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Final outcomes from Phase II of the GLORIA-AF registry program
Mazurek, M., Teutsch, C., Diener, H.-C., Dubner, S. J., Halperin, J. L., Ma, C.-S., Rothman, K. J., Paquette, M., Zint, K., França, L. R., Lu, S., Bartels, D. B., Huisman, M. V., Lip, G. Y. H., & GLORIA-AF Investigators (2019). Safety and effectiveness of dabigatran at 2 years: Final outcomes from Phase II of the GLORIA-AF registry program. American Heart Journal, 218, 123-127. https://doi.org/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.