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

Coronary Artery Disease Clinical Trial

— ESSENCE-DM2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01186107
• Other study ID #: 2009-0220
• Status: Completed
• Phase: Phase 4
• First received: August 19, 2010
• Last updated: July 28, 2014
• Start date: August 2010
• Est. completion date: July 2013

Study information

• Verified date: July 2014
• Source: CardioVascular Research Foundation, Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 256
• Est. completion date: July 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Diabetes
• Myocardial Ischemia

Intervention

Device:
• Endeavor Resolute stent
zotarolimus-eluting stent
• Cypher stent
sirolimus-eluting stent

Locations

Country	Name	City	State
Korea, Republic of	Hallym University Sacred Heart Hospital	Anyang	Gyeong-gi
Korea, Republic of	Soonchunhyang University Bucheon Hospital	Bucheon
Korea, Republic of	Soonchunhyang University Cheonan Hospital	Cheonan
Korea, Republic of	Kangwon University Hospital	Chuncheon
Korea, Republic of	Daejeon St Mary's Hospital Catholic University	Daejeon
Korea, Republic of	GangNeung Asan Hospital	GangNeung
Korea, Republic of	Chonbuk National University Hospital	Jeonju
Korea, Republic of	Pusan National University Yangsan Hospital	Pusan
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Seoul Veterans Hospital	Seoul
Korea, Republic of	Ulsan University Hospital	Ulsan

Sponsors (2)

Lead Sponsor	Collaborator
Seung-Jung Park	CardioVascular Research Foundation, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Angiographic in-segment late loss		9-month angiographic follow-up	No
Secondary	Death (all-cause and cardiac)		at 12 months	Yes
Secondary	myocardial infarction		at 12 months	Yes
Secondary	stent thrombosis		at 12 months	Yes
Secondary	target-lesion revascularization		at 12 months	No
Secondary	target-vessel revascularization		at 12 months	No