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

May 8, 2019 updated by: Seung-Jung Park

Randomized Comparison of Coronary Artery Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients With Multivessel Coronary Artery Disease (BEST)

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
888

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Hangzhou, China
        • Sir Run Run Shaw Hospital
      • Shanghai, China
        • Zhongshan Hospital
  • Korea, Republic of
      • Chuncheon, Korea, Republic of
        • Gangwon National Univ. Hospital
      • Daegu, Korea, Republic of
        • Keimyung University Dongsan Medical Center
      • Daegu, Korea, Republic of
        • Yeungnam University Medical Center
      • Daejeon, Korea, Republic of
        • Konyang University Hospital
      • Gwangju, Korea, Republic of
        • Chonnam National University Hospital
      • Ilsan, Korea, Republic of
        • Inje University Ilsan Paik Hospital
      • Ilsan, Korea, Republic of
        • National Health Insurance Corporation Ilsan Hospital
      • Incheon, Korea, Republic of
        • Gachon University Gil Hospital
      • Pusan, Korea, Republic of
        • Inje University Pusan Paik Hospital
      • Pusan, Korea, Republic of
        • Pusan National University Yangsan Hospital
      • Seoul, Korea, Republic of
        • Asan Medical Center
      • Seoul, Korea, Republic of
        • The Catholic University of Korea Seoul St. Mary'S Hospital
      • Seoul, Korea, Republic of
        • Gangnam Severance Hospital
      • Seoul, Korea, Republic of
        • Korea University Guro Hospital
      • Seoul, Korea, Republic of
        • Severance Hospital
      • Seoul, Korea, Republic of
        • Korea University Anam Hospital
      • Seoul, Korea, Republic of
        • The Catholic University of Korea, Yeouido St. Mary's Hospital
      • Seoul, Korea, Republic of
        • Inje University Sanggye Paik Hospital
      • Seoul, Korea, Republic of
        • Hanyang National University Medical Center
      • Suncheon, Korea, Republic of
        • St.carollo Hospital
      • Ulsan, Korea, Republic of
        • Ulsan University Hospital
      • Wonju, Korea, Republic of
        • Wonju Christian Hospital
  • Malaysia
      • Kuala Lumpur, Malaysia
        • National Heart Institue
      • Kuching, Malaysia
        • Sarawak General Hospital
  • Thailand
      • Bangkok, Thailand
        • Siriraj Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: everolimus-eluting stent
Device: everolimus-eluting stent
Xience V stent
Other Names:
  • everolimu-eluting stent
Active Comparator: coronary artery bypass graft surgery
Procedure: coronary artery bypass graft surgery
coronary artery bypass graft surgery

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
at 2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
the composite of death, myocardial infarction, and any target vessel revascularization
Time Frame: at 2years
at 2years
Ischemic MACCE (The composite of death, MI, stroke and ischemia-driven TVR)
Time Frame: at 2 years
at 2 years
MACCE (The composite of death, MI, stroke and any TVR)
Time Frame: at 2 years
at 2 years
the composite of death, MI, and any TVR
Time Frame: at 30 days and yearly to 5 years
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
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
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
at 30 days and yearly to 5 years
all cause death
Time Frame: at 30 days and yearly to 5 years
at 30 days and yearly to 5 years
cardiac death
Time Frame: at 30 days and yearly to 5 years
at 30 days and yearly to 5 years
myocardial infarction
Time Frame: at 3o days and yearly to 5 years
at 3o days and yearly to 5 years
stroke
Time Frame: at 30 days and yearly to 5 years
at 30 days and yearly to 5 years
ischemic-driven TVR
Time Frame: at 30 days and yearly to 5 years
at 30 days and yearly to 5 years
any target vessel revascularization
Time Frame: at 30 days and yearly to 5 years
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
at 30 days and yearly to 5 years
non-target vessel revascularization
Time Frame: at 30 days and yearly to 5 years
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
at 30 days and yearly to 5 years
analysis segment and in-stent binary restenosis
Time Frame: at 9 months angiographic follow-up
at 9 months angiographic follow-up
analysis segment and in-stent late loss
Time Frame: at 9 months angiographic follow-up
at 9 months angiographic follow-up
angina status
Time Frame: at 2 years
at 2 years
Follow-up in-stent, in-segment neointimal hyperplasia volume by IVUS
Time Frame: at 9 months angiographic follow-up
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
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
at 9 months angiographic follow up
Cardiac re-hospitalizations
Time Frame: at 1 years and yearly to 5 years
at 1 years and yearly to 5 years
Quality of life measurements
Time Frame: at 1 year
at 1 year
use of cardiac medications
Time Frame: at 1 year and yearly to 5 years
at 1 year and yearly to 5 years
Dialysis/hemofiltration
Time Frame: at 30 days and yearly to 5 years
at 30 days and yearly to 5 years
Infectious complications
Time Frame: at 30 days
at 30 days
duration of hospitalization related to the target procedure
Time Frame: at every event time
at every event time
2-year MACE according to the use of FFR-guided multivessel PCI
Time Frame: at 2 years after index procedure
at 2 years after index procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seung-Jung Park

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Abbott Medical Devices
CardioVascular Research Foundation, Korea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 28, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 5, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 18, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 18, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 19, 2009

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 10, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2008-0272

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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