Comparison of the Incidence of Major Bleeding with Rivaroxaban Use among Nonvalvular Atrial Fibrillation Patients With versus Without Diabetes Mellitus

• Published in: The American journal of cardiology 2017-03, Vol.119 (5), p.753-759
• Main Authors: Peacock, W. Frank, MD, Tamayo, Sally, CAPT, Sicignano, Nicholas, MPH, Hopf, Kathleen P., MPH, Yuan, Zhong, MD, PhD, Patel, Manesh, MD
• Format: Article
• Language: English
• Subjects: Age; Aged; Aged, 80 and over; Algorithms; Atrial Fibrillation - complications; Atrial Fibrillation - drug therapy; Atrial Fibrillation - epidemiology; Cardiovascular; Cardiovascular disease; Codes; Comorbidity; Diabetes; Diabetes Mellitus - epidemiology; Embolisms; Factor Xa Inhibitors - adverse effects; FDA approval; Female; Gastrointestinal Hemorrhage - chemically induced; Gastrointestinal Hemorrhage - epidemiology; Health care; Heart failure; Hemorrhage - chemically induced; Hemorrhage - epidemiology; Hospitalization; Humans; Hypertension; Hypothesis testing; Incidence; Intracranial Hemorrhages - chemically induced; Intracranial Hemorrhages - epidemiology; Male; Patients; Retrospective Studies; Rivaroxaban - adverse effects; Standard deviation; Stroke; Stroke - etiology; Stroke - prevention & control; Studies; Thromboembolism
• ISSN: 0002-9149; 1879-1913
• DOI: 10.1016/j.amjcard.2016.11.023

Abstract Diabetes mellitus (DM) is a common comorbidity in those with nonvalvular atrial fibrillation (NVAF). Most patients with DM and NVAF have a CHA2 DS2 -VASc score of ≥1 and should be considered for oral anticoagulation therapy for stroke prevention per treatment guidelines. The most important risk associated with anticoagulation is bleeding, which may be higher in those with NVAF plus DM. Our objective was to evaluate the incidence and characteristics of major bleeding (MB) in rivaroxaban users diagnosed with NVAF, further comparing those with DM versus those without DM, in a real-world clinical setting. Electronic medical records of over 10 million patients from the Department of Defense Military Health System were queried to identify rivaroxaban users with NVAF over a 2.5 year period. Major bleeding related hospitalization was identified by a validated case-finding algorithm. Patient characteristics, incidence and management of MB, and fatal outcomes were assessed by DM status. Of 44,793 rivaroxaban users with NVAF, 12,039 (26.9%) had DM, who were more likely male, younger, with more comorbidity and higher CHA2 DS2 -VASc scores. Major bleeding incidence was higher among those with DM compared to those without, 3.68 (95% CI 3.37-4.03) versus 2.51 (95% CI 2.34-2.69) per 100 person-years, and intracranial bleeding incidence was 0.19 (95% CI 0.13-0.28) versus 0.25 (95% CI 0.20-0.31) per 100 person-years. Fatal outcomes were rare for both cohorts, 0.09 per 100 person-years. In conclusion, in this post-marketing study of 44,793 rivaroxaban users with NVAF, patients with DM had more comorbidities and higher incidence of MB compared to non-DM patients.