Dabigatran versus vitamin K antagonists for atrial fibrillation in clinical practice: final outcomes from Phase III of the GLORIA-AF registry.

Abstract

BACKGROUND:

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.

METHODS AND RESULTS:

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.

CONCLUSIONS:

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.

• Authors: Menno V Huisman, Christine Teutsch, Shihai Lu, Hans-Christoph Diener, Sergio J Dubner, Jonathan L Halperin, Chang-Sheng Ma, Kenneth J Rothman, Ragna Lohmann, Venkatesh Kumar Gurusamy, Dorothee B Bartels, Gregory Y H Lip, GLORIA-AF Investigators
• Journal: Clinical research in cardiology : official journal of the German Cardiac Society (Clin Res Cardiol) Vol. 111 Issue 5 Pg. 548-559 (May 2022) ISSN: 1861-0692 [Electronic] Germany
• PMID: 35294623 (Publication Type: Journal Article)
• Copyright: © 2022. The Author(s).

Chemical References

• Anticoagulants
• Fibrinolytic Agents
• Vitamin K
• Dabigatran

Topics

• Administration, Oral
• Aged
• Anticoagulants (adverse effects)
• Atrial Fibrillation (drug therapy)
• Clinical Trials, Phase III as Topic
• Dabigatran (adverse effects)
• Fibrinolytic Agents (therapeutic use)
• Hemorrhage (chemically induced, epidemiology)
• Humans
• Myocardial Infarction (complications)
• Prospective Studies
• Registries
• Stroke (epidemiology, etiology, prevention & control)
• Vitamin K (antagonists & inhibitors)