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

Last updated: May 8, 2019
Sponsor: Seung-Jung Park
Overall Status: Terminated

Phase

N/A

Condition

Chest Pain

Coronary Artery Disease

Cardiovascular Disease

Treatment

N/A

Clinical Study ID

NCT00997828
2008-0272
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age 18 years of older

  • Angiographically confirmed multivessel CAD [critical (>70%) lesions in at least twomajor 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 objectiveevidence of myocardial ischemia

  • Geographically accessible and willing to come in for required study visits

  • Signed informed consent.

Exclusion

Exclusion Criteria:

  • Severe congestive heart failure (class III or IV according to NYHA, or pulmonaryedema) 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 requiringrevascularization

  • Abnormal creatine kinase (CK > 2x normal) and/or abnormal CK-MB levels and/or elevatedTroponin levels at time of randomization

  • Previous stroke within 6 months or patients with stroke at more than 6 months withsignificant 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 orsignificant hepatic failure, severe renal disease.

  • Prior history of significant bleeding (within the previous 6 months) that might beexpected 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 bleedingdiathesis

  • Intolerance or contraindication to aspirin or both clopidogrel and ticlopidine

  • Suspected pregnancy. A pregnancy test (urine or serum) will be administeredprerandomization to all women not clearly menopausal

  • Concurrent enrollment in another clinical trial

Study Design

Total Participants: 888
Study Start date:
July 28, 2008
Estimated Completion Date:
April 05, 2019

Study 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.

Connect with a study center

  • Sir Run Run Shaw Hospital

    Hangzhou,
    China

    Site Not Available

  • Zhongshan Hospital

    Shanghai,
    China

    Site Not Available

  • Queen Elizabeth Hospital

    Hong Kong,
    Hong Kong

    Site Not Available

  • Dankook University Hospital

    Chunahn,
    Korea, Republic of

    Site Not Available

  • Gangwon National Univ. Hospital

    Chuncheon,
    Korea, Republic of

    Site Not Available

  • Keimyung University Dongsan Medical Center

    Daegu,
    Korea, Republic of

    Site Not Available

  • Yeungnam University Medical Center

    Daegu,
    Korea, Republic of

    Site Not Available

  • Konyang University Hospital

    Daejeon,
    Korea, Republic of

    Site Not Available

  • GangNeung Asan Hospital

    GangNeung,
    Korea, Republic of

    Site Not Available

  • Chonnam National University Hospital

    Gwangju,
    Korea, Republic of

    Site Not Available

  • Inje University Ilsan Paik Hospital

    Ilsan,
    Korea, Republic of

    Site Not Available

  • National Health Insurance Corporation Ilsan Hospital

    Ilsan,
    Korea, Republic of

    Site Not Available

  • Gachon University Gil Hospital

    Incheon,
    Korea, Republic of

    Site Not Available

  • Chonbuk National University Hospital

    Jeonju,
    Korea, Republic of

    Site Not Available

  • Gyeongsang National University Hospital

    Jinju,
    Korea, Republic of

    Site Not Available

  • Inje University Pusan Paik Hospital

    Pusan,
    Korea, Republic of

    Site Not Available

  • Pusan National University Yangsan Hospital

    Pusan,
    Korea, Republic of

    Site Not Available

  • Bundang CHA Hospital

    Seongnam,
    Korea, Republic of

    Site Not Available

  • Asan Medical Center

    Seoul,
    Korea, Republic of

    Site Not Available

  • Gangnam Severance Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • Hanyang National University Medical Center

    Seoul,
    Korea, Republic of

    Site Not Available

  • Inje University Sanggye Paik Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • Korea University Anam Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • Korea University Guro Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • Severance Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • The Catholic University of Korea Seoul St. Mary's Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • The Catholic University of Korea, Yeouido St. Mary's Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • St.carollo Hospital

    Suncheon,
    Korea, Republic of

    Site Not Available

  • Ulsan University Hospital

    Ulsan,
    Korea, Republic of

    Site Not Available

  • Wonju Christian Hospital

    Wonju,
    Korea, Republic of

    Site Not Available

  • National Heart Institue

    Kuala Lumpur,
    Malaysia

    Site Not Available

  • Sarawak General Hospital

    Kuching,
    Malaysia

    Site Not Available

  • Siriraj Hospital

    Bangkok,
    Thailand

    Site Not Available

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