Extended duration rivaroxaban versus short-term enoxaparin for the prevention of venous thromboembolism after total hip arthroplasty: a double-blind, randomised controlled trial
Extended duration rivaroxaban versus short-term enoxaparin for the prevention of venous thromboembolism after total hip arthroplasty: a double-blind, randomised controlled trial
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DOI：
10.1016/s0140-6736(08)60880-6
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发表时间：
2008-07-05
期刊：
影响因子：
168.9
通讯作者：
Haas, Sylvia
中科院分区：
文献类型：
--
作者：
Kakkar, Ajay K.;Brenner, Benjamin;Haas, Sylvia
背景 全髋关节置换术后静脉血栓栓塞的风险很高，并且在出院后可能持续存在。我们的目的是比较使用利伐沙班进行长期血栓预防与依诺肝素进行短期血栓预防。方法 2509 名计划接受选择性全髋关节置换术的患者被随机分配，根据中心分层，并使用计算机生成的随机化代码，接受每日一次口服利伐沙班 10 mg，持续 31-39 天（使用安慰剂） 注射10-14天； n=1252)，或依诺肝素 40 mg，每日一次皮下注射，持续 10-14 天（安慰剂片剂持续 31-39 天；n=1257）。主要疗效结果是深静脉血栓形成（通过强制双侧静脉造影检测到有症状或无症状）、非致命性肺栓塞和截至 30-42 天的全因死亡率的综合结果。分析是在修改后的意向治疗人群中进行的，该人群包括接受至少一剂研究药物、接受过计划手术并对血栓栓塞进行充分评估的所有患者。这项研究在 ClinicalTrials.gov 上注册，编号为 NCT00332020。 结果 用于分析主要疗效结果的改良意向治疗人群包括利伐沙班组的 864 名患者和依诺肝素组的 869 名患者。利伐沙班组有 17 名患者 (2. 0%) 发生主要结局，而依诺肝素组有 81 名患者 (9.3%) 发生主要结局（绝对风险降低 7.3%，95% CI 5.2-9.4；p
Background The risk of venous thromboembolism is high after total hip arthroplasty and could persist after hospital discharge. Our aim was to compare the use of rivaroxaban for extended thromboprophylaxis with short-term thromboprophylaxis with enoxaparin.Methods 2509 patients scheduled to undergo elective total hip arthroplasty were randomly assigned, stratified according to Centre, with a computer-generated randomisation code, to receive,oral rivaroxaban 10 mg once daily for 31-39 days (with placebo injection for 10-14 days; n=1252), or enoxaparin 40 mg once daily subcutaneously for 10-14 days (with placebo tablet for 31-39 days; n=1257). The primary efficacy outcome was the composite of deep-vein thrombosis (symptomatic or asymptornatic detected by mandatory, bilateral venography), non-fatal pulmonary embolism, and all-cause mortality up to day 30-42. Analyses were done in the modified intention-to-treat population, which consisted of all patients who had received at least one dose of study medication, had undergone planned surgery, and had adequate assessment of thromboembolism. This study is registered at ClinicalTrials.gov, number NCT00332020.Findings The modified intention-to-treat population for the analysis of the primary efficacy outcome consisted of 864 patients in the rivaroxaban group and 869 in the enoxaparin group. The primary outcome occurred in 17 (2 . 0%) patients in the rivaroxaban group, compared with 81 (9.3%) in the enoxaparin group (absolute risk reduction 7.3%, 95% CI 5.2-9.4; p