Clinical trial for Zilver PTX paclitaxel-eluting stent shows sustained patency after three years


Three-year data from the Zilver PTX randomised controlled trial of paclitaxel-eluting stents for femoropopliteal disease have shown 70.7% primary patency in the superficial femoral artery (SFA) at 36 months for patients treated with the Zilver PTX paclitaxel-eluting stent (Cook Medical). This compares to 49.1% 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% in a head-to-head comparison of provisional paclitaxel-eluting versus bare metal stent placement.

Michael Dake, 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, California, USA, principal investigator for the Zilver PTX trial, presented the study findings at the Vascular Interventional Advances (VIVA) 2012 (Las Vegas, USA, 9–12 October 2012)

Zilver PTX is neither approved by the FDA nor available for sale in the United States.