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 - Tập 111 - Trang 548-559 - 2022
Menno V. Huisman1, Christine Teutsch2, Shihai Lu3, Hans-Christoph Diener4, Sergio J. Dubner5, Jonathan L. Halperin6, Chang-Sheng Ma7, Kenneth J. Rothman8, Ragna Lohmann9, Venkatesh Kumar Gurusamy10, Dorothee B. Bartels11, Gregory Y. H. Lip12
1Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, The Netherlands
2Department of CardioMetabolism and Respiratory Medicine, Boehringer Ingelheim International GmbH, Ingelheim, Germany
3Biostatistics, Biogen, Cambridge, USA
4Institute for Medical Informatics, Biometry and Epidemiology, Medical Faculty of the University of Duisburg-Essen, Essen, Germany
5Cardiology Department, Electrophysiology Service, Clínica y Maternidad Suizo Argentina, Buenos Aires, Argentina
6The Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, USA
7Cardiology Department, Atrial Fibrillation Center, Beijing Anzhen Hospital, Capital Medical University, Beijing, China
8RTI Health Solutions, Research Triangle Park, USA
9Clinical Operations, Boehringer Ingelheim Pharma and Co. KG, Ingelheim, Germany
10Global Epidemiology, Boehringer Ingelheim International GmbH, Ingelheim, Germany
11Institute for Epidemiology, Social Medicine and Health System, Hannover Medical School, Hannover, Germany
12Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart and Chest Hospital, Liverpool, UK

Tóm tắt

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. GLORIA-AF is a large, prospective, global registry program. Consecutive patients with newly diagnosed AF and CHA2DS2-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 CHA2DS2-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. 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.clinicaltrials.gov . NCT01468701, NCT01671007.

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Tài liệu tham khảo

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Clinical Research in Cardiology

Tập 111

548-559

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