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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

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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.

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Acknowledgment

This study is supported in part by a grant from GlaxoSmithKline.

Conflict of interest

There are no financial disclosures from any authors

Author information

Authors and Affiliations

  1. Hofstra North Shore–LIJ School of Medicine, Monter Cancer Center, Lake Success, NY, USA

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

  2. Feinstein Institute for Medical Research, Manhasset, NY, USA

    Meredith Akerman & Martin Lesser

Authors
  1. Myra F. Barginear
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  2. Richard J. Gralla
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  3. Thomas P. Bradley
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  4. Syed S. Ali
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  5. Iuliana Shapira
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  6. Craig Greben
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  7. Nanette Nier-Shoulson
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  8. Meredith Akerman
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  9. Martin Lesser
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  10. Daniel R. Budman
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Corresponding author

Correspondence to Myra F. Barginear.

Appendix 1

Appendix 1

Table 5 Adapted from Common Terminology Criteria for Adverse Events (CTCAE), version 3.0
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Barginear, M.F., Gralla, R.J., Bradley, T.P. et al. 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. Support Care Cancer 20, 2865–2872 (2012). https://doi.org/10.1007/s00520-012-1413-z

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  • DOI: https://doi.org/10.1007/s00520-012-1413-z

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