Comparison of Everolimus-Eluting Stent vs Sirolimus-Eluting Stent in Patients With DIABETES Mellitus

Study Overview
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Brief Summary
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The purpose of this study is to establish the safety and effectiveness of coronary stenting with the Everolimus- Eluting stent compared to the Sirolimus-Eluting stent in the treatment of de novo coronary stenosis in patients with diabetic patients.

Detailed Description
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Diabetic patients often present unfavorable coronary anatomy with small and diffusely diseased vessels (1) and exhibit exaggerated neointimal hyperplasia after bare-metal stent (BMS) implantation as compared with nondiabetics (2). Although drug-eluting stent (DES) implantation significantly reduced the neointimal hyperplasia and angiographic restenosis compared to BMS in diabetic patients (3), presence of diabetes mellitus (DM) have been still associated with an increased risk of restenosis and unfavorable clinical outcomes in the era of DES (4,5). Recently, the relative efficacies of sirolimua-eluting stent (SES) and paclitaxel-eluting stent (PES) in patients with DM have been evaluated in randomized and registry studies (6-10). The present study, ESSENCE-DIABETES Study, compare 8-month angiographic and 1-year clinical outcomes in patients with diabetes mellitus treated with sirolimus-eluting stent (CYPHER) or everolimus-eluting stent (XIENCE V)

Official Title
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Randomized Comparison of Everolimus- Eluting Stent Versus Sirolimus-Eluting Stent Implantation for De Novo Coronary Artery DisEase in Patients With DIABETES Mellitus

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: XIENCE V
* Device: CYPHER


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diabetic patients with angina and documented ischemia or patients with documented silent ischemia Patients who are eligible for intracoronary stenting Age >18 years, <75 ages De novo lesion Percent diameter stenosis ≥50% Reference vessel size ≥ 2.5 mm by visual estimation Exclusion Criteria: History of bleeding diathesis or coagulopathy Pregnant state Known hypersensitivity or contra-indication to contrast agent and heparin Limited life-expectancy (less than 1 year) Acute ST elevation myocardial infarction on admission Characteristics of lesion Left main disease In-stent restenosis Graft vessels Hematological disease (Neutropenia <3000/mm3, Thrombocytopenia <100,000/mm3) Hepatic dysfunction, liver enzyme (ALT and AST) elevation ≥ 3 times normal Renal dysfunction, creatinine ≥ 2.0mg/dL Contraindication to aspirin, clopidogrel or cilostazol Left ventricular ejection fraction <30% Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period. Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment).

Ages Eligible for Study
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Minimum Age: 18 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: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: XIENCE V<br>everolimus-eluting stent | Device: XIENCE V<br>* everolimus-eluting stent<br>* Other names: Xience V stent;|
| Active Comparator: CYPHER<br>Using Cypher stent | Device: CYPHER<br>* sirolimus-eluting stent<br>* Other names: Cypher elect stent;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Angiographic in-segment late loss at angiography |  | 8-month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause Death |  | 12 month | 
| All-cause Death |  | 5 year | 
| Cardiac death |  | 12 months | 
| Cardiac death |  | 5 year | 
| Myocardial infarction |  | 12 months | 
| Myocardial infarction |  | 5 year | 
| Target vessel revascularization (all and ischemia-driven) |  | 12 months | 
| Target lesion revascularization (all and ischemia-driven) |  | 5 year | 
| Stent thrombosis by definition of Academic Research Consortium (ARC) |  | 12 months | 
| Stent thrombosis by definition of Academic Research Consortium (ARC) |  | 5 year | 
| Binary restenosis in both in-stent and in-segment |  | 8 months | 
| Angiographic pattern of restenosis |  | 8 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stenting, XIENCE V, CYPHER