Promising Results for New DES in Peripheral Disease

September 27th, 2010

Promising Results for New DES in Peripheral Disease

Larry Husten, PHD

A new drug-eluting stent designed to treat peripheral disease showed promising results in the largest trial yet of endovascular treatment in this population. The 12-month results of the Zilver PTX randomized trial comparing a novel paclitaxel-eluting stent versus balloon angioplasty and bare-metal stenting in patients with symptomatic above-the-knee femoropopliteal artery disease were presented at TCT2010 by Michael Dake.

Patients (n=479) were randomized to either the Zilver PTX or percutaneous transluminal angioplasty (PTA). In addition, for the patients who had suboptimal results with PTA, a second randomization was performed, to either the bare Zilver stent or the Zilver PTX stent.

The rate of event-free survival at one year was 90.4% in the Zilver PTX group versus 82.6% in the PTA group. The patency rate at one year was 83.1% for the Zilver PTX versus 67% for the standard care group who received PTA with provisional bare metal stenting. In the second randomization, the patency rate was significantly higher in the Zilver PTX group than in the bare Zilver group (89.9% versus 73%), resulting in a dramatic 63% reduction in the 12-month restenosis rate.

symptomatic disease of the above-the-knee femoropopliteal artery

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September 27th, 2010