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

Randomized Comparison of Everolimus- 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 Everolimus- 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
• Intervention / Treatment: Device: XIENCE V; Device: CYPHER

Detailed 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)

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Bucheon, Korea, Republic of
    • SoonChunHyang University Bucheon Hospital
  • Busan, Korea, Republic of
    • Busan Saint Mary's Hospital
  • Cheonan, Korea, Republic of
    • Soonchunhyang University Cheonan Hospital
  • Cheongju, Korea, Republic of
    • Cheongju Saint Mary's Hospital
  • Chuncheon, Korea, Republic of
    • Kangwon University Hospital
  • Daejeon, Korea, Republic of
    • Chungnam National University Hospital
  • Daejeon, Korea, Republic of
    • Daejeon St Mary's Hospital Catholic University
  • GangNeung, Korea, Republic of
    • Asan Medical Center
  • Jeonju, Korea, Republic of
    • Chonbuk National University Hospital
  • Jinju, Korea, Republic of
    • Kyungsang University Hospital
  • Pusan, Korea, Republic of
    • Inje University Pusan Paik Hospital
  • Pusan, Korea, Republic of
    • Pusan Natioanal University Hospital
  • PyeongChon, Korea, Republic of
    • Hallym University Sacred Heart Hospital
  • Seoul, Korea, Republic of
    • Asan Medical Center
  • Seoul, Korea, Republic of
    • SoonChunHyang University Seoul Hospital
  • Seoul, Korea, Republic of
    • Hallym University Sacred Heart Hospital
  • Seoul, Korea, Republic of
    • Korea Veterans Hospital
  • Ulsan, Korea, Republic of
    • Ulsan University 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 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).

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
Active Comparator: XIENCE V; everolimus-eluting stent	Device: XIENCE V; everolimus-eluting stent; Other Names: Xience V stent
Active Comparator: CYPHER; Using Cypher stent	Device: CYPHER; sirolimus-eluting stent; Other Names: Cypher elect stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Angiographic in-segment late loss at angiography	8-month

Secondary Outcome Measures

Outcome Measure	Time Frame
Cardiac death	12 months
Myocardial infarction	12 months
All-cause Death	12 month
All-cause Death	5 year
Cardiac death	5 year
Myocardial infarction	5 year
Target vessel revascularization (all and ischemia-driven)	12 months
Target lesion revascularization (all and ischemia-driven)	5 year
Stent thrombosis by definition of Academic Research Consortium (ARC)	12 months
Stent thrombosis by definition of Academic Research Consortium (ARC)	5 year
Binary restenosis in both in-stent and in-segment	8 months
Angiographic pattern of restenosis	8 months

Collaborators and Investigators

• Sponsor: Seung-Jung Park
• Collaborators: CardioVascular Research Foundation, Korea

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: October 18, 2009
• First Submitted That Met QC Criteria: October 18, 2009
• First Posted (Estimate): October 19, 2009

Study Record Updates

• Last Update Posted (Estimate): December 13, 2016
• Last Update Submitted That Met QC Criteria: December 12, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: stenting, XIENCE V, CYPHER
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Endocrine System Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Diabetes Mellitus
• Other Study ID Numbers: 2008-0220

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: This is not a publicly funded trial.