Antithrombotic Usage, Including Three-Year Outcomes With Dabigatran and Vitamin K Antagonists for Atrial Fibrillation, in Eastern Europe: A Descriptive Analysis From Phase 3 of the GLORIA-AF Registry.

Background: Global Registry on Long-Term Oral Antithrombotic Treatment in Patients with Atrial Fibrillation (GLORIA-AF) is a prospective registry of outcomes from patients with newly diagnosed AF at risk of stroke. In the propensity score (PS)-matched global population of phase 3 GLORIA-AF, at 3 years, dabigatran-treated patients experienced reduced risk for major bleeding, and similar risk for stroke and myocardial infarction, compared with vitamin K antagonist (VKA)-treated patients.
Study Question: Do patients in Eastern Europe benefit from treatment with dabigatran versus VKA?
Study Design: Descriptive analysis, without PS matching. To contextualize the Eastern Europe results of GLORIA-AF phase 3, we also descriptively analyzed the global population without PS matching. Consecutive patients with newly diagnosed AF and CHA2DS2-VASc-score ≥1 were enrolled until December 2016 in 38 countries (9 in Eastern Europe).
Measures and Outcomes: Three-year outcomes with dabigatran and VKA.
Results: In Eastern Europe, 1341 patients were eligible (6% of patients globally), and incidence rates (per 100 patient-years) for the following outcomes were numerically lower with dabigatran (N = 498) versus VKA (N = 466): major bleeding (0.26 vs. 0.90), all-cause death (2.04 vs. 3.50), and a composite of stroke, systemic embolism, myocardial infarction, life-threatening bleeding, and vascular death (1.37 vs. 1.92); stroke was comparable (0.51 vs. 0.50). All incidence rates were numerically lower in Eastern Europe versus the global population for both treatments. Chronic concomitant use of high bleeding risk medications (eg, nonsteroidal anti-inflammatories) was lower in Eastern Europe (dabigatran 3.8%, VKA 9.3%) than globally (dabigatran 14.8%, VKA 20.6%) and persistence with dabigatran was higher in Eastern Europe (76%) than globally (64%).
Conclusions: Dabigatran was associated with numerically reduced major bleeding, all-cause death, and cardiovascular (CV) composite, with comparable risk of stroke versus VKA, in Eastern Europe. Limitations of this descriptive analysis include few CV events (n = 11 for stroke, in the dabigatran and VKA groups combined) and a lack of statistical analysis and PS matching, which precludes definitive conclusions; however, the CV outcomes in Eastern Europe were consistent with the beneficial impact of dabigatran versus VKA in the statistically analyzed global population with PS matching.
Competing Interests: J. Bergler-Klein reports no conflicts of interest. N. Gotcheva reports no conflicts of interest. O. Kalējs reports grants and personal fees from Bayer and Boehringer Ingelheim. Z. Kalarus has lectured for Boehringer Ingelheim. D. Kovačić reports no conflicts of interest. V. Peršić reports no conflicts of interest. E. Shlyakhto reports no conflicts of interest. T. Uuetoa reports grants and personal fees from Bayer and Boehringer Ingelheim. M. V. Huisman reports grants from ZonMW Dutch Healthcare Fund, and grants and consultation honoraria from Boehringer Ingelheim, Pfizer/Bristol-Myers Squibb, Bayer Health Care, Aspen, and Daiichi-Sankyo. G. Y. H. Lip reports consultancy and speaking for BMS/Pfizer, Boehringer Ingelheim, and Daiichi-Sankyo. No fees are received personally. D. Vinereanu reports grants and personal fees from Bayer, Boehringer Ingelheim, and Pfizer.
(Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc.)