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

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: Terminated
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: everolimus-eluting stent; Procedure: 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.

• Study Type: Interventional
• Enrollment (Actual): 888
• Phase: Not Applicable

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
the composite of death, nonfatal myocardial infarction, and ischemia-driven target vessel revascularization (TVR)	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

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

Collaborators and Investigators

• Sponsor: Seung-Jung Park
• Collaborators: Abbott Medical Devices; CardioVascular Research Foundation, Korea

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2008
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 5, 2019

Study Registration Dates

• First Submitted: October 18, 2009
• First Submitted That Met QC Criteria: October 18, 2009
• First Posted (Estimate): October 19, 2009

Study Record Updates

• Last Update Posted (Actual): May 10, 2019
• Last Update Submitted That Met QC Criteria: May 8, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Coronary Artery Disease; stent; coronary artery bypass graft surgery; multivessel coronary artery disease
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Physiological Effects of Drugs; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Everolimus
• Other Study ID Numbers: 2008-0272