Iberoamerican Cochrane Centre, Institute of Biomedical Research-CIBER of Epidemiology and Public Health (CIBERESP-IIB Sant Pau), Barcelona, Spain.
Thromb Haemost. 2012 Oct;108(4):647-53. doi: 10.1160/TH12-01-0027. Epub 2012 Aug 23.
Oral anticoagulation with vitamin k antagonists (VKAs) requires regular testing and dose adjustment. Home-monitoring (self-testing or self-management) is more effective than usual management. Dabigatran, does not require dose-adjustment and appears to be more effective at reducing the risk of stroke with similar risks of bleeding in patients with atrial fibrillation (AF). Dabigatran, however, has not been compared to the home-monitoring. It was the objective to evaluate the efficacy of dabigatran compared with home-monitoring of oral anticoagulation with VKAs. Randomised controlled trials (RCTs) comparing usual management of oral anticoagulation with home-monitoring, dabigatran with usual management, and RCTs comparing dabigatran with home-monitoring and including patient-important outcomes (thromboembolic events, death and major bleeding) were eligible. For our direct comparison we calculated pooled relative risks (RRs) using the Mantzel-Haenzel random effect model. For the indirect comparison we estimated lnRRs and back transformed to RR. We evaluated the quality of the evidence with the GRADE system. Dabigatran, compared with warfarin, was associated with lower rates of stroke or thromboembolism and systemic embolism but similar rates of major haemorrhage and death. Dabigatran 150 mg also increased non-significantly the rate of myocardial infarction. The quality of the evidence was high. Our indirect comparison of home-monitoring of oral anticoagulation versus dabigatran showed no convincing differences in the risk of thromboembolism, death or major bleeding. The estimates for self-management vs. dabigatran showed stronger but still non-significant trends. The quality of the evidence was low. In conclusion, the indirect comparison of home monitoring of oral anticoagulation with dabigatran suggests that the treatments have similar impact on thrombosis, bleeding and death. However, the confidence in the estimate of effect is low to very low. Our analyses contrast with the available comparison of dabigatran with conventional warfarin monitoring.
口服抗凝剂（VKA）需要定期检测和剂量调整。家庭监测（自我检测或自我管理）比常规管理更有效。达比加群无需调整剂量，并且似乎在降低房颤（AF）患者中风风险方面更有效，同时出血风险相似。然而，达比加群尚未与家庭监测进行比较。本研究旨在评估与 VKA 口服抗凝剂常规管理相比，达比加群的疗效。符合条件的随机对照试验（RCT）比较了常规管理的口服抗凝剂与家庭监测、达比加群与常规管理，以及比较达比加群与家庭监测并包含患者重要结局（血栓栓塞事件、死亡和大出血）的 RCT。对于我们的直接比较，我们使用 Mantzel-Haenzel 随机效应模型计算了合并相对风险（RR）。对于间接比较，我们估计了 lnRR 并反向转换为 RR。我们使用 GRADE 系统评估证据质量。与华法林相比，达比加群与较低的中风或血栓栓塞和全身性栓塞发生率相关，但大出血和死亡率相似。达比加群 150mg 也非显著增加心肌梗死发生率。证据质量为高。我们对口服抗凝剂家庭监测与达比加群的间接比较显示，在血栓栓塞、死亡或大出血风险方面没有明显差异。自我管理与达比加群的估计值显示出更强但仍非显著的趋势。证据质量为低。总之，口服抗凝剂家庭监测与达比加群的间接比较表明，两种治疗方法在血栓形成、出血和死亡方面的影响相似。然而，对效应估计的置信度低至非常低。我们的分析与达比加群与常规华法林监测的可用比较形成对比。
