Aspirin or Rivaroxaban for VTE Prophylaxis after Hip or Knee Arthroplasty
Aspirin or Rivaroxaban for VTE Prophylaxis after Hip or Knee Arthroplasty
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DOI：
10.1056/nejmoa1712746
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发表时间：
2018-02-22
影响因子：
158.5
通讯作者：
Vendittoli, P. -A.
中科院分区：
文献类型：
--
作者：
Anderson, D. R.;Dunbar, M.;Vendittoli, P. -A.
背景：临床试验和荟萃分析表明，阿司匹林可有效预防全髋关节或全膝关节置换术后静脉血栓形成(近端深静脉血栓形成或肺栓塞)，但在出院后的预防方面缺乏与直接口服抗凝剂的比较。方法我们进行了一项多中心、双盲、随机、对照试验，涉及全髋关节或膝关节置换患者。所有患者均口服利伐沙班(10 mg/d)至术后第5天，然后随机分为两组，分别在全膝关节置换术后9d或全髋关节置换术后30d内继续服用利伐沙班或阿司匹林81 mg/d。随访90天，观察症状性静脉血栓栓塞症(主要有效结果)和出血并发症，包括重大或临床相关的非重大出血(主要安全结果)。结果共有3424名患者进入试验，其中1804例行全髋关节置换术，1620例行全膝关节置换术。阿司匹林组1707例患者中发生静脉血栓11例(0.64%)，利伐沙班组1717例患者中12例(0.70%)发生静脉血栓形成(差异0.06个百分点；95%可信区间[CI]，-0.55~0.66；P
BACKGROUNDClinical trials and meta-analyses have suggested that aspirin may be effective for the prevention of venous thromboembolism (proximal deep-vein thrombosis or pulmonary embolism) after total hip or total knee arthroplasty, but comparisons with direct oral anticoagulants are lacking for prophylaxis beyond hospital discharge.METHODSWe performed a multicenter, double-blind, randomized, controlled trial involving patients who were undergoing total hip or knee arthroplasty. All the patients received once-daily oral rivaroxaban (10 mg) until postoperative day 5 and then were randomly assigned to continue rivaroxaban or switch to aspirin (81 mg daily) for an additional 9 days after total knee arthroplasty or for 30 days after total hip arthroplasty. Patients were followed for 90 days for symptomatic venous thromboembolism (the primary effectiveness outcome) and bleeding complications, including major or clinically relevant nonmajor bleeding (the primary safety outcome).RESULTSA total of 3424 patients (1804 undergoing total hip arthroplasty and 1620 undergoing total knee arthroplasty) were enrolled in the trial. Venous thromboembolism occurred in 11 of 1707 patients (0.64%) in the aspirin group and in 12 of 1717 patients (0.70%) in the rivaroxaban group (difference, 0.06 percentage points; 95% confidence interval [CI], -0.55 to 0.66; P