Five-year results from the largest and longest-running clinical trial of a drug-eluting stent for treating peripheral arterial disease confirmed long-term patency for patients treated with Zilver PTX (Cook).
The results were presented by Michael Dake, Stanford University School of Medicine, Stanford, USA,at the 2014 Vascular Interventional Advances (VIVA) meeting.
Data from the Zilver PTX randomised controlled trial of paclitaxel-eluting stents for femoropopliteal disease showed five-year primary patency of 66.4% percent in the superficial femoral artery for patients treated with the paclitaxel-eluting stent. This compares to 43.4% patency for patients with balloon angioplasty or provisional bare metal stent placement.
“At five years, Zilver PTX demonstrated a 48% reduction in reintervention and a 41% reduction in restenosis compared to standard care [angioplasty],” Dake told the VIVA audience. “Five-year data for Zilver PTX vs. bare metal stenting confirm a more sustained benefit for the paclitaxel-eluting stent.”
“Cook’s commitment to providing clinical evidence of the effectiveness of drug-eluting devices in the peripheral vessels is substantial. With this new data showing durable patency at five years, we are confident our Zilver PTX stent offers peripheral arterial disease patients a lasting benefit,” said Mark Breedlove, vice president and global leader of Cook Medical’s Peripheral Intervention clinical division.
The Zilver PTX randomized trial of paclitaxel-eluting stents for femoropoliteal artery disease was a 479-patient multicentre, prospective, randomised study.