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

View this study on Beta.ClinicalTrials.gov

Sponsor:

Collaborators:

Abbott Medical Devices

CardioVascular Research Foundation, Korea

Information provided by (Responsible Party):

Seung-Jung Park, CardioVascular Research Foundation, Korea

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).

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.

Study Design

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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

MedlinePlus related topics: Coronary Artery Bypass Surgery Coronary Artery Disease

Drug Information available for: Everolimus

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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 :

the composite of death, myocardial infarction, and any target vessel revascularization [ Time Frame: at 2years ]
Ischemic MACCE (The composite of death, MI, stroke and ischemia-driven TVR) [ Time Frame: at 2 years ]
MACCE (The composite of death, MI, stroke and any TVR) [ Time Frame: at 2 years ]
the composite of death, MI, and any TVR [ Time Frame: 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 ]
MACCE (The composite of death, MI, stroke and ischemia-driven TVR) [ Time Frame: 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 ]
all cause death [ Time Frame: at 30 days and yearly to 5 years ]
cardiac death [ Time Frame: at 30 days and yearly to 5 years ]
myocardial infarction [ Time Frame: at 3o days and yearly to 5 years ]
stroke [ Time Frame: at 30 days and yearly to 5 years ]
ischemic-driven TVR [ Time Frame: at 30 days and yearly to 5 years ]
any target vessel revascularization [ Time Frame: 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 ]
non-target vessel revascularization [ Time Frame: 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 ]
analysis segment and in-stent binary restenosis [ Time Frame: at 9 months angiographic follow-up ]
analysis segment and in-stent late loss [ Time Frame: at 9 months angiographic follow-up ]
angina status [ Time Frame: at 2 years ]
Follow-up in-stent, in-segment neointimal hyperplasia volume by IVUS [ Time Frame: 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 ]
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 ]
Cardiac re-hospitalizations [ Time Frame: at 1 years and yearly to 5 years ]
Quality of life measurements [ Time Frame: at 1 year ]
use of cardiac medications [ Time Frame: at 1 year and yearly to 5 years ]
Dialysis/hemofiltration [ Time Frame: at 30 days and yearly to 5 years ]
Infectious complications [ Time Frame: at 30 days ]
duration of hospitalization related to the target procedure [ Time Frame: at every event time ]
2-year MACE according to the use of FFR-guided multivessel PCI [ Time Frame: at 2 years after index procedure ]

Eligibility Criteria

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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

Contacts and Locations

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 27 study locations

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China
Sir Run Run Shaw Hospital
Hangzhou, China
Zhongshan Hospital
Shanghai, China
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 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

More Information

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

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.

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.

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.

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.

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.

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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 Everolimus Antineoplastic Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs

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