Rivaroxaban versus Enoxaparin for Thromboprophylaxis after Total Knee Arthroplasty
Open accessAbstract
BACKGROUND: We investigated the efficacy of rivaroxaban, an orally active direct factor Xa inhibitor, in preventing venous thrombosis after total knee arthroplasty. METHODS: In this randomized, double-blind trial, 2531 patients who were to undergo total knee arthroplasty received either oral rivaroxaban, 10 mg once daily, beginning 6 to 8 hours after surgery, or subcutaneous enoxaparin, 40 mg once daily, beginning 12 hours before surgery. The primary efficacy outcome was the composite of any deep-vein thrombosis, nonfatal pulmonary embolism, or death from any cause within 13 to 17 days after surgery. Secondary efficacy outcomes included major venous thromboembolism (i.e., proximal deep-vein thrombosis, nonfatal pulmonary embolism, or death related to venous thromboembolism) and symptomatic venous thromboembolism. The primary safety outcome was major bleeding. RESULTS: The primary efficacy outcome occurred in 79 of 824 patients (9.6%) who received rivaroxaban and in 166 of 878 (18.9%) who received enoxaparin (absolute risk reduction, 9.2%; 95% confidence interval [CI], 5.9 to 12.4; P<0.001). Major venous thromboembolism occurred in 9 of 908 patients (1.0%) given rivaroxaban and 24 of 925 (2.6%) given enoxaparin (absolute risk reduction, 1.6%; 95% CI, 0.4 to 2.8; P=0.01). Symptomatic events occurred less frequently with rivaroxaban than with enoxaparin (P=0.005). Major bleeding occurred in 0.6% of patients in the rivaroxaban group and 0.5% of patients in the enoxaparin group. The incidence of drug-related adverse events, mainly gastrointestinal, was 12.0% in the rivaroxaban group and 13.0% in the enoxaparin group. CONCLUSIONS: Rivaroxaban was superior to enoxaparin for thromboprophylaxis after total knee arthroplasty, with similar rates of bleeding. (ClinicalTrials.gov number, NCT00361894.)
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The investigation into the use of the lower doses of these 2 anticoagulants for secondary prevention was prompted by the desire to reduce the risk of bleeding, as well as the documented efficacy of the lower doses to prevent VTE after elective hip or knee arthroplasty.
“The investigation into the use of the lower doses of these 2 anticoagulants for secondary prevention was prompted by the desire to reduce the risk of bleeding, as well as the documented efficacy of the lower doses to prevent VTE after elective hip or knee arthroplasty. 317-321”
From American Society of Hematology 2020 guidelines for management of venous thromboembolism: treatment of deep vein thrombosis and pulmonary embolism (2020) · cites this paper as [319]
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- Authors
- Lassen, M. R., Ageno, W., Borris, L. C., Lieberman, J. R., Rosencher, N., Bandel, T. J., Misselwitz, F., & Turpie, A. G. G.
- Affiliations
- Nordsjællands Hospital (DK)
- University of Insubria (IT)
- Aarhus University Hospital (DK)
- UConn Health (US)
- Hôpital Cochin (FR)
- Bayer (Germany) (DE)
- McMaster University (CA)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2008-06-26
- Volume
- 358
- Issue
- 26
- Pages
- 2776-2786
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2036506340
- Cited by
- 1,295
- References
- 20
- Citations by year
- 2026: 11 · 2025: 22 · 2024: 20 · 2023: 20 · 2022: 30 · 2021: 37 · 2020: 35 · 2019: 45 · 2018: 50 · 2017: 59 · 2016: 81 · 2015: 82 · 2014: 105 · 2013: 150 · 2012: 152
- FWCI
- 73.34
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Institutional Research Information System (University of Udine) (submittedVersion)
- IrInSubria (University of Insubria) (submittedVersion)
- Lund University Publications (Lund University) (submittedVersion)
- INFM-OAR (INFN Catania) (submittedVersion, other-oa)
- Funders
- Sanofi
- Bayer HealthCare
- Topics
- Health Sciences › Medicine › Internal Medicine › Venous Thromboembolism Diagnosis and Management
- Health Sciences › Medicine › Hematology › Blood Coagulation and Thrombosis Mechanisms
- Health Sciences › Medicine › Surgery › Total Knee Arthroplasty Outcomes
- Keywords
- rivaroxaban, enoxaparin, thromboprophylaxis, total knee arthroplasty, venous thromboembolism, deep vein thrombosis, pulmonary embolism, factor Xa inhibitors, major bleeding, drug safety, gastrointestinal adverse effects, postoperative thromboprophylaxis
- MeSH terms
- Rivaroxaban, Adult, Aged, Aged, 80 and over, Anticoagulants, Double-Blind Method, Female, Humans, Male, Middle Aged, Morpholines, Pulmonary Embolism, Thiophenes, Enoxaparin, Arthroplasty, Replacement, Knee, Venous Thrombosis, Venous Thromboembolism, Factor Xa Inhibitors
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