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 P<0.001). Patients with IDDM (adj HR 1.46, p=0.004), but not those with NIDDM (adj HR 1.01, p=0.85), had a higher risk of stroke/SEE compared to pts with no DM (Figure). Major bleeding was increased in both pts with IDDM (adj HR 1.60) and NIDDM (adj HR 1.23), P≤0.001 for both. The annualized rate of the net outcome of stroke/SEE, major bleed, or CV death was 7.2% in no-DM vs 7.0% in NIDDM (adj HR 1.15) vs 11.2% in IDDM (adj HR 1.80), both P<0.001. Secondary outcomes followed similar patterns. The efficacy and safety profiles of edoxaban as compared to warfarin were not modified by DM status (each P-int >0.10).
Conclusions: In patients with AF treated with oral anticoagulation, the adjusted rates of thromboembolic, bleeding, and mortality rates are highest in those with IDDM and modestly increased in patients with NIDDM compared with no-DM. The efficacy and safety of edoxaban was consistent regardless of DM, making it a good alternative to warfarin in both patients with and without DM.
Author Disclosures: A. Plitt: None. C. Ruff: Research Grant; Significant; Daiichi-Sankyo. Honoraria; Modest; Daiichi-Sankyo, Bayer, Portola, Boehringer Ingelheim. A. Goudev: Research Grant; Significant; Daiichi Sankyo. J. Morais: Research Grant; Significant; Daiichi Sankyo. J. Park: Research Grant; Significant; Daiichi Sankyo. E.M. Antman: Research Grant; Significant; Daiichi Sankyo. E. Braunwald: Research Grant; Modest; AstraZeneca, Merck & Co, GSK, Bristol-Myers Squibb, Beckman Coulter, Roche Diagnostics, Pfizer, Sanofi, Johnson & Johnson. Research Grant; Significant; Daiichi Sankyo. Speakers Bureau; Modest; Uncompensated lectures for Merck and CVRx. Consultant/Advisory Board; Modest; Merck (unpaid consultant). Other; Modest; Lecture fees from Eli Lilly, Menarini, Medscape, and Bayer HealthCare. Consulting fees from Sanofi, Genzyme, Amorcyte, the Medicines Company, and Cardiorentis. R.P. Giugliano: Research Grant; Significant; Daiichi-Sankyo. Honoraria; Significant; Daiichi-Sankyo, American College of Cardiology. Consultant/Advisory Board; Modest; Boehering Ingelheim, Bristol Myers Squibb, Merck, Portola, Pfizer. Consultant/Advisory Board; Significant; Daiichi-Sankyo, Lexicon.
- © 2016 by American Heart Association, Inc.