Posted on May 23, 2001 at 4:30 p.m.

BIRMINGHAM, AL — UAB has begun a revolutionary study designed to improve the performance of cardiovascular stents — tiny, metal scaffolding-like structures used to prop open clogged heart vessels. In the study, the stents will be coated with an immunosuppressant drug to prevent restenosis — a build-up of scar tissue in and around the stent.

“Depending on the results, this technique could very easily revolutionize the practice of using stents,” said Gregory Chapman, M.D., director of Interventional Cardiology and lead investigator of UAB's portion of the SIRIUS study. “The potential benefits to the patient are enormous. UAB is very excited to be among the first to participate in this study.” UAB is one of 55 sites across the country to begin the study.

Each year about 700,000 cardiovascular patients in the United States are treated with a procedure called angioplasty, in which a catheter is inserted into the clogged vessel, a balloon is inflated to open up the clog and a stent is placed in the vessel. But approximately 30 percent of those patients suffer from restenosis (renarrowing or reclogging) and have to be retreated.

The multi-center SIRIUS study, sponsored by Cordis, a Johnson & Johnson company, uses a stent coated with a pharmaceutical agent known as sirolimus. Developed by Wyeth-Ayerst Laboratories and marketed under the trade name Rapamune^®, sirolimus is a potent immunosuppressive agent approved by the FDA for the prevention of organ rejection following renal transplantation. Sirolimus prevents cell replication rather than killing cells.

Eleven hundred patients will be enrolled in the nationwide study. Patients will be included in the five-year study based on their medical history and diagnosis and the size and length of the clog in their artery. Results will be measured through patient monitoring and review of follow-up angiogram results.

The U.S. study was pushed into action following extraordinary results from a small pilot study in Brazil (30 patients) and The Netherlands (15 patients). The 12-month follow-up assessment of the 30 patients in Brazil revealed no evidence of in-stent or edge restenosis. And the six-month follow-up in The Netherlands yielded similar results.

For more information on the SIRIUS study, call Dr. Gregory Chapman or JoAnn Key, R.N. at (205) 934-7898.