João Carmo, MD, Cardiology Department, Santa Cruz Hospital, Avenida Prof. Reinaldo dos Santos 2790-134, Carnaxide, Portugal, Tel.: +35 1 210433000, Fax: +35 1 214241388, E-mail:
Thromb Haemost. 2016 Sep 27;116(4):754-63. doi: 10.1160/TH16-03-0203. Epub 2016 Jul 28.
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.
在 RE-LY 临床试验中，与华法林相比，达比加群呈现出更好的疗效/安全性特征。然而，临床试验并不能很好地代表真实世界的情况。我们旨在通过对与维生素 K 拮抗剂（VKA）的观察性比较研究的系统评价和荟萃分析，评估达比加群在真实世界中房颤（AF）患者中的表现。我们检索了 PubMed、Embase 和 Scopus 数据库，检索时间截至 2015 年 11 月，并根据以下标准选择研究：非瓣膜性 AF 患者的观察性研究；报告随访期间临床事件的调整后危险比（HR）；达比加群 75mg、110mg 或 150mg 与 VKA 的比较。共选择了 20 项研究，共纳入 711298 例患者，其中 210279 例接受达比加群治疗，其余 501019 例接受 VKA 治疗。达比加群的缺血性卒中发生率为 1.65/100 患者-年，而 VKA 的发生率为 2.85/100 患者-年（HR 0.86，95%置信区间 0.74-0.99）。达比加群的大出血发生率为 3.93/100 患者-年，而 VKA 的发生率为 5.61/100 患者-年（0.79，0.69-0.89）。与 VKA 相比，达比加群治疗的患者死亡率（0.73，0.61-0.87）和颅内出血（0.45，0.38-0.52）风险显著降低。达比加群治疗的患者胃肠道（GI）出血风险显著升高（1.13，1.00-1.28）。心肌梗死（MI）的风险无显著差异（0.99，0.89-1.11）。在这项与 VKA 的真实世界观察性比较研究的综合分析中，达比加群与较低的缺血性卒中、大出血、颅内出血和死亡率风险相关，与较高的胃肠道出血风险相关，与相似的心肌梗死风险相关。
