Amr F Barakat1, Sandeep Jain1, Ahmad Masri2, Laith Alkukhun1, Mourad Senussi1, Ahmet Sezer1, Yisi Wang1, Floyd Thoma1, Aditya Bhonsale1, Samir Saba1, Suresh Mulukutla3. 1. University of Pittsburgh Medical Center Heart and Vascular Institute, University of Pittsburgh, Pittsburgh, Pennsylvania, USA. 2. The Knight Cardiovascular Institute, Oregon Health and Science University, Portland, Oregon, USA. 3. University of Pittsburgh Medical Center Heart and Vascular Institute, University of Pittsburgh, Pittsburgh, Pennsylvania, USA. Electronic address: mulukutlasr@upmc.edu.
Abstract
OBJECTIVES: This study sought to evaluate direct oral anticoagulant (DOAC) outcomes (vs. warfarin) in patients with atrial fibrillation (AF) across body mass index (BMI) categories, including ≥40 and <18.5 kg/m2. BACKGROUND: Clinical trials have not systematically tested the fixed DOAC dosing in underweight and morbidly obese patients. METHODS: We retrospectively included consecutive patients with nonvalvular AF with CHA2DS2-VASc (Congestive heart failure, Hypertension, Age ≥75, Diabetes, Stroke/transient ischemic attack/systemic thromboembolism, Vascular disease, Age 65-74, Sex) of ≥1 receiving OACs at our hospital system (2010-2018). Patients were categorized into groups 1 (underweight: BMI of <18.5 kg/m2), 2 (normal/overweight: BMI of 18.5 to <30 kg/m2), 3 (grade 1/2 obesity: BMI of 30 to <40 kg/m2), and 4 (grade 3 obesity: BMI of ≥40 kg/m2). We further classified patients by DOAC versus warfarin use. Outcomes were ischemic stroke, significant bleeding events (i.e., resulting in hospitalization), and mortality. RESULTS: We included 36,094 patients with a mean age of 74 ± 11 years and CHA2DS2-VASc of 3.4 ± 1.5. Groups 1 through 4 included 455 (1.3%), 18,339 (50.8%), 13,376 (37.1%), and 3,924 (10.9%) patients, respectively. DOAC use ranged from 49% to 56%. At 3.8 follow-up years, with multivariable Cox regression, DOACs (vs. warfarin) were associated with lower risk of ischemic stroke, bleeding, and mortality across all BMI groups, with hazard ratios (HRs) of 0.73 (95% confidence interval [CI]: 0.63 to 0.85), 0.75 (95% CI: 0.64 to 0.87), 0.75 (95% CI: 0.65 to 0.88), and 0.75 (95% CI: 0.64 to 0.87) (p < 0.001 for all) for ischemic stroke; 0.42 (95% CI: 0.19 to 0.92), 0.41 (95% CI: 0.19 to 0.89), 0.45 (95% CI: 0.20 to 1.00), and 0.43 (95% CI: 0.20 to 0.94) (p < 0.05 for all) for bleeding; and 0.90 (95% CI: 0.68 to 1.19; p = 0.5), 0.70 (95% CI: 0.66 to 0.75; p < 0.0001), 0.65 (95% CI: 0.60 to 0.71; p < 0.0001), and 0.66 (95% CI: 0.56 to 0.77; p < 0.0001) for mortality, in groups 1 to 4, respectively. CONCLUSIONS: In patients with nonvalvular AF, DOACs compared to warfarin were associated with better safety and effectiveness across all BMI categories, including underweight and morbidly obese patients.
OBJECTIVES: This study sought to evaluate direct oral anticoagulant (DOAC) outcomes (vs. warfarin) in patients with atrial fibrillation (AF) across body mass index (BMI) categories, including ≥40 and <18.5 kg/m2. BACKGROUND: Clinical trials have not systematically tested the fixed DOAC dosing in underweight and morbidly obesepatients. METHODS: We retrospectively included consecutive patients with nonvalvular AF with CHA2DS2-VASc (Congestive heart failure, Hypertension, Age ≥75, Diabetes, Stroke/transient ischemic attack/systemic thromboembolism, Vascular disease, Age 65-74, Sex) of ≥1 receiving OACs at our hospital system (2010-2018). Patients were categorized into groups 1 (underweight: BMI of <18.5 kg/m2), 2 (normal/overweight: BMI of 18.5 to <30 kg/m2), 3 (grade 1/2 obesity: BMI of 30 to <40 kg/m2), and 4 (grade 3 obesity: BMI of ≥40 kg/m2). We further classified patients by DOAC versus warfarin use. Outcomes were ischemic stroke, significant bleeding events (i.e., resulting in hospitalization), and mortality. RESULTS: We included 36,094 patients with a mean age of 74 ± 11 years and CHA2DS2-VASc of 3.4 ± 1.5. Groups 1 through 4 included 455 (1.3%), 18,339 (50.8%), 13,376 (37.1%), and 3,924 (10.9%) patients, respectively. DOAC use ranged from 49% to 56%. At 3.8 follow-up years, with multivariable Cox regression, DOACs (vs. warfarin) were associated with lower risk of ischemic stroke, bleeding, and mortality across all BMI groups, with hazard ratios (HRs) of 0.73 (95% confidence interval [CI]: 0.63 to 0.85), 0.75 (95% CI: 0.64 to 0.87), 0.75 (95% CI: 0.65 to 0.88), and 0.75 (95% CI: 0.64 to 0.87) (p < 0.001 for all) for ischemic stroke; 0.42 (95% CI: 0.19 to 0.92), 0.41 (95% CI: 0.19 to 0.89), 0.45 (95% CI: 0.20 to 1.00), and 0.43 (95% CI: 0.20 to 0.94) (p < 0.05 for all) for bleeding; and 0.90 (95% CI: 0.68 to 1.19; p = 0.5), 0.70 (95% CI: 0.66 to 0.75; p < 0.0001), 0.65 (95% CI: 0.60 to 0.71; p < 0.0001), and 0.66 (95% CI: 0.56 to 0.77; p < 0.0001) for mortality, in groups 1 to 4, respectively. CONCLUSIONS: In patients with nonvalvular AF, DOACs compared to warfarin were associated with better safety and effectiveness across all BMI categories, including underweight and morbidly obesepatients.
Authors: Alison R Novak; Courtney Shakowski; Toby C Trujillo; Garth C Wright; Scott W Mueller; Tyree H Kiser Journal: J Thromb Thrombolysis Date: 2022-06-10 Impact factor: 5.221