Coronary Artery Disease
Conditions
Keywords
stenting, XIENCE V, CYPHER
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)
Sponsors
CardioVascular Research Foundation, Korea
Seung-Jung Park
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 1. Left main disease 2. In-stent restenosis 3. 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Angiographic in-segment late loss at angiography | 8-month |
Secondary
| Measure | Time frame |
|---|---|
| Cardiac death | 12 months |
| Myocardial infarction | 12 months |
| Target vessel revascularization (all and ischemia-driven) | 12 months |
| All-cause Death | 12 month |
| Stent thrombosis by definition of Academic Research Consortium (ARC) | 12 months |
| Binary restenosis in both in-stent and in-segment | 8 months |
| Angiographic pattern of restenosis | 8 months |
| Target lesion revascularization (all and ischemia-driven) | 5 year |
Countries
South Korea
Outcome results
None listed