Author + information
- 1University of Miami Hospital/Jackson Memorial Hospital, Miami, Florida, United States
- 2Lankenau Medical Center, Wynwood, Pennsylvania, United States
- 3Cardiovascular Research Foundation, New York, New York, United States
- 4Uppsala Clinical Research Centre, Uppsala, Sweden
- 5Sidney Kimmel Med Sch at Jefferson University, Philadelphia, Pennsylvania, United States
Dabigatran was shown effective for stroke prevention in atrial fibrillation (AF) in the RE-LY trial. Many pharmaceuticals are dosed according to body weight. We have previously shown the effect of Body Mass Index (BMI) on outcomes using BMI as a continuous variable. We augment that analysis by dividing patients into quintiles according to BMI.
Major cardiovascular outcomes were compared using BMI at the time of randomization between quintiles using a cox-proportional hazard model. The relative efficacy and safety of D110/150 versus W were analyzed between BMI groups.
Of the 18.087 RE-LY subjects, BMI information was available in 99.9% of total randomized. These patients were divided into 5 quintiles the largest quintile having 3622 patients and the lowest having 3614 patients. In a comparison of the lowest and highest quintiles independent of drug allocation the risk of stroke (Hazard ratio [HR] 2.11; 95% confidence interval [CI] 1.60-2.79), death (HR] 1.65; [CI] 1.41-1.92), and intracranial bleeding (ICH) ([HR] 2.10; interval [CI] 1.27-3.48) were all higher in the lowest quintile. In the lowest quintile, D110/150 were superior to W for stroke and ICH. For stroke in the lowest quintile, when D110 was compared to D150, D150 was superior ([HR] 1.65; [CI] 1.07 – 2.54).
Atrial fibrillation patients in RE-LY at the lowest quintile were at the highest risk of stroke, death, and ICH, with D150 showing the lowest risk of stroke.
CORONARY: Thrombus / Thrombectomy and Embolic Protection