Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty
- PMID: 18579812
- DOI: 10.1056/NEJMoa076016
Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty
Abstract
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.)
2008 Massachusetts Medical Society
Comment in
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New anticoagulants--the path from discovery to clinical practice.N Engl J Med. 2008 Jun 26;358(26):2827-9. doi: 10.1056/NEJMe0804291. N Engl J Med. 2008. PMID: 18579818 No abstract available.
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Thromboprophylaxis with rivaroxaban or enoxaparin did not differ for major bleeding in knee arthroplasty.ACP J Club. 2008 Nov-Dec;149(4):6-7. ACP J Club. 2008. PMID: 18937385 No abstract available.
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Rivaroxaban for thromboprophylaxis.N Engl J Med. 2008 Nov 13;359(20):2174; author reply 2175-6. doi: 10.1056/NEJMc081524. N Engl J Med. 2008. PMID: 19005203 No abstract available.
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Rivaroxaban for thromboprophylaxis.N Engl J Med. 2008 Nov 13;359(20):2174; author reply 2175-6. N Engl J Med. 2008. PMID: 19009674 No abstract available.
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Rivaroxaban for thromboprophylaxis.N Engl J Med. 2008 Nov 13;359(20):2174; author reply 2175-6. N Engl J Med. 2008. PMID: 19009675 No abstract available.
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