Comparison of Everolimus-Eluting Stent vs Sirolimus-Eluting Stent in Patients With DIABETES Mellitus

Coronary Artery Disease Clinical Trial

— ESSENCE-DM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00997763
• Other study ID #: 2008-0220
• Status: Completed
• Phase: Phase 4
• First received: October 18, 2009
• Last updated: December 12, 2016
• Start date: July 2008
• Est. completion date: August 2015

Study information

• Verified date: December 2016
• Source: CardioVascular Research Foundation, Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Diabetes Mellitus
• Myocardial Ischemia

Intervention

Device:
• XIENCE V
everolimus-eluting stent
• CYPHER
sirolimus-eluting stent

Locations

Country	Name	City	State
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

Sponsors (2)

Lead Sponsor	Collaborator
Seung-Jung Park	CardioVascular Research Foundation, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Angiographic in-segment late loss at angiography		8-month	Yes
Secondary	All-cause Death		12 month	Yes
Secondary	All-cause Death		5 year	Yes
Secondary	Cardiac death		12 months	Yes
Secondary	Cardiac death		5 year	Yes
Secondary	Myocardial infarction		12 months	Yes
Secondary	Myocardial infarction		5 year	Yes
Secondary	Target vessel revascularization (all and ischemia-driven)		12 months	Yes
Secondary	Target lesion revascularization (all and ischemia-driven)		5 year	Yes
Secondary	Stent thrombosis by definition of Academic Research Consortium (ARC)		12 months	Yes
Secondary	Stent thrombosis by definition of Academic Research Consortium (ARC)		5 year	Yes
Secondary	Binary restenosis in both in-stent and in-segment		8 months	Yes
Secondary	Angiographic pattern of restenosis		8 months	Yes