The American College of Cardiology Presented by Dr. Nikolaus Marx Pioglitazone Trial Pioglitazone Reduces Neointima Formation After Coronary Stent Implantation Presented at The American College of Cardiology Scientific Sessions 2005 Presented by Dr. Nikolaus Marx

50 nondiabetic patients undergoing PCI in de novo lesions Piaglitazone Trial 50 nondiabetic patients undergoing PCI in de novo lesions Study arms had equivalent baseline fasting blood glucose, fasting insulin, HbA1c, and lipid levels Pioglitazone 30 mg/OD n=25 Placebo n=25 Endpoints: Primary – Neoinimal volume measured (measured with IVUS) within the stented segment at 6 months Secondary – Total plaque volume, minimum lumen diameter and percent stenosis at 6 months ACC 2005

Pioglitazone Trial: Primary endpoint Neointima volume by intravascular untrasound at six months p = <0.05 The primary endpoint of neointimal volume within the stented segment at 6 months was significantly lower in the pioglitazone group compared with placebo. ACC 2005

Pioglitazone Trial: Secondary Endpoint Total Plaque volume p<0.05 Percent stenosis p=0.01 Minimum lumen diameter p=0.29 ACC 2005

Pioglitazone Trial: Summary Among nondiabetic patients undergoing coronary stent implantation for de novo lesions, treatment with pioglitazone was associated with a reduction in neointima formation compared with treatment with placebo at 6 month follow-up. The pioglitazone group also showed significant reductions in total plaque volume and stenosis at six months compared with the placebo group. ACC 2005

Pioglitazone Trial: Summary Past trials have shown pioglitazone to be associated with reduced rates of restenosis in diabetic patients. In this trial, there were no differences in change in fasting blood glucose, fasting insulin, HbA1c or lipid levels, suggesting that pioglitazone’s vessel wall benefits are unrelated to its role in regulating metobolic factors. Consistent with this, previous studies have shown that glitazones interact with a vessel wall receptors, ultimately inhibiting neointima proliferation and reducing inflammation. The sample size is of the trial is small (50), so while the results of the trial are promising, they will need to be validated by larger randomized trials with additional clinical endpoints. ACC 2005