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

Primary Purpose

Coronary Artery Disease

Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
everolimus-eluting stent
coronary artery bypass graft surgery
Sponsored by
Seung-Jung Park
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary Artery Disease, stent, coronary artery bypass graft surgery, multivessel coronary artery disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sir Run Run Shaw Hospital
  • Zhongshan Hospital
  • Gangwon National Univ. Hospital
  • Keimyung University Dongsan Medical Center
  • Yeungnam University Medical Center
  • Konyang University Hospital
  • Chonnam National University Hospital
  • Inje University Ilsan Paik Hospital
  • National Health Insurance Corporation Ilsan Hospital
  • Gachon University Gil Hospital
  • Inje University Pusan Paik Hospital
  • Pusan National University Yangsan Hospital
  • Asan Medical Center
  • Gangnam Severance Hospital
  • Hanyang National University Medical Center
  • Inje University Sanggye Paik Hospital
  • Korea University Anam Hospital
  • Korea University Guro Hospital
  • Severance Hospital
  • The Catholic University of Korea Seoul St. Mary's Hospital
  • The Catholic University of Korea, Yeouido St. Mary's Hospital
  • St.carollo Hospital
  • Ulsan University Hospital
  • Wonju Christian Hospital
  • National Heart Institue
  • Sarawak General Hospital
  • Siriraj Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

everolimus-eluting stent

coronary artery bypass graft surgery

Arm Description

everolimus-eluting stent

coronary artery bypass graft surgery

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

the composite of death, myocardial infarction, and any target vessel revascularization
Ischemic MACCE (The composite of death, MI, stroke and ischemia-driven TVR)
MACCE (The composite of death, MI, stroke and any TVR)
the composite of death, MI, and any TVR
ischemic MACE(the composite of death, MI, and any TVR)
MACCE (The composite of death, MI, stroke and ischemia-driven TVR)
ischemic MACCE(The composite of death, MI, stroke and ischemia-driven TVR)
all cause death
cardiac death
myocardial infarction
stroke
ischemic-driven TVR
any target vessel revascularization
any target vessel revascularization or target lesion revascularization
non-target vessel revascularization
stent thrombosis for the percutaneous coronary intervention arm; acute, subacute, and late
analysis segment and in-stent binary restenosis
analysis segment and in-stent late loss
angina status
Follow-up in-stent, in-segment neointimal hyperplasia volume by IVUS
Incidence of stent malapposition, strut fracture, and peri-stent remodeling by IVUS
Graft patency in subjects undergoing CABG (defined as: stenosis [DS>50%] in any of the grafts from touch-down to touch-down point)
Cardiac re-hospitalizations
Quality of life measurements
use of cardiac medications
Dialysis/hemofiltration
Infectious complications
duration of hospitalization related to the target procedure
2-year MACE according to the use of FFR-guided multivessel PCI

Full Information

First Posted
October 18, 2009
Last Updated
May 8, 2019
Sponsor
Seung-Jung Park
Collaborators
Abbott Medical Devices, CardioVascular Research Foundation, Korea
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1. Study Identification

Unique Protocol Identification Number
NCT00997828
Brief Title
Bypass Surgery Versus Everolimus-Eluting Stent Implantation for Multivessel Coronary Artery Disease (BEST)
Acronym
BEST
Official Title
Randomized Comparison of Coronary Artery Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients With Multivessel Coronary Artery Disease (BEST)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Terminated
Why Stopped
Problem with recruitment of subjects
Study Start Date
July 28, 2008 (Actual)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 5, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Seung-Jung Park
Collaborators
Abbott Medical Devices, CardioVascular Research Foundation, Korea

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Coronary Artery Disease, stent, coronary artery bypass graft surgery, multivessel coronary artery disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
888 (Actual)

8. Arms, Groups, and Interventions

Arm Title
everolimus-eluting stent
Arm Type
Experimental
Arm Description
everolimus-eluting stent
Arm Title
coronary artery bypass graft surgery
Arm Type
Active Comparator
Arm Description
coronary artery bypass graft surgery
Intervention Type
Device
Intervention Name(s)
everolimus-eluting stent
Other Intervention Name(s)
everolimu-eluting stent
Intervention Description
Xience V stent
Intervention Type
Procedure
Intervention Name(s)
coronary artery bypass graft surgery
Intervention Description
coronary artery bypass graft surgery
Primary Outcome Measure Information:
Title
the composite of death, nonfatal myocardial infarction, and ischemia-driven target vessel revascularization (TVR)
Description
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
Secondary Outcome Measure Information:
Title
the composite of death, myocardial infarction, and any target vessel revascularization
Time Frame
at 2years
Title
Ischemic MACCE (The composite of death, MI, stroke and ischemia-driven TVR)
Time Frame
at 2 years
Title
MACCE (The composite of death, MI, stroke and any TVR)
Time Frame
at 2 years
Title
the composite of death, MI, and any TVR
Time Frame
at 30 days and yearly to 5 years
Title
ischemic MACE(the composite of death, MI, and any TVR)
Time Frame
at 30 days and yearly to 5 years
Title
MACCE (The composite of death, MI, stroke and ischemia-driven TVR)
Time Frame
at 30 days and yearly to 5 years
Title
ischemic MACCE(The composite of death, MI, stroke and ischemia-driven TVR)
Time Frame
at 30 days and yearly to 5 years
Title
all cause death
Time Frame
at 30 days and yearly to 5 years
Title
cardiac death
Time Frame
at 30 days and yearly to 5 years
Title
myocardial infarction
Time Frame
at 3o days and yearly to 5 years
Title
stroke
Time Frame
at 30 days and yearly to 5 years
Title
ischemic-driven TVR
Time Frame
at 30 days and yearly to 5 years
Title
any target vessel revascularization
Time Frame
at 30 days and yearly to 5 years
Title
any target vessel revascularization or target lesion revascularization
Time Frame
at 30 days and yearly to 5 years
Title
non-target vessel revascularization
Time Frame
at 30 days and yearly to 5 years
Title
stent thrombosis for the percutaneous coronary intervention arm; acute, subacute, and late
Time Frame
at 30 days and yearly to 5 years
Title
analysis segment and in-stent binary restenosis
Time Frame
at 9 months angiographic follow-up
Title
analysis segment and in-stent late loss
Time Frame
at 9 months angiographic follow-up
Title
angina status
Time Frame
at 2 years
Title
Follow-up in-stent, in-segment neointimal hyperplasia volume by IVUS
Time Frame
at 9 months angiographic follow-up
Title
Incidence of stent malapposition, strut fracture, and peri-stent remodeling by IVUS
Time Frame
at 9 months angiographic follow-up
Title
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
Title
Cardiac re-hospitalizations
Time Frame
at 1 years and yearly to 5 years
Title
Quality of life measurements
Time Frame
at 1 year
Title
use of cardiac medications
Time Frame
at 1 year and yearly to 5 years
Title
Dialysis/hemofiltration
Time Frame
at 30 days and yearly to 5 years
Title
Infectious complications
Time Frame
at 30 days
Title
duration of hospitalization related to the target procedure
Time Frame
at every event time
Title
2-year MACE according to the use of FFR-guided multivessel PCI
Time Frame
at 2 years after index procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seung-Jung Park, MD, PhD
Organizational Affiliation
Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sir Run Run Shaw Hospital
City
Hangzhou
Country
China
Facility Name
Zhongshan Hospital
City
Shanghai
Country
China
Facility Name
Gangwon National Univ. Hospital
City
Chuncheon
Country
Korea, Republic of
Facility Name
Keimyung University Dongsan Medical Center
City
Daegu
Country
Korea, Republic of
Facility Name
Yeungnam University Medical Center
City
Daegu
Country
Korea, Republic of
Facility Name
Konyang University Hospital
City
Daejeon
Country
Korea, Republic of
Facility Name
Chonnam National University Hospital
City
Gwangju
Country
Korea, Republic of
Facility Name
Inje University Ilsan Paik Hospital
City
Ilsan
Country
Korea, Republic of
Facility Name
National Health Insurance Corporation Ilsan Hospital
City
Ilsan
Country
Korea, Republic of
Facility Name
Gachon University Gil Hospital
City
Incheon
Country
Korea, Republic of
Facility Name
Inje University Pusan Paik Hospital
City
Pusan
Country
Korea, Republic of
Facility Name
Pusan National University Yangsan Hospital
City
Pusan
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Gangnam Severance Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Hanyang National University Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Inje University Sanggye Paik Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Severance Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
The Catholic University of Korea Seoul St. Mary's Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Yeouido St. Mary's Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
St.carollo Hospital
City
Suncheon
Country
Korea, Republic of
Facility Name
Ulsan University Hospital
City
Ulsan
Country
Korea, Republic of
Facility Name
Wonju Christian Hospital
City
Wonju
Country
Korea, Republic of
Facility Name
National Heart Institue
City
Kuala Lumpur
Country
Malaysia
Facility Name
Sarawak General Hospital
City
Kuching
Country
Malaysia
Facility Name
Siriraj Hospital
City
Bangkok
Country
Thailand

12. IPD Sharing Statement

Citations:
PubMed Identifier
35422242
Citation
Takahashi K, Serruys PW, Fuster V, Farkouh ME, Spertus JA, Cohen DJ, Park SJ, Park DW, Ahn JM, Onuma Y, Kent DM, Steyerberg EW, van Klaveren D; SYNTAX, BEST, and FREEDOM Trial investigators. External Validation of the FREEDOM Score for Individualized Decision Making Between CABG and PCI. J Am Coll Cardiol. 2022 Apr 19;79(15):1458-1473. doi: 10.1016/j.jacc.2022.01.049.
Results Reference
derived
PubMed Identifier
28495897
Citation
Sotomi Y, Onuma Y, Cavalcante R, Ahn JM, Lee CW, van Klaveren D, de Winter RJ, Wykrzykowska JJ, Farooq V, Morice MC, Steyerberg EW, Park SJ, Serruys PW. Geographical Difference of the Interaction of Sex With Treatment Strategy in Patients With Multivessel Disease and Left Main Disease: A Meta-Analysis From SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery), PRECOMBAT (Bypass Surgery Versus Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease), and BEST (Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients With Multivessel Coronary Artery Disease) Randomized Controlled Trials. Circ Cardiovasc Interv. 2017 May;10(5):e005027. doi: 10.1161/CIRCINTERVENTIONS.117.005027.
Results Reference
derived
PubMed Identifier
27651390
Citation
Cavalcante R, Sotomi Y, Zeng Y, Lee CW, Ahn JM, Collet C, Tenekecioglu E, Suwannasom P, Onuma Y, Park SJ, Serruys PW. Coronary bypass surgery versus stenting in multivessel disease involving the proximal left anterior descending coronary artery. Heart. 2017 Mar;103(6):428-433. doi: 10.1136/heartjnl-2016-309720. Epub 2016 Sep 20.
Results Reference
derived
PubMed Identifier
27491605
Citation
Sotomi Y, Cavalcante R, van Klaveren D, Ahn JM, Lee CW, de Winter RJ, Wykrzykowska JJ, Onuma Y, Steyerberg EW, Park SJ, Serruys PW. Individual Long-Term Mortality Prediction Following Either Coronary Stenting or Bypass Surgery in Patients With Multivessel and/or Unprotected Left Main Disease: An External Validation of the SYNTAX Score II Model in the 1,480 Patients of the BEST and PRECOMBAT Randomized Controlled Trials. JACC Cardiovasc Interv. 2016 Aug 8;9(15):1564-72. doi: 10.1016/j.jcin.2016.04.023.
Results Reference
derived
PubMed Identifier
25774645
Citation
Park SJ, Ahn JM, Kim YH, Park DW, Yun SC, Lee JY, Kang SJ, Lee SW, Lee CW, Park SW, Choo SJ, Chung CH, Lee JW, Cohen DJ, Yeung AC, Hur SH, Seung KB, Ahn TH, Kwon HM, Lim DS, Rha SW, Jeong MH, Lee BK, Tresukosol D, Fu GS, Ong TK; BEST Trial Investigators. Trial of everolimus-eluting stents or bypass surgery for coronary disease. N Engl J Med. 2015 Mar 26;372(13):1204-12. doi: 10.1056/NEJMoa1415447. Epub 2015 Mar 16.
Results Reference
derived

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

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