Comparison of Cilotax Stent and Everolimus -Eluting Stent With Diabetes Mellitus (ESSENCE-DM III)

Prospective, randomized multi-center trial of 300 patients will be enrolled at 7 centers in Korea. Following angiography, diabetic patients with significant diameter stenosis >50% by visual estimation have documented myocardial ischemia or symptoms of angina, and eligible for stenting without any exclusion criteria will be randomized 1:1 to: a) Cilotax stent vs. b) Xience Prime stent. All patients will be followed for at least 1 year. Angiographic follow-up at 9-months is routinely recommended.

Inclusion criteria

Clinical:

• Diabetic patients with active treatment (oral agent or insulin)
• Patients with angina and documented ischemia or patients with documented silent ischemia
• Patients who are eligible for intracoronary stenting
• Age > 20 years, < 75 years

Angiographic:

• 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)
• ST-elevation acute myocardial infraction requiring primary stenting
• 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 ≥ 3times normal
• Renal dysfunction, creatinine ≥ 2.0mg/dL
• Contraindication to aspirin, clopidogrel or cilostazol
• Contraindication to Paclitaxel or everolimus
• 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 for example: oxygen dependent chronic obstructive pulmonary disease, active hepatitis or severe liver function or kidney disease)