Cook's Zilver PTX Compares Favorably to PTA for SFA Treatment in Diabetic Patients

June 18, 2011—The Society for Vascular Surgery (SVS) announced that results of a prospective, randomized trial indicate that the Zilver PTX paclitaxel-eluting stent (Cook Medical Group, Bloomington, IN) has sustained effectiveness compared to percutaneous transluminal angioplasty (PTA) in diabetic patients in the treatment of superficial femoral artery (SFA) lesions. Sean P. Lyden, MD, presented the trial’s most recent findings at the SVS’s 2011 Vascular Annual Meeting in Chicago.

“There were 479 patients in the study who were treated at 55 institutions in the United States, Japan, and Germany,” stated Dr. Lyden. "Patients with symptomatic de novo or restenotic SFA lesions were randomized to receive either primary Zilver PTX stent implantation or percutaneous transluminal angioplasty."

According to Dr. Lyden, 120 of the PTA procedures failed acutely (defined as 30% or more residual stenosis); those that failed underwent secondary randomization to a provisional bare-metal stent or provisional Zilver PTX implantation. A total of 302 patients were randomized to Zilver PTX stent implantation, including 156 patients with no diabetes mellitus (non-DM) and 146 diabetic (DM) patients.

Demographics and lesion characteristics were comparable, with an average lesion length of 69 ± 39 mm and 31% total occlusions for non-DM (P = .37), and an average lesion length of 65 ± 39 mm and 27% total occlusions for DM (P =.46). The event-free survival rates were similar for non-DM and DM patients treated with the Zilver PTX stent (93.5% vs 89.2% at 12 months and 88.7% vs 84.4% at 24 months; P = .47). The Zilver PTX patency rates were similar for non-DM and DM patients (85.2% vs 83.9% at 12 months and 77.5% vs 74.1% at 24 months; P = .37) in the study, as detailed by the SVS.