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

Launched by SEUNG-JUNG PARK · Aug 20, 2010

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

• 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).