Clinical trial NCT00997763: Comparison of Everolimus-Eluting Stent vs Sirolimus-Eluting Stent in Patients With DIABETES Mellitus
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: stenting, XIENCE V, CYPHER
Lead sponsor: CardioVascular Research Foundation, Korea
Sponsor class: OTHER
Collaborators: name: CardioVascular Research Foundation, Korea
First posted: 2009-10-19
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

Eligibility 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).

Primary outcomes:
measure: Angiographic in-segment late loss at angiography
timeFrame: 8-month
Secondary outcomes:
measure: All-cause Death
timeFrame: 12 month
measure: All-cause Death
timeFrame: 5 year
measure: Cardiac death
timeFrame: 12 months
measure: Cardiac death
timeFrame: 5 year
measure: Myocardial infarction
timeFrame: 12 months
measure: Myocardial infarction
timeFrame: 5 year
measure: Target vessel revascularization (all and ischemia-driven)
timeFrame: 12 months
measure: Target lesion revascularization (all and ischemia-driven)
timeFrame: 5 year
measure: Stent thrombosis by definition of Academic Research Consortium (ARC)
timeFrame: 12 months
measure: Stent thrombosis by definition of Academic Research Consortium (ARC)
timeFrame: 5 year
measure: Binary restenosis in both in-stent and in-segment
timeFrame: 8 months
measure: Angiographic pattern of restenosis
timeFrame: 8 months
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: Soonchunhyang University Bucheon Hospital
city: Busan
country: Korea, Republic of
facility: Busan Saint Mary's Hospital
city: Cheonan
country: Korea, Republic of
facility: Soonchunhyang University Cheonan Hospital
city: Cheongju
country: Korea, Republic of
facility: Cheongju Saint Mary's Hospital
city: Chuncheon
country: Korea, Republic of
facility: Kangwon University Hospital
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Daejeon
country: Korea, Republic of
facility: Daejeon St Mary's Hospital Catholic University
city: GangNeung
country: Korea, Republic of
facility: Asan Medical Center
city: Jeonju
country: Korea, Republic of
facility: Chonbuk National University Hospital
city: Jinju
country: Korea, Republic of
facility: Kyungsang University Hospital
city: Pusan
country: Korea, Republic of
facility: Inje University Pusan Paik Hospital
city: Pusan
country: Korea, Republic of
facility: Pusan Natioanal University Hospital
city: PyeongChon
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Korea Veterans Hospital
city: Seoul
country: Korea, Republic of
facility: Soonchunhyang University Seoul Hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
Study officials:
References: