Cook Medical's Zilver PTX Data Show Continued Patency at 5 Years

November 4, 2014—Cook Medical announced that 5-year results from the clinical trial of the Zilver PTX paclitaxel-eluting stent for treating peripheral arterial disease (PAD) confirmed long-term patency for patients treated with the device. The trial’s global principal investigator, Michael Dake, MD, of Stanford University, presented the findings at the VIVA 2014: Vascular InterVentional Advances meeting in Las Vegas, Nevada.

According to Cook Medical, the 479-patient multicenter, prospective, randomized study was designed to evaluate the Zilver PTX stent as a treatment for PAD in the superficial femoral artery (SFA).

The data from the ZILVER PTX trial of paclitaxel-eluting stents for femoropopliteal disease showed 5-year primary patency of 66.4% in the SFA for patients treated with the Zilver PTX. This compares to 43.4% patency for patients with balloon angioplasty or provisional bare-metal stent placement.

As noted in the announcement, Dr. Dake commented to the VIVA audience, “At 5 years, Zilver PTX demonstrated a 48% reduction in reintervention and a 41% reduction in restenosis compared to standard care. 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 5 years with no late catch-up.”

In related news at the VIVA meeting, Cook Medical announced that 1-year postmarket surveillance (PMS) study data from Japanese patients who received the Zilver PTX confirmed the benefits of the device at 12 months. The PMS study was based in Japan and presented at VIVA 2014 by coprincipal investigator Hiroyoshi Yokoi, MD, of Fukuoka Sanno Hospital in Fukuoka, Japan.

According to Cook Medical, the Zilver PTX PMS study included 907 patients with PAD treated with the Zilver PTX device at 95 institutions in Japan. Of those patients, 802 were eligible for 12-month follow up. After 1 year, 91.4% of the patients in the follow-up group did not need target lesion revascularization (TLR) of the SFA. The 84.8% primary patency result in the PMS study is similar to results from earlier Zilver PTX studies, advised the company.

Cook Medical also noted that the patients studied were real-world cases, many of whom had more severe PAD than patients in the randomized control trial for Zilver PTX. Complex lesion subgroup results at 12 months showed 88.3% freedom from TLR and 81% primary patency.

In the press release, Dr. Yokoi commented, “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 randomized controlled trial patient cohort. Yet the results were quite favorable even in the more complex lesion sub-group.”

Zilver PTX was approved in Japan for treating PAD in 2012. It has been approved for use in the European Union since August 2009 and in the United States since 2012.