Prairie Heart Institute Part of Revolutionary Study of Coated Stents

SPRINGFIELD -- Prairie Heart Institute at St. John's Hospital today announced that it will
be among the first five key hospital centers in the country conducting the first U.S. human interventional cardiology investigational procedure for a potentially revolutionary new treatment to reduce restenosis in coronary arteries after placement of a stent. Prairie physicians began enrolling patients in the study today. Three patients were anticipated.

Utilizing an intravascular stent coated with a pharmaceutical agent known as sirolimus, Prairie Cardiovascular Consultants, Ltd. physicians, led by local clinical investigator Gregory Mishkel, M.D., will begin enrolling patients in the SIRIUS Study on Tuesday. SIRIUS is a large, randomized, double-blinded clinical trial sponsored by Cordis, a Johnson & Johnson company. Cordis received approval on February 2 from the U.S. Food and Drug Administration (FDA) to conduct the SIRIUS clinical
trial.

Overall, the SIRIUS Study is designed to include 1,100 patients at 55 hospital centers across the United States. Clinical results at the close of the study will be measured through on-going patient monitoring and review of angiographic follow-up.

The SIRIUS Study follows the initiation of two small, preliminary trials with extremely favorable results involving the coated stent. "There has yet to be an incidence of restenosis," says Mishkel. "The drug used to coat the stents is not new -- it is a potent immunosuppressive agent already approved by the Food and Drug Administration for the prevention of organ rejection following renal transplantation. It has been found to be both safe and effective in human use."

Mishkel says, "A total of 60 patients have been treated in the pilot studies in Europe and South America and sophisticated follow-up at both 4-months and 12-months has indicated no evidence of recurring narrowing (restenosis) for these patients either in the stent or along the edge of the stent.
This is in contra-distinction to the most recently developed tool to prevent restenosis, radiation therapy, which still has significant limitations. Additionally, there have been no untoward clinical events either during the placement or follow-up period in these patients."

"If the results of the first trials are confirmed through this study, coated stents will be the next major advancement in the treatment of coronary artery disease since stents were made widely available a decade ago," says Mishkel. Mishkel also notes that another Prairie Cardiovascular Consultants Ltd. physician, Krishna Rocha-Singh, M.D., director of the peripheral vascular program at Prairie Heart
Institute at St. John's Hospital, will be the national principal investigator on the peripheral vascular coated stent trials. These trials will evaluate the usefulness of coated stents used in the
arteries of the legs and are expected to begin soon.

"The SIRIUS Study will be a landmark study that will allow us to futher extend non-surgical treatment of coronary artery disease and hopefully reduce the Achilles heel of angioplasty the renarrowing of arteries after stenting," Mishkel says. "One of the real breakthroughs in this technology is the process of coating the stent so that the drug does not come off during placement and can be released appropriately over a period of time. We are very excited about the hope of improved outcomes this technology can offer our patients." Mishkel anticipates additional trials to begin at Prairie Heart Institute using other drugs, including taxol, a chemotherapy agent used intravenously for breast and ovarian cancer treatment.