Originally published as JCO Early Release 10.1200/JCO.2005.06.084 on March 14 2005

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Enoxaparin for the Prevention of Venous Thromboembolism Associated With Central Vein Catheter: A Double-Blind, Placebo-Controlled, Randomized Study in Cancer Patients

From the Sezione di Medicina Interna e Cardiovascolare, Dipartimento di Medicina Interna; Sezione di Anestesia, Analgesia e Terapia Intensiva, Dipartimento di Medicina Clinica e Sperimentale; and Istituto di Radiologia Diagnostica ed Interventistica, Università di Perugia, Perugia; Unità Operativa di Chirurgia Gastroenterologica, Dipartimento di Oncologia, and Dipartimento di Chirurgia, Istituto Nazionale per la Ricerca sul Cancro, Genua; Dipartimento di Medicina Clinica, Universita' dell'Insubria, Varese; Ospedale Evangelico Valdese, Turin; Divisione di Medicina, Ospedale di Gubbio, Gubbio; Unità di Patologia Vascolare e della Coagulazione, Azienda Ospedaliera di Parma, Parma; Unità Organica di Oncologia Medica e Sperimentale, Bari; Istituto Clinico Humanitas Rozzano, Milan; III° Unità Operativa di Medicina Interna e Oncoematologia, Ospedale di Piacenza, Piacenza; and Unità Operativa di Oncologia, Ospedale di Camposampiero, Padua, Italy

Address reprint requests to Melina Verso, MD, Sezione di Medicina Interna e Cardiovascolare, Dipartimento di Medicina Interna, Università di Perugia, Via Enrico dal Pozzo, 06123 Perugia, Italy; e-mail: agnellig{at}unipg.it

PURPOSE: The extent of venous thromboembolism (VTE) associated with central vein catheters (CVC) in cancer patients remains unclear. The aim of this study was to evaluate the efficacy and safety of the low molecular weight heparin, enoxaparin, in the prevention of VTE.

PATIENTS AND METHODS: In a multicenter, double-blind study, consecutive cancer patients scheduled for CVC insertion were randomly assigned to receive either subcutaneous enoxaparin 40 mg once a day or placebo. Treatment was started 2 hours before CVC insertion and continued for 6 weeks. The primary end points of the study were deep vein thrombosis (DVT), confirmed by venography of the CVC limb performed 6 weeks after randomization, or clinically overt pulmonary embolism, confirmed by objective testing during the study drug administration. Patients were assessed for bleeding complications.

RESULTS: Three hundred eighty-five patients were randomized, of which 321 (83.4%) underwent venography. A venography was adequate for adjudication in 155 patients in each treatment group. A DVT was observed in 22 patients (14.1%) treated with enoxaparin and in 28 patients (18.0%) treated with placebo, corresponding to a relative risk of 0.78 (95% CI, 0.47 to 1.31). No major bleeding occurred. Five patients (2.6%) in the enoxaparin group and two patients (1.0%) in the placebo group died during the treatment period.

CONCLUSION: In this study, no difference in the rate of CVC-related VTE was detected between patients receiving enoxaparin and patients receiving placebo. The dose of enoxaparin used in this study proved to be safe. Clinical trials evaluating higher enoxaparin doses could optimize the efficacy of this agent for this indication.

Supported by a grant-in-aid from Aventis, Bridgewater, NJ. This study was an investigator-initiated study.

Authors' disclosures of potential conflicts of interest are found at the end of this article.

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