Comparison Between Pioglitazone and SES With type2 DM

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Comparison of Bare Metal Stent With Pioglitazone Versus Sirolimus-Eluting Stent for Percutaneous Coronary Intervention in Patients With Type 2 Diabetes Mellitus.

Conditions
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Coronary Artery Disease, Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: Pioglitazone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with type 2 diabetes mellitus who had received coronary stenting were eligible for the study. Exclusion Criteria: spastic angina pectoris congestive heart failure hepatic dysfunction chronic renal disease recent stroke impaired glucose tolerance insulin dependent diabetes mellitus familial hypercholesterolemia thyroid dysfunction adrenal dysfunction an intolerance of aspirin, ticlopidine, heparin, pioglitazone, stainless steel, or contrast material.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Pioglitazone|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary angiographic end point is in-stent luminal late loss, as determined by quantitative angiography. |  | Within 12minths after the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary end points include the percentage of in-stent stenosis of luminal diameter, the rate of restenosis. |  | 6 months after procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bare metal stent, Major adverse cardiac events, Pioglitazone, Restenosis, Sirolimus eluting stent