Cook’s Zilver PTX Trial Shows Sustained Patency After Three Years


October 15, 2012
Zilver PTX Randomized Controlled Trial Stents Peripheral artery disease (PAD)

October 15, 2012 — Three-year data from the Zilver PTX randomized controlled trial of paclitaxel-eluting stents for femoropopliteal disease from Cook Medical demonstrate 70.7 percent primary patency in the superficial femoral artery (SFA) at 36 months for patients treated with the paclitaxel-eluting stent. This compares to 49.1 percent patency for patients with percutaneous transluminal angioplasty and provisional bare metal stent placement in the 479-patient study.

In addition, the paclitaxel coating 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.

Michael Dake, M.D., professor in the department of cardiothoracic surgery at Stanford University Medical School and medical director of the cath/angio laboratories at Stanford University Medical Center, Palo Alto, Calif., presented the study findings at the 2012 Vascular Interventional Advances 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 the U.S. Food and Drug Administration (FDA) nor available for sale in the United States. Dake, the global principal investigator for the Zilver PTX trial, is a paid consultant to Cook Medical regarding the research and development of medical devices.

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