Randomized Comparison of Zotarolimus-Eluting Stent Versus Sirolimus-Eluting Stent Implantation for De Novo Coronary Artery DisEase in Patients With DIABETES Mellitus
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- Seung-Jung Park
- Enrollment
- 256
- Locations
- 11
- Primary Endpoint
- Angiographic in-segment late loss
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Seung-Jung Park
M.D., Ph.D.,Professor of Medicine Asan Medical Center, University of Ulsan, College of Medicine
CardioVascular Research Foundation, Korea
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
Outcomes
Primary Outcomes
Angiographic in-segment late loss
Time Frame: 9-month angiographic follow-up
Secondary Outcomes
- Death (all-cause and cardiac)(at 12 months)
- myocardial infarction(at 12 months)
- stent thrombosis(at 12 months)
- target-lesion revascularization(at 12 months)
- target-vessel revascularization(at 12 months)