Study Of Efficacy And Safety Of Dabigatran Etexilate Versus Warfarin For Antithrombotic Therapy In Nonvalvular Atrial Filbrillation

ObjectiveAtrial fibrillation is an independent risk factor for stroke, which has high mortality, disability and recurernce rate. So anticoagulant therapy has been an important part of patients with atrial fibrillation. Warfarin as a conventional oral anticoagulant, is underutilized as a result of some limitations, such as requiring monitoring, interreaction with some foods and agents. In recent years, new oral anticoagulants with reliable effect, good safety and administered conveniently have been developed. Dabigatran etexilate, an novel oral direct factor II a inhibitor, can prevent thrombosis as a result of binding thrombin specifically. It has been proved to prevent stroke and systemic embolism effectively in patients with nonvalvular atrial fibrillation as a substitute for warfarin. In our country, clinical studies are not enough for dabigatran etexilate. This clinical study aims to evaluate the efficacy and safety of dabigatran etexilate for thromboembolism prevention in patients with nonvalvular atrial fibrillation, compared with warfarin.MethodsWe selected 110 patients with nonvalvular atrial fibrillation from XX hospital, with at least one of the following:congestive heart failure, hypertension, at least 75 years old, diabetes mellitus, previous stroke or transient ischemic attack. They were identified a dabigatran etexilate group(110mg, twice daily) and a dose-adjusted warfarin group (target international normalized ratio,2.0～3.0). We compared the efficacy and safety of two drugs on the basis of stroke or systemic embolism and major bleeding outcomes during a follow-up period of 6 months. The data were analysed by SPSS 19.0 statistical software. P values<0.05 were considered statistically significant.ResultsThe thromboembolism events occurred in no patient in the dabigatran etexilate group and in 1 patient in warfarin group, there was no significant differences between dabigatran etexilate and warfarin group in the thromboembolism events (0.00% vs 1.82%, P>0.05). The bleeding events occurred in 2 patients in the dabigatran etexilate group consist of 1 subcutaneous and 1 gingival bleeding, and in 2 patients in the warfarin group consist of 2 gastrointestinal bleeding. The rate of bleeding was similar between the dabigatran etexilate and warfarin group (P>0.05).Conclusions1.Dabigatran etexilate can effectively prevent thromboembolism in patients who have nonvalvular atrial fibrillation, similar to wafarin.2.Dabigatran etexilate can be used with no more bleeding compared with warfarin in patients with nonvalvular atrial fibrillation.