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

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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Diabetes
• Intervention / Treatment: Device: Endeavor Resolute stent; Device: Cypher stent

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.

• Study Type: Interventional
• Enrollment (Actual): 256
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Endeavor Resolute stent; zotarolimus-eluting stent	Device: Endeavor Resolute stent; zotarolimus-eluting stent
Active Comparator: Cypher stent; sirolimus-eluting stent	Device: Cypher stent; sirolimus-eluting stent

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Seung-Jung Park
• Collaborators: CardioVascular Research Foundation, Korea
• Investigators: Principal Investigator: Seung-Jung Park, Asan Medical Center

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: August 19, 2010
• First Submitted That Met QC Criteria: August 20, 2010
• First Posted (Estimate): August 23, 2010

Study Record Updates

• Last Update Posted (Estimate): July 29, 2014
• Last Update Submitted That Met QC Criteria: July 28, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: coronary disease; stent
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: 2009-0220