Comparison of Zotarolimus-Eluting Stent vs Sirolimus-Eluting Stent for Diabetic Patients

Randomized Comparison of Zotarolimus-Eluting Stent Versus Sirolimus-Eluting Stent Implantation for De Novo Coronary Artery DisEase in Patients With DIABETES Mellitus

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01186107

Acronym

ESSENCE-DM2

Enrollment

256

Registered

2010-08-23

Start date

2010-08-31

Completion date

2013-07-31

Last updated

2014-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease, Diabetes

Keywords

coronary disease, stent

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.

Interventions

DEVICEEndeavor Resolute stent

zotarolimus-eluting stent

DEVICECypher stent

sirolimus-eluting stent

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

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).

Design outcomes

Primary

Measure	Time frame
Angiographic in-segment late loss	9-month angiographic follow-up

Secondary

Measure	Time frame
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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026