From the Departments of Medicine (D.R.A.), Surgery (M.D.), and Community Health and Epidemiology (P.A.), Dalhousie University, and the Nova Scotia Health Authority (S. Pleasance, S. Doucette, C.T., A.A.), Halifax, the Department of Surgery, University of Toronto, Toronto (J.M.), the Departments of Medicine (S.R.K.) and Surgery (W.F., D.Z.), McGill University, and the Department of Surgery, University of Montreal (P.-A.V.), Montreal, the Department of Medicine, McMaster University, Hamilton, ON (P.G., M. Crowther), the Department of Surgery, Dalhousie University, Moncton, NB (M.F.), the Department of Surgery, Laval University, Quebec, QC (S. Pelet, E. Belzile), the Department of Medicine, Dalhousie University, Saint John, NB (S. Dolan), the Department of Surgery, University of Manitoba, Winnipeg (E. Bohm), the Departments of Surgery (S.J.M.) and Medicine (M.J.K.), University of Western Ontario, London, and the Department of Surgery (W.G., P.K.), Division of Hematology, Department of Medicine (M. Carrier, M.A.R., P.S.W.), and School of Epidemiology and Public Health (D.C.), University of Ottawa, Ottawa - all in Canada.
N Engl J Med. 2018 Feb 22;378(8):699-707. doi: 10.1056/NEJMoa1712746.
Clinical 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.
We 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).
A 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<0.001 for noninferiority and P=0.84 for superiority). Major bleeding complications occurred in 8 patients (0.47%) in the aspirin group and in 5 (0.29%) in the rivaroxaban group (difference, 0.18 percentage points; 95% CI, -0.65 to 0.29; P=0.42). Clinically important bleeding occurred in 22 patients (1.29%) in the aspirin group and in 17 (0.99%) in the rivaroxaban group (difference, 0.30 percentage points; 95% CI, -1.07 to 0.47; P=0.43).
Among patients who received 5 days of rivaroxaban prophylaxis after total hip or total knee arthroplasty, extended prophylaxis with aspirin was not significantly different from rivaroxaban in the prevention of symptomatic venous thromboembolism. (Funded by the Canadian Institutes of Health Research; ClinicalTrials.gov number, NCT01720108 .).
临床试验和荟萃分析表明，阿司匹林可能对预防全髋关节或全膝关节置换术后的静脉血栓栓塞症（近端深静脉血栓形成或肺栓塞）有效，但缺乏阿司匹林与直接口服抗凝剂在出院后预防的比较。
我们进行了一项多中心、双盲、随机、对照试验，纳入了正在接受全髋关节或全膝关节置换术的患者。所有患者均接受每日一次口服利伐沙班（10mg），直至术后第 5 天，然后随机分配继续使用利伐沙班或改用阿司匹林（81mg 每日），在全膝关节置换术后再加用 9 天，或在全髋关节置换术后再加用 30 天。患者在 90 天内接受症状性静脉血栓栓塞症（主要有效性结局）和出血并发症的随访，包括主要或临床上显著的非主要出血（主要安全性结局）。
共纳入 3424 例患者（1804 例接受全髋关节置换术，1620 例接受全膝关节置换术）。阿司匹林组 1707 例患者中有 11 例（0.64%）发生静脉血栓栓塞症，利伐沙班组 1717 例患者中有 12 例（0.70%）发生静脉血栓栓塞症（差异，0.06 个百分点；95%置信区间[CI]，-0.55 至 0.66；非劣效性 P<0.001，优效性 P=0.84）。阿司匹林组 8 例（0.47%）患者发生大出血并发症，利伐沙班组 5 例（0.29%）患者发生大出血并发症（差异，0.18 个百分点；95%CI，-0.65 至 0.29；P=0.42）。阿司匹林组 22 例（1.29%）患者发生临床上显著的出血，利伐沙班组 17 例（0.99%）患者发生临床上显著的出血（差异，0.30 个百分点；95%CI，-1.07 至 0.47；P=0.43）。
在接受全髋关节或全膝关节置换术后 5 天接受利伐沙班预防的患者中，阿司匹林的延长预防与利伐沙班在预防症状性静脉血栓栓塞症方面无显著差异。（由加拿大卫生研究院资助；临床试验.gov 编号，NCT01720108）。
