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

This study has been completed.
Sponsor:
Information provided by:
CardioVascular Research Foundation, Korea
ClinicalTrials.gov Identifier:
NCT00997763
First received: October 18, 2009
Last updated: April 25, 2011
Last verified: October 2009
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
Device: XIENCE V
Device: CYPHER
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Randomized Comparison of Everolimus- Eluting Stent Versus Sirolimus-Eluting Stent Implantation for De Novo Coronary Artery DisEase in Patients With DIABETES Mellitus

Resource links provided by NLM:


Further study details as provided by CardioVascular Research Foundation, Korea:

Primary Outcome Measures:
  • Angiographic in-segment late loss at angiography [ Time Frame: 8-month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • All-cause Death [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]
  • Cardiac death [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Myocardial infarction [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Target vessel revascularization (all and ischemia-driven) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Target lesion revascularization (all and ischemia-driven) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Stent thrombosis by definition of Academic Research Consortium (ARC) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Binary restenosis in both in-stent and in-segment [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]
  • Angiographic pattern of restenosis [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 280
Study Start Date: July 2008
Study Completion Date: January 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: XIENCE V
everolimus-eluting stent
Device: XIENCE V
everolimus-eluting stent
Other Name: Xience V stent
Active Comparator: CYPHER
Using Cypher stent
Device: CYPHER
sirolimus-eluting stent
Other Name: Cypher elect stent

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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00997763

Locations
Korea, Republic of
Soonchunhyang University Bucheon Hospital
Bucheon, Korea, Republic of
Busan Saint Mary's Hospital
Busan, Korea, Republic of
Soonchunhyang University Cheonan Hospital
Cheonan, Korea, Republic of
Cheongju Saint Mary's Hospital
Cheongju, Korea, Republic of
Kangwon University Hospital
Chuncheon, Korea, Republic of
Chungnam National University Hospital
Daejeon, Korea, Republic of
Daejeon St Mary's Hospital Catholic University
Daejeon, Korea, Republic of
Asan Medical Center
GangNeung, Korea, Republic of
Chonbuk National University Hospital
Jeonju, Korea, Republic of
Kyungsang University Hospital
Jinju, Korea, Republic of
Inje University Pusan Paik Hospital
Pusan, Korea, Republic of
Pusan Natioanal University Hospital
Pusan, Korea, Republic of
Hallym University Sacred Heart Hospital
PyeongChon, Korea, Republic of
Korea Veterans Hospital
Seoul, 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
Ulsan University Hospital
Ulsan, Korea, Republic of
Sponsors and Collaborators
CardioVascular Research Foundation, Korea
Investigators
Principal Investigator: Seong-Wook Park, MD, PhD Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine
  More Information

No publications provided

Responsible Party: Seong-Wook Park, CardioVascular Research Foundation
ClinicalTrials.gov Identifier: NCT00997763     History of Changes
Other Study ID Numbers: 2008-0220
Study First Received: October 18, 2009
Last Updated: April 25, 2011
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by CardioVascular Research Foundation, Korea:
stenting, XIENCE V, CYPHER

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Diabetes Mellitus
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Heart Diseases
Metabolic Diseases
Vascular Diseases
Everolimus
Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014