and
hypertension were specific predictors for major
bleeding and no specific predictors were found for
stroke/non-CNS SE/MI in patients aged ≥ 75 years. In conclusion, safety and effectiveness event rates were higher in patients aged ≥ 75 years compared with those aged < 75 years, yet, no distinct differences were observed among the 3 elderly sub-populations.