Drug helps arteries stay open after angioplasty.

Researchers in the Emory Heart Center have found that the drug cilostazol (Pletal) reduces in-stent restenosis (the renarrowing of arteries following angioplasty) by almost 40 percent over standard therapy alone--a conclusion that could mark a significant new treatment option for coronary artery disease.

Cardiologist William Weintraub, director of the Emory Center for Outcomes Research, presented the findings of the national "Cilostazol for RESTenosis" (CREST) study on Nov. 22 in New York at an international conference for vascular specialists.

"The results of CREST have revealed that cilostazol offers an inexpensive means to control restenosis, which is the major limitation of coronary stents," said Weintraub, co-investigator of the study along with John Douglas, director of interventional cardiology at Emory, and David Holmes of the Mayo Clinic.

A multicenter, randomized, double-blind and placebo-controlled trial, CREST involved 705 patients enrolled at 19 clinical sites across the United States who received a standard therapy of aspirin and clopidogrel plus a dose of cilostazol (a phosphodiesterase III inhibitor with multiple actions) or placebo after successful coronary stent implantation. Treatment with study medication (cilostazol or placebo) and aspirin was continued for six months.

Weintraub said the CREST study showed cilostazol to be effective in patients with diabetes and small blood vessels, two important subgroups that are among the most difficult to treat.

"In addition, the benefit of cilostazol in preventing restenosis in all groups was achieved with no increase in complications or coronary stenting," he said.

During angioplasty (the most common procedure in this country to treat potentially life-threatening coronary blockages) a balloon-tipped catheter pushes aside atherosclerotic plaques in arteries. Once the vessel has been widened and adequate blood flow is returned, stents (tiny mesh wire tubes) are frequently used to keep arteries open.

However, renarrowing of the arteries has proved to be a frequent problem following angioplasty and stenting; restenosis affects 300,000 coronary stent recipients in the United States each year. Patients who experience restenosis may require additional angioplasty procedures, another stent or bypass surgery.

"Cilostazol appears to be a safe and highly effective weapon in the war on heart disease that can potentially reduce the need for further invasive procedures following angioplasty," Weintraub said.