title: 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.
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.
authors.affiliation: Hofstra North Shore-LIJ School of Medicine, Monter Cancer Center, Lake Success, NY, USA. MBarginear@nshs.edu
authors.forename: Myra F
authors.initials: MF
authors.lastname: Barginear
authors.forename: Richard J
authors.initials: RJ
authors.lastname: Gralla
authors.forename: Thomas P
authors.initials: TP
authors.lastname: Bradley
authors.forename: Syed S
authors.initials: SS
authors.lastname: Ali
authors.forename: Iuliana
authors.initials: I
authors.lastname: Shapira
authors.forename: Craig
authors.initials: C
authors.lastname: Greben
authors.forename: Nanette
authors.initials: N
authors.lastname: Nier-Shoulson
authors.forename: Meredith
authors.initials: M
authors.lastname: Akerman
authors.forename: Martin
authors.initials: M
authors.lastname: Lesser
authors.forename: Daniel R
authors.initials: DR
authors.lastname: Budman
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000009:adverse effects / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D000077425:Fondaparinux; D006470:Hemorrhage / Q000139:chemically induced / Q000453:epidemiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000150:complications / Q000473:pathology; D011134:Polysaccharides / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D012008:Recurrence; D015996:Survival Rate; D016896:Treatment Outcome; D016306:Vena Cava Filters / Q000009:adverse effects; D054556:Venous Thromboembolism / Q000473:pathology / Q000628:therapy*
chemical_list: D000925:Anticoagulants; D011134:Polysaccharides; D000077425:Fondaparinux