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Thromb Haemost 2010; 104(01): 86-91
DOI: 10.1160/TH09-12-0870
Blood Coagulation, Fibrinolysis and Cellular Haemostasis
Schattauer GmbH

Idraparinux versus standard therapy in the treatment of deep venous thrombosis in cancer patients: A subgroup analysis of the Van Gogh DVT trial

Frederiek F. van Doormaal
1   The Department of Vascular Medicine, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands
,
Alexander T. Cohen
2   King's College Hospital, London, UK
,
Bruce L. Davidson
3   Division of Pulmonary and Critical Care Medicine, University of Washington School of Medicine, Seattle, Washington, USA
,
Herve Decousus
4   Université Saint-Etienne, Centre Hospitalier Universitaire de Saint-Etienne, Hôpital Bellevue, Service de Médecine Interne et Thérapeutique, Saint-Etienne, France
,
Alexander S. Gallus
5   SA Pathology at Flinders Medical Centre, and Flinders University, Bedford Park, South Australia, Australia
,
Michael Gent
6   Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada
,
Franco Piovella
7   Angiologia – Malattie Tromboemboliche, Fondazione I.R.C.C.S., Policlinico San Matteo, Pavia, Italy
,
Martin H. Prins
8   Department of Epidemiology, Care and Public Health Research Institute, University of Maastricht, and Department of Clinical Epidemiology and Medical Technology Assessment, Academic Hospital, Maastricht, the Netherlands
,
Gary E. Raskob
9   College of Public Health, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, USA
,
Harry R. Büller
1   The Department of Vascular Medicine, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands
› Author Affiliations Financial support: The original trial was sponsored by sanofi-aventis (Paris, France).
Further Information

Publication History

Received: 27 December 2009

Accepted after major revision: 26 February 2010

Publication Date:
23 November 2017 (online)

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Summary

Standard treatment with heparin followed by vitamin K antagonists is frequently complicated by bleeding and recurrent venous thromboembolism (VTE) in cancer patients with VTE. To compare the efficacy, safety and overall survival of long-term idraparinux treatment to standard therapy in cancer patients we conducted a post-hoc analysis in the subgroup of non-active and active cancer patients included in the Van Gogh DVT clinical trial. The cancer patients with deep venous thrombosis (DVT) and without pulmonary embolism (PE) were randomised to standard treatment or a once-weekly subcutaneous injection of idraparinux (2.5 mg), a synthetic pentasaccharide. 421 cancer patients were included. A total of 220 patients received idraparinux and 201 were allocated to standard therapy for three months (8%) or six months (92%). A recurrent VTE was observed during the first six months in 2.5% (n=5) of the idraparinux recipients compared to 6.4% (n=12) in the standard therapy group (hazard ratio 0.39, 95% confidence interval [CI]; 0.14–1.11). The rate of bleeding was comparable (odds ratio 0.89, 95% CI; 0.50–1.59). The outcomes were similar at three months after randomisation in all patients. Of the idraparinux recipients, 22.7% (n=50) died during the study period compared to 48 patients (23.9%) in the standard treatment group (hazard ratio 0.99, 95% CI; 0.66–1.48). In conclusion, no significant safety or survival differences were observed between cancer patients with DVT treated with idraparinux for six months compared to standard therapy. Fewer recurrent VTEs were observed in the idraparinux group; however, this was not statistically significant and also because of study limitations this should be interpreted with caution.

Keywords

Anticoagulation - cancer - idraparinux - deep venous thrombosis
 

  • References

  • 1 Heit JA, Silverstein MD, Mohr DN. et al. Risk factors for deep vein thrombosis and pulmonary embolism: a population-based case-control study. Arch Intern Med 2000; 160: 809-815.
    CrossrefPubMedGoogle Scholar
  • 2 Prandoni P, Lensing AW, Piccioli A. et al. Recurrent venous thromboembolism and bleeding complications during anticoagulant treatment in patients with cancer and venous thrombosis. Blood 2002; 100: 3484-3488.
    CrossrefPubMedGoogle Scholar
  • 3 Hutten BA, Prins MH, Gent M. et al. Incidence of recurrent thromboembolic and bleeding complications among patients with venous thromboembolism in relation to both malignancy and achieved international normalized ratio: a retrospective analysis. J Clin Oncol 2000; 18: 3078-3083.
    CrossrefPubMedGoogle Scholar
  • 4 Geerts WH, Bergqvist D, Pineo GF. et al. Prevention of venous thromboembolism: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest 2008; 133 (Suppl. 06) 381S-453S.
    CrossrefPubMedGoogle Scholar
  • 5 Lee AY, Levine MN, Baker I R. et al. Low-molecular-weight heparin versus a coumarin for the prevention of recurrent venous thromboembolism in patients with cancer. N Engl J Med 2003; 349: 146-153.
    CrossrefPubMedGoogle Scholar
  • 6 Hull RD, Pineo GF, Brant RF. et al. Long-term low-molecular-weight heparin versus usual care in proximal-vein thrombosis patients with cancer. Am J Med 2006; 119: 1062-1072.
    CrossrefPubMedGoogle Scholar
  • 7 Deitcher SR, Kessler CM, Merli G. et al. Secondary prevention of venous thromboembolic events in patients with active cancer: enoxaparin alone versus initial enoxaparin followed by warfarin for a 180-day period. Clin Appl Thromb Hemost 2006; 12: 389-396.
    CrossrefPubMedGoogle Scholar
  • 8 Meyer G, Marjanovic Z, Valcke J. et al. Comparison of low-molecular-weight heparin and warfarin for the secondary prevention of venous thromboembolism in patients with cancer: a randomized controlled study. Arch Intern Med 2002; 162: 1729-1735.
    CrossrefPubMedGoogle Scholar
  • 9 Akl EA, Barba M, Rohilla S. et al. Anticoagulation for the long term treatment of venous thromboembolism in patients with cancer. Cochrane Database Syst Rev 2008: CD006650.
    Google Scholar
  • 10 Lee AY, Rickles FR, Julian JA. et al. Randomized comparison of low molecular weight heparin and coumarin derivatives on the survival of patients with cancer and venous thromboembolism. J Clin Oncol 2005; 23: 2123-2129.
    CrossrefPubMedGoogle Scholar
  • 11 Akl EA, van Doormaal FF, Barba M. et al. Parenteral anticoagulation for prolonging survival in patients with cancer who have no other indication for anticoagulation. Cochrane Database Syst Rev 2007: CD006652.
    Google Scholar
  • 12 Buller HR, van Doormaal FF, van Sluis GL. et al. Cancer and thrombosis: from molecular mechanisms to clinical presentations. J Thromb Haemost 2007; 05 (Suppl. 01) 246-254.
    CrossrefPubMedGoogle Scholar
  • 13 van Doormaal FF, Raskob GE, Davidson BL. et al. Treatment of venous thromboembolism in patients with cancer: Subgroup analysis of the Matisse clinical trials. Thromb Haemost 2009; 101: 762-769.
    Article in Thieme ConnectPubMedGoogle Scholar
  • 14 Buller HR, Cohen AT, Davidson B. et al. Idraparinux versus standard therapy for venous thromboembolic disease. N Engl J Med 2007; 357: 1094-1104.
    CrossrefPubMedGoogle Scholar
  • 15 Veeger NJ, Piersma-Wichers M, Tijssen JG. et al. Individual time within target range in patients treated with vitamin K antagonists: main determinant of quality of anticoagulation and predictor of clinical outcome. A retrospective study of 2300 consecutive patients with venous thromboembolism. Br J Haematol 2005; 128: 513-519.
    CrossrefPubMedGoogle Scholar