NEW YORK CITY -- A drug used to treat peripheral vascular disease symptoms also may reduce renarrowing of arteries by as much as 40%. Researchers said that cilostazol (Pletal, Otsuka America Pharmaceutical) reduced restenosis by 39.5% over standard therapy alone in the Cilostazol for RESTenosis (CREST) study, presented in November at the American Heart Association meeting.
Vascular surgeons and specialists discussing the study here at the 30th Annual VEITH Symposium, later in November, told Veins1.com that the results were better than expected.
"This was over the top," said William Weintraub, MD, director of the Emory Center for Outcomes Research and a co-investigator for the trial.
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Restenosis is a frequent problem after angioplasty or stent placement and affects about 300,000 coronary stent recipients in the United States each year, according to an Emory Heart Center press release. Patients who experience renarrowing may require additional angioplasty procedures, another stent or bypass surgery.
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"We achieved a very good benefit with cilostazol in the CREST trial." CREST was a multi-center, randomized, double-blind, placebo-controlled trial with 705 patients at 19 clinical sites across the United States. After successful coronary stent implantation, patients received standard therapy (aspirin plus clopidogrel [Plavix, Bristol-Myers Squibb/Sanofi] for clot prevention) plus either cilostazol or a placebo.
After six months of treatment, angiography was performed to determine the presence of restenosis. Researchers also kept track of complications, costs and patient’s quality of life. In addition to the overall 39.5% reduction in restenosis, researchers found that patients with diabetes had an even greater benefit -- restenosis among that group dropped from 37% to 16.9%.
"It’s a home run study," said Samuel R. Money, MD, clinical associate professor of surgery at Tulane University School of Medicine and head of the section of vascular surgery at the Ochsner Clinic Foundation in New Orleans. Money is a researcher and consultant for Otsuka America.
"Look at the rate of change in diabetics," Money said. "That’s tremendous."
He said cilostazol is a phosphorous type 2 inhibitor marketed for patients with intermittent claudication, painful cramping in the legs associated with peripheral vascular disease. Animal studies in Japan indicated it might work for restenosis as well, but CREST was the first large human study showing those benefits. Otsuka is now considering a second trial and possibly seeking the FDA’s approval for the new use of the drug.
Weintraub, who spoke about the study at the VEITH Symposium, said that even in the era of drug-eluting stents this is good news. He pointed out that drug-eluting stents are expensive, harder to place than bare stents, and, although they have reduced restenosis greatly, the use of cilostazol will help to reduce that further.
"Cilostazol taken orally after successful stent placement will significantly and safely decrease the rate of restenosis," he said.
"Cilostazol may indeed hold promise for a broad spectrum of patients at risk for restenosis," said John S. Douglas Jr., MD, principal investigator for CREST, in a press release. "This is the most successful and safe oral agent we are aware of at this time. It can be administered via two simple pills a day."
Douglas is professor of medicine and director of interventional cardiology at Emory University. The VEITH Symposium is an international congress on vascular surgery and treatments sponsored by Montefiore Medical Center, Bronx, NY.
