Background: The postmarketing surveillance registry evaluated the safety and efficacy of rivaroxaban in Japanese patients with atrial fibrillation (AF) treated with rivaroxaban.
Methods: A total of 10,038 patients with AF were enrolled between April 18, 2012 and December 16, 2013. Overall, 48.9% of the patients were of 75 years or older. The median CHADS2 score was 2 (interquartile range, 1-3). A total of 54.7% of patients had switched from an anticoagulant/antiplatelet drug, whereas 45.3% were treatment naive. Initial analysis was conducted for the 1039 patients who had completed the 6-month follow-up examinations by the end of June 2013. The low dose (10 mg/d) of rivaroxaban had been selected for approximately one quarter of the patients because of bleeding risks and advanced age in addition to renal impairment, although the high dose (15 mg/d) should have been selected.
Results: Major and nonmajor clinically relevant bleeding events were observed in 36 of 1035 patients. Five of 16 patients who concomitantly used 2 or more antiplatelet agents developed a bleeding event. Bleeding events were observed in 8 of 158 patients who were of 75 years or older and weighed 50 kg or less. The composite end point event of stroke, systemic embolism, or myocardial infarction was observed in 6 of 1034 patients.
Conclusions: This registry will continue to provide insights into the safety and efficacy of rivaroxaban in real-world practice.
Keywords: Atrial fibrillation; Japanese; multicenter registry; oral anticoagulation.
Copyright © 2014. Published by Elsevier Inc.