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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Abbott Vascular
CardioVascular Research Foundation, Korea
Information provided by (Responsible Party):
Seung-Jung Park, CardioVascular Research Foundation, Korea
ClinicalTrials.gov Identifier:
NCT00997828
First received: October 18, 2009
Last updated: July 25, 2014
Last verified: July 2014
  Purpose

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).


Condition Intervention Phase
Coronary Artery Disease
Device: everolimus-eluting stent
Procedure: coronary artery bypass graft surgery
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by CardioVascular Research Foundation, Korea:

Primary Outcome Measures:
  • the composite of death, nonfatal myocardial infarction, and ischemia-driven target vessel revascularization (TVR) [ Time Frame: at 2 years ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: at 2years ] [ Designated as safety issue: Yes ]
  • Ischemic MACCE (The composite of death, MI, stroke and ischemia-driven TVR) [ Time Frame: at 2 years ] [ Designated as safety issue: Yes ]
  • MACCE (The composite of death, MI, stroke and any TVR) [ Time Frame: at 2 years ] [ Designated as safety issue: Yes ]
  • the composite of death, MI, and any TVR [ Time Frame: at 30 days and yearly to 5 years ] [ Designated as safety issue: Yes ]
  • ischemic MACE(the composite of death, MI, and any TVR) [ Time Frame: at 30 days and yearly to 5 years ] [ Designated as safety issue: Yes ]
  • MACCE (The composite of death, MI, stroke and ischemia-driven TVR) [ Time Frame: at 30 days and yearly to 5 years ] [ Designated as safety issue: Yes ]
  • ischemic MACCE(The composite of death, MI, stroke and ischemia-driven TVR) [ Time Frame: at 30 days and yearly to 5 years ] [ Designated as safety issue: Yes ]
  • all cause death [ Time Frame: at 30 days and yearly to 5 years ] [ Designated as safety issue: Yes ]
  • cardiac death [ Time Frame: at 30 days and yearly to 5 years ] [ Designated as safety issue: Yes ]
  • myocardial infarction [ Time Frame: at 3o days and yearly to 5 years ] [ Designated as safety issue: Yes ]
  • stroke [ Time Frame: at 30 days and yearly to 5 years ] [ Designated as safety issue: Yes ]
  • ischemic-driven TVR [ Time Frame: at 30 days and yearly to 5 years ] [ Designated as safety issue: No ]
  • any target vessel revascularization [ Time Frame: at 30 days and yearly to 5 years ] [ Designated as safety issue: No ]
  • any target vessel revascularization or target lesion revascularization [ Time Frame: at 30 days and yearly to 5 years ] [ Designated as safety issue: No ]
  • non-target vessel revascularization [ Time Frame: at 30 days and yearly to 5 years ] [ Designated as safety issue: No ]
  • stent thrombosis for the percutaneous coronary intervention arm; acute, subacute, and late [ Time Frame: at 30 days and yearly to 5 years ] [ Designated as safety issue: Yes ]
  • analysis segment and in-stent binary restenosis [ Time Frame: at 9 months angiographic follow-up ] [ Designated as safety issue: No ]
  • analysis segment and in-stent late loss [ Time Frame: at 9 months angiographic follow-up ] [ Designated as safety issue: No ]
  • angina status [ Time Frame: at 2 years ] [ Designated as safety issue: No ]
  • Follow-up in-stent, in-segment neointimal hyperplasia volume by IVUS [ Time Frame: at 9 months angiographic follow-up ] [ Designated as safety issue: No ]
  • Incidence of stent malapposition, strut fracture, and peri-stent remodeling by IVUS [ Time Frame: at 9 months angiographic follow-up ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Cardiac re-hospitalizations [ Time Frame: at 1 years and yearly to 5 years ] [ Designated as safety issue: No ]
  • Quality of life measurements [ Time Frame: at 1 year ] [ Designated as safety issue: No ]
  • use of cardiac medications [ Time Frame: at 1 year and yearly to 5 years ] [ Designated as safety issue: No ]
  • Dialysis/hemofiltration [ Time Frame: at 30 days and yearly to 5 years ] [ Designated as safety issue: No ]
  • Infectious complications [ Time Frame: at 30 days ] [ Designated as safety issue: No ]
  • duration of hospitalization related to the target procedure [ Time Frame: at every event time ] [ Designated as safety issue: No ]
  • 2-year MACE according to the use of FFR-guided multivessel PCI [ Time Frame: at 2 years after index procedure ] [ Designated as safety issue: Yes ]

Enrollment: 888
Study Start Date: July 2009
Estimated Study Completion Date: May 2019
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: everolimus-eluting stent
everolimus-eluting stent
Device: everolimus-eluting stent
Xience V stent
Other Name: everolimu-eluting stent
Active Comparator: coronary artery bypass graft surgery
coronary artery bypass graft surgery
Procedure: coronary artery bypass graft surgery
coronary artery bypass graft surgery
Other Name: coronary artery bypass graft surgery

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00997828

Locations
China
Sir Run Run Shaw Hospital
Hangzhou, China
Zhongshan Hospital
Shanghai, China
Hong Kong
Queen Elizabeth Hospital
Hong Kong, Hong Kong
Korea, Republic of
Gangwon National Univ. Hospital
Chuncheon, Korea, Republic of
Keimyung University Dongsan Medical Center
Daegu, Korea, Republic of
Yeungnam University Medical Center
Daegu, Korea, Republic of
Konyang University Hospital
Daejeon, Korea, Republic of
Chonnam National University Hospital
Gwangju, Korea, Republic of
Inje University Ilsan Paik Hospital
Ilsan, Korea, Republic of
National Health Insurance Corporation Ilsan Hospital
Ilsan, Korea, Republic of
Gachon University Gil Hospital
Incheon, Korea, Republic of
Inje University Pusan Paik Hospital
Pusan, Korea, Republic of
Pusan National University Yangsan Hospital
Pusan, Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Gangnam Severance Hospital
Seoul, Korea, Republic of
Hanyang National University Medical Center
Seoul, Korea, Republic of
Inje University Sanggye Paik Hospital
Seoul, Korea, Republic of
Korea University Anam Hospital
Seoul, Korea, Republic of
Korea University Guro Hospital
Seoul, Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul, Korea, Republic of
The Catholic University of Korea, Yeouido St. Mary's Hospital
Seoul, Korea, Republic of
St.carollo Hospital
Suncheon, Korea, Republic of
Ulsan University Hospital
Ulsan, Korea, Republic of
Wonju Christian Hospital
Wonju, Korea, Republic of
Malaysia
National Heart Institue
Kuala Lumpur, Malaysia
Sarawak General Hospital
Kuching, Malaysia
Thailand
Siriraj Hospital
Bangkok, Thailand
Sponsors and Collaborators
Seung-Jung Park
Abbott Vascular
CardioVascular Research Foundation, Korea
Investigators
Principal Investigator: Seung-Jung Park, MD, PhD Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine
  More Information

No publications provided

Responsible Party: Seung-Jung Park, MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine, CardioVascular Research Foundation, Korea
ClinicalTrials.gov Identifier: NCT00997828     History of Changes
Other Study ID Numbers: 2008-0272
Study First Received: October 18, 2009
Last Updated: July 25, 2014
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by CardioVascular Research Foundation, Korea:
Coronary Artery Disease
stent
coronary artery bypass graft surgery
multivessel coronary artery disease

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases
Everolimus
Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014