Cook Medical today touted five-year data from a study into the use of its Zilver PTX paclitaxel-coated stent for peripheral arterial disease (PAD).
The study concluded that there was no increase in long-term all-cause mortality due to paclitaxel after treatment using the Zilver PTX stent compared to traditional angioplasty or a bare-metal stent, according to a release.
Cook Medical’s announcement follows an August 2019 FDA warning to healthcare providers to carefully consider whether to use paclitaxel-coated devices. Use of the devices plunged after a meta-analysis published in the Journal of the American Heart Association last December suggested that PAD patients treated with paclitaxel-coated balloons and stents could be at a higher risk for late death.
Dr. Michael Dake, senior vice president of health sciences at the University of Arizona, Tucson, and president-elect of the Society of Interventional Radiology executive council, presented the data at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) conference.
Cook Medical considered information from a randomized controlled trial comparing the drug-eluting stent and percutaneous transluminal angioplasty, and a Japan post-market surveillance study comparing the DES with the bare metal stent. In the randomized controlled trial, 336 were patients treated with the DES and 143 patients underwent percutaneous transluminal angioplasty (PTA). In Japan, there were 904 DES patients and 190 patients treated with bare-metal stents (BMS).
The studies found no difference in all-cause mortality for the DES (19.1%) compared to PTA/BMS (17.1%) in the randomized controlled trial, and found the same in Japan, with 15.8% all-cause mortality for DES compared to 15.3% for BMS.
The results also showed that age, tissue loss, and congestive heart failure were significantly associated with mortality in the randomized controlled trial, and that critical limb ischemia, age, renal failure, and gender were significantly associated with mortality in Japan. Neither Zilver, nor paclitaxel, was associated with mortality, according to the study.
“Our clinical program evaluates the Zilver PTX technology across a broad, real-world patient population — including patients at high risk for restenosis and reintervention,” Mark Breedlove, vice president of Cook Medical’s vascular division, said in a news release. “Zilver PTX offers proven long-term benefits that help patients get back to living.”