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 sites in 4 countries888 target enrollmentJuly 28, 2008

ConditionsCoronary Artery Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Coronary Artery Disease
Sponsor: Seung-Jung Park
Enrollment: 888
Locations: 27
Primary Endpoint: the composite of death, nonfatal myocardial infarction, and ischemia-driven target vessel revascularization (TVR)
Status: Terminated
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 28, 2008

End Date

April 5, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Seung-Jung Park

Responsible Party

Sponsor Investigator

Principal Investigator

Seung-Jung Park

MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine

CardioVascular Research Foundation, Korea

Eligibility Criteria

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

Outcomes

Primary Outcomes

the composite of death, nonfatal myocardial infarction, and ischemia-driven target vessel revascularization (TVR)

Time Frame: 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 Outcomes

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)