Randomized Comparison of Everolimus- Eluting Stent Versus Sirolimus-Eluting Stent Implantation for De Novo Coronary Artery DisEase in Patients With DIABETES Mellitus
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 18
- 主要终点
- Angiographic in-segment late loss at angiography
研究概览
简要总结
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.
详细描述
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •Left main disease
- •In-stent restenosis
- •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).
结局指标
主要结局
Angiographic in-segment late loss at angiography
时间窗: 8-month
次要结局
- 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)
研究者
Seung-Jung Park
MD, PhD
CardioVascular Research Foundation, Korea