New Long-Term Safety Data for Paclitaxel From Cook Medical's Zilver PTX Trial Presented at CIRSE

September 9, 2019—Cook Medical announced that new data on the use of the company's Zilver PTX paclitaxel-coated stent for peripheral artery disease (PAD) were presented at CIRSE 2019, the annual conference of the Cardiovascular and Interventional Radiology Society of Europe held September 7–11 in Barcelona, Spain.

At CIRSE, 5-year data from the Zilver PTX randomized controlled trial (RCT) that supported FDA approval were presented by Michael D. Dake, MD, who serves as Global Principal Investigator for the study. Additionally, the findings were published online by Dr. Dake, et al in CardioVascular and Interventional Radiology. The patient-level data used for the RCT analysis, Dr. Dake’s CIRSE presentation, and other Zilver PTX information are available on Cook Medical's website.

According to the company, the long-term patient-level data on the use of paclitaxel-coated devices for PAD included both previously released information and new data that had not been published. The new data includes information from patients who previously had not completed the study, such as those who had been lost to follow-up. The additional data provide a more complete view of how paclitaxel-coated devices affect patients.

Cook Medical stated that the data confirm no significant difference in all-cause mortality for the Zilver PTX device compared with traditional angioplasty or a bare-metal stent. Furthermore, the findings 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.

Dr. Dake, who is President-Elect of the Society of Interventional Radiology Executive Council, is the Senior Vice President of Health Sciences at the University of Arizona in Tucson, Arizona.

All articles from Endovascular Today's continuing coverage of the paclitaxel safety data review are available online here.