Safety and efficacy of apixaban, dabigatran and rivaroxaban in obese and morbidly obese patients with heart failure and atrial fibrillation: A real-world analysis.

ABSTRACT

BACKGROUND: Atrial fibrillation and heart failure are combined risk factors for thromboembolic events. Obese and morbidly obese individuals have been underrepresented in clinical trials studying safety and efficacy of direct oral anticoagulants (DOACs). OBJECTIVES: Study the comparative safety and efficacy of DOACs in obese and morbidly obese patients with atrial fibrillation or flutter, and concomitant congestive heart failure. METHODS: In the present single-center retrospective observational study, patients with an ICD-9 code of atrial fibrillation or atrial flutter, and congestive heart failure on a DOAC (apixaban[n = 155], rivaroxaban[n = 335], dabigatran[n = 393]) were followed for a median 12.5 months (IQR 22.1 months). Obesity was defined as a body mass index, BMI ≥ 30 and < 40 kg/m2 [n = 614], and morbid obesity as BMI ≥ 40 kg/m2 [n = 269]. Clinical endpoints were grouped into safety (composite of intracranial-hemorrhage, gastrointestinal-bleeds, hemorrhagic-stroke, and other bleeds), and efficacy (composite of ischemic-stroke and systemic-embolism) endpoints. Cox proportional hazard models were used to compare safety, efficacy, and all-cause mortality outcomes. RESULTS: In obese patients, no statistical difference was observed in efficacy of DOACs. A statistical difference was observed in the safety of DOACs in obese patients. Apixaban was found to be safer than dabigatran [hazard ratio [HR] 0.37 (0.16-0.87), p = .02] and rivaroxaban [HR 0.29 (0.12-0.67), p = .004]. In morbidly obese patients, there was no overall statistical difference in the efficacy or safety of DOACs. CONCLUSION: In obese patients with congestive heart failure and atrial fibrillation or atrial flutter on DOACs, apixaban has the most favorable safety profile compared to rivaroxaban and dabigatran.