Is there an advantage to adding inferior vena cava filter (IVCF) placement to anticoagulation with fondaparinux in patients with cancer and venous thromboemboli (VTE): Results of the Cancer and Thrombosis (CAT) prospective randomized clinical trial (RCT).

9063 Background: The efficacy and safety of IVCF addition to parenteral anticoagulation (AC) in treating cancer patients with VTE remains controversial and no RCTs have been conducted in this population. We initiated this prospective RCT to determine if the addition of IVCF placement is advantageous in cancer patients. Methods: 64 patients with a DVT (86%) and/or PE (55%) were randomly assigned (1:1) to receive AC with fondaparinux sodium (FS) [5mg, 7.5mg or 10mg] with or without an IVCF. Endpoints included: rates of complications by treatment arm; recurrent or residual DVTs or PEs on days 14, 30, and 56; and survival rates. Results: 64 patients were randomized and 63 evaluated. Cancer types included: lung (25%); breast (18%), colon (14%), pancreas (14%), lymphoma (8%), ovarian (6%), and 15% with other cancers. ECOG performance status: 0 or 1 in 44%; 2 in 47%; and 3 in 9%. 8 patients (12.5%) had stable brain metastases. Findings included: no patient had a recurrent DVT; 2 (3%) patients had new PEs (one in...