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

NCT ID: NCT00997828

Last Updated: 2019-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

888 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-28

Study Completion Date

2019-04-05

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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everolimus-eluting stent

everolimus-eluting stent

Group Type EXPERIMENTAL

everolimus-eluting stent

Intervention Type DEVICE

Xience V stent

coronary artery bypass graft surgery

coronary artery bypass graft surgery

Group Type ACTIVE_COMPARATOR

coronary artery bypass graft surgery

Intervention Type PROCEDURE

coronary artery bypass graft surgery

Interventions

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everolimus-eluting stent

Xience V stent

Intervention Type DEVICE

coronary artery bypass graft surgery

coronary artery bypass graft surgery

Intervention Type PROCEDURE

Other Intervention Names

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everolimu-eluting stent

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott Medical Devices

INDUSTRY

Sponsor Role collaborator

CardioVascular Research Foundation, Korea

OTHER

Sponsor Role collaborator

Seung-Jung Park

OTHER

Sponsor Role lead

Responsible Party

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Seung-Jung Park

MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Seung-Jung Park, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Sir Run Run Shaw Hospital

Hangzhou, , China

Site Status

Zhongshan Hospital

Shanghai, , China

Site Status

National Heart Institue

Kuala Lumpur, , Malaysia

Site Status

Sarawak General Hospital

Kuching, , Malaysia

Site Status

Gangwon National Univ. Hospital

Chuncheon, , South Korea

Site Status

Keimyung University Dongsan Medical Center

Daegu, , South Korea

Site Status

Yeungnam University Medical Center

Daegu, , South Korea

Site Status

Konyang University Hospital

Daejeon, , South Korea

Site Status

Chonnam National University Hospital

Gwangju, , South Korea

Site Status

Inje University Ilsan Paik Hospital

Ilsan, , South Korea

Site Status

National Health Insurance Corporation Ilsan Hospital

Ilsan, , South Korea

Site Status

Gachon University Gil Hospital

Incheon, , South Korea

Site Status

Inje University Pusan Paik Hospital

Pusan, , South Korea

Site Status

Pusan National University Yangsan Hospital

Pusan, , South Korea

Site Status

Asan Medical Center

Seoul, , South Korea

Site Status

Gangnam Severance Hospital

Seoul, , South Korea

Site Status

Hanyang National University Medical Center

Seoul, , South Korea

Site Status

Inje University Sanggye Paik Hospital

Seoul, , South Korea

Site Status

Korea University Anam Hospital

Seoul, , South Korea

Site Status

Korea University Guro Hospital

Seoul, , South Korea

Site Status

Severance Hospital

Seoul, , South Korea

Site Status

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

Seoul, , South Korea

Site Status

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

Seoul, , South Korea

Site Status

St.carollo Hospital

Suncheon, , South Korea

Site Status

Ulsan University Hospital

Ulsan, , South Korea

Site Status

Wonju Christian Hospital

Wŏnju, , South Korea

Site Status

Siriraj Hospital

Bangkok, , Thailand

Site Status

Countries

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China Malaysia South Korea Thailand

References

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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.

Reference Type DERIVED
PMID: 40368452 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37821187 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36121700 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35422242 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28495897 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27651390 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27491605 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25774645 (View on PubMed)

Other Identifiers

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2008-0272

Identifier Type: -

Identifier Source: org_study_id

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