Comparison of Zotarolimus-Eluting Stent vs Sirolimus-Eluting Stent for Diabetic Patients (ESSENCE-DM2)

Seung-Jung Park

Status and phase

Completed

Phase 4

Conditions

Coronary Artery Disease

Diabetes

Treatments

Device: Endeavor Resolute stent

Device: Cypher stent

Study type

Interventional

Funder types

Other

Identifiers

NCT01186107

2009-0220

Details and patient eligibility

About

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.

Full 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.

Enrollment

256 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).