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

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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

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).

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: everolimus-eluting stent Procedure: coronary artery bypass graft surgery Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 888 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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)
Actual Study Start Date : July 28, 2008
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 5, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Everolimus

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. the composite of death, myocardial infarction, and any target vessel revascularization [ Time Frame: at 2years ]
  2. Ischemic MACCE (The composite of death, MI, stroke and ischemia-driven TVR) [ Time Frame: at 2 years ]
  3. MACCE (The composite of death, MI, stroke and any TVR) [ Time Frame: at 2 years ]
  4. the composite of death, MI, and any TVR [ Time Frame: at 30 days and yearly to 5 years ]
  5. ischemic MACE(the composite of death, MI, and any TVR) [ Time Frame: at 30 days and yearly to 5 years ]
  6. MACCE (The composite of death, MI, stroke and ischemia-driven TVR) [ Time Frame: at 30 days and yearly to 5 years ]
  7. ischemic MACCE(The composite of death, MI, stroke and ischemia-driven TVR) [ Time Frame: at 30 days and yearly to 5 years ]
  8. all cause death [ Time Frame: at 30 days and yearly to 5 years ]
  9. cardiac death [ Time Frame: at 30 days and yearly to 5 years ]
  10. myocardial infarction [ Time Frame: at 3o days and yearly to 5 years ]
  11. stroke [ Time Frame: at 30 days and yearly to 5 years ]
  12. ischemic-driven TVR [ Time Frame: at 30 days and yearly to 5 years ]
  13. any target vessel revascularization [ Time Frame: at 30 days and yearly to 5 years ]
  14. any target vessel revascularization or target lesion revascularization [ Time Frame: at 30 days and yearly to 5 years ]
  15. non-target vessel revascularization [ Time Frame: at 30 days and yearly to 5 years ]
  16. stent thrombosis for the percutaneous coronary intervention arm; acute, subacute, and late [ Time Frame: at 30 days and yearly to 5 years ]
  17. analysis segment and in-stent binary restenosis [ Time Frame: at 9 months angiographic follow-up ]
  18. analysis segment and in-stent late loss [ Time Frame: at 9 months angiographic follow-up ]
  19. angina status [ Time Frame: at 2 years ]
  20. Follow-up in-stent, in-segment neointimal hyperplasia volume by IVUS [ Time Frame: at 9 months angiographic follow-up ]
  21. Incidence of stent malapposition, strut fracture, and peri-stent remodeling by IVUS [ Time Frame: at 9 months angiographic follow-up ]
  22. 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 ]
  23. Cardiac re-hospitalizations [ Time Frame: at 1 years and yearly to 5 years ]
  24. Quality of life measurements [ Time Frame: at 1 year ]
  25. use of cardiac medications [ Time Frame: at 1 year and yearly to 5 years ]
  26. Dialysis/hemofiltration [ Time Frame: at 30 days and yearly to 5 years ]
  27. Infectious complications [ Time Frame: at 30 days ]
  28. duration of hospitalization related to the target procedure [ Time Frame: at every event time ]
  29. 2-year MACE according to the use of FFR-guided multivessel PCI [ Time Frame: at 2 years after index procedure ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00997828


Locations
Show Show 27 study locations
Sponsors and Collaborators
Seung-Jung Park
Abbott Medical Devices
CardioVascular Research Foundation, Korea
Investigators
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Principal Investigator: Seung-Jung Park, MD, PhD Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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    
Other Study ID Numbers: 2008-0272
First Posted: October 19, 2009    Key Record Dates
Last Update Posted: May 10, 2019
Last Verified: May 2019
Keywords provided by Seung-Jung Park, CardioVascular Research Foundation, Korea:
Coronary Artery Disease
stent
coronary artery bypass graft surgery
multivessel coronary artery disease
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Sirolimus
Everolimus
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents