NCT00997828终止不适用
Randomized Comparison of Coronary Artery Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients With Multivessel Coronary Artery Disease (BEST)
Seung-Jung Park27 个研究点 分布在 4 个国家目标入组 888 人开始时间: 2008年7月28日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 888
- 试验地点
- 27
- 主要终点
- the composite of death, nonfatal myocardial infarction, and ischemia-driven target vessel revascularization (TVR)
研究概览
简要总结
The purpose of this study is to determine whether the safety and efficacy of coronary stent implantation using Everolimus-Eluting Coronary Stent System (Abbott, Boston Scientific) is not inferior to coronary artery bypass grafting (CABG) for the treatment of patient with multivessel coronary artery disease (CAD).
详细描述
The primary purpose of the BEST Study is to determine whether the safety and efficacy of coronary stent implantation using everolimus-eluting balloon expandable stents is not inferior to coronary artery bypass grafting for the treatment of multivessel coronary artery disease.
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
- •Age 18 years of older
- •Angiographically confirmed multivessel CAD [critical (>70%) lesions in at least two major epicardial vessels and in at least two separate coronary artery territories (LAD, LCX, RCA)] and amenable to either PCI or CABG.
- •Indication for revascularization based upon symptoms of angina and/or objective evidence of myocardial ischemia
- •Geographically accessible and willing to come in for required study visits
- •Signed informed consent.
排除标准
- •Severe congestive heart failure (class III or IV according to NYHA, or pulmonary edema) at the time of enrollment.
- •Planned simultaneous surgical procedure unrelated to coronary revascularization (e.g. valve repair/replacement, aneurysmectomy, carotid endarterectomy or carotid stent).
- •In-stent restenosis of a target vessel
- •Prior CABG surgery
- •Prior PCI with stent implantation within 1 year
- •Two or more chronic total occlusions in major coronary territories
- •Acute ST-elevation MI(Q-wave) within 72 hours prior to enrollment requiring revascularization
- •Abnormal creatine kinase (CK > 2x normal) and/or abnormal CK-MB levels and/or elevated Troponin levels at time of randomization
- •Previous stroke within 6 months or patients with stroke at more than 6 months with significant residual neurologic involvement, as reflected in a Rankin Score > 1
- •Dementia with a Mini Mental Status Examination (MMSE) score of ≤ 20
- •Extra-cardiac illness that is expected to limit survival to less than 2 years; e.g. oxygen-dependent chronic obstructive pulmonary disease, active hepatitis or significant hepatic failure, severe renal disease.
- •Prior history of significant bleeding (within the previous 6 months) that might be expected to occur during CABG or PCI/DES related anticoagulation.
- •Contraindication either CABG or PCI/DES because of a coexisting clinical condition
- •Significant leucopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis
- •Intolerance or contraindication to aspirin or both clopidogrel and ticlopidine
- •Suspected pregnancy. A pregnancy test (urine or serum) will be administered prerandomization to all women not clearly menopausal
- •Concurrent enrollment in another clinical trial
研究组 & 干预措施
everolimus-eluting stent
Experimental
everolimus-eluting stent
干预措施: everolimus-eluting stent (Device)
coronary artery bypass graft surgery
Active Comparator
coronary artery bypass graft surgery
干预措施: coronary artery bypass graft surgery (Procedure)
结局指标
主要结局
the composite of death, nonfatal myocardial infarction, and ischemia-driven target vessel revascularization (TVR)
时间窗: at 2 years
Death includes all cause mortality. MI includes both Q wave and non Q wave, per protocol definition. TVR should be defined by the protocol.
次要结局
- myocardial infarction(at 3o days and yearly to 5 years)
- angina status(at 2 years)
- stroke(at 30 days and yearly to 5 years)
- Cardiac re-hospitalizations(at 1 years and yearly to 5 years)
- 2-year MACE according to the use of FFR-guided multivessel PCI(at 2 years after index procedure)
- non-target vessel revascularization(at 30 days and yearly to 5 years)
- cardiac death(at 30 days and yearly to 5 years)
- the composite of death, myocardial infarction, and any target vessel revascularization(at 2years)
- the composite of death, MI, and any TVR(at 30 days and yearly to 5 years)
- Ischemic MACCE (The composite of death, MI, stroke and ischemia-driven TVR)(at 2 years)
- MACCE (The composite of death, MI, stroke and any TVR)(at 2 years)
- ischemic MACE(the composite of death, MI, and any TVR)(at 30 days and yearly to 5 years)
- MACCE (The composite of death, MI, stroke and ischemia-driven TVR)(at 30 days and yearly to 5 years)
- Follow-up in-stent, in-segment neointimal hyperplasia volume by IVUS(at 9 months angiographic follow-up)
- any target vessel revascularization(at 30 days and yearly to 5 years)
- any target vessel revascularization or target lesion revascularization(at 30 days and yearly to 5 years)
- stent thrombosis for the percutaneous coronary intervention arm; acute, subacute, and late(at 30 days and yearly to 5 years)
- all cause death(at 30 days and yearly to 5 years)
- ischemic-driven TVR(at 30 days and yearly to 5 years)
- analysis segment and in-stent binary restenosis(at 9 months angiographic follow-up)
- analysis segment and in-stent late loss(at 9 months angiographic follow-up)
- Quality of life measurements(at 1 year)
- ischemic MACCE(The composite of death, MI, stroke and ischemia-driven TVR)(at 30 days and yearly to 5 years)
- Incidence of stent malapposition, strut fracture, and peri-stent remodeling by IVUS(at 9 months angiographic follow-up)
- Dialysis/hemofiltration(at 30 days and yearly to 5 years)
- Infectious complications(at 30 days)
- duration of hospitalization related to the target procedure(at every event time)
- Graft patency in subjects undergoing CABG (defined as: stenosis [DS>50%] in any of the grafts from touch-down to touch-down point)(at 9 months angiographic follow up)
- use of cardiac medications(at 1 year and yearly to 5 years)
研究者
Seung-Jung Park
MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine
CardioVascular Research Foundation, Korea
研究点 (27)
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