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

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.