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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
888
Xience V stent
coronary artery bypass graft surgery
Sir Run Run Shaw Hospital
Hangzhou, China
the composite of death, nonfatal myocardial infarction, and ischemia-driven target vessel revascularization (TVR)
Death includes all cause mortality. MI includes both Q wave and non Q wave, per protocol definition. TVR should be defined by the protocol.
Time frame: at 2 years
the composite of death, myocardial infarction, and any target vessel revascularization
Time frame: at 2years
Ischemic MACCE (The composite of death, MI, stroke and ischemia-driven TVR)
Time frame: at 2 years
MACCE (The composite of death, MI, stroke and any TVR)
Time frame: at 2 years
the composite of death, MI, and any TVR
Time frame: at 30 days and yearly to 5 years
ischemic MACE(the composite of death, MI, and any TVR)
Time frame: at 30 days and yearly to 5 years
MACCE (The composite of death, MI, stroke and ischemia-driven TVR)
Time frame: at 30 days and yearly to 5 years
ischemic MACCE(The composite of death, MI, stroke and ischemia-driven TVR)
Time frame: at 30 days and yearly to 5 years
all cause death
Time frame: at 30 days and yearly to 5 years
cardiac death
Time frame: at 30 days and yearly to 5 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Zhongshan Hospital
Shanghai, China
National Heart Institue
Kuala Lumpur, Malaysia
Sarawak General Hospital
Kuching, Malaysia
Gangwon National Univ. Hospital
Chuncheon, South Korea
Keimyung University Dongsan Medical Center
Daegu, South Korea
Yeungnam University Medical Center
Daegu, South Korea
Konyang University Hospital
Daejeon, South Korea
Chonnam National University Hospital
Gwangju, South Korea
Inje University Ilsan Paik Hospital
Ilsan, South Korea
...and 17 more locations
myocardial infarction
Time frame: at 3o days and yearly to 5 years
stroke
Time frame: at 30 days and yearly to 5 years
ischemic-driven TVR
Time frame: at 30 days and yearly to 5 years
any target vessel revascularization
Time frame: at 30 days and yearly to 5 years
any target vessel revascularization or target lesion revascularization
Time frame: at 30 days and yearly to 5 years
non-target vessel revascularization
Time frame: at 30 days and yearly to 5 years
stent thrombosis for the percutaneous coronary intervention arm; acute, subacute, and late
Time frame: at 30 days and yearly to 5 years
analysis segment and in-stent binary restenosis
Time frame: at 9 months angiographic follow-up
analysis segment and in-stent late loss
Time frame: at 9 months angiographic follow-up
angina status
Time frame: at 2 years
Follow-up in-stent, in-segment neointimal hyperplasia volume by IVUS
Time frame: at 9 months angiographic follow-up
Incidence of stent malapposition, strut fracture, and peri-stent remodeling by IVUS
Time frame: at 9 months angiographic follow-up
Graft patency in subjects undergoing CABG (defined as: stenosis [DS>50%] in any of the grafts from touch-down to touch-down point)
Time frame: at 9 months angiographic follow up
Cardiac re-hospitalizations
Time frame: at 1 years and yearly to 5 years
Quality of life measurements
Time frame: at 1 year
use of cardiac medications
Time frame: at 1 year and yearly to 5 years
Dialysis/hemofiltration
Time frame: at 30 days and yearly to 5 years
Infectious complications
Time frame: at 30 days
duration of hospitalization related to the target procedure
Time frame: at every event time
2-year MACE according to the use of FFR-guided multivessel PCI
Time frame: at 2 years after index procedure