Rivaroxaban or Aspirin for Extended Treatment of Venous Thromboembolism
Rivaroxaban or Aspirin for Extended Treatment of Venous Thromboembolism
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DOI：
10.1056/nejmoa1700518
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发表时间：
2017-03-30
影响因子：
158.5
通讯作者：
Prandoni, P.
中科院分区：
文献类型：
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作者：
Weitz, J. I.;Lensing, A. W. A.;Prandoni, P.
尽管许多静脉血栓栓塞症患者需要延长治疗，但尚不确定是否更好地使用全强度或低强度抗凝治疗或阿司匹林。METHODS在这项随机、双盲、3期研究中，我们将3396例静脉血栓栓塞症患者分配为每日一次利伐沙班（剂量为20 mg或10 mg）或100 mg阿司匹林。所有研究患者均已完成6至12个月的抗凝治疗，并且对于继续抗凝的需要处于平衡状态。研究药物给药长达12个月。主要疗效结局是有症状的复发性致死性或非致死性静脉血栓栓塞，主要安全性结局是大出血。意向治疗分析共纳入3365例患者（中位治疗持续时间为351天）。1107例患者中有17例发生了主要疗效结局（1.5%）接受20 mg利伐沙班，1127例患者中有13例（1.2%）接受10 mg利伐沙班，而1131例患者中有50例（4.4%）接受阿司匹林（利伐沙班20 mg vs阿司匹林的风险比为0.34; 95%置信区间[ CI]为0.20 - 0.59; 10 mg利伐沙班与阿司匹林的风险比，0.26; 95% CI，0.14 - 0.47; P
BACKGROUNDAlthough many patients with venous thromboembolism require extended treatment, it is uncertain whether it is better to use full- or lower-intensity anticoagulation therapy or aspirin.METHODSIn this randomized, double-blind, phase 3 study, we assigned 3396 patients with venous thromboembolism to receive either once-daily rivaroxaban (at doses of 20 mg or 10 mg) or 100 mg of aspirin. All the study patients had completed 6 to 12 months of anticoagulation therapy and were in equipoise regarding the need for continued anticoagulation. Study drugs were administered for up to 12 months. The primary efficacy outcome was symptomatic recurrent fatal or nonfatal venous thromboembolism, and the principal safety outcome was major bleeding.RESULTSA total of 3365 patients were included in the intention-to-treat analyses (median treatment duration, 351 days). The primary efficacy outcome occurred in 17 of 1107 patients (1.5%) receiving 20 mg of rivaroxaban and in 13 of 1127 patients (1.2%) receiving 10 mg of rivaroxaban, as compared with 50 of 1131 patients (4.4%) receiving aspirin (hazard ratio for 20 mg of rivaroxaban vs. aspirin, 0.34; 95% confidence interval [ CI], 0.20 to 0.59; hazard ratio for 10 mg of rivaroxaban vs. aspirin, 0.26; 95% CI, 0.14 to 0.47; P