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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00997763
Recruitment Status : Completed
First Posted : October 19, 2009
Last Update Posted : December 13, 2016
CardioVascular Research Foundation, Korea
Information provided by (Responsible Party):
Seung-Jung Park, CardioVascular Research Foundation, Korea

Brief Summary:
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 or disease Intervention/treatment Phase
Coronary Artery Disease Device: XIENCE V Device: CYPHER Phase 4

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)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
Study Start Date : July 2008
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Angiographic in-segment late loss at angiography [ Time Frame: 8-month ]

Secondary Outcome Measures :
  1. All-cause Death [ Time Frame: 12 month ]
  2. All-cause Death [ Time Frame: 5 year ]
  3. Cardiac death [ Time Frame: 12 months ]
  4. Cardiac death [ Time Frame: 5 year ]
  5. Myocardial infarction [ Time Frame: 12 months ]
  6. Myocardial infarction [ Time Frame: 5 year ]
  7. Target vessel revascularization (all and ischemia-driven) [ Time Frame: 12 months ]
  8. Target lesion revascularization (all and ischemia-driven) [ Time Frame: 5 year ]
  9. Stent thrombosis by definition of Academic Research Consortium (ARC) [ Time Frame: 12 months ]
  10. Stent thrombosis by definition of Academic Research Consortium (ARC) [ Time Frame: 5 year ]
  11. Binary restenosis in both in-stent and in-segment [ Time Frame: 8 months ]
  12. Angiographic pattern of restenosis [ Time Frame: 8 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00997763

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Sponsors and Collaborators
Seung-Jung Park
CardioVascular Research Foundation, Korea
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Responsible Party: Seung-Jung Park, MD, PhD, CardioVascular Research Foundation, Korea Identifier: NCT00997763    
Other Study ID Numbers: 2008-0220
First Posted: October 19, 2009    Key Record Dates
Last Update Posted: December 13, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: This is not a publicly funded trial.
Keywords provided by Seung-Jung Park, CardioVascular Research Foundation, Korea:
stenting, XIENCE V, CYPHER
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases