Comparison of Everolimus-Eluting Stent vs Sirolimus-Eluting Stent in Patients With DIABETES Mellitus (ESSENCE-DM)

Seung-Jung Park

Status and phase

Completed

Phase 4

Conditions

Coronary Artery Disease

Treatments

Device: CYPHER

Device: XIENCE V

Study type

Interventional

Funder types

Other

Identifiers

NCT00997763

2008-0220

Details and patient eligibility

About

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.

Full 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)

Enrollment

300 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).