Comparison of the Efficacy of Everolimus-Eluting Versus Sirolimus-Eluting Stent for Coronary Lesions
试验速览
- 阶段
- 4 期
- 入组人数
- 1,466
- 试验地点
- 1
- 主要终点
- In-segment late luminal loss (LL) at 9 months for comparison of stenting with EECSS vs. SECSS.
研究概览
简要总结
Objectives
- To evaluate the safety and long-term effectiveness of coronary stenting with the Everolimus-eluting coronary stent system(EECSS) (XIENCETM V, Abbott Vascular, Santa Clara, CA, PromusTM, Boston Scientific, Natick, MA), compared with the sirolimus-eluting coronary stent system(SECSS) (CypherTM, Cordis Johnson & Johnson, Warren, NJ) in the treatment of coronary stenosis.
- To evaluate the safety and efficacy of 6-month clopidogrel therapy compared with 12-month clopidogrel therapy.
Study Design: Prospective, open label, two-arm, randomized multi-center trial to test the non-inferiority of EECSS compared with the SECSS, and to test the non-inferiority of 6 months duration compared with 12 months duration of clopidogrel therapy. Patients will be randomized in a two by two factorial manner according to the type of drug eluting stent (EECSS vs. SECSS) and the duration of dual anti-platelet therapy (6 months vs. 12 months). Randomization will also be stratified per hospital for the presence of DM and the presence of long lesions (lesion length ≥ 28mm)
Patient Enrollment: 1,372 patients enrolled at 17 centers in Korea.
Patient Follow-Up: Clinical follow-up will occur at 1, 3, and 9 months, and at 1, 2, 3, 4, and 5 years. Investigator or designee may conduct follow-up as telephone contacts or office visits.
Primary Endpoint
- In-segment late luminal loss (LL) at 9 months for comparison of stenting with EECSS vs. SECSS.
- Target vessel failure (TVF) (cardiac death, myocardial infarction, ischemia driven target vessel revascularization) at 12 months for comparison of 6 months vs. 12 months of clopidogrel therapy
Secondary Endpoint
- All Death
- Cardiac death
- Myocardial infarction
- Target vessel revascularization (TVR) (all and ischemia-driven)
- Target lesion revascularization (TLR) (all and ischemia-driven)
- Stent thrombosis
- Acute success (device, lesion, and procedure)
- Bleeding
- Cerebrovascular accident
- In-stent LL at 9 months
- Angiographic pattern of restenosis at 9-month angiographic follow-up
- In-stent and in-segment % diameter stenosis (%DS) at 9 months
- In-stent % volume obstruction (%VO) at 9 months
- Incomplete stent apposition post index procedure
- Persisting incomplete stent apposition, late-acquired incomplete stent apposition, aneurysm, thrombosis, and persisting dissection at 9 months
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
- None
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
- •Subject must be at least 18 years of age.
- •Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving the XIENCE V EECS and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.
- •Subject must have significant coronary artery stenosis (>50% by visual estimate)
- •Subject must have evidence of myocardial ischemia (e.g., stable, unstable angina, recent infarction, silent ischemia, positive functional study or a reversible changes in the electrocardiogram (ECG) consistent with ischemia. In subjects with coronary artery stenosis > 75%, evidence of myocardial ischemia does not have to be documented.
- •Subjects must be an acceptable candidate for Coronary Artery Bypass Graft (CABG) surgery.
- •Angiographically Inclusion Criteria
- •Target lesion(s) must be located in a native coronary artery with visually estimated diameter of ≥ 2.25 mm and ≤ 4.25 mm.
- •Target lesion(s) must be amenable for percutaneous coronary intervention
排除标准
- •The patient has a known hypersensitivity or contraindication to any of the following medications (heparin, aspirin, clopidogrel, sirolimus, everolimus, Contrast media
- •Systemic (intravenous) Sirolimus, everolimus use within 12 months.
- •Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study.
- •History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions.
- •Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months.
- •Current known current platelet count <100,000 cells/mm3 or Hgb <10 g/dL.
- •An elective surgical procedure is planned that would necessitate interruption of clopidogrel during the first 12 months post enrollment.
- •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).
- •Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
- •Patients who have received any stent implantation in the target vessel prior to enrollment.
- •Patients with LVEF<25% or those with cardiogenic shock
- •Patients with myocardial infarction within 72 hours
- •Creatinine level ≥ 3.0mg/dL or dependence on dialysis.
- •Severe hepatic dysfunction (AST and ALT: 3 times upper normal reference values).
- •Angiographic Exclusion Criteria
- •Patients with significant left main coronary artery stenosis
- •Patients who's target lesion has in-stent restenosis at the stented segment of drug-eluting stents or bare metal stents
- •Target lesions with chronic total occlusion
- •True bifurcation lesions requiring two stents
研究组 & 干预措施
E6
Everolimus-eluting stent 6-month clopidogrel therapy
干预措施: Everolimus-eluting stent (Xience or Promus) (Device)
E6
Everolimus-eluting stent 6-month clopidogrel therapy
干预措施: 6-month clopidogrel therapy (Drug)
S6
Sirolimus-eluting stent 6-month clopidogrel therapy
干预措施: Sirolimus-eluting stent (Cypher) (Device)
S6
Sirolimus-eluting stent 6-month clopidogrel therapy
干预措施: 6-month clopidogrel therapy (Drug)
E12
Everolimus-eluting stent 12-month clopidogrel therapy
干预措施: Everolimus-eluting stent (Xience or Promus) (Device)
E12
Everolimus-eluting stent 12-month clopidogrel therapy
干预措施: 12-month clopidogrel therapy (Drug)
S12
Sirolimus-eluting stent 12-month clopidogrel therapy
干预措施: Sirolimus-eluting stent (Cypher) (Device)
S12
Sirolimus-eluting stent 12-month clopidogrel therapy
干预措施: 12-month clopidogrel therapy (Drug)
结局指标
主要结局
In-segment late luminal loss (LL) at 9 months for comparison of stenting with EECSS vs. SECSS.
时间窗: 9 months
Target vessel failure (TVF) (cardiac death, myocardial infarction, ischemia driven target vessel revascularization) at 12 months for comparison of 6 months vs. 12 months of clopidogrel therapy
时间窗: 12 months
次要结局
- All death(5 years)
- Cardiac death(5 Years)
- Myocardial infarction(5 years)
- Target vessel revascularization (TVR) (all and ischemia-driven)(5 years)
- Target lesion revascularization (TLR) (all and ischemia-driven)(5 years)
- Stent thrombosis(5 years)
- Acute success (device, lesion, and procedure)(Index procedure)
- Bleeding(5 years)
- Cerebrovascular accident(5 years)
- In-stent LL at 9 months(9 months)
- Angiographic pattern of restenosis at 9-month angiographic follow-up(9 months)
- In-stent and in-segment % diameter stenosis (%DS) at 9 months(9 months)
- In-stent % volume obstruction (%VO) at 9 months(9 months)
- Incomplete stent apposition post index procedure(Index procedure)
- Persisting incomplete stent apposition, late-acquired incomplete stent apposition, aneurysm, thrombosis, and persisting dissection at 9 months(9 months)