Zilver PTX randomized trial of paclitaxel-eluting stents for femoropopliteal disease demonstrates superior results

Four-year results of the Zilver^® PTX^® Randomized Controlled Trial of Paclitaxel-Eluting Stents for Femoropopliteal Disease continue to demonstrate consistent, superior results when compared to bare metal stents (BMS) and percutaneous transluminal angioplasty (PTA) in terms of primary patency, restenosis reduction and revascularization rates. Designed to evaluate BMS and PTA coated stents as treatments for peripheral arterial disease (PAD) in the superficial femoral artery (SFA), the study is the first of its kind with long-term data. Results were presented for the first time during the Controversies and Updates in Vascular Surgery (CACVS) Congress 2014 in France.

Four-year data confirmed the indications from previous study results at one, two and three years in terms of

• primary patency: Patients treated with Cook Medical’s paclitaxel-eluting stent, Zilver PTX, demonstrated 75.0 percent primary patency in the SFA. This compares to 57.9 percent patency for patients with provisional BMS placement in the study.
• restenosis reduction:  Four-year restenosis was reduced by 41 percent with the paclitaxel coating in the head-to-head comparison of provisional paclitaxel-eluting stent placement versus BMS placement.
• revascularization rate: 83.2 percent of patients with femoropopliteal lesions who were treated with Zilver PTX did not require revascularization after four years. In comparison, 69.4 percent of patients treated with acutely successful PTA or provisional BMS placement did not require revascularization.

“These long-term results show that this paclitaxel-eluting stent consistently has a higher efficacy profile compared to bare metal stents in the treatment of femoropoliteal disease in lesions less than 14cm. Restenosis, which can reappear within the first year, is a major issue in treating these patients. The significant reduction of restenosis shown in this study, in particular claudicants, with 3 PAD patients out of 4 remaining free from restenosis over a four-year period, underlines the therapeutic interest of this treatment approach to femoropoliteal disease,” said Professor Patrick Lermusiaux, vascular surgeon at CHU Lyon, who presented the data at CACVS in Paris.

Dr. Bertrand Le Halle, vascular surgeon at Clinique Louis Pasteur in Nancy, France also took part in the symposium presenting his experiences using Zilver PTX in diabetic patients.

“With diabetes being a leading cause of amputation and with 10 percent of diabetics at risk of amputation, early revascularization with a paclitaxel-eluting stent is of real therapeutic interest in both avoiding amputation and improving the overall long-term management of the disease. Once treated, patients with diabetes can start to increase their physical activity which is very important in managing this chronic disease,” said Dr. Le Halle.

The five-year data of the Zilver PTX Randomized Trial of Paclitaxel-Eluting Stents for Femoropoliteal Disease in PAD patients will be unveiled by the company this autumn.