Clin Exp Emerg Med.
2018 Mar;5(1):43-50. 10.15441/ceem.17.216.
Incidence and characteristics of major bleeding among rivaroxaban users with renal disease and nonvalvular atrial fibrillation
- Affiliations
-
- 1Duke University Health System and Duke Clinical Research Institute, Durham, NC, USA. manesh.patel@duke.edu
- 2Department of Emergency Medicine, Baylor College of Medicine, Houston, TX, USA.
- 3Department of Cardiology, Medical Corps, United States Navy, Naval Medical Center, Portsmouth, VA, USA.
- 4Clinical Epidemiology, Health ResearchTx LLC, Trevose, PA, USA.
- 5Janssen Research and Development, LLC, Titusville, NJ, USA.
- KMID: 2409818
- DOI: http://doi.org/10.15441/ceem.17.216
Abstract
OBJECTIVE
Patients with nonvalvular atrial fibrillation (AF) and renal disease (RD) who receive anticoagulation therapy appear to be at greater risk of major bleeding (MB) than AF patients without RD. As observed in past studies, anticoagulants are frequently withheld from AF patients with RD due to concerns regarding bleeding. The objective of this study was to evaluate the incidence and pattern of MB in those with RD, as compared to those without RD, in a population of rivaroxaban users with nonvalvular AF.
METHODS
Electronic medical records of over 10 million patients from the Department of Defense Military Health System were queried to identify rivaroxaban users with nonvalvular AF. A validated algorithm was used to identify MB-related hospitalizations. RD was defined through diagnostic codes present within 6 months prior to the bleeding date for MB cases and end of study participation for non-MB patients. Data were collected on patient characteristics, comorbidities, MB management, and outcomes.
RESULTS
Overall, 44,793 rivaroxaban users with nonvalvular AF were identified. RD was present among 6,921 patients (15.5%). Patients with RD had a higher rate of MB than those without RD, 4.52 per 100 person-years versus 2.54 per 100 person-years, respectively. The fatal bleeding outcome rate (0.09 per 100 person-years) was identical between those with and without RD.
CONCLUSION
In this post-marketing study of 44,793 rivaroxaban users with nonvalvular AF, RD patients experienced a higher MB rate than those without RD. The higher rate of MB among those with RD may be due to the confounding effects of comorbidities.
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