Department of Clinical Cardiology, Thrombosis Centre, University of Padua, Padua, Italy.
J Thromb Haemost. 2012 Oct;10(10):1979-87. doi: 10.1111/j.1538-7836.2012.04866.x.
In this overview we address the three phase III studies that compared new oral anticoagulants (dabigatran, rivaroxaban and apixaban) with warfarin in the setting of stroke prevention in atrial fibrillation. Strengths and weaknesses of the studies were examined in detail through indirect comparison. We analyze and comment the inclusion and exclusion criteria, the characteristics of randomized patients, the primary efficacy and safety end points and side effects. All new oral anticoagulants resulted in being non-inferior to vitamin K antagonists in reducing stroke or systemic embolism in patients with atrial fibrillation. Dabigatran 150 mg and apixaban were superior to vitamin K antagonists. Importantly, new oral anticoagulants significantly reduced hemorrhagic stroke in all three studies. Major differences among new oral anticoagulants include the way they are eliminated and side effects. Both dabigatran and apixaban were tested in low- to moderate-risk patients (mean CHADS2 [Congestive heart failure, Hypertension, Age, Diabetes, Stroke] score = 2.1-2.2) whereas rivaroxaban was tested in high-risk patients (mean CHADS2 score = 3.48) and at variance with dabigatran and apixaban was administered once daily. Apixaban significantly reduced mortality from any cause. The choice of a new oral anticoagulant should take into account these and other differences between the new drugs.
在这篇综述中，我们讨论了三项 III 期研究，这些研究比较了新型口服抗凝剂（达比加群、利伐沙班和阿哌沙班）与华法林在预防房颤中风中的应用。通过间接比较详细检查了研究的优缺点。我们分析和评论了纳入和排除标准、随机患者的特征、主要疗效和安全性终点以及副作用。所有新型口服抗凝剂在降低房颤患者中风或全身性栓塞方面均不劣于维生素 K 拮抗剂。达比加群 150mg 和阿哌沙班优于维生素 K 拮抗剂。重要的是，所有三项研究均表明新型口服抗凝剂显著降低了脑出血的发生率。新型口服抗凝剂之间的主要差异包括它们的消除方式和副作用。达比加群和阿哌沙班均在中低危患者（平均 CHADS2[充血性心力衰竭、高血压、年龄、糖尿病、中风]评分=2.1-2.2）中进行了测试，而利伐沙班则在高危患者（平均 CHADS2 评分=3.48）中进行了测试，且与达比加群和阿哌沙班不同，利伐沙班每天服用一次。阿哌沙班显著降低了任何原因导致的死亡率。选择一种新型口服抗凝剂应考虑这些因素以及新药之间的其他差异。
