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

Phase 4

Completed

• Conditions: Coronary Artery Disease
• Interventions: Device: XIENCE V; Device: CYPHER

• Registration Number: NCT00997763
• Lead Sponsor: Seung-Jung Park

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.

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 Timeline

• Study Start: 2008-07
• Study First Submitted: 2009-10-18
• Study First Submitted QC: 2009-10-18
• Study First Posted: 2009-10-19
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-12
• Last Update Posted: 2016-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
XIENCE V	XIENCE V	everolimus-eluting stent
CYPHER	CYPHER	Using Cypher stent

Primary Outcome Measures

Name	Time	Method
Angiographic in-segment late loss at angiography	8-month

Secondary Outcome Measures

Name	Time	Method
All-cause Death	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)	5 year
Cardiac death	5 year
Myocardial infarction	5 year
Angiographic pattern of restenosis	8 months
Binary restenosis in both in-stent and in-segment	8 months

Trial Locations

Locations (16)

Busan Saint Mary's Hospital; 🇰🇷 Busan, Korea, Republic of

Cheongju Saint Mary's Hospital; 🇰🇷 Cheongju, Korea, Republic of

Soonchunhyang University Bucheon Hospital; 🇰🇷 Bucheon, Korea, Republic of

Soonchunhyang University Cheonan Hospital; 🇰🇷 Cheonan, 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; 🇰🇷 Seoul, 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; 🇰🇷 Seoul, Korea, Republic of

Soonchunhyang University Seoul Hospital; 🇰🇷 Seoul, Korea, Republic of

Ulsan University Hospital; 🇰🇷 Ulsan, Korea, Republic of

Korea Veterans Hospital; 🇰🇷 Seoul, Korea, Republic of