Zilver PTX® Paclitaxel-Eluting Stent Shows Sustained Effectiveness even in diabetic patients
CHICAGO--Results of a prospective, randomized trial indicate that when treating femoral artery (SFA) lesions, the Zilver PTX® Paclitaxel-Eluting Stent shows sustained effectiveness compared to percutaneous transluminal angioplasty, even in diabetic patients. Sean P. Lyden, MD, from department of vascular surgery at the Cleveland Clinic in Cleveland, OH, presented his findings today at the 65th Vascular Annual Meeting® of the Society for Vascular Surgery®.
“There were 479 patients in the study who were treated at 55 institutions in the United States, Japan and Germany,” said Lyden. “Patients with symptomatic de novo or restenotic SFA lesions were randomized to receive either primary Zilver PTX® stent implantation to percutaneous transluminal angioplasty (PTA).”
Dr. Lyden said 120 of the PTAprocedures failed acutely (defined as 30 percent or more residual stenosis); those that failed underwent secondary randomization to a provisional bare metal stent (BMS) or provisional Zilver PTX® implantation. “Therefore, 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,” said Lyden.
Demographics and lesion characteristics were comparable (e.g., average lesion length of 69 ± 39 mm and 31 percent total occlusions for non-DM, and average lesion length of 65 ± 39 mm and 27 percent total occlusions for DM, p=0.37 and p=0.46, respectively). The event free survival rates were similar for non-DM and DM patients treated with the Zilver PTX® stent (93.5 percent vs. 89.2 percent at 12 months and 88.7 percent vs. 84.4 percent at 24 months, p=0.47). Furthermore, the Zilver PTX® patency rates were similar for non-DM and DM patients (85.2 percent vs. 83.9 percent at 12 months and 77.5 percent vs. 74.1 percent at 24 months, p=0.37\.
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