Emory Research: Drug Coated Stents
May Keep Arteries Open
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 (CSS) 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.
For more information about the DELIVER study, call Dr. Ziyad Ghazzal
at 404-712-7424.
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