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First results of SIRIUS trial bolster evidence new treatment keeps arteries open

Emory University : 24 May, 2002  (Technical Article)
Stents are tiny wire mesh tubes used to prop arteries open after angioplasty clears them of potentially heart attack causing plaque. Unfortunately, in many cases, stented arteries eventually close back up with fatty deposits, a process called restenosis. Now there's hope restenosis can be eliminated or greatly reduced in the not-too-distant future, thanks to stents coated with pharmaceutical agents that prevent excess tissue growth.
The first preliminary findings of the landmark SIRIUS study, just released at the Paris Course on Revascularization, reveal a remarkably decreased rate of restenosis in patients who received drug coated stents, according to Emory interventional cardiologist John Douglas Jr., M.D., Primary Clinical Investigator for the study at Emory.

Sponsored by Johnson & Johnson's Cordis Corporation, the Sirius research is an ongoing study at the Emory Heart Center and 52 other U.S. medical centers. The randomized, double blind clinical trial involves about 1,000 patients who have received either a plain metal stent or one coated with the pharmaceutical agent rapamycin. In data released on 400 patients participating in the Sirius trial, researchers concluded that only two percent who received the CYPHER(TM) drug-eluting stents experienced restenosis within arteries. In approximately nine percent of study participants, there was restenosis found near the stent edges. However, with non-drug coated metal stents, reclogging occurs in approximately 25 to 30 percent of patients.

The drug coating does not kill cells, but allows the endothelium (layer of cells lining vessel walls and the heart) to cover the stent. 'This is important because the stent becomes coated with cells and incorporated into the heart,' says Dr. Douglas, who implanted the first coronary artery stent in the U.S. at Emory Hospital in l987.

He points out that without this cell covering, a stent may promote blood clot formation when the body 'reads' the device as foreign material. 'In fact, that's one of the limitations of radiation treatment for preventing the renarrowing process in arteries. Radiation prevents the growth of tissue over the stent and that can up the risk for blood clot formation there later and lead to heart attack. The drug coated stent may be a solution to this problem,' he notes.

' We are very excited about the results of the Sirius trial, so far. We believe the rapamycin coated stent may prove to be a major breakthrough in defeating restenosis after stenting and could possibly FDA approved and ready for interventional cardiologists to use by 2003,' Dr. Douglas says.
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