Randomized Comparison of Everolimus- 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
- 300
- Locations
- 16
- Primary Endpoint
- Angiographic in-segment late loss at angiography
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
The purpose of this study is to establish the safety and effectiveness of coronary stenting with the Everolimus- Eluting stent compared to the Sirolimus-Eluting stent in the treatment of de novo coronary stenosis in patients with diabetic patients.
Detailed Description
Diabetic patients often present unfavorable coronary anatomy with small and diffusely diseased vessels (1) and exhibit exaggerated neointimal hyperplasia after bare-metal stent (BMS) implantation as compared with nondiabetics (2). Although drug-eluting stent (DES) implantation significantly reduced the neointimal hyperplasia and angiographic restenosis compared to BMS in diabetic patients (3), presence of diabetes mellitus (DM) have been still associated with an increased risk of restenosis and unfavorable clinical outcomes in the era of DES (4,5). Recently, the relative efficacies of sirolimua-eluting stent (SES) and paclitaxel-eluting stent (PES) in patients with DM have been evaluated in randomized and registry studies (6-10). The present study, ESSENCE-DIABETES Study, compare 8-month angiographic and 1-year clinical outcomes in patients with diabetes mellitus treated with sirolimus-eluting stent (CYPHER) or everolimus-eluting stent (XIENCE V)
Investigators
Seung-Jung Park
MD, PhD
CardioVascular Research Foundation, Korea
Eligibility Criteria
Inclusion Criteria
- •Diabetic patients with angina and documented ischemia or patients with documented silent ischemia
- •Patients who are eligible for intracoronary stenting
- •Age \>18 years, \<75 ages
- •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)
Outcomes
Primary Outcomes
Angiographic in-segment late loss at angiography
Time Frame: 8-month
Secondary Outcomes
- All-cause Death(5 year)
- Target vessel revascularization (all and ischemia-driven)(12 months)
- Target lesion revascularization (all and ischemia-driven)(5 year)
- Stent thrombosis by definition of Academic Research Consortium (ARC)(5 year)
- Cardiac death(5 year)
- Myocardial infarction(5 year)
- Angiographic pattern of restenosis(8 months)
- Binary restenosis in both in-stent and in-segment(8 months)