Background. This meta-analysis was performed to compare the efficacy and safety of direct oral anticoagulants (DOACs) with vitamin K antagonists (VKAs) for stroke prevention in real-world patients with diabetes and nonvalvular atrial fibrillation (NVAF) through observational studies. Methods. PubMed, Embase, and Web of Science databases were searched up to August 2020 for eligible studies. Outputs were presented as risk ratios (RRs) and corresponding 95% confidence intervals (CIs) by using a random-effect model. Results. Seven observational studies involving 249,794 diabetic NVAF patients were selected. Compared with VKAs, the use of DOACs was associated with significantly reduced risks of stroke (, 95% CI 0.45-0.70; ), ischemic stroke (, 95% CI 0.48-0.78; ), stroke or systemic embolism (SSE) (, 95% CI 0.68-0.95; ), myocardial infarction (, 95% CI 0.55-0.88; ), major bleeding (, 95% CI 0.63-0.90; ), intracranial hemorrhage (, 95% CI 0.44-0.56; ), and major gastrointestinal bleeding (, 95% CI 0.62-0.95; ), and a borderline significant decrease in major adverse cardiac events (, 95% CI 0.75-1.00; ) in NVAF patients with diabetes. Conclusion. For patients with NVAF and diabetes in real-world clinical settings, DOACs showed superior efficacy and safety profile over VKAs and significantly reduced risks of stroke, ischemic stroke, SSE, myocardial infarction, major bleeding, intracranial hemorrhage, and major gastrointestinal bleeding.

中文翻译：

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直接口服抗凝剂对糖尿病和非瓣膜性房颤患者的疗效和安全性：观察性研究的荟萃分析

背景。本荟萃分析旨在通过观察性研究，比较直接口服抗凝剂 (DOAC) 与维生素 K 拮抗剂 (VKA) 在糖尿病和非瓣膜性心房颤动 (NVAF) 患者中预防卒中的有效性和安全性。方法。在 PubMed、Embase 和 Web of Science 数据库中搜索了截至 2020 年 8 月的符合条件的研究。使用随机效应模型将输出表示为风险比 (RR) 和相应的 95% 置信区间 (CI)。结果。选择了七项观察性研究，涉及 249,794 名糖尿病 NVAF 患者。与 VKA 相比，DOAC 的使用与卒中风险显着降低相关。, 95% CI 0.45-0.70;),缺血性中风 (, 95% CI 0.48-0.78;)、中风或全身性栓塞 (SSE) (, 95% CI 0.68-0.95;)、心肌梗塞(, 95% CI 0.55-0.88;),大出血 (, 95% CI 0.63-0.90;),颅内出血 (, 95% CI 0.44-0.56;),和严重的胃肠道出血 (, 95% CI 0.62-0.95;），以及主要不良心脏事件的临界显着减少（, 95% CI 0.75-1.00;)在患有糖尿病的 NVAF 患者中。结论。对于真实世界临床环境中的 NVAF 和糖尿病患者，DOAC 显示出优于 VKA 的疗效和安全性，并显着降低中风、缺血性中风、SSE、心肌梗塞、大出血、颅内出血和大消化道出血的风险。