Abstract 16551: Efficacy and Safety of Oral Anticoagulation in 21105 Patients With Atrial Fibrillation Stratified by Diabetic Status in the ENGAGE AF-TIMI 48 Trial

Introduction: AF is twice as prevalent in patients with diabetes mellitus (DM) and DM is associated with increased risk of stroke, morbidity, and mortality in patients with AF. We explored outcomes by DM status and randomized anticoagulant in a large AF trial. Methods: 21,105 patients in ENGAGE AF-TIMI 48 trial were stratified into pre-specified categories: no-DM (n=13481); non-insulin dependent DM (NIDDM, n=6354); and IDDM (n=1270). We compared efficacy, safety, and net outcomes adjusted for baseline differences across the 3 groups. We assessed for effect modification by DM status on the relative efficacy and safety of edoxaban vs warfarin. The primary endpoints were stroke/SEE and ISTH major bleeding. Results: Patients with IDDM were younger (mean age 68.8 vs 69.5 vs 71.3 yrs) and had higher BMIs (32.9 vs 31.0 vs 28.4kg/m2) and CHA2DS2-VASc scores (mean 4.8 vs 4.6 vs 4.2) as compared to those with NIDDM or no-DM (each Pu003c0.001). Patients with IDDM (adj HR 1.46, p=0.004), but not those with NIDDM (adj HR ...