Comparison of Zotarolimus-Eluting Stent vs Sirolimus-Eluting Stent for Diabetic Patients (ESSENCE-DM2)

• Death (all-cause and cardiac) [ Time Frame: at 12 months ] [ Designated as safety issue: Yes ]
• myocardial infarction [ Time Frame: at 12 months ] [ Designated as safety issue: Yes ]
• stent thrombosis [ Time Frame: at 12 months ] [ Designated as safety issue: Yes ]
• target-lesion revascularization [ Time Frame: at 12 months ] [ Designated as safety issue: No ]
• target-vessel revascularization [ Time Frame: at 12 months ] [ Designated as safety issue: No ]

The purpose of this study is to establish the safety and effectiveness of coronary stenting with the Zotarolimus-Eluting stent compared to the Sirolimus-Eluting stent in the treatment of de novo coronary stenosis in patients with 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.

• Coronary Artery Disease
• Diabetes

• Device: Endeavor Resolute stent
  zotarolimus-eluting stent
• Device: Cypher stent
  sirolimus-eluting stent

• Experimental: Endeavor Resolute stent
  zotarolimus-eluting stent
  Intervention: Device: Endeavor Resolute stent
• Active Comparator: Cypher stent
  sirolimus-eluting stent
  Intervention: Device: Cypher stent

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).