Huisman, Menno V, Teutsch, Christine 
ORCID: 0000-0002-8494-2876, Lu, Shihai, Diener, Hans-Christoph, Dubner, Sergio J, Halperin, Jonathan L, Ma, Chang-Sheng, Rothman, Kenneth J, Lohmann, Ragna, Gurusamy, Venkatesh Kumar et al (show 3 more authors)
(2022)
Dabigatran versus vitamin K antagonists for atrial fibrillation in clinical practice: final outcomes from Phase III of the GLORIA-AF registry.
Clinical research in cardiology : official journal of the German Cardiac Society, 111 (5).
pp. 548-559.
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Dabigatran versus vitamin K antagonists for atrial fibrillation in clinical practice final outcomes from Phase III of the GL.pdf - Open Access published version Download (1MB) | Preview |
Abstract
<h4>Background</h4>Prospectively collected, routine clinical practice-based data on antithrombotic therapy in non-valvular atrial fibrillation (AF) patients are important for assessing real-world comparative outcomes. The objective was to compare the safety and effectiveness of dabigatran versus vitamin K antagonists (VKAs) in patients with newly diagnosed AF.<h4>Methods and results</h4>GLORIA-AF is a large, prospective, global registry program. Consecutive patients with newly diagnosed AF and CHA<sub>2</sub>DS<sub>2</sub>-VASc scores ≥ 1 were included and followed for 3 years. To control for differences in patient characteristics, the comparative analysis for dabigatran versus VKA was performed on a propensity score (PS)-matched patient set. Missing data were multiply imputed. Proportional-hazards regression was used to estimate hazard ratios (HRs) for outcomes of interest. Between 2014 and 2016, 21,300 eligible patients were included worldwide: 3839 patients were prescribed dabigatran and 4836 VKA with a median age of 71.0 and 72.0 years, respectively; > 85% in each group had a CHA<sub>2</sub>DS<sub>2</sub>-VASc-score ≥ 2. The PS-matched comparative analysis for dabigatran and VKA included on average 3326 pairs of matched initiators. For dabigatran versus VKAs, adjusted HRs (95% confidence intervals) were: stroke 0.89 (0.59-1.34), major bleeding 0.61 (0.42-0.88), all-cause death 0.78 (0.63-0.97), and myocardial infarction 0.89 (0.53-1.48). Further analyses stratified by PS and region provided similar results.<h4>Conclusions</h4>Dabigatran was associated with a 39% reduced risk of major bleeding and 22% reduced risk for all-cause death compared with VKA. Stroke and myocardial infarction risks were similar, confirming a more favorable benefit-risk profile for dabigatran compared with VKA in clinical practice. Clinical trial registration https://www.<h4>Clinicaltrials</h4>gov . NCT01468701, NCT01671007.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | GLORIA-AF Investigators, Humans, Atrial Fibrillation, Myocardial Infarction, Hemorrhage, Vitamin K, Fibrinolytic Agents, Anticoagulants, Administration, Oral, Registries, Prospective Studies, Aged, Clinical Trials, Phase III as Topic, Stroke, Dabigatran |
| Divisions: | Faculty of Health and Life Sciences Faculty of Health and Life Sciences > Institute of Life Courses and Medical Sciences |
| Depositing User: | Symplectic Admin |
| Date Deposited: | 29 Sep 2023 10:29 |
| Last Modified: | 29 Sep 2023 10:29 |
| DOI: | 10.1007/s00392-021-01957-1 |
| Related URLs: | |
| URI: | https://livrepository.liverpool.ac.uk/id/eprint/3173214 |
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