Abstract 15047: Evaluation of the Incidence of Major Bleeding in a Heterogeneous Population of 51,842 Rivaroxaban Users With Nonvalvular Atrial Fibrillation
Introduction: Rivaroxaban, a direct factor Xa inhibitor, reduces the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (NVAF). The central risk associated with oral anticoagulation therapy is bleeding. Because the registration trial for rivaroxaban enrolled a selected patient population, the incidence of major bleeding (MB) in a large and diverse real-world patient population was explored.
Hypothesis: To evaluate MB events among NVAF patients taking rivaroxaban in a real-world clinical setting.
Methods: From January 1, 2013 to December 31, 2015, over 10 million electronic medical records from the Department of Defense Military Health System (MHS) were queried. A validated MB case-finding algorithm was used to identify MB-related hospitalizations. Major bleeding incidence, patient characteristics, comorbid conditions, concomitant medications, bleeding management, and fatal outcomes were assessed.
Results: Among 51,842 rivaroxaban users with NVAF, 56.1% were male and the overall mean (SD) age was 76.5 (10.0) years. In total, 1,613 experienced at least one MB event; incidence rate of 2.71 per 100 person-years (95% CI 2.58-2.84).. Patient characteristics are displayed in Table 1. Of the 49 MB patients who died during hospitalization (incidence of 0.08 per 100 person-years), the mean (SD) age was 79.7 (7.7) years. Among the fatal cases, 75.5% had an intracranial hemorrhage and 24.5% had a gastrointestinal bleed.
Conclusions: The incidence, pattern, and management of MB in rivaroxaban users with NVAF in this large, heterogeneous population were generally consistent with the findings from the registration trial. Fatal bleeding was rare.
- Atrial fibrillation
- Cardiovascular disease prevention
- Direct factor Xa inhibitor
- Disease management
Author Disclosures: S. Tamayo: None. M. Patel: Consultant/Advisory Board; Significant; MP is a member of the Janssen and Bayer Advisory Boards. Z. Yuan: Employment; Significant; ZY is a salaried employee of Janssen Research & Development. Ownership Interest; Significant; ZY owns stocks of Johnson & Johnson. N. Sicignano: Other; Modest; NMS is an employee of Health ResearchTx, which has a business relationship with Janssen. K. Hopf: Other; Modest; KPH is an employee of Health ResearchTx, which has a business relationship with Janssen. F. Peacock: Research Grant; Significant; FP is a consultant and has received a research grant from Janssen. FP is also a consultant for Bayer.
- © 2016 by American Heart Association, Inc.