Dabigatran in the secondary prevention of stroke: an evidence-based evaluation

Abstract

Objective To evaluate the efficiency, safety and indications of dabigatran for the secondary prevention of stroke.  Methods Taking dabigatran, stroke, ischemia, hemorrhagic, TIA, transient ischemic attack, prevention, secondary prevention, treatment as search terms, retrieve in databases such as PubMed, ScienceDirect and Cochrane Library, assisted by manual searching, in order to collect relevant literatures including clinical guidelines, systematic reviews (including Meta-analyses), randomized controlled trials (RCTs), retrospective case analyses, case-observation studies and reviews. Jadad Scale was applied for scoring clinical researches while PRISMA statement was for evaluating the quality of systematic reviews (including Meta-analyses) and reviews.  Results A total of 23 articles were selected out of 1067 search results, in which 2 clinical guidelines, 6 systematic reviews (including Meta-analyses) and reviews, 8 RCTs, 3 retrospective case analyses, and 4 case-observation studies were enrolled. According to the Jadad Scale, 8 clinical studies were evaluated as high-quality literature (score ≥ 4), and the remaining 7 were low-quality literature (score < 4). All of systematic reviews (including Meta-analyses) and reviews were of high quality. The results were as follows: 1) the use of dabigatran in stroke patients, especially Asian patients, with non-valvular atrial fibrillation showed no inferior efficiency and lower risk for major bleeding for the secondary prevention of stroke than warfarin, while the elder should be given lower dosage and blood concentration of drug might be in need of monitoring. 2) Applying dabigatran for the secondary prevention of stroke in patients with mechanical valve replacement must be cautious. Insufficient evidence had shown its inferiority in both efficiency and safety when compared to warfarin. 3) Large-scale clinical trials are needed to provide evidence for the application of dabigatran in valvular heart disease, cardiomyopathy, myocardial infarction, and other diseases in need of anticoagulants for secondary prevention of stroke. 4) Current evidence is limited for the regular usage of dabigatran for secondary prevention of stroke.  Conclusions Critical findings have been demonstrated in the evidence-based evaluation on dabigatran in the secondary prevention of stroke. Decision making on the clinical application of dabigatran in the secondary prevention of stroke should be cautious.

DOI: 10.3969/j.issn.1672-6731.2015.03.006