Rivaroxaban or Aspirin for Extended Treatment of Venous Thromboembolism

        静脉血栓的后续处理：利伐沙班还是阿司匹林

        Background

        Although 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.

        许多静脉血栓的病人需要后期继续治疗，但是使用全强度或稍低强度抗凝治疗还是阿司匹林抗板治疗，暂不明确哪种治疗更佳。

        Methods

        In 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.

        这是一个随机、双盲、三期试验，纳入了3396名静脉血栓病人，试验设计：一组使用每日一次的利伐沙班(20mg或10mg/次)，另一组服用100mg阿司匹林。所有的病人在此之前都完成了6-12个月的抗凝治疗，然后根据抗凝需要继续使用。该研究的药物使用都是长达12个月的。研究的主要结果是出现致命或非致命的血栓栓塞复发症状，主要的安全结局是大出血。

        Results

        A 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<0.001 for both comparisons). Rates of major bleeding were 0.5% in the group receiving 20 mg of rivaroxaban, 0.4% in the group receiving 10 mg of rivaroxaban, and 0.3% in the aspirin group; the rates of clinically relevant nonmajor bleeding were 2.7%, 2.0%, and 1.8%, respectively. The incidence of adverse events was similar in all three groups.

        共有3365名患者被纳入意向治疗分析(中位治疗时间，351天)。主要疗效结果为： 1107例接受20 mg利伐沙班的患者中出现17例(1.5%)，1127例接受10毫克利伐沙班的患者中出现13例(1.2%)，1131例接受阿司匹林的患者中出现50例(4.4%)(危险比：20毫克利伐沙班vs.阿司匹林，0.34;95%可信区间[CI] 0.20-0.59;10毫克利伐沙班vs.阿司匹林，0.26;95% CI 0.14-0.47;两组P<0.001)。20毫克利伐沙班组大出血率为0.5%，10毫克利伐沙班组为0.4%，阿司匹林组有0.3%;临床相关的非大出血率分别为2.7%、2%和1.8%。三组患者的不良事件发生率相似。

        Conclusions

        Among patients with venous thromboembolism in equipoise for continued anticoagulation, the risk of a recurrent event was significantly lower with rivaroxaban at either a treatment dose (20 mg) or a prophylactic dose (10 mg) than with aspirin, without a significant increase in bleeding rates.

        继续抗凝的静脉血栓栓塞患者中，治疗剂量(20毫克)或预防剂量(10毫克)的利伐沙班，其复发风险显著低于阿司匹林，而并无出血率的显著增加。