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Published on: February 26, 2013
Antithrombotic Usage, Including Three-Year Outcomes With Dabigatran and Vitamin K Antagonists for Atrial
Jutta Bergler-Klein1, Nina Gotcheva2, Oskars Kalējs3
1Department of Cardiology, University Clinic of Internal Medicine II, Medical University of Vienna, Vienna, Austria.
Insights
In Eastern Europe, dabigatran showed numerically lower rates of major bleeding and death compared to vitamin K antagonists (VKA). Stroke risk was similar between treatments in this patient population.
Area of Science:
- Cardiology
- Pharmacology
- Public Health
Background:
- The GLORIA-AF registry prospectively collects outcomes for newly diagnosed atrial fibrillation (AF) patients at risk of stroke.
- Phase 3 GLORIA-AF demonstrated dabigatran's reduced major bleeding risk and similar stroke/myocardial infarction risk compared to VKAs in a global, propensity score-matched population.
Purpose of the Study:
- To evaluate the comparative effectiveness and safety of dabigatran versus VKAs in patients from Eastern Europe with newly diagnosed AF.
- To assess if Eastern European patients benefit similarly to the global population from dabigatran treatment.
Main Methods:
- A descriptive analysis of the GLORIA-AF phase 3 registry data, focusing on patients from Eastern Europe.
- Included consecutive patients with newly diagnosed AF and CHA2DS2-VASc-score ≥1, enrolled until December 2016.
- Compared three-year outcomes between dabigatran and VKA treatments without propensity score matching.
Main Results:
- In Eastern Europe, dabigatran (N=498) showed numerically lower incidence rates per 100 patient-years for major bleeding (0.26 vs. 0.90) and all-cause death (2.04 vs. 3.50) compared to VKA (N=466).
- Stroke incidence was comparable between dabigatran and VKA (0.51 vs. 0.50).
- Lower use of high bleeding risk medications and higher dabigatran persistence were observed in Eastern Europe compared to the global population.
Conclusions:
- Dabigatran was associated with numerically lower major bleeding, all-cause death, and a composite cardiovascular outcome in Eastern European patients compared to VKAs.
- Stroke risk was comparable between the two treatments.
- While limitations exist (e.g., small number of CV events, lack of PS matching), findings align with the global GLORIA-AF results, suggesting a consistent benefit of dabigatran.
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.
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