Sirolimus-Eluting Stent Versus Standard Stent in Diabetic

Study Overview
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Brief Summary
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The purpose of this study was to determine whether Sirolimus stent implantation is effective in reducing neointimal hyperplasia as compared to Bare metal stent in diabetic patients with de novo coronary artery stenosis.

Official Title
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A Randomized Comparison of Sirolimus-Eluting Stent Versus Standard Stent for Percutaneous Coronary Revascularization in Diabetic Patients

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: Drug eluting stent
* Device: Bare metal stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diabetic either non-insulin or insulin-dependent (according to World Health Organization Report) on pharmacologic treatment (insulin or hypoglycaemic agents) for at least 1 month, and presented de novo coronary stenoses in 1,2 or 3 native vessels with symptoms or objective evidence of ischemia. Stenoses had to be amenable for stent implantation, with vessel size smaller than 4.0 mm (as assessed visually on angiography) Exclusion Criteria: Impaired glucose tolerance without pharmacologic treatment, gestational diabetes or transient hyperglycaemia Stenoses located in saphenous bypass, arterial bypass grafting, unprotected left main or involving important side branches (> 2 mm) that should be treated during the procedure Left ventricle ejection fraction < 25% Prior treatment with intracoronary brachytherapy or other drug eluting stent at target site Restenotic lesions; known allergies to aspirin, ticlopidine and clopidogrel acute coronary syndromes with persistent ST elevation < 72 hours and/or CPK twice the upper normal limit Non-ST elevation acute coronary syndromes with CPK twice the upper normal limit Severe hepatic or renal disease (creatinin clearance < 30 ml/min or hepatic enzymes twice the upper normal limit); and life expectancy < 1 year
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: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2<br> | Device: Drug eluting stent<br>* Drug eluting stent implantation<br>|
| Placebo Comparator: 1<br>Bare metal stent | Device: Bare metal stent<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint of this study was in-segment late lumen loss as assessed by quantitative coronary angiography |  | 270-day follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other angiographic parameters of restenosis such as binary restenosis, and minimal luminal diameter; major adverse cardiac events including cardiac death, myocardial infarction, target lesion (in-segment zone) revascularization stent thrombosis |  | 1, 9, 12 and 24-month follow-up |