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Bypass Surgery Versus Everolimus-Eluting Stent Implantation for Multivessel Coronary Artery Disease (BEST) (BEST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00997828
Recruitment Status : Terminated (Problem with recruitment of subjects)
First Posted : October 19, 2009
Last Update Posted : May 10, 2019
Sponsor:
Collaborators:
Abbott Medical Devices
CardioVascular Research Foundation, Korea
Information provided by (Responsible Party):
Seung-Jung Park, CardioVascular Research Foundation, Korea

Tracking Information
First Submitted Date  ICMJE October 18, 2009
First Posted Date  ICMJE October 19, 2009
Last Update Posted Date May 10, 2019
Actual Study Start Date  ICMJE July 28, 2008
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 2, 2011)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 18, 2009)
the composite of death (all cause mortality), nonfatal myocardial infarction (both Q wave and non Q wave, per protocol definition) and ischemia-driven target vessel revascularization (TVR, as per protocol definition) at a mean of 2 years follow-up. [ Time Frame: at 2 years ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 7, 2012)
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 18, 2009)
  • 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 ]
  • 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 ]
  • anlysis 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bypass Surgery Versus Everolimus-Eluting Stent Implantation for Multivessel Coronary Artery Disease (BEST)
Official Title  ICMJE Randomized Comparison of Coronary Artery Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients With Multivessel Coronary Artery Disease (BEST)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Coronary Artery Disease
Intervention  ICMJE
  • Device: everolimus-eluting stent
    Xience V stent
    Other Name: everolimu-eluting stent
  • Procedure: coronary artery bypass graft surgery
    coronary artery bypass graft surgery
Study Arms  ICMJE
  • Experimental: everolimus-eluting stent
    everolimus-eluting stent
    Intervention: Device: everolimus-eluting stent
  • Active Comparator: coronary artery bypass graft surgery
    coronary artery bypass graft surgery
    Intervention: Procedure: coronary artery bypass graft surgery
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 25, 2014)
888
Original Estimated Enrollment  ICMJE
 (submitted: October 18, 2009)
1776
Actual Study Completion Date  ICMJE April 5, 2019
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China,   Korea, Republic of,   Malaysia,   Thailand
Removed Location Countries Hong Kong
 
Administrative Information
NCT Number  ICMJE NCT00997828
Other Study ID Numbers  ICMJE 2008-0272
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Seung-Jung Park, CardioVascular Research Foundation, Korea
Study Sponsor  ICMJE Seung-Jung Park
Collaborators  ICMJE
  • Abbott Medical Devices
  • CardioVascular Research Foundation, Korea
Investigators  ICMJE
Principal Investigator: Seung-Jung Park, MD, PhD Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine
PRS Account CardioVascular Research Foundation, Korea
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP