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Drug-Eluting Peripheral Stent Continues to Show Positive Data at Two Years
Date:5/7/2010

The characteristics of the 787 patients who were enrolled and treated included restenosis of previously treated lesions in 24 percent, in-stent restenosis in 14 percent, and total occlusions in 38 percent; 22 percent of patients had lesions longer than 15 cm. The mean lesion length was 10.0 +/- 8.2 cm, the mean percent diameter stenosis was 84.6 +/- 16.4 percent, with an average of 2.2 Zilver® PTX® stents used per patient.

At 12 months, the event-free survival rate was 87.0 percent, and freedom from target lesion revascularization was 90.5 percent. X-ray evaluation found a very low rate of stent fractures, 1.5 percent of patients at 12 months. Patients available for 24-month follow-up had an event-free survival rate of 80.0 percent, and freedom from target lesion revascularization was 83.3 percent.

This low rate of target lesion revascularization translated into meaningful clinical improvement for the majority of patients, with both the average walking distance and average walking speed more than doubling following Zilver PTX stent implantation, and being sustained to two years. In addition there was a very good safety profile, and a very low rate of stent fractures.

"These interim data suggest this device is safe and efficacious for the treatment of SFA lesions," said William A. Gray, M.D., FSCAI, who presented the study data and is associate professor of clinical medicine and director of endovascular services at Columbia University Medical Center/New York Presbyterian Hospital. "Prior attempts to demonstrate drug-eluting stent effectiveness using sirolimus or its analogues have fallen short, but the use of a paclitaxel-coated, non-polymeric stent appears to have improved the outcomes for patients who received this study stent. If these results are confirmed in the sep
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