Abstract 14219: Efficacy and Safety of Direct Oral Anticoagulants in Patients With Atrial Fibrillation in the Real-world: The Fushimi AF Registry
Introduction: Oral anticoagulants (OAC) are essential for stroke prevention in patients with atrial fibrillation (AF). Due to the preferable results of randomized clinical trials and use of ease in daily clinical practice, direct oral anticoagulants (DOAC) have become widespread use. These changes in OAC therapy may have influenced the outcomes of AF, but it has not been fully characterized in unselected patients of the real-world.
Methods: The Fushimi AF Registry is a community-based prospective survey of AF patients who visited the participating institutions in Fushimi district, Japan. Follow-up data with OAC therapy status were available for 3,731 patients by the end of November 2015. We evaluated stroke/systemic embolism (SE) and major bleeding events according to OAC therapy status.
Results: After the release of DOACs, the proportion of DOACs increased gradually. The incidence rates of stroke/SE and major bleeding events in the entire cohort during a median follow-up of 3.0 years were 2.3%/year and 1.8%/year. There was no significant difference in the incidence of stroke/SE or major bleeding events according to OAC therapy status at baseline. Cox proportional hazards model incorporating the transition of OAC therapy status as a time-dependent covariate for stroke/SE and major bleeding events revealed that use of DOACs was not associated with stroke/SE events, compared with use of warfarin or non-OAC treatment [HR, 0.95 (0.59-1.51), P=0.82; vs. warfarin: HR, 0.99 (0.61-1.61), P=0.98; vs. no-OAC, respectively] (Figure). Similarly, use of DOACs was not associated with major bleeding events, compared with use of warfarin or non-OAC treatment [HR, 0.82 (0.50-1.36), P=0.45; vs. warfarin: HR, 1.24 (0.73-2.10), P=0.43; vs. no-OAC, respectively] (Figure).
Conclusions: In the real-world, use of DOACs neither showed significant differences in stroke/SE events nor major bleeding events compared with use of warfarin or non-OAC treatment in Japanese patients with AF.
Author Disclosures: Y. Yamashita: Speakers Bureau; Modest; Lecture fees from Daiichi-Sankyo. R. Uozumi: None. M. Esato: None. Y. Chun: None. H. Wada: None. K. Hasegawa: None. H. Ogawa: None. M. Abe: None. S. Morita: None. M. Akao: Speakers Bureau; Modest; Pfizer, Bristol-Myers Squibb, Boehringer Ingelheim, Bayer Healthcare.
- © 2016 by American Heart Association, Inc.