Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty

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MARC

Lassen, Michael RNordsjællands Hospital (author)

Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty

Article/chapterEnglish2008

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2008

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LIBRIS-ID:oai:lup.lub.lu.se:d8184a98-8c7f-41d6-a80e-4a39b20d9587
https://lup.lub.lu.se/record/d8184a98-8c7f-41d6-a80e-4a39b20d9587URI
https://doi.org/10.1056/NEJMoa076016DOI

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Language:English
Summary in:English

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SwePubSwePub

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Subject category:art swepub-publicationtype
Subject category:ref swepub-contenttype

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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.)

Subject headings and genre

MEDICIN OCH HÄLSOVETENSKAP Klinisk medicin Kardiologi hsv//swe
MEDICAL AND HEALTH SCIENCES Clinical Medicine Cardiac and Cardiovascular Systems hsv//eng
MEDICIN OCH HÄLSOVETENSKAP Klinisk medicin Kirurgi hsv//swe
MEDICAL AND HEALTH SCIENCES Clinical Medicine Surgery hsv//eng
Adult
Aged
Aged, 80 and over
Anticoagulants/adverse effects
Arthroplasty, Replacement, Knee
Double-Blind Method
Enoxaparin/adverse effects
Factor Xa Inhibitors
Female
Humans
Male
Middle Aged
Morpholines/adverse effects
Pulmonary Embolism/epidemiology
Rivaroxaban
Thiophenes/adverse effects
Venous Thromboembolism/epidemiology
Venous Thrombosis/epidemiology

Added entries (persons, corporate bodies, meetings, titles ...)

Ageno, WalterUniversity of Insubria (author)
Borris, Lars CAarhus University Hospital (author)
Lieberman, Jay RUniversity of Connecticut (author)
Rosencher, NadiaCochin Hospital (author)
Bandel, Tiemo JBayer Corporation, USA (author)
Misselwitz, FrankBayer Corporation, USA (author)
Turpie, Alexander G GMcMaster University (author)
Levine, M (creator_code:cre_t)
Flondell, M.Lund University,Lunds universitet,Medicinska fakulteten,Faculty of Medicine(Swepub:lu)med-mfd (creator_code:cre_t)
Wykman, A (creator_code:cre_t)
Nordsjællands HospitalUniversity of Insubria (creator_code:org_t)
RECORD3 Investigators

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In:The New England journal of medicine358:26, s. 86-27760028-4793

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MEDICAL AND HEALTH SCIENCES: MEDICAL AND HEAL ...; and Clinical Medicin ...; and Cardiac and Card ...

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