Four-year data from the Zilver® PTX® Randomized Controlled Trial of Paclitaxel-Eluting Stents for Femoropopliteal Disease from Cook Medical presented at the 2013 Vascular Interventional Advances (VIVA) meeting demonstrates 75 percent primary patency in the superficial femoral artery (SFA) at four years for patients treated with Cook Medical's paclitaxel-eluting stent. This compares to 57.9 percent patency for patients with provisional bare metal stent placement in the study.
This represents a 41 percent reduction in four-year restenosis with the paclitaxel coating in the head-to-head comparison of provisional paclitaxel-eluting stent placement versus BMS placement.
"Certainly as we face the challenge of 'health care value,' the Zilver PTX results allow for confidence of long-term procedural success and patient benefit," said Gary Ansel, M.D., director for the Center for Critical Limb Care at Riverside Methodist Hospital in Columbus, Ohio. One of the trial's principal investigators, Dr. Ansel presented the data at VIVA today in Las Vegas, NV.
As presented last month at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2013 meeting in Spain, the four-year data shows that 83.2 percent of patients with femoropopliteal lesions who were treated with Zilver PTX did not require revascularization after four years. In comparison, 69.4 percent of patients treated with acutely successful percutaneous transluminal angioplasty (PTA) or provisional BMS placement did not require revascularization.
The Zilver PTX Randomized Trial of Paclitaxel-Eluting Stents for Femoropoliteal Artery Disease was a 479-patient multicenter, prospective, randomized study, designed to evaluate the stent as a treatment for peripheral arterial disease (PAD) in the superficial femoral artery (SFA). Dr. Michael Dake, professor of cardiothoracic surgery at Stanford University Medical School, presented the four-year data, which showed freedom from target lesion revascularization (TLR), at CIRSE last month.
Dr. Dake remarked, "The 4-year freedom from TLR data documents the sustained clinical benefit of Zilver PTX. When compared to standard of care therapy, consisting of either acutely successful PTA or provisional bare stent placement after sub-optimal PTA, the paclitaxel-eluting Zilver stent provides a 45 percent reduction in the reintervention rate in this study."
"Cook's commitment to providing clinical evidence of the efficacy of drug-eluting devices in the peripheral vessels is unmatched. With this new data showing lasting patency at four years, we're confident our Zilver PTX stent offers PAD patients a lasting solution," said Rob Lyles, vice president and global leader of Cook Medical's Peripheral Intervention clinical division.