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

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ClinicalTrials.gov Identifier: NCT00997763
Recruitment Status : Completed
First Posted : October 19, 2009
Last Update Posted : December 13, 2016
Sponsor:
Collaborator:
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)

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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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).

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 ClinicalTrials.gov identifier (NCT number): 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
Asan Medical Center
Seoul, Korea, Republic of
Hallym University Sacred Heart Hospital
Seoul, Korea, Republic of
Korea Veterans Hospital
Seoul, Korea, Republic of
Soonchunhyang University Seoul Hospital
Seoul, Korea, Republic of
Ulsan University Hospital
Ulsan, Korea, Republic of
Sponsors and Collaborators
Seung-Jung Park
CardioVascular Research Foundation, Korea

Responsible Party: Seung-Jung Park, MD, PhD, CardioVascular Research Foundation, Korea
ClinicalTrials.gov Identifier: NCT00997763     History of Changes
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:
Diabetes Mellitus
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Everolimus
Sirolimus
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents