Comparison Between Pioglitazone and SES With type2 DM
Drug-eluting stents have been shown to decrease restenosis, but were associated with an increased rate of death, as compared with bare-metal stents. Recently, thiazolidinediones effectively reduced restenosis and the risk of repeat target vessel revascularization. We conducted a study to compare the performance of a drug-eluting stent with that of a bare-metal stent with pioglitazone in patients with type 2 diabetic mellitus.
Coronary Artery Disease
Type 2 Diabetes Mellitus
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Comparison of Bare Metal Stent With Pioglitazone Versus Sirolimus-Eluting Stent for Percutaneous Coronary Intervention in Patients With Type 2 Diabetes Mellitus.|
- The primary angiographic end point is in-stent luminal late loss, as determined by quantitative angiography. [ Time Frame: Within 12minths after the procedure ]
- Secondary end points include the percentage of in-stent stenosis of luminal diameter, the rate of restenosis. [ Time Frame: 6 months after procedure ]
|Study Start Date:||July 2003|
|Study Completion Date:||June 2007|
The study is a prospective cohort trial involving 38 type 2 diabetic patients referred for coronary stenting who were assigned to either the sirolimus-eluting stent group or the pioglitazone group. Quantitative coronary angiography will be performed at study entry and at six months follow-up to evaluate in-stent late luminal loss and the percentage of the luminal diameter and the rate of restenosis. We also analyze major adverse cardiac events at 12 months.