Mazurek M, Teutsch C, Diener H-C, Dubner SJ, Halperin JL, Ma C-S, Rothman KJ, Paquette M, Zint K, Franca L, Lu S, Bartels DB, Huisman MV, Lip GYH, GLORIA-AF Investigators. Safety and effectiveness of dabigatran at 2 years: final outcomes from Phase II of the GLORIA-AF registry program. Am Heart J. 2019 Dec;218:123-7. doi: 10.1016/j.ahj.2019.08.012

GLORIA-AF is a large, ongoing, prospective, global registry program run in 3 phases, assessing long-term safety and effectiveness of dabigatran etexilate (dabigatran) in patients with newly diagnosed atrial fibrillation (AF) in clinical practice. This report provides the final analysis of 2-year clinical outcomes of the full cohort of 4873 patients prescribed dabigatran and followed for a mean of 18.0 +/− 9.4 months out of the 15,308 eligible patients enrolled in Phase II (2011-2014). The overall incidence rates per 100 person-years were: stroke 0.65 (95% CI 0.48-0.87), major bleeding 0.97 (0.76-1.23) and myocardial infarction (MI) 0.50 (0.35-0.69), with observed event rates broadly consistent in all study regions, which confirms the sustained safety and effectiveness of dabigatran over 2 years of observation in clinical practice.