Real-world outcomes of the Xarelto Post-Authorization Safety & Effectiveness Study in Japanese Patients with Atrial Fibrillation (XAPASS)

Background: Although the efficacy and safety of the factor Xa inhibitor rivaroxaban for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF) were shown in global and Japanese phase III clinical trials, safety and effectiveness data from unselected patients in everyday clinical practice are limited. The objective of the XAPASS (Xarelto Post-Authorization Safety & Effectiveness Study in Japanese Patients with Atrial Fibrillation) is to investigate the safety and effectiveness of rivaroxaban in Japanese real-world clinical practice. Methods: The XAPASS is a prospective, single-arm, real-world observational study mandated by the Japanese authority as post-marketing surveillance. In total, 11,308 patients with NVAF who began treatment with rivaroxaban were enrolled from April 2012 to June 2014, and 9578 patients were analyzed to examine the one-year outcomes. Results: The mean treatment duration was 300 ± 119 days. The patients’ age was 73.2 ± 9.8 years, and their CHADS₂ score was 2.2 ± 1.3. Any bleeding and major bleeding occurred in 602 patients (7.6 events per 100 patient-years) and 143 patients (1.8 events per 100 patient-years), respectively. Stroke/non-central nervous system systemic embolism/myocardial infarction was observed in 144 patients (1.8 events per 100 patient-years). Conclusions: Real-world outcomes of the XAPASS showed incidence rates of major bleeding and thromboembolic events, suggesting that rivaroxaban is safe and effective in Japanese daily clinical practice (Clinicaltrials.gov: NCT01582737).