Investigating the benefit of adding a vena cava filter to anticoagulation with fondaparinux sodium in patients with cancer and venous thromboembolism in a prospective randomized clinical trial

Myra F. Barginear, Richard J. Gralla, Thomas P. Bradley, Syed S. Ali, Iuliana Shapira, Craig Greben, Nanette Nier-Shoulson, Meredith Akerman, Martin Lesser, Daniel R. Budman

Research output: Contribution to journalArticle

45 Scopus citations

Abstract

Background The benefit of adding a vena cava filter to anticoagulation in treating cancer patients with venous thromboembolism remains controversial. We initiated this study as the first prospectively randomized trial to evaluate the addition of a vena cava filter placement to anticoagulation with the factor Xa inhibitor fondaparinux sodium in patients with cancer. Methods Sixty-four patients with deep vein thrombosis (86%) and/or pulmonary embolism (55%) were randomly assigned to receive anticoagulation with fondaparinux sodium with or without a vena cava filter. Endpoints included rates of complications by treatment arm, recurrent thromboembolism, complete resolution of thromboembolism, and survival rates. Results No patient had a recurrent deep vein thrombosis; two (3%) patients had new pulmonary emboli, one in each randomized cohort. Major bleeding occurred in three patients (5%). Two patients on the vena cava filter arm (7%) had complications from the filter. Median survivals were 493 days in the anticoagulation only arm and 266 days for anticoagulation+ vena cava filter (p<0.57). Complete resolution of venous thromboembolism occurred in 51% of patients within 8 weeks of initiating anticoagulation. Conclusions No advantage was found for placement of a vena cava filter in addition to anticoagulation with fondaparinux sodium in terms of safety, recurrent thrombosis, recurrent pulmonary embolism, or survival in this prospective randomized trial evaluating anticoagulation plus a vena cava filter in cancer patients. Favorable complete resolution rates of thrombosis were observed on both study arms.

Original languageEnglish (US)
Pages (from-to)2865-2872
Number of pages8
JournalSupportive Care in Cancer
Volume20
Issue number11
DOIs
StatePublished - Nov 1 2012

Keywords

  • Fondaparinux sodium
  • Vena cava filter
  • Venous Thromboembolism

ASJC Scopus subject areas

  • Oncology

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    Barginear, M. F., Gralla, R. J., Bradley, T. P., Ali, S. S., Shapira, I., Greben, C., Nier-Shoulson, N., Akerman, M., Lesser, M., & Budman, D. R. (2012). Investigating the benefit of adding a vena cava filter to anticoagulation with fondaparinux sodium in patients with cancer and venous thromboembolism in a prospective randomized clinical trial. Supportive Care in Cancer, 20(11), 2865-2872. https://doi.org/10.1007/s00520-012-1413-z