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

NCT00997828 | Terminated DMC

• 1 other identifier: 2008-0272
• Study Type: interventional
• Target: 888
• Locations: 4 countries
• Sites: 27

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).

Conditions

Coronary Artery Disease

Keywords

Coronary Artery Disease; stent; coronary artery bypass graft surgery; multivessel coronary artery disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (29)

• 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

Study Arms (2)

everolimus-eluting stent

EXPERIMENTAL

everolimus-eluting stent

Device: everolimus-eluting stent

coronary artery bypass graft surgery

ACTIVE COMPARATOR

coronary artery bypass graft surgery

Procedure: coronary artery bypass graft surgery

Interventions

everolimus-eluting stent DEVICE

Xience V stent

Also known as: everolimu-eluting stent

everolimus-eluting stent

coronary artery bypass graft surgery PROCEDURE

coronary artery bypass graft surgery

coronary artery bypass graft surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Seung-Jung Park: lead
• Abbott Medical Devices: collaborator
• CardioVascular Research Foundation, Korea: collaborator

Study Sites (27)

Sir Run Run Shaw Hospital

Hangzhou, China

Location

Zhongshan Hospital

Shanghai, China

Location

National Heart Institue

Kuala Lumpur, Malaysia

Location

Sarawak General Hospital

Kuching, Malaysia

Location

Gangwon National Univ. Hospital

Chuncheon, South Korea

Location

Keimyung University Dongsan Medical Center

Daegu, South Korea

Location

Yeungnam University Medical Center

Daegu, South Korea

Location

Konyang University Hospital

Daejeon, South Korea

Location

Chonnam National University Hospital

Gwangju, South Korea

Location

Inje University Ilsan Paik Hospital

Ilsan, South Korea

Location

National Health Insurance Corporation Ilsan Hospital

Ilsan, South Korea

Location

Gachon University Gil Hospital

Incheon, South Korea

Location

Inje University Pusan Paik Hospital

Pusan, South Korea

Location

Pusan National University Yangsan Hospital

Pusan, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

Gangnam Severance Hospital

Seoul, South Korea

Location

Hanyang National University Medical Center

Seoul, South Korea

Location

Inje University Sanggye Paik Hospital

Seoul, South Korea

Location

Korea University Anam Hospital

Seoul, South Korea

Location

Korea University Guro Hospital

Seoul, South Korea

Location

Severance Hospital

Seoul, South Korea

Location

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

Seoul, South Korea

Location

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

Seoul, South Korea

Location

St.carollo Hospital

Suncheon, South Korea

Location

Ulsan University Hospital

Ulsan, South Korea

Location

Wonju Christian Hospital

Wŏnju, South Korea

Location

Siriraj Hospital

Bangkok, Thailand

Location

Related Publications (8)

• Lee J, Ahn JM, Kim H, Choi Y, Jo S, Kang DY, Kim MJ, Hur SH, Park HJ, Tresukosol D, Kang WC, Kwon HM, Rha SW, Lim DS, Jeong MH, Lee BK, Huang H, Lim YH, Bae JH, Kim BO, Ong TK, Ahn SG, Chung CH, Park DW, Park SJ; BEST Extended Follow-up Study investigators. Long-term outcomes of intravascular ultrasound-guided percutaneous coronary intervention versus coronary artery bypass grafting for multivessel coronary artery disease. Heart. 2025 Sep 11;111(19):918-924. doi: 10.1136/heartjnl-2024-325107.

  PMID: 40368452 DERIVED

• Kim H, Kang DY, Ahn JM, Lee J, Choi Y, Hur SH, Park HJ, Tresukosol D, Kang WC, Kwon HM, Rha SW, Lim DS, Jeong MH, Lee BK, Huang H, Lim YH, Bae JH, Kim BO, Ong TK, Ahn SG, Chung CH, Park DW, Park SJ; BEST Extended Follow-Up Study Investigators. Everolimus-Eluting Stents or Bypass Surgery for Multivessel Disease in Diabetics: The BEST Extended Follow-Up Study. JACC Cardiovasc Interv. 2023 Oct 9;16(19):2412-2422. doi: 10.1016/j.jcin.2023.07.028.

  PMID: 37821187 DERIVED

• Ahn JM, Kang DY, Yun SC, Ho Hur S, Park HJ, Tresukosol D, Chol Kang W, Moon Kwon H, Rha SW, Lim DS, Jeong MH, Lee BK, Huang H, Hyo Lim Y, Ho Bae J, Ok Kim B, Kiam Ong T, Gyun Ahn S, Chung CH, Park DW, Park SJ; BEST Extended Follow-Up Study Investigators. Everolimus-Eluting Stents or Bypass Surgery for Multivessel Coronary Artery Disease: Extended Follow-Up Outcomes of Multicenter Randomized Controlled BEST Trial. Circulation. 2022 Nov 22;146(21):1581-1590. doi: 10.1161/CIRCULATIONAHA.122.062188. Epub 2022 Sep 19.

  PMID: 36121700 DERIVED

• 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.

  PMID: 35422242 DERIVED

• 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.

  PMID: 28495897 DERIVED

• 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.

  PMID: 27651390 DERIVED

• 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.

  PMID: 27491605 DERIVED

• 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.

  PMID: 25774645 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Coronary Artery Bypass

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Myocardial Revascularization; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Vascular Grafting; Vascular Surgical Procedures; Thoracic Surgical Procedures

Study Officials

• Seung-Jung Park, MD, PhD

  Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine

Study Record Dates

• First Submitted: October 18, 2009
• First Posted: October 19, 2009
• Study Start: July 28, 2008
• Primary Completion: April 1, 2016
• Study Completion: April 5, 2019
• Last Updated: May 10, 2019

Record last verified: 2019-05

Locations

TH (1); MY (2); CN (2); KR (22)