Coronary Artery Disease
Conditions
Keywords
Coronary Artery Disease, stent, coronary artery bypass graft surgery, multivessel coronary artery disease
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.
Interventions
DEVICEeverolimus-eluting stent
Xience V stent
PROCEDUREcoronary artery bypass graft surgery
coronary artery bypass graft surgery
Sponsors
Abbott Medical Devices
CardioVascular Research Foundation, Korea
Seung-Jung Park
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| use of cardiac medications | at 1 year and yearly to 5 years |
| 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 |
| 2-year MACE according to the use of FFR-guided multivessel PCI | at 2 years after index procedure |
| 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 |
| the composite of death, myocardial infarction, and any target vessel revascularization | at 2years |
| 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 |
| the composite of death, MI, and any TVR | at 30 days and yearly to 5 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 |
| ischemic MACCE(The composite of death, MI, stroke and ischemia-driven TVR) | at 30 days and yearly to 5 years |
| all cause death | at 30 days and yearly to 5 years |
| Quality of life measurements | at 1 year |
| myocardial infarction | at 3o days and yearly to 5 years |
| stroke | at 30 days and yearly to 5 years |
| ischemic-driven TVR | at 30 days and yearly to 5 years |
| Cardiac re-hospitalizations | at 1 years and yearly to 5 years |
| 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 |
| non-target vessel 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 |
| 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 |
| angina status | at 2 years |
| Follow-up in-stent, in-segment neointimal hyperplasia volume by IVUS | at 9 months angiographic follow-up |
| Incidence of stent malapposition, strut fracture, and peri-stent remodeling by IVUS | at 9 months angiographic follow-up |
| cardiac death | at 30 days and yearly to 5 years |
Countries
China, Malaysia, South Korea, Thailand
Outcome results
None listed