Four-year ZILVER PTX trial data show paclitaxel coating confers 41% reduction in restenosis vs. bare metal stenting

Cook Zilver PTX
Cook Zilver PTX

Data from the ZILVER PTX randomised controlled trial, presented at the 2013 Vascular Interventional Advances (VIVA) meeting, demonstrates 75% primary patency in the superficial femoral artery at four years for patients treated with Cook Medical’s paclitaxel-eluting stent. This compares to 57.9% patency for patients with provisional bare metal stent placement in the study.

This represents a 41% reduction in four-year restenosis with the paclitaxel coating in the head-to-head comparison of provisional paclitaxel-eluting stent placement vs. bare metal stent 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, director for the Center for Critical Limb Care at Riverside Methodist Hospital in Columbus, Ohio. One of the trial’s principal investigators, Ansel presented the data at VIVA (8-11 October, Las Vegas, USA).

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% of patients with femoropopliteal lesions who were treated with Zilver PTX did not require revascularisation after four years. In comparison, 69.4% of patients treated with acutely successful percutaneous transluminal angioplasty or provisional bare metal stent placement did not require revascularisation.

The Zilver PTX randomised trial of paclitaxel-eluting stents for femoropoliteal artery disease was a 479-patient multicentre, prospective, randomised study, designed to evaluate the stent as a treatment for peripheral arterial disease in the superficial femoral artery. Michael Dake, professor of cardiothoracic surgery at Stanford University Medical School, presented the four-year data, which showed freedom from target lesion revascularisation, at CIRSE last month.

Dake remarked, “The four-year freedom from target lesion revascularisation data documents the sustained clinical benefit of Zilver PTX. When compared to standard of care therapy, consisting of either acutely successful angioplasty or provisional bare stent placement after suboptimal angioplasty, the paclitaxel-eluting Zilver stent provides a 45% reduction in the re-intervention 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 are confident our Zilver PTX stent offers peripheral arterial; disease patients a lasting solution,” said Rob Lyles, vice president and global leader of Cook Medical’s Peripheral Intervention clinical division.