Comparison Between Pioglitazone and SES With type2 DM

Condition(s) targeted: Coronary Artery Disease; Type 2 Diabetes Mellitus

Intervention: Pioglitazone (Drug)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: Showa University

Official(s) and/or principal investigator(s):
Youichi Kobayashi, Professor, Study Chair, Affiliation: Showa University

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.

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

Study design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Primary outcome: The primary angiographic end point is in-stent luminal late loss, as determined by quantitative angiography.

Secondary outcome: Secondary end points include the percentage of in-stent stenosis of luminal diameter, the rate of restenosis.

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.

Minimum age: 20 Years. Maximum age: 90 Years. Gender(s): Both.

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

- an intolerance of aspirin, ticlopidine, heparin, pioglitazone, stainless steel, or

contrast material.

Starting date: July 2003
Ending date: June 2007
Last updated: June 4, 2007