Three-Year Data From Paclitaxel-Eluting Stent Trial Now Available

Patients treated with Cook Medical’s Zilver PTX paclitaxel-eluting stents for femoro-popliteal disease experienced a 70.7 percent opening in their blocked superficial femoral arteries at 36 months, according to three-year clinical trial data. The 70.7 percent opening compares with a 49.1 percent patency for patients with percutaneous transluminal angioplasty (PTA) and provisional bare metal stent placement in the 479-patient study.

The paclitaxel coating also was shown to reduce the restenosis rate by 53 percent in a head-to-head comparison of provisional paclitaxel-eluting versus bare metal stent placement. Paclitaxel is an inhibitor that prevents cell mitosis, and in peripheral artery disease applications, prevents the proliferation of arterial smooth muscle cells, which can narrow arteries.

Michael Dake, M.D., professor in the department of cardiothoracic surgery at Stanford University Medical School and medical director of the catheter/angio laboratories at Stanford University Medical Center in Palo Alto, Calif., presented the study findings on Oct. 10 at the Vascular InterVentional Advances 2012 conference in Las Vegas, Nev.

“These data, from the largest clinical study ever conducted on peripheral stenting, clearly show a sustained drug effect for paclitaxel-eluting stents versus bare metal stents after three years,” said Rob Lyles, vice president and global leader of Cook Medical’s Peripheral Intervention clinical division.

Zilver PTX is neither approved by U.S. Food and Drug Administration nor available for sale in the United States, but it did receive the CE Mark in July 2009. Dake, the global principal investigator for the Zilver PTX trial, is a paid consultant to Cook Medical in the research and development of medical devices.

Headquartered in Bloomington, Ind., Cook Medical provides a wide range of medical technologies combining medical devices, drugs, biologic grafts and cell therapies.

Photo of Zilver PTX stent courtesy of Cook Medical.