Comparison of Zotarolimus-Eluting Stent vs Sirolimus-Eluting Stent for Diabetic Patients

Prospective, two arms, single blind, randomized multi-center trial of 380 patients enrolled at 24 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) Endeavor Resolute stent vs. b) Cypher select. All patients will be followed for at least 1 year. Angiographic follow-up at 9-months is routinely recommended.

Inclusion criteria

• Diabetic patients with angina and documented ischemia
• Patients who are eligible for intracoronary stenting
• 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).