Rivaroxaban versus enoxaparin for thromboprophylaxis after hip arthroplasty
Rivaroxaban versus enoxaparin for thromboprophylaxis after hip arthroplasty
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DOI：
10.1056/nejmoa0800374
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发表时间：
2008-06-26
影响因子：
158.5
通讯作者：
Geerts, William
中科院分区：
文献类型：
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作者：
Eriksson, Bengt I.;Borris, Lars C.;Geerts, William
背景资料：这项3期试验比较了利伐沙班（一种口服Xa因子直接抑制剂）与依诺肝素在全髋关节置换术患者中延长血栓预防的疗效和安全性。在这项随机、双盲研究中，我们将4541例患者分配为接受10 mg口服利伐沙班，每日一次，从手术后开始，或40 mg依诺肝素皮下注射，每日一次，从手术前一天晚上开始，加上安慰剂片剂或注射剂。主要疗效结局为36天时深静脉血栓形成（有症状或通过双侧静脉造影检测，如果患者无症状）、非致死性肺栓塞或全因死亡的复合终点（范围：30 - 42）。主要次要疗效结局为严重静脉血栓栓塞（近端深静脉血栓形成、非致死性肺栓塞或静脉血栓栓塞死亡）。主要安全性结局为大出血。结果：共有3153例患者纳入优效性分析（排除1388例后），4433例患者纳入安全性分析（排除108例后）。利伐沙班组1595例患者中有18例（1.1%）发生主要疗效结局，依诺肝素组1558例患者中有58例（3.7%）发生主要疗效结局（绝对风险降低，2.6%; 95%置信区间[CI]，1.5 - 3.7; P
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