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

42 Citations (Scopus)

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 2012
Externally publishedYes

Fingerprint

Vena Cava Filters
Venous Thromboembolism
Randomized Controlled Trials
Neoplasms
Thromboembolism
Pulmonary Embolism
Venous Thrombosis
Thrombosis
fondaparinux
Survival
Embolism
Survival Rate
Hemorrhage
Safety
Lung

Keywords

  • Fondaparinux sodium
  • Vena cava filter
  • Venous Thromboembolism

ASJC Scopus subject areas

  • Oncology

Cite this

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

In: Supportive Care in Cancer, Vol. 20, No. 11, 11.2012, p. 2865-2872.

Research output: Contribution to journalArticle

Barginear, Myra F. ; Gralla, Richard J. ; Bradley, Thomas P. ; Ali, Syed S. ; Shapira, Iuliana ; Greben, Craig ; Nier-Shoulson, Nanette ; Akerman, Meredith ; Lesser, Martin ; Budman, Daniel R. / 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. In: Supportive Care in Cancer. 2012 ; Vol. 20, No. 11. pp. 2865-2872.
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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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AU - Barginear, Myra F.

AU - Gralla, Richard J.

AU - Bradley, Thomas P.

AU - Ali, Syed S.

AU - Shapira, Iuliana

AU - Greben, Craig

AU - Nier-Shoulson, Nanette

AU - Akerman, Meredith

AU - Lesser, Martin

AU - Budman, Daniel R.

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N2 - 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.

AB - 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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