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)

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.

 
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