Abstract 15905: Incidence and Characteristics of Major Bleeding Among Rivaroxaban Users With Renal Disease and Non-valvular Atrial Fibrillation
Background: Patients with renal impairment (as compared to those without) who receive anticoagulants appear to be at increased risk of bleeding based on recent clinical trials. Rivaroxaban is a direct factor Xa inhibitor used to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (NVAF).
Purpose: To quantify the rates and better understand the pattern of major bleeding (MB) among NVAF patients with and without a coded diagnosis of renal disease (RD) who take rivaroxaban.
Methods: Nearly 10 million electronic medical records from the Department of Defense healthcare system were evaluated to identify MB related hospitalizations among rivaroxaban users with NVAF over a 2 year period as part of an ongoing post-marketing study. A validated algorithm (Cunningham 2011) was used to identify MB. Renal disease (reflective of impaired renal function) was defined via diagnostic codes within 6 months prior to the bleeding date for MB cases, or the reporting quarter for non-MB patients. Rates of MB were quantified by renal disease status. Additional data were collected on patient characteristics and comorbidities, MB management, and outcomes.
Results: Overall, 39,052 rivaroxaban users with NVAF were identified; 6,034 patients (15.5%) had RD. Patients with RD had a higher rate of MB than those without RD, 4.65 per 100 person-years versus 2.59 per 100 person-years, respectively. Patients with RD also had a greater prevalence of comorbidities and higher CHA2DS2-VASc scores. Key findings are presented in Table 1.
Conclusion: In a post-marketing study of 39,052 rivaroxaban users with nonvalvular atrial fibrillation, patients with renal disease experienced a higher rate of MB than those without renal disease. This higher rate of MB may be partly due to the confounding effects of comorbidities in patients with RD, as reflected by their higher CHA2DS2-VASc scores, and is worthy of further investigation.
Author Disclosures: S. Tamayo: None. M. Patel: Research Grant; Significant; Johnson & Johnson, AstraZeneca, National Heart Lung and Blood Institute, Agency for Healthcare Research and Quality, and Maquet. Consultant/Advisory Board; Significant; Janssen, Bayer, Genzyme, and Merck. Z. Yuan: Employment; Significant; Janssen Research and Development. Ownership Interest; Significant; Johnson & Johnson. N. Sicignano: Employment; Significant; Health ResearchTx, which has a business relationship with Janssen Research and Development. K. Hopf: Other; Significant; Independent contractor for Health ResearchTx, which has a business relationship with Janssen Research and Development. F. Peacock: Research Grant; Significant; Abbott, Alere, Banyan, Cardiorentis, Janssen,Portola, Roche, The Medicine’s Company. Ownership Interest; Significant; Comprehensive Research Associates LLC, Emergencies in Medicine LLC. Consultant/Advisory Board; Modest; BG Medicine, Beckman, Boehringer-Ingelheim, Instrument Labs, Prevencio, Singulex, The Medicine’s Company, ZS Pharma. Consultant/Advisory Board; Significant; Alere, Cardiorentis, Janssen.
- © 2015 by American Heart Association, Inc.