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Cilostazol Significantly Reduces Stent Restenosis Rate: Presented at AHA

By Jill Stein

ORLANDO, FL -- November 13, 2003 -- The phosphodiesterase III inhibitor cilostazol (Pletal®) decreases coronary artery stent restenosis by about 40%, researchers reported here on November 9^th at the American Heart Association's Scientific Sessions 2003.

John S. Douglas, Jr., MD, with Emory University, Atlanta, Georgia, United States, and colleagues randomized 705 patients who underwent successful coronary stent implantation to 6 months' treatment with cilostazol, 100 mg twice daily, or placebo. All subjects received standard therapy with aspirin plus clopidogrel.

The trial excluded patients with acute myocardial infarction, thrombus, bifurcation stenoses, and hepatic or renal insufficiency.

The primary endpoint was minimal lumen diameter (MLD) at 6 months by quantitative coronary angiography.

Results in 507 patients who underwent 6-month coronary angiography showed a 1.81 mm MLD for the analysis segment in cilostazol-treated patients, compared with 1.67 mm in the placebo group, P = .0188. The analysis segment referred to the stent plus 5 mm borders. Late loss was 0.52 mm and 0.70 mm in the two groups, respectively, P = .0035.

Binary stenosis, defined as a >50% diameter stenosis, occurred in the analysis segment in 20.88% of cilostazol patients, compared with 34.59% of placebo patients, P = .0006. "This translates into a 39.5% decrease in the relative risk of restenosis over conventional therapy alone," Dr. Douglas said.

This favorable effect also occurred in diabetics and in vessels less than 3 mm. "This is important because these populations are notoriously difficult to treat," he added.

The frequency of major adverse cardiac events, bleeding, and re-hospitalization were similar in the treatment groups.

The study, known as Cilostazol for RESTenosis (CREST), was conducted at 19 U.S. sites. Cilostazol is presently indicated in the U.S. as a treatment for intermittent claudication.


[Study title: Cilostazol for RESTenosis (CREST) Trial.]

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