Postmarket Surveillance Study Confirms Benefits of Cook Medical’s Zilver® PTX® Drug Eluting Stent at 12 Months in Japanese Patients

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.

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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.

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.