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Rivaroxaban versus ...
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Lassen, Michael RNordsjællands Hospital
(author)
Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty
- Article/chapterEnglish2008
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LIBRIS-ID:oai:lup.lub.lu.se:d8184a98-8c7f-41d6-a80e-4a39b20d9587
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https://lup.lub.lu.se/record/d8184a98-8c7f-41d6-a80e-4a39b20d9587URI
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https://doi.org/10.1056/NEJMoa076016DOI
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Language:English
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Summary in:English
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Subject category:art swepub-publicationtype
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Subject category:ref swepub-contenttype
Notes
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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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Ageno, WalterUniversity of Insubria
(author)
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Borris, Lars CAarhus University Hospital
(author)
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Lieberman, Jay RUniversity of Connecticut
(author)
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Rosencher, NadiaCochin Hospital
(author)
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Bandel, Tiemo JBayer Corporation, USA
(author)
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Misselwitz, FrankBayer Corporation, USA
(author)
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Turpie, Alexander G GMcMaster University
(author)
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Levine, M
(creator_code:cre_t)
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Flondell, M.Lund University,Lunds universitet,Medicinska fakulteten,Faculty of Medicine(Swepub:lu)med-mfd
(creator_code:cre_t)
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Wykman, A
(creator_code:cre_t)
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Nordsjællands HospitalUniversity of Insubria
(creator_code:org_t)
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RECORD3 Investigators
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In:The New England journal of medicine358:26, s. 86-27760028-4793
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Lassen, Michael ...
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Ageno, Walter
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Borris, Lars C
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Lieberman, Jay R
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Rosencher, Nadia
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Bandel, Tiemo J
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Misselwitz, Fran ...
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Turpie, Alexande ...
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Levine, M
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Flondell, M.
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Wykman, A
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