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Prevention of venous thromboembolism after major orthopaedic surgery: is fondaparinux an advance?

Third, the results for the clinically irrelevant surrogate endpoint (asymptomatic deep-vein thrombosis), emphasised in the reports of the trials and meta-analyses that "favour" fondaparinux, are highly dependent on both choice of drug regimens and timing of venograms.12,13 The risk of venous thrombo... Full description

Journal Title: The Lancet (British edition) 2003, Vol.362 (9383), p.504-505
Main Author: Lowe, Gordon DO
Other Authors: Sandercock, Peter AG , Rosendaal, Frits R
Format: Electronic Article Electronic Article
Language: English
Subjects:
Quelle: Alma/SFX Local Collection
Publisher: England: Elsevier Ltd
ID: ISSN: 0140-6736
Link: https://www.ncbi.nlm.nih.gov/pubmed/12932379
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title: Prevention of venous thromboembolism after major orthopaedic surgery: is fondaparinux an advance?
format: Article
creator:
  • Lowe, Gordon DO
  • Sandercock, Peter AG
  • Rosendaal, Frits R
subjects:
  • Abridged Index Medicus
  • Anticoagulants (Medicine)
  • Anticoagulants - therapeutic use
  • Arthroplasty, Replacement
  • Clinical outcomes
  • Clinical Trials as Topic - standards
  • Disease control
  • Dosage and administration
  • Drug therapy
  • Evaluation
  • Humans
  • Orthopedic Procedures
  • Orthopedics
  • Osteoarthritis, Hip - surgery
  • Osteoarthritis, Knee - surgery
  • Polysaccharides - therapeutic use
  • Postoperative Complications - prevention & control
  • Prevention
  • Research Design - standards
  • Risk factors
  • Surgery
  • Thromboembolism - prevention & control
  • Treatment Outcome
  • Venous thrombosis
  • Venous Thrombosis - prevention & control
ispartof: The Lancet (British edition), 2003, Vol.362 (9383), p.504-505
description: Third, the results for the clinically irrelevant surrogate endpoint (asymptomatic deep-vein thrombosis), emphasised in the reports of the trials and meta-analyses that "favour" fondaparinux, are highly dependent on both choice of drug regimens and timing of venograms.12,13 The risk of venous thromboembolism continues for 3 months after major orthopaedic surgery, and there is a "rebound" of venous thromboembolism incidence after discontinuation of thromboprophylaxis with heparins after 5-11 days. That this rebound also happens after discontinuation of fondaparinux was recently shown by Bengt Eriksson and colleagues14 in a further randomised controlled trial of extended-duration fondaparinux (19-23 days) compared with short-duration fondaparinux (6-8 days) in patients with hip fractures. In the group on the short-duration regimen the incidence of asymptomatic venous thrombosis at 3 weeks was 35%. Hence the efficacy of short-duration fondaparinux must be questioned. Whilst extended-duration fondaparinux appeared effective in reducing the risk of symptomatic venous thromboembolism at 3 weeks (0[middot]3% vs 2[middot]7%), this finding again was balanced by an increase in major bleeding compared with placebo (2[middot]5% vs 0[middot]6%).
language: eng
source: Alma/SFX Local Collection
identifier: ISSN: 0140-6736
fulltext: fulltext
issn:
  • 0140-6736
  • 1474-547X
url: Link


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descriptionThird, the results for the clinically irrelevant surrogate endpoint (asymptomatic deep-vein thrombosis), emphasised in the reports of the trials and meta-analyses that "favour" fondaparinux, are highly dependent on both choice of drug regimens and timing of venograms.12,13 The risk of venous thromboembolism continues for 3 months after major orthopaedic surgery, and there is a "rebound" of venous thromboembolism incidence after discontinuation of thromboprophylaxis with heparins after 5-11 days. That this rebound also happens after discontinuation of fondaparinux was recently shown by Bengt Eriksson and colleagues14 in a further randomised controlled trial of extended-duration fondaparinux (19-23 days) compared with short-duration fondaparinux (6-8 days) in patients with hip fractures. In the group on the short-duration regimen the incidence of asymptomatic venous thrombosis at 3 weeks was 35%. Hence the efficacy of short-duration fondaparinux must be questioned. Whilst extended-duration fondaparinux appeared effective in reducing the risk of symptomatic venous thromboembolism at 3 weeks (0[middot]3% vs 2[middot]7%), this finding again was balanced by an increase in major bleeding compared with placebo (2[middot]5% vs 0[middot]6%).
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subjectAbridged Index Medicus ; Anticoagulants (Medicine) ; Anticoagulants - therapeutic use ; Arthroplasty, Replacement ; Clinical outcomes ; Clinical Trials as Topic - standards ; Disease control ; Dosage and administration ; Drug therapy ; Evaluation ; Humans ; Orthopedic Procedures ; Orthopedics ; Osteoarthritis, Hip - surgery ; Osteoarthritis, Knee - surgery ; Polysaccharides - therapeutic use ; Postoperative Complications - prevention & control ; Prevention ; Research Design - standards ; Risk factors ; Surgery ; Thromboembolism - prevention & control ; Treatment Outcome ; Venous thrombosis ; Venous Thrombosis - prevention & control
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descriptionThird, the results for the clinically irrelevant surrogate endpoint (asymptomatic deep-vein thrombosis), emphasised in the reports of the trials and meta-analyses that "favour" fondaparinux, are highly dependent on both choice of drug regimens and timing of venograms.12,13 The risk of venous thromboembolism continues for 3 months after major orthopaedic surgery, and there is a "rebound" of venous thromboembolism incidence after discontinuation of thromboprophylaxis with heparins after 5-11 days. That this rebound also happens after discontinuation of fondaparinux was recently shown by Bengt Eriksson and colleagues14 in a further randomised controlled trial of extended-duration fondaparinux (19-23 days) compared with short-duration fondaparinux (6-8 days) in patients with hip fractures. In the group on the short-duration regimen the incidence of asymptomatic venous thrombosis at 3 weeks was 35%. Hence the efficacy of short-duration fondaparinux must be questioned. Whilst extended-duration fondaparinux appeared effective in reducing the risk of symptomatic venous thromboembolism at 3 weeks (0[middot]3% vs 2[middot]7%), this finding again was balanced by an increase in major bleeding compared with placebo (2[middot]5% vs 0[middot]6%).
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4Clinical outcomes
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abstractThird, the results for the clinically irrelevant surrogate endpoint (asymptomatic deep-vein thrombosis), emphasised in the reports of the trials and meta-analyses that "favour" fondaparinux, are highly dependent on both choice of drug regimens and timing of venograms.12,13 The risk of venous thromboembolism continues for 3 months after major orthopaedic surgery, and there is a "rebound" of venous thromboembolism incidence after discontinuation of thromboprophylaxis with heparins after 5-11 days. That this rebound also happens after discontinuation of fondaparinux was recently shown by Bengt Eriksson and colleagues14 in a further randomised controlled trial of extended-duration fondaparinux (19-23 days) compared with short-duration fondaparinux (6-8 days) in patients with hip fractures. In the group on the short-duration regimen the incidence of asymptomatic venous thrombosis at 3 weeks was 35%. Hence the efficacy of short-duration fondaparinux must be questioned. Whilst extended-duration fondaparinux appeared effective in reducing the risk of symptomatic venous thromboembolism at 3 weeks (0[middot]3% vs 2[middot]7%), this finding again was balanced by an increase in major bleeding compared with placebo (2[middot]5% vs 0[middot]6%).
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pubElsevier Ltd
pmid12932379
doi10.1016/S0140-6736(03)14149-9