BACKGROUND:This phase 3 trial compared the efficacy and safety of rivaroxaban, an oral direct inhibitor of factor Xa, with those of enoxaparin for extended thromboprophylaxis in patients undergoing total hip arthroplasty. METHODS:In this randomized, double-blind study, we assigned 4541 patients to receive either 10 mg of oral rivaroxaban once daily, beginning after surgery, or 40 mg of enoxaparin subcutaneously once daily, beginning the evening before surgery, plus a placebo tablet or injection. The primary efficacy outcome was the composite of deep-vein thrombosis (either symptomatic or detected by bilateral venography if the patient was asymptomatic), nonfatal pulmonary embolism, or death from any cause at 36 days (range, 30 to 42). The main secondary efficacy outcome was major venous thromboembolism (proximal deep-vein thrombosis, nonfatal pulmonary embolism, or death from venous thromboembolism). The primary safety outcome was major bleeding. RESULTS:A total of 3153 patients were included in the superiority analysis (after 1388 exclusions), and 4433 were included in the safety analysis (after 108 exclusions). The primary efficacy outcome occurred in 18 of 1595 patients (1.1%) in the rivaroxaban group and in 58 of 1558 patients (3.7%) in the enoxaparin group (absolute risk reduction, 2.6%; 95% confidence interval [CI], 1.5 to 3.7; P<0.001). Major venous thromboembolism occurred in 4 of 1686 patients (0.2%) in the rivaroxaban group and in 33 of 1678 patients (2.0%) in the enoxaparin group (absolute risk reduction, 1.7%; 95% CI, 1.0 to 2.5; P<0.001). Major bleeding occurred in 6 of 2209 patients (0.3%) in the rivaroxaban group and in 2 of 2224 patients (0.1%) in the enoxaparin group (P=0.18). CONCLUSIONS:A once-daily, 10-mg oral dose of rivaroxaban was significantly more effective for extended thromboprophylaxis than a once-daily, 40-mg subcutaneous dose of enoxaparin in patients undergoing elective total hip arthroplasty. The two drugs had similar safety profiles. (ClinicalTrials.gov number, NCT00329628.)

译文

背景:这项3期试验比较了口服Xa因子直接抑制剂利伐沙班和依诺肝素对全髋关节置换术患者延长血栓预防的疗效和安全性。
方法:在这项随机,双盲研究中,我们分配4541名患者,使其在手术后开始每天一次接受10 mg口服利伐沙班治疗,或者在手术前一天晚上开始皮下每天一次接受40 mg依诺肝素的治疗,再加上安慰剂片或注射。主要疗效结果是深静脉血栓形成(有症状或如果患者无症状则可通过双侧静脉造影检查发现),非致命性肺栓塞或任何原因在36天时死亡(30至42天)。次要疗效的主要结果是主要的静脉血栓栓塞(近端深静脉血栓形成,非致命性肺栓塞或静脉血栓栓塞死亡)。主要安全结果是大出血。
结果:优势分析共纳入3153例患者(1388例除外),安全性分析共4433例(108例除外)。利伐沙班组1595例患者中有18例(1.1%)发生了主要疗效,依诺肝素组1558例中58例(3.7%)发生了(绝对风险降低2.6%; 95%置信区间[CI]为1.5至1.5)。 3.7; P <0.001)。利伐沙班组1686例患者中有4例发生严重静脉血栓栓塞(0.2%),依诺肝素组1678例患者中有33例(2.0%)发生(绝对风险降低1.7%; 95%CI为1.0至2.5; P <0.001 )。利伐沙班组2209例患者中有6例发生大出血(0.3%),依诺肝素组2222例患者中有2例(0.1%)(P = 0.18)。
结论:对于行择期全髋关节置换术的患者,每天口服10 mg利伐沙班对延长血栓预防效果比每天一次40 mg皮下剂量依诺肝素有效。两种药物的安全性相似。 (ClinicalTrials.gov编号,NCT00329628。)

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