Researchers Compare Treatment Options for Superficial Femoral Artery Lesions

by Kathy Jones on  June 20, 2011 at 9:37 PM Clinical Trials News   - G J E 4
When treating femoral artery (SFA) lesions, the Zilver PTX® Paclitaxel-Eluting Stent shows sustained effectiveness compared to percutaneous transluminal angioplasty, even in diabetic patients, results of a prospective, randomized trial indicate.
 Researchers Compare Treatment Options for Superficial Femoral Artery Lesions
Researchers Compare Treatment Options for Superficial Femoral Artery Lesions

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\.

About the Society for Vascular Surgery
The Society for Vascular Surgery® (SVS) is a not-for-profit professional medical society, composed primarily of vascular surgeons, that seeks to advance excellence and innovation in vascular health through education, advocacy, research, and public awareness. SVS is the national advocate for 3,370 specialty-trained vascular surgeons and other medical professionals who are dedicated to the prevention and cure of vascular disease. Visit its Web site at® and follow SVS on Twitter by searching for VascularHealth or at

Source: Newswise

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