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.
RCT Entities:
BACKGROUND: The benefit of adding a vena cava filter to anticoagulation in treating cancerpatients 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 cancerpatients. Favorable complete resolution rates of thrombosis were observed on both study arms.
Authors: H Decousus; A Leizorovicz; F Parent; Y Page; B Tardy; P Girard; S Laporte; R Faivre; B Charbonnier; F G Barral; Y Huet; G Simonneau Journal: N Engl J Med Date: 1998-02-12 Impact factor: 91.245
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Authors: H R Büller; B L Davidson; H Decousus; A Gallus; M Gent; F Piovella; M H Prins; G Raskob; A E M van den Berg-Segers; R Cariou; O Leeuwenkamp; A W A Lensing Journal: N Engl J Med Date: 2003-10-30 Impact factor: 91.245
Authors: Behnood Bikdeli; Yun Wang; Karl E Minges; Nihar R Desai; Nancy Kim; Mayur M Desai; John A Spertus; Frederick A Masoudi; Brahmajee K Nallamothu; Samuel Z Goldhaber; Harlan M Krumholz Journal: J Am Coll Cardiol Date: 2016-03-08 Impact factor: 24.094
Authors: Catherine Coombs; Deborah Kuk; Sean Devlin; Robert H Siegelbaum; Jeremy C Durack; Rekha Parameswaran; Simon Mantha; Kathy Deng; Gerald Soff Journal: J Thromb Thrombolysis Date: 2017-11 Impact factor: 2.300
Authors: Samyuktha Balabhadra; Joshua D Kuban; Stephen Lee; Steven Yevich; Zeyad Metwalli; Colin J McCarthy; Steven Y Huang; Alda Tam; Sanjay Gupta; Sunil A Sheth; Rahul A Sheth Journal: JAMA Netw Open Date: 2020-07-01