Abstract
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.
Highlights
Atrial fibrillation (AF) is a growing epidemic and an important public health problem as the world population ages
Stepwise regression analysis suggested that creatinine clearance (CrCl) < 50 mL/min, hepatic dysfunction, and hypertension were specific predictive factors of major bleeding and no factors were predictive of stroke/non-central nervous system (non-CNS) systemic embolism (SE)/ myocardial infarction (MI) for patients aged ≥ 75 years (Supplementary Table 3). This sub-analysis was aimed at evaluating the safety and effectiveness of rivaroxaban treatment for stroke prevention in nonvalvular atrial fibrillation (NVAF) patients aged ≥ 75 years
These patients presented higher rates of both major bleeding and the composite endpoint of stroke/non-CNS SE/MI compared to patients aged < 75 years
Summary
Atrial fibrillation (AF) is a growing epidemic and an important public health problem as the world population ages. Extended author information available on the last page of the article from multiple complicating factors, including comorbidities, polypharmacotherapy, cognitive deficits, and falling [2, 3]. Due to those complexities, practicing physicians often must perform a delicate balance and proper decision making. The decision making for such an elderly patient population is a challenge due to the limited availability of clinical and real-world data. In the ROCKET AF study, which included 14,264 patients with nonvalvular atrial fibrillation (NVAF) worldwide, rivaroxaban demonstrated non-inferiority to warfarin for the prevention of stroke or systemic embolism [4].
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