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; Alexander T. Cohen; Bruce L. Davidson; Herve Decousus; Alexander S. Gallus; Michael Gent; Franco Piovella; Martin H. Prins; Gary E. Raskob; Harry R. Büller

doi:10.1160/TH09-12-0870

Thrombosis and Haemostasis, Inhaltsverzeichnis

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

¹The Department of Vascular Medicine, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands

,

Alexander T. Cohen

²King's College Hospital, London, UK

,

Bruce L. Davidson

³Division of Pulmonary and Critical Care Medicine, University of Washington School of Medicine, Seattle, Washington, USA

,

Herve Decousus

⁴Université Saint-Etienne, Centre Hospitalier Universitaire de Saint-Etienne, Hôpital Bellevue, Service de Médecine Interne et Thérapeutique, Saint-Etienne, France

,

Alexander S. Gallus

⁵SA Pathology at Flinders Medical Centre, and Flinders University, Bedford Park, South Australia, Australia

,

Michael Gent

⁶Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada

,

Franco Piovella

⁷Angiologia – Malattie Tromboemboliche, Fondazione I.R.C.C.S., Policlinico San Matteo, Pavia, Italy

,

Martin H. Prins

⁸Department 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

⁹College of Public Health, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, USA

,

Harry R. Büller

¹The Department of Vascular Medicine, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands

› Institutsangaben

Abstract

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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

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Referenzen

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