Clinical Research News
Drug-Eluting Stent for Blockages in the Leg Arteries
Peripheral arterial disease (PAD)
Cholesterol or scar tissue build up in the arteries of the legs, causing them to narrow.
The Division of Vascular Surgery is participating in the first trial of a drug-eluting stent to treat peripheral arterial disease (PAD), or blocked arteries in the legs.
Once implanted, the stent releases a medication within the artery to prevent restenosis, or re-blockage, of the vessel.
The Zilver® stent may be appropriate for many patients with occluded arteries and pain with walking (claudication).
While such patients used to endure their pain rather than undergo a major operation to unblock their vessels, the advent of minimally invasive techniques brought relief to millions of patients.
"The use of drug-eluting stents is part of the natural evolution of perfecting minimally invasive surgery," according to Nicholas J. Morrissey, MD, Director of Clinical Trials, Division of Vascular Surgery.
"This study is designed to determine if drug-coated stents can prevent recurrence of occlusions and the need for second surgeries to open blocked vessels."
The ZILVER® stent is the first paclitaxel-coated stent to be tested for treatment of peripheral arterial disease.
Physicians insert the stent through a tiny hole in the groin and advance it through a catheter to the narrowed segment of the artery.
After the stent is deployed, it expands and keeps the artery open indefinitely.
The addition of paclitaxel may help to prevent restenosis, or recurrent narrowing of the artery.
Drug-eluting stents have been studied in the coronary arteries, but this is the first U.S. trial in the leg arteries.
This large, randomized controlled trial includes patients who have already undergone angioplasty to open a blockage in the leg, and whose angioplasty failed to keep the artery open.
"In about 30% of cases, blockages recur after one year," says Dr. Morrissey, who is Principal Investigator at both campuses of NewYork-Presbyterian Hospital.
Patients are randomized to receive either a bare metal stent or one coated with paclitaxel, an immunosuppressant medication that helps to inhibit the inflammatory process leading to blockages.
"We are hoping that the drug-eluting stent will be effective in over 90% of patients long-term," says Dr. Morrissey.
Although some institutions are beginning to place coated stents in leg arteries without being part of a clinical trial, Dr. Morrissey emphasizes the importance of studying their benefits in the leg arteries before widespread use.
"In the legs, it could behave differently, and so we have to study it and not just assume it will behave the same as it does in the coronary arteries."
| 
