Document Detail

Postoperative fondaparinux versus preoperative enoxaparin for prevention of venous thromboembolism in elective hip-replacement surgery: a randomised double-blind comparison.
MedLine Citation:
PMID:  12049858     Owner:  NLM     Status:  MEDLINE    
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.
Michael Rud Lassen; Kenneth A Bauer; Bengt I Eriksson; Alexander G G Turpie;
Related Documents :
8835758 - Veno-occlusive disease (vod) of the liver in korean patients following allogeneic bone ...
16856928 - Abdominal vein thrombosis in essential thrombocythemia: prevalence, clinical correlates...
19630818 - What happens after venous thromboembolism?
19524938 - Topical heparin: a promising agent for the prevention of tracheal stenosis in airway su...
3767138 - Role of preoperative hemodynamic monitoring in intraoperative fluid management.
11352248 - Etanercept combined with conventional treatment in wegener's granulomatosis: a six-mont...
Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Lancet     Volume:  359     ISSN:  0140-6736     ISO Abbreviation:  Lancet     Publication Date:  2002 May 
Date Detail:
Created Date:  2002-06-06     Completed Date:  2002-06-18     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  2985213R     Medline TA:  Lancet     Country:  England    
Other Details:
Languages:  eng     Pagination:  1715-20     Citation Subset:  AIM; IM    
Department of Orthopaedics, University Hospital of Copenhagen Hillerød, DK-3400, Hillerød, Denmark.
Export Citation:
APA/MLA Format     Download EndNote     Download BibTex
MeSH Terms
Aged, 80 and over
Arthroplasty, Replacement, Hip*
Double-Blind Method
Enoxaparin / administration & dosage,  therapeutic use*
Fibrinolytic Agents / administration & dosage,  therapeutic use*
Hospital Mortality
Middle Aged
Polysaccharides / administration & dosage,  therapeutic use*
Postoperative Care
Postoperative Complications / prevention & control*
Preoperative Care
Venous Thrombosis / prevention & control*
Reg. No./Substance:
0/Enoxaparin; 0/Fibrinolytic Agents; 0/Polysaccharides; 0/fondaparinux
Comment In:
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

Previous Document:  Calcium supplementation during lactation blunts erythrocyte lead levels and delta-aminolevulinic aci...
Next Document:  Postoperative fondaparinux versus postoperative enoxaparin for prevention of venous thromboembolism ...