Resolution of venous thrombo-emboli (VTE) with a factor Xa inhibitor: Initial safety and efficacy results of a randomized, phase III trial of anticoagulation plus inferior vena cava (IVC) filter versus anticoagulation alone in patients with cancer and VTE

20544 Background: Cancer-associated thrombosis is a major cause of death in patients (pts) with cancer. The 1-year survival in pts with cancer with VTE is 12% (vs. 36% without VTE). More than 20% of pts have VTE propagation and re-thrombosis on standard therapeutic anticoagulation (AC) (Prandoni 2007). The role of IVC filters in terms of efficacy, safety, prevention of pulmonary embolism (PE), and impact on survival remains controversial. Resolution of DVT takes an average of 6 months in non-cancer pts (Asbeutah 2004) and thrombi remain detectable in half of pts after a year (Kearon 2004). Methods: Pts with malignancy were eligible if they had an acute VTE (DVT and/or PE), and were randomized to standard fondaparinux sodium (FS) alone [5mg SC for pts 100 kg] vs FS+IVC filter. A total of 106 pts are planned. The primary endpoint is survival without recurrent VTE. Secondary endpoints include safety and clot resolution, given in this report. Due to safe...