EMORY RESEARCH: DRUG COATED STENTS MAY KEEP ARTERIES OPEN

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EMORY RESEARCH: DRUG COATED STENTS MAY KEEP ARTERIES OPEN
31 October 2001 - Emory University

Emory cardiologists at Emory University Hospital and Crawford Long Hospital are participating in a new clinical trial, called DELIVER, to study a drug-coated stent that holds the promise of virtually eliminating restenosis (re-narrowing of arteries) following angioplasty by halting the proliferation of endothelial cells, cells that line the blood vessels.

Although stenting (inserting a tiny wire scaffold) has reduced restenosis after angioplasty from about 50 percent to 20 percent, once a stented area re-narrows the chance of future restenosis is around 60 percent. Irradiating the blood vessels, a process known as brachytherapy, has proven helpful in reducing, but not halting, the rate of restenosis.

The DELIVER clinical trial incorporates a new stent system, called ACHIEVE, manufactured by Cook Incorporated and utilizing drug-coating technology developed by Cook, along with stent and delivery system components created by the Guidant Corporation. The device is coated with paclitaxel, a cytostatic drug that prevents excessive cell regrowth at the site of the stent placement. Paclitaxel is the same ingredient found in the cancer drug TAXOL, which is given in intravascular dosages 500 to 3,000 times greater than patients will receive through the ACHIEVE stent.

"In preliminary trials, stents coated with similar antiproliferative drugs have shown the remarkable ability to prevent restenosis, "says Emory Heart Center cardiologist Ziyad Ghazzal, M.D., the DELIVER studyÕs chief investigator at Emory. "We hope to enroll patients in the study quickly, so if our results are similar to earlier trials, we can begin to use this new therapy soon and help patients avoid restenosis."

Up to 1,042 patients will be enrolled in the single-blinded, randomized DELIVER study at approximately 80 hospitals in the U.S. As many as 156 patients can participate at Emory. Half will receive the ACHIEVE Drug Coated Stent containing 3 micrograms (unit of measure) of paclitaxel per mm2 (unit of measure) of metal surface area. The control group will receive the uncoated MULTI-LINK PENTA CSS containing no paclitaxel. The participants will be implanted with stents at Emory University Hospital or Crawford Long Hospital.

The Emory Heart Center, known as one of the birthplaces of interventional cardiology, has been in the forefront of finding new and better approaches to the treatment of heart disease for decades. Patients with severe blockage of coronary arteries faced possible open heart surgery prior to the mid-l980s, when the late Andreas Gruentzig, M.D., revolutionized interventional cardiology by pioneering angioplasty at Emory, allowing blocked arteries to be opened via the minimally invasive procedure. In l987, the treatment of heart disease made another dramatic advance when Emory cardiologist John Douglas, M.D., used an angioplasty balloon to insert a stent to prop open a blood vessel for the first time in the U.S.

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About: Emory University
Emory University is home to nine major academic divisions, numerous centres for advanced study, and a host of prestigious affiliated institutions. In addition to Emory College, the University encompasses a graduate school of arts and sciences; professional schools of medicine, theology, law, nursing, public health, and business; and Oxford College, a two-year undergraduate division on the original campus of Emory in Oxford, Ga.

Emory was founded at Oxford by the Methodist Church in 1836. Led by President James W. Wagner, an award-winning teacher and scholar, the University has 11,300 students and 2,500 faculty members who represent all regions of the United States and more than 100 foreign nations.

Emory University is known for its demanding academics, outstanding undergraduate college of arts and sciences, highly ranked professional schools and state-of-the-art research facilities. For more than a decade Emory has been named one of the country's top 25 national universities by U.S. News & World Report. In addition to its nine schools, the university encompasses The Carter Center, Yerkes National Primate Research Center and Emory Healthcare, a comprehensive metropolitan health care system.

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