For the prevention of thrombo-embolic events in patients with atrial fibrillation and a high thrombotic risk, the standard treatment is warfarin, an anticoagulant. Dabigatran, a thrombin inhibitor, is the alternative when warfarin fails to maintain the INR within the therapeutic range. Patients with a moderate thrombotic risk may receive either warfarin or low-dose aspirin.Apixaban, a factor Xa inhibitor anticoagulant, has been authorised in the European Union for use in patients with non-valvular atrial fibrillation and a moderate or high risk of thrombosis. In a double-blind, randomised non-inferiority trial versus warfarin in 18 201 patients, the incidence of stroke or systemic embolism was lower in the apixaban group (average 1.3 versus 1.6 events per 100 patient-years; p = 0.01). This difference was mainly due to a lower incidence of haemor-rhagic stroke and did not result in a clear decline in mortality. In addition, these results are undermined by multiple methodological flaws.
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机译:为了预防房颤和高血栓形成风险的患者发生血栓栓塞事件,标准治疗方法是抗凝剂华法林。当华法令未能将INR维持在治疗范围内时,凝血酶抑制剂达比加群是替代品。具有中度血栓形成风险的患者可以接受华法林或小剂量阿司匹林治疗。Apixaban是一种Xa因子抗凝剂,已在欧盟授权用于非瓣膜性房颤的中度或高血栓形成风险患者。在一项针对18201例患者的华法林双盲,非劣效性随机试验中,阿哌沙班组中风或全身性栓塞的发生率较低(每100患者年平均1.3例事件与1.6例事件; p = 0.01)。这种差异主要是由于流血性流产性中风的发生率较低,并且并未导致死亡率明显下降。此外,这些结果还受到多种方法缺陷的破坏。
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