Résumé
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.
| Langue d'origine | English |
|---|---|
| Pages (de-à) | 699-707 |
| Nombre de pages | 9 |
| Journal | New England Journal of Medicine |
| Volume | 378 |
| Numéro de publication | 8 |
| DOI | |
| Statut de publication | Published - févr. 22 2018 |
Note bibliographique
Funding Information: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.)
Funding Information:
The trial was approved by the research ethics board at each trial center and was conducted in accordance with the principles of the Declaration of Helsinki and Good Clinical Practice guidelines. All the patients provided written informed consent. The trial was designed by the authors and supported by the Canadian Institutes of Health Research, which was not involved in the trial design, conduct, or analyses. There was no industry support or funding. The trial was monitored by an independent data and safety monitoring board. The results were collected and analyzed by the authors, who vouch for the data, its analysis, and adherence to the protocol, available at NEJM.org. No interim analysis was planned in the protocol or performed on the basis of the recommendation of the data and safety monitoring board. No one who is not an author contributed to the writing of the manuscript.
Funding Information:
Supported by the Canadian Institutes of Health Research.
Funding Information:
Dr. Gross reports receiving lecture fees from Bayer Pharma, Bristol-Myers Squibb, Pfizer, and Leo Pharma, receiving grant support from Boehringer Ingelheim, and holding a patent (EP3047033A1) on a method for assaying a protease; Dr. Belzile, receiving consulting fees from Pendopharm, Victhom, and Body-cad, lecture fees from Sanofi, Smith & Nephew, and Stryker, and grant support from the Canadian Institutes of Health Research and Ministère de la Santé et des Services Sociaux; Dr. Crowther, receiving grant support, consulting fees, and drugs supplied for a study from Bayer, advisory board fees from Octapharma, Shionogi, and Bristol-Myers Squibb/Pfizer, fees for preparation and presentation of educational materials from Pfizer, Alexion, and Boehringer Ingelheim, advisory board fees, fees for serving on a steering committee, and travel support from Portola, grant support from Leo Pharma, fees for providing expert testimony from McCarthy Tétrault, fees for serving on a data and safety monitoring board from Daiichi Sankyo, and owning stock in Alnylam; Dr. MacDonald, receiving grant support, consulting fees, and royalties from DePuy Synthes, and grant support from Smith & Nephew, Stryker, and Zimmer Biomet; Dr. Gofton, receiving fees for education courses from Zimmer Biomet and MicroPort and grant support from DePuy Synthes; Dr. Carrier, receiving grant support from Bristol-Myers Squibb, grant support and honoraria from Leo Pharma, and honoraria from Bayer, Pfizer, and Sanofi; Dr. Kovacs, receiving grant support and honoraria from Pfizer and Bayer and grant support from Daiichi Sankyo Pharma and Bristol-Myers Squibb; and Dr. Wells, receiving lecture fees and advisory fees from Bayer Healthcare and grant support from Bristol-Myers Squibb/Pfizer. No other potential conflict of interest relevant to this article was reported.
Publisher Copyright:
Copyright © 2018 Massachusetts Medical Society.
ASJC Scopus Subject Areas
- General Medicine