Bypass Surgery Versus Everolimus-Eluting Stent Implantation for Multivessel Coronary Artery Disease (BEST)
NCT ID: NCT00997828
Last Updated: 2019-05-10
Study Results
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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TERMINATED
NA
888 participants
INTERVENTIONAL
2008-07-28
2019-04-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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everolimus-eluting stent
everolimus-eluting stent
everolimus-eluting stent
Xience V stent
coronary artery bypass graft surgery
coronary artery bypass graft surgery
coronary artery bypass graft surgery
coronary artery bypass graft surgery
Interventions
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everolimus-eluting stent
Xience V stent
coronary artery bypass graft surgery
coronary artery bypass graft surgery
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
CardioVascular Research Foundation, Korea
OTHER
Seung-Jung Park
OTHER
Responsible Party
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Seung-Jung Park
MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine
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
Zhongshan Hospital
Shanghai, , China
National Heart Institue
Kuala Lumpur, , Malaysia
Sarawak General Hospital
Kuching, , Malaysia
Gangwon National Univ. Hospital
Chuncheon, , South Korea
Keimyung University Dongsan Medical Center
Daegu, , South Korea
Yeungnam University Medical Center
Daegu, , South Korea
Konyang University Hospital
Daejeon, , South Korea
Chonnam National University Hospital
Gwangju, , South Korea
Inje University Ilsan Paik Hospital
Ilsan, , South Korea
National Health Insurance Corporation Ilsan Hospital
Ilsan, , South Korea
Gachon University Gil Hospital
Incheon, , South Korea
Inje University Pusan Paik Hospital
Pusan, , South Korea
Pusan National University Yangsan Hospital
Pusan, , South Korea
Asan Medical Center
Seoul, , South Korea
Gangnam Severance Hospital
Seoul, , South Korea
Hanyang National University Medical Center
Seoul, , South Korea
Inje University Sanggye Paik Hospital
Seoul, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
Severance Hospital
Seoul, , South Korea
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul, , South Korea
The Catholic University of Korea, Yeouido St. Mary's Hospital
Seoul, , South Korea
St.carollo Hospital
Suncheon, , South Korea
Ulsan University Hospital
Ulsan, , South Korea
Wonju Christian Hospital
Wŏnju, , South Korea
Siriraj Hospital
Bangkok, , Thailand
Countries
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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.
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.
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.
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.
Other Identifiers
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2008-0272
Identifier Type: -
Identifier Source: org_study_id
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