Bypass Surgery Versus Everolimus-Eluting Stent Implantation for Multivessel Coronary Artery Disease (BEST)
- Conditions
- Coronary Artery Disease
- Interventions
- Procedure: coronary artery bypass graft surgeryDevice: everolimus-eluting stent
- Registration Number
- NCT00997828
- Lead Sponsor
- Seung-Jung Park
- Brief Summary
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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 888
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description coronary artery bypass graft surgery coronary artery bypass graft surgery coronary artery bypass graft surgery everolimus-eluting stent everolimus-eluting stent everolimus-eluting stent
- Primary Outcome Measures
Name Time Method the composite of death, nonfatal myocardial infarction, and ischemia-driven target vessel revascularization (TVR) 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.
- Secondary Outcome Measures
Name Time Method angina status at 2 years stroke at 30 days and yearly to 5 years 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 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 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 myocardial infarction at 3o 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
Trial Locations
- Locations (27)
Keimyung University Dongsan Medical Center
🇰🇷Daegu, Korea, Republic of
Yeungnam University Medical Center
🇰🇷Daegu, Korea, Republic of
National Health Insurance Corporation Ilsan Hospital
🇰🇷Ilsan, Korea, Republic of
Gangwon National Univ. Hospital
🇰🇷Chuncheon, Korea, Republic of
Konyang University Hospital
🇰🇷Daejeon, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
Inje University Ilsan Paik Hospital
🇰🇷Ilsan, Korea, Republic of
Severance Hospital
🇰🇷Seoul, Korea, Republic of
Gachon University Gil Hospital
🇰🇷Incheon, Korea, Republic of
Chonnam National University Hospital
🇰🇷Gwangju, Korea, Republic of
Inje University Pusan Paik Hospital
🇰🇷Pusan, Korea, Republic of
St.carollo Hospital
🇰🇷Suncheon, Korea, Republic of
Inje University Sanggye Paik Hospital
🇰🇷Seoul, Korea, Republic of
National Heart Institue
🇲🇾Kuala Lumpur, Malaysia
Sir Run Run Shaw Hospital
🇨🇳Hangzhou, China
Zhongshan Hospital
🇨🇳Shanghai, China
Siriraj Hospital
🇹🇭Bangkok, Thailand
Sarawak General Hospital
🇲🇾Kuching, Malaysia
Pusan National University Yangsan Hospital
🇰🇷Pusan, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Gangnam Severance Hospital
🇰🇷Seoul, Korea, Republic of
Hanyang National University Medical Center
🇰🇷Seoul, Korea, Republic of
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea Seoul St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea, Yeouido St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Wonju Christian Hospital
🇰🇷Wonju, Korea, Republic of
Ulsan University Hospital
🇰🇷Ulsan, Korea, Republic of