| Postoperative fondaparinux versus preoperative enoxaparin for prevention of venous thromboembolism in elective hip-replacement surgery: a randomised double-blind comparison. | |
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MedLine Citation:
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PMID: 12049858 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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BACKGROUND: Despite use of thromboprophylaxis, elective hip-replacement surgery carries a high risk of venous thromboembolic complications. We aimed to assess the ability of the pentasaccharide fondaparinux, the first of a new class of synthetic antithrombotic agents, to further reduce this risk. METHODS: In a double-blind study, we randomly assigned 2309 consecutive patients aged 18 years or older who were undergoing elective hip-replacement surgery to once daily, subcutaneous injections of either 2.5 mg fondaparinux, starting postoperatively, or 40 mg enoxaparin, starting preoperatively. The primary efficacy outcome was venous thromboembolism up to day 11, defined as deep-vein thrombosis detected by mandatory bilateral venography, documented symptomatic deep-vein thrombosis, or documented symptomatic pulmonary embolism. The main safety outcomes were bleeding and death. The duration of follow-up was 6 weeks. Analysis was per protocol. FINDINGS: We assessed the primary efficacy outcome in 1827 (79%) of 2309 patients. By day 11, venous thromboembolisms were recorded in 37 (4%) of 908 patients assigned to fondaparinux and in 85 (9%) of 919 assigned to enoxaparin (difference -5.2% [95% CI -8.1 to -2.7], p<0.0001). The relative reduction in risk was 55.9% (95% CI 33.1-72.8). The two groups did not differ in frequency of death or clinically relevant bleeding. INTERPRETATION: Drugs that act through specific inhibition of factor Xa, such as fondaparinux, could be more effective than low molecular weight heparins in prevention of venous thromboembolism in patients undergoing hip-replacement surgery. |
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Authors:
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Michael Rud Lassen; Kenneth A Bauer; Bengt I Eriksson; Alexander G G Turpie; |
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Publication Detail:
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Type: Clinical Trial; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: Lancet Volume: 359 ISSN: 0140-6736 ISO Abbreviation: Lancet Publication Date: 2002 May |
Date Detail:
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Created Date: 2002-06-06 Completed Date: 2002-06-18 Revised Date: 2006-11-15 |
Medline Journal Info:
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Nlm Unique ID: 2985213R Medline TA: Lancet Country: England |
Other Details:
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Languages: eng Pagination: 1715-20 Citation Subset: AIM; IM |
Affiliation:
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Department of Orthopaedics, University Hospital of Copenhagen Hillerød, DK-3400, Hillerød, Denmark. mirula@fa.dk |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adult Aged Aged, 80 and over Arthroplasty, Replacement, Hip* Double-Blind Method Enoxaparin / administration & dosage, therapeutic use* Female Fibrinolytic Agents / administration & dosage, therapeutic use* Hospital Mortality Humans Male Middle Aged Polysaccharides / administration & dosage, therapeutic use* Postoperative Care Postoperative Complications / prevention & control* Preoperative Care Venous Thrombosis / prevention & control* |
| Chemical | |
Reg. No./Substance:
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0/Enoxaparin; 0/Fibrinolytic Agents; 0/Polysaccharides; 0/fondaparinux |
| Comments/Corrections | |
Comment In:
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Lancet. 2002 May 18;359(9319):1710-1
[PMID:
12049854
]
Lancet. 2002 Nov 16;360(9345):1604-5; author reply 1605 [PMID: 12443628 ] Lancet. 2002 Nov 16;360(9345):1604; author reply 1605 [PMID: 12443627 ] Lancet. 2002 Nov 16;360(9345):1603-4; author reply 1605 [PMID: 12443626 ] |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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