Dabigatran is a univalent low-molecular-weight direct thrombin inhibitor that has
been developed as an alternative to vitamin K antagonists (VKAs). However, uncertainty
remains regarding dabigatran's safety profile with respect to bleeding. Our objective
was to compare the risk of bleeding and all-cause mortality of dabigatran with that
of VKAs in a systematic review and meta-analysis of randomized controlled trials (RCTs).
We systematically searched MEDLINE, Embase, and the Cochrane Library of clinical trials
to identify RCTs comparing the bleeding risk of dabigatran (150 mg twice daily) with
that of VKAs. Included RCTs had treatment duration ≥90 days and were published in
English or French. Data were meta-analyzed using random-effects models. Five RCTs
(n = 20,332) were included in our systematic review. Study populations consisted of
patients with atrial fibrillation (n = 18,615) and venous thromboembolism (n = 7,998).
When data were pooled across the 4 RCTs (n = 17,466) without overlapping populations,
dabigatran was not associated with an increased risk of major bleeding compared with
VKAs (relative risk [RR] 0.92, 95% confidence interval [CI] 0.81 to 1.05). Dabigatran
was associated with a decreased risk of intracranial bleeding (RR 0.40, 95% CI 0.27
to 0.59) but an increased risk of gastrointestinal bleeding (RR 1.51, 95% CI 1.23
to 1.84). Dabigatran was also associated with a trend toward decreased all-cause mortality
(RR 0.90, 95% CI 0.80 to 1.01). In conclusion, results suggest that dabigatran has
a favorable safety profile with respect to bleeding compared with VKAs.
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Article info
Publication history
Published online: December 26, 2013
Accepted:
November 23,
2013
Received in revised form:
November 23,
2013
Received:
August 28,
2013
Footnotes
See page 1073 for disclosure information.
Identification
Copyright
© 2014 Elsevier Inc. Published by Elsevier Inc. All rights reserved.
