The prospective, single-arm study is ongoing to evaluate the drug-eluting stent for the treatment of peripheral artery disease (PAD). Results of a separate pivotal randomized study in a similar cohort of patients are expected to be available later this year.
Reportedly, although the use of Drug Eluting Stent (DES) is common in the coronary arteries in the peripheral arteries, including those in the legs, experience different types of stress caused by walking and other movement. In some instances, blockages in these arteries are very difficult to treat, and may lead to limb amputation. The study is the third to evaluate the effectiveness of a drug-eluting stent outside of the coronary arteries, but the first to suggest clinical efficacy. The Zilver PTX is an investigational device.
According to the study, the characteristics of the 787 patients who were enrolled and treated included restenosis of previously treated lesions in 24%, in-stent restenosis in 14%, and total occlusions in 38%; 22% of patients had lesions longer than 15 cm. The mean lesion length was 10.0 +/- 8.2 cm, the mean% diameter stenosis was 84.6 +/- 16.4%, with an average of 2.2 Zilver PTX stents used per patient.
At 12 months, the event-free survival rate was 87%, and freedom from target lesion revascularization was 90.5%. X-ray evaluation found a very low rate of stent fractures, 1.5% of patients at 12 months. Patients available for 24-month follow-up had an event-free survival rate of 80%, and freedom from target lesion revascularization was 83.3%.
The 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 good safety profile, and a very low rate of stent fractures.
William Gray, associate professor of clinical medicine and director of endovascular services at Columbia University Medical Center/New York Presbyterian Hospital, said: “The interim data suggest this device is safe and efficacious for the treatment of SFA lesions.
“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 separate randomized study using the same device, it will be welcome news to patients who suffer from this disease.”
