Based on the clinical trial data, the investigators concluded that Angiotech’s 5-Fluorouracil-coated (5-FU) Central Venous Catheter (CVC) met the primary endpoint of the study: non-inferior in its ability to prevent bacterial colonization of the catheter tip when compared to catheters coated with chlorhexidine or silver sulfadiazine (CH-SS). The rate of colonization of the 5-FU CVC was 2.9% (n=12), compared to 5.3% (n=21) in the CH-SS coated catheters (relative reduction in colonization with 5-FU coating of 46%, p=0.055).
There were no statistically significant differences in the rate of adverse events related to the study devices (2.5% for 5-FU versus 3.1% for CH-SS), or in the rates of catheter-related bloodstream infections (CRBSI), (0% for 5-FU versus 2.8% for CH-SS). In addition to meeting the non-inferiority endpoint, these data show a trend toward superiority for the 5-FU coated catheter over the market leading device, both in frequency and nature of colonizations and infections.