New data on the use of Zilver PTX, Cook Medical’s paclitaxel-coated stent for peripheral arterial disease (PAD), confirms the safety of the device. These data were presented at the Annual Scientific Meeting of the Cardiovascular and Interventional Radiological Society of Europe (CIRSE 2019; 7–11 September, Barcelona, Spain).
Michael Dake, senior vice president of health sciences at the University of Arizona, Tucson, president-elect of the Society of Interventional Radiology Executive Council, and global principal investigator, presented new 5-year data on Zilver PTX that Cook Medical gathered from the randomised controlled trial (RCT) performed to obtain US Food and Drug Administration (FDA) approval.
Cook Medical is the only organisation that has publicly provided long-term, patient-level data on the use of paclitaxel-coated devices for PAD. In addition to previously released information, the presentation included new data that had not been previously published.
These new data include information from patients who had not previously completed the study, such as those who had been lost to follow up, giving a more complete view of how paclitaxel-coated devices affect patients.
The data confirm no significant difference in all-cause mortality for the Zilver PTX drug-eluting stent compared to traditional angioplasty or a bare metal stent (BMS). The findings further show that treatment with Zilver PTX and paclitaxel dose were not predictors of mortality. However, age and other serious conditions common in PAD patients were associated with mortality.
The findings that Dake presented have been published online in CardioVascular and Interventional Radiology (CVIR), a peer-reviewed journal, which can be found here.
“Our clinical program evaluates the Zilver PTX technology across a broad, real-world patient population—including patients at high risk for restenosis and reintervention. Zilver PTX offers proven long-term benefits that help patients get back to living,” said Mark Breedlove, vice president of Cook Medical’s Vascular division.
The patient-level data used for the RCT analysis, as well as Dr Dake’s presentation and other Zilver PTX information, is available at https://www.cookmedical.com/peripheral-intervention/paclitaxel/.
Dr Michael Dake is a paid consultant for Cook Medical.