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Zilver® PTX® drug-eluting stent study data show continued patency at five years

Five-year results from the largest and longest-running clinical trial of a drug-eluting stent for treating (PAD) confirmed long-term patency for patients treated with Zilver .

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.1

“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 ’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).

One-year post-market surveillance (PMS) study data from Japanese patients who received the Zilver® PTX® drug-eluting stent confirmed the benefits of the device at 12 months, researchers announced today. Japanese researchers presented the PMS study results at the Vascular Interventional Advances 2014 meeting in Las Vegas. This was the first time the study has been presented in the United States.

“Yet the results were quite favorable even in the more complex lesion sub-group.”

The PMS study was based in Japan and presented at VIVA by Hiroyoshi Yokoi, M.D. of Fukuoka Sanno Hospital. It included 907 patients with peripheral arterial disease (PAD) treated at 95 institutions with Zilver PTX. Of those, 802 were eligible for 12-month follow up. After one year, 91.4 percent of the patients in the follow-up group did not need target lesion revascularization (TLR) of the SFA. The 84.8 percent primary patency result in the PMS study is similar to results from earlier Zilver PTX studies1.

The patients studied were real-world cases, many of whom had more severe peripheral arterial disease than patients in the randomized control trial (RCT) for Zilver PTX.

“Many of the Japanese PMS patients’ lesions were more complex, with longer stenosed segments, more in-stent restenosis and fewer patent runoff vessels, compared to the RCT patient cohort,” Dr. Yokoi said. “Yet the results were quite favorable even in the more complex lesion sub-group.” Complex lesion sub-group results at 12 months showed 88.3 percent freedom from TLR and 81.0 percent primary patency.

“We’re very pleased with the data from the Japan PMS study because the study included a broad range of lesion types and lengths similar to what doctors treat on a daily basis. Like our other studies, this evaluation shows that for most patients there is an enduring drug effect from Zilver PTX a year after implantation,” said Mark Breedlove, global leader for Cook Medical’s Peripheral Interventional (PI) division.

Zilver PTX is the only drug-eluting stent approved in Japan for treating PAD. It has been approved for use in the European Union since August 2009 and the United States and Japan since 2012. Since its release, the stent has been used to treat more than 25,000 patients in North America, Europe, Asia, South America, Australia and New Zealand.

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.

Dr. Yokoi is a paid consultant to Cook Medical as a co-principal investor of the Zilver PTX PMS trial in Japan.


1 Yokoi H. Zilver PTX post-market surveillance study of paclitaxel-eluting stents for treating femoropopliteal artery disease in Japan: 12-month results in real-world patients. Presented at: Vascular Interventional Advances (VIVA); November 4-7, 2014; Las Vegas, NV.

Source: Cook Medical