《NEJM》:阿司匹林或利伐沙班可对髋关节或膝关节置换术后进行VTE预防

背景:

人工全膝关节置换术(total knee arthroplasty TKA)和人工全髋关节置换术(total hip arthroplasty,THA)已成为治疗晚期骨关节炎、股骨头坏死等的重要方法。

临床试验和荟萃分析表明,阿司匹林可能是预防全髋关节置换术或全膝关节置换术后静脉血栓栓塞(近端深静脉血栓或肺栓塞)的有效方法,但与直接口服抗凝血剂相比,在出院后缺乏预防措施。


方法:

我们进行了一项多中心、双盲、随机、对照试验,涉及全髋关节置换术或膝关节置换术患者。所有患者接受每日一次口服利伐沙班(10毫克)直到术后5天,然后被随机分配到在人工全膝关节置换术后9天或全髋关节置换术后30天继续服用利伐沙班或改用阿司匹林(每天81毫克)的组别里。患者随访90天,看是否有症状性静脉血栓形成(主要有效性结局)和出血并发症,包括严重或临床相关的非大出血(主要安全性结果)。


结果:

共纳入3424例患者(其中1804例行全髋关节置换术,1620例行全膝关节置换术)。在服用阿司匹林的1707例患者中有11例发生了静脉血栓栓塞症(0.64%),在服用利伐沙班的1717例患者中有12例(0.70%)(差0.06个百分点;95%可信区间[CI],-0.55 到0.66;非劣效性P<0.001,优势P = 0.84。)阿司匹林组有8例大出血并发症的发生(0.47%)和在利伐沙班组则有5例(0.29%)(差0.18个百分点;95% CI,-0.65到0.29;P = 0.42)。临床上重要的出血发生阿司匹林组有22例(1.29%),利伐沙班组有17例(0.99%)(差0.30个百分点;95% CI,-1.07到0.47;P = 0.43)。


结论:

全髋或全膝关节置换术后接受了5天利伐沙班预防的患者,继续使用阿司匹林长期预防,与利用利伐沙班预防症状性静脉血栓的形成相比,差异并不显著。



BACKGROUND: 

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.


METHODS: 

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).


RESULTS: 

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).


CONCLUSIONS: 

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 .).


引用

Anderson DR, Dunbar M, Murnaghan J, Kahn SR, Gross P, Forsythe M, Pelet S, Fisher W, Belzile E, Dolan S, Crowther M, Bohm E, MacDonald SJ, Gofton W, Kim P, Zukor D, Pleasance S, Andreou P, Doucette S, Theriault C, Abianui A, Carrier M, Kovacs MJ, Rodger MA, Coyle D, Wells PS, Vendittoli PA. Aspirin or Rivaroxaban for VTE Prophylaxis after Hip or Knee Arthroplasty. N Engl J Med. 2018 Feb 22;378(8):699-707.


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