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Thromb Haemost 2016; 116(04): 754-763
DOI: 10.1160/TH16-03-0203
Stroke, Systemic or Venous Thromboembolism
Schattauer GmbH

Dabigatran in real-world atrial fibrillation

Meta-analysis of observational comparison studies with vitamin K antagonists
João Carmo
1   Cardiology Department, Santa Cruz Hospital, Western Lisbon Hospital Centre, Portugal
,
Francisco Moscoso Costa
2   Cardiology Unit, Luz Hospital, Lisbon, Portugal
,
Jorge Ferreira
1   Cardiology Department, Santa Cruz Hospital, Western Lisbon Hospital Centre, Portugal
,
Miguel Mendes
1   Cardiology Department, Santa Cruz Hospital, Western Lisbon Hospital Centre, Portugal
› Author Affiliations
Further Information

Publication History

Received: 10 March 2016

Accepted after major revision: 24 May 2016

Publication Date:
20 November 2017 (online)

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Summary

In the RE-LY clinical trial, dabigatran presented a better effectiveness/ safety profile when compared to warfarin. However, clinical trials are not very representative of the real-world setting. We aimed to assess the performance of dabigatran in real-world patients with atrial fibrillation (AF) by means of a systematic review and meta-analysis of observational comparison studies with vitamin K antagonists (VKA). We searched PubMed, Embase and Scopus databases until November 2015 and selected studies according to the following criteria: observational study performed with nonvalvular AF patients; reporting adjusted hazard ratios (HR) of clinical events in a follow-up period; for dabigatran 75 mg, 110 mg or 150 mg versus VKA. Twenty studies were selected which included 711,298 patients, 210,279 of which were treated with dabigatran and the remaining 501,019 with VKA. Ischaemic stroke incidence was of 1.65 /100 patient-years for dabigatran and 2.85/100 patient-years for VKA (HR 0.86, 95 % confidence interval of 0.74–0.99). Major bleeding rate was 3.93/100 patient-years for dabigatran and 5.61/100 patient-years for VKA (0.79, 0.69–0.89). Risk of mortality (0.73, 0.61–0.87) and intracranial bleeding (0.45, 0.38–0.52) were significantly lower in patients treated with dabigatran when compared to patients on VKA. Risk of gastrointestinal (GI) bleeding was significantly higher in patients treated with dabigatran (1.13, 1.00–1.28). No significant difference was observed in risk of myocardial infarction (0.99, 0.89–1.11). In this combined analysis of real-world observational comparison studies with VKA, dabigatran was associated with a lower risk of ischaemic stroke, major bleeding, intracranial bleeding and mortality, higher risk of GI bleeding and a similar risk of myocardial infarction.

Supplementary Material to this article is available online at www.thrombosis-online.com.

Keywords

Atrial fibrillation - dabigatran - vitamin K antagonist - real-world - meta-analysis

 

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