Abstract 19608: Real-World Comparisons of Major Bleeding Risk for Commercially Insured Non-Valvular Atrial Fibrillation Patients Initiating Apixaban, Dabigatran, Rivaroxaban, or Warfarin
Objective: Clinical trials have demonstrated that non-VKA oral anticoagulants (NOACs) are at least as effective as warfarin for risk reduction of stroke or systemic embolism and are associated with similar or lower bleeding rates. This study compared the risk of major bleeding among non-valvular atrial fibrillation (NVAF) patients initiating oral anticoagulants.
Methods: Commercially-insured adult patients in the Optum database prescribed apixaban, rivaroxaban, dabigatran, or warfarin were selected from 01JAN2013 -30SEP2015. Patients were required to have an AF diagnosis (ICD-9-CM code: 427.31), continuous health plan enrollment for ≥12 months, and no OAC use in the 12 months before the index date (first OAC claim date). Patients with claims suggestive of valvular heart disease, cardiac surgery, venous thromboembolism, reversible AF, or evidence of pregnancy were excluded. Major bleeding, defined as bleeding requiring hospitalization, was compared using a Cox proportional hazards model adjusted for age, sex, and baseline comorbidities. Patient data were assessed until health plan disenrollment, inpatient death, 1 year post-index date, or end of the study period, whichever occurred first.
Results: The study included 13,103 patients: 2,656 apixaban, 1,376 dabigatran, 5,348 rivaroxaban, and 3,723 warfarin patients. Apixaban, dabigatran, and rivaroxaban patients were younger and had lower CHA2DS2-VASc scores compared to warfarin patients. After adjusting for baseline characteristics, apixaban patients had a significantly lower risk of major bleeding than warfarin patients (HR=0.62; 95% CI=0.39-0.99). Dabigatran (HR=0.81; 95% CI=0.45-1.45) patients had a non-significant numerically lower risk of major bleeding and rivaroxaban (HR=1.05; 95% CI=0.75-1.48) patients had a similar risk of major bleeding compared to warfarin patients.
Conclusions: In a large national commercially-insured population, treatment-naïve NVAF patients prescribed apixaban had a significantly lower risk of major bleeding compared to those prescribed warfarin. Patients prescribed dabigatran or rivaroxaban had similar risks of major bleeding compared to those prescribed warfarin.
Author Disclosures: A. Amin: Consultant/Advisory Board; Significant; A Amin is a paid consultant to Bristol-Myers Squibb Company. A. Keshishian: Employment; Significant; A Keshishian is an employee of STATinMED Research, which is a paid consultant to Bristol-Myers Squibb Company and Pfizer Inc., the study sponsors. L. Vo: Employment; Significant; L Vo is an employee of Bristol-Myers Squibb Company, the study sponsor. J. Mardekian: Employment; Significant; J Mardekian is an employee of Pfizer Inc, the study sponsor. S. Singhal: Employment; Significant; S Singhal is an employee of Bristol-Myers Squibb Company. C. Patel: Employment; Significant; C Patel is an employee of Bristol-Myers Squibb Company, the study sponsor. K. Odell: Employment; Significant; K Odell is an employee of Pfizer Inc, the study sponsor. J. Trocio: Employment; Significant; J Trocio is an employee of Pfizer Inc, the study sponsor..
- © 2016 by American Heart Association, Inc.