Las Vegas, Nev., November 4, 2014 — Five-year results from the largest and longest-running clinical trial of a drug-eluting stent for treating peripheral arterial disease (PAD) confirmed long-term patency for patients treated with Zilver PTX.
The results were presented today by Michael Dake, M.D., of Stanford University, at the 2014 Vascular Interventional Advances (VIVA) meeting.
Data from the Zilver® PTX® Randomized Controlled Trial of Paclitaxel-Eluting Stents for Femoropopliteal Disease showed 5-year primary patency of 66.4 percent in the superficial femoral artery (SFA) for patients treated with Cook’s paclitaxel-eluting stent. This compares to 43.4 percent patency for patients with balloon angioplasty or provisional bare metal stent placement.
“At five years, Zilver PTX demonstrated a 48 percent reduction in reintervention and a 41 percent reduction in restenosis compared to standard care,” Dr. Dake told the VIVA audience. “Five-year data for Zilver PTX versus bare metal stenting confirm a sustained benefit for the paclitaxel-eluting stent. Zilver PTX continues to show benefit through five years with no late catch-up.”
“Cook’s commitment to providing clinical evidence of the effectiveness of drug-eluting devices in the peripheral vessels is unmatched. With this new data showing durable patency at five years, we’re confident our Zilver PTX stent offers PAD 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 multicenter, prospective, randomized study. It was designed to evaluate the PTX stent as a treatment for peripheral arterial disease (PAD) in the superficial femoral artery (SFA).
Dr. Dake, a global principal investigator for the Zilver PTX trial, is a paid consultant to Cook Medical regarding the research and development of medical devices.
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Use and potential contraindications: The Zilver PTX Drug Eluting Stent is intended for treatment of de novo or restenotic symptomatic lesions in native vascular disease of the above-the-knee femoropopliteal arteries having reference vessel size from 4 mm to 7 mm and total lesion lengths of up to 140 mm per limb or 280 mm per patient. The use of this drug-eluting peripheral stent carries the risks associated with peripheral artery stenting including vascular complications, and/or bleeding events.
Dake M. The Zilver PTX randomized trial of treating femoropopliteal artery disease: 5-year results. Presented at: Vascular Interventional Advances (VIVA); November 4-7, 2014; Las Vegas, NV.