CE-539-03 LARGE OBSERVATIONAL STUDY EVALUATING SAFETY AND EFFICACY OF DIRECT ORAL ANTICOAGULANTS IN EXTREME OBESITY

Abstract

Obesity is an independent risk factor for atrial fibrillation (AF) influencing the pharmacokinetics and pharmacodynamics of drug therapy and direct oral anticoagulants (DOACs). There is limited data in the randomized clinical trials for patients with extreme obesity (BMI ≥ 40.0 kg/m2 or weight > 120 Kg). To evaluate the effectiveness and safety of DOACs versus vitamin K antagonists (VKA) for the treatment of nonvalvular AF (NVAF) in extreme obese patients. Using retrospective cohort study design, adult extreme obese patients with NVAF using DOACs or VKA during 2014 - 2020 with BMI ≥ 40.0 or weight > 120 Kg were selected from a large south-east hospital system. Patients were categorized into four groups based on BMI and weight (weight > 120 Kg and BMI ≤ 40; BMI 41-44; BMI 45-49; BMI ≥ 50). Primary efficacy outcome is stroke or systemic embolism (SE) and primary safety outcome is major bleeding. A total of 6,930 patients with a mean age of 64.1 years and a mean follow-up of 3.8 ±2.3 years were included. Extreme obese groups I through 4 included 2216 (32%), 2240 (32.3%), 1277 (18.4%), and 1197 (17.3%) with DAOCs use ranging from 60% to 63%. In Cox regression for the entire cohort, DOACs were associated with a significantly lower risk of stroke or SE (hazard ratio [HR]: 0.52; 95% confidence interval [CI]: 0.42, 0.65) and major bleeding (HR: 0.55; 95% CI: 0.59, 0.90) compared to VKA. Results remained similar across all groups except non-significant results for groups 3 and 4 for major bleeding. DOAC utilization in patients with extreme obesity was far greater than use of VKA despite not having significant clinical trial evidence of safety and efficacy in this unique population. Our observational retrospective study revealed significantly better prevention of stroke or SE without increased major bleeding in patients who are on DOACs versus VKA.