Comparison of Bare Metal Stent With Pioglitazone Versus Sirolimus-Eluting Stent for Percutaneous Coronary Intervention in Patients With Type 2 Diabetes Mellitus.
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- Showa University
- Enrollment
- 38
- Primary Endpoint
- The primary angiographic end point is in-stent luminal late loss, as determined by quantitative angiography.
- Status
- Completed
- Last Updated
- 18 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
The primary angiographic end point is in-stent luminal late loss, as determined by quantitative angiography.
Time Frame: Within 12minths after the procedure
Secondary Outcomes
- Secondary end points include the percentage of in-stent stenosis of luminal diameter, the rate of restenosis.(6 months after procedure)