Most Popular Angioplasty Web Site
Stent Center Stent Center
with support from Medtronic Cardiovascular
Four-Year Data for Cook's Zilver® PTX® Drug-Eluting Stent Show 41% Reduction in Restenosis over BMS
Share This Story:
Bookmark and Share

external sites:
Cook Medical

Zilver® PTX® Drug Eluting Peripheral Stent
Zilver® PTX® Drug Eluting Peripheral Stent
October 9, 2013 -- Cook Medical's Zilver® PTX® drug-eluting stent for use in the treatment of peripheral artery disease shows excellent outcomes at four years when used in the superficial femoral artery (SFA). At the 2013 Vascular Interventional Advances (VIVA) meeting in Las Vegas yesterday, Dr. Gary Ansel of Riverside Methodist Hospital in Columbus, Ohio presented the results of a randomized controlled trial comparing the Zilver PTX vs. bare metal stent (BMS) placement.

After four years the Zilver PTX showed a primary patency of 75% compared to only 57.9% for the BMS, representing a 41% reduction in restenosis at four-years. Last month at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2013 meeting in Spain, the four-year revascularization results for the Zilver were presented for femoropopliteal lesions, and they were 16.8% for the Zilver DES vs. 30.6% for blockages treated either by balloon angioplasty alone or BMS -- a 55% reduction in repeat procedures. More than 83% of patients with the Zilver did not need revascularization at four years, an excellent result for peripheral treatment where durability of the procedure historically has been difficult to maintain.

A spokesperson for Cook explained to Angioplasty.Org the difference between the patency result (75%) and the freedom from revascularization (83.2%): loss of primary patency is measured when imaging shows a > 50% narrowing; however revascularization often is not necessary unless progression of the blockage is more severe, usually in the 70+% range.

The Zilver PTX was approved by the FDA in November 2012 after an FDA panel had recommended unanimously in favor. The stent was briefly taken off the market earlier this year to address a structural tip separation problem; distribution of the Zilver resumed in August of this year.

Yesterday's press release announcement from Cook Medical follows:

New Zilver® PTX® Drug-Eluting Stent Study Data Shows Excellent SFA Patency Results at Four Years

October 8, 2013 -- Las Vegas, Nevada -- Four-year data from the Zilver® PTX® Randomized Controlled Trial of Paclitaxel-Eluting Stents for Femoropopliteal Disease from Cook Medical presented today 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.

Gary M. Ansel, MD, FACC
Gary M. Ansel, MD, FACC

"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, randomised 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.

Drs. Dake and Ansel, the global principal investigators for the Zilver PTX trial, are paid consultants to Cook Medical regarding the research and development of medical devices.

[1] Data is available upon request.

About Cook Medical
Since 1963 Cook Medical has worked closely with physicians to develop technologies that eliminate the need for open surgery. Today we are combining medical devices, biologic materials and cellular therapies to help the world's healthcare systems deliver better outcomes more efficiently. We have always remained family-owned so that we have the freedom to focus on what we care about: patients, our employees and our communities. Find out more at, and for the latest news, follow us on Twitter and LinkedIn.

Reported by Burt Cohen, October 9, 2013