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
