Clinical trial NCT00997828: Bypass Surgery Versus Everolimus-Eluting Stent Implantation for Multivessel Coronary Artery Disease (BEST)
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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Coronary Artery Disease
stent
coronary artery bypass graft surgery
multivessel coronary artery disease
Lead sponsor: CardioVascular Research Foundation, Korea
Sponsor class: OTHER
Collaborators: name: Abbott Medical Devices
name: CardioVascular Research Foundation, Korea
First posted: 2009-10-19
Enrollment: 888
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Eligibility 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

Primary outcomes:
measure: the composite of death, nonfatal myocardial infarction, and ischemia-driven target vessel revascularization (TVR)
timeFrame: at 2 years
Secondary outcomes:
measure: the composite of death, myocardial infarction, and any target vessel revascularization
timeFrame: at 2years
measure: Ischemic MACCE (The composite of death, MI, stroke and ischemia-driven TVR)
timeFrame: at 2 years
measure: MACCE (The composite of death, MI, stroke and any TVR)
timeFrame: at 2 years
measure: the composite of death, MI, and any TVR
timeFrame: at 30 days and yearly to 5 years
measure: ischemic MACE(the composite of death, MI, and any TVR)
timeFrame: at 30 days and yearly to 5 years
measure: MACCE (The composite of death, MI, stroke and ischemia-driven TVR)
timeFrame: at 30 days and yearly to 5 years
measure: ischemic MACCE(The composite of death, MI, stroke and ischemia-driven TVR)
timeFrame: at 30 days and yearly to 5 years
measure: all cause death
timeFrame: at 30 days and yearly to 5 years
measure: cardiac death
timeFrame: at 30 days and yearly to 5 years
measure: myocardial infarction
timeFrame: at 3o days and yearly to 5 years
measure: stroke
timeFrame: at 30 days and yearly to 5 years
measure: ischemic-driven TVR
timeFrame: at 30 days and yearly to 5 years
measure: any target vessel revascularization
timeFrame: at 30 days and yearly to 5 years
measure: any target vessel revascularization or target lesion revascularization
timeFrame: at 30 days and yearly to 5 years
measure: non-target vessel revascularization
timeFrame: at 30 days and yearly to 5 years
measure: stent thrombosis for the percutaneous coronary intervention arm; acute, subacute, and late
timeFrame: at 30 days and yearly to 5 years
measure: analysis segment and in-stent binary restenosis
timeFrame: at 9 months angiographic follow-up
measure: analysis segment and in-stent late loss
timeFrame: at 9 months angiographic follow-up
measure: angina status
timeFrame: at 2 years
measure: Follow-up in-stent, in-segment neointimal hyperplasia volume by IVUS
timeFrame: at 9 months angiographic follow-up
measure: Incidence of stent malapposition, strut fracture, and peri-stent remodeling by IVUS
timeFrame: at 9 months angiographic follow-up
measure: Graft patency in subjects undergoing CABG (defined as: stenosis [DS>50%] in any of the grafts from touch-down to touch-down point)
timeFrame: at 9 months angiographic follow up
measure: Cardiac re-hospitalizations
timeFrame: at 1 years and yearly to 5 years
measure: Quality of life measurements
timeFrame: at 1 year
measure: use of cardiac medications
timeFrame: at 1 year and yearly to 5 years
measure: Dialysis/hemofiltration
timeFrame: at 30 days and yearly to 5 years
measure: Infectious complications
timeFrame: at 30 days
measure: duration of hospitalization related to the target procedure
timeFrame: at every event time
measure: 2-year MACE according to the use of FFR-guided multivessel PCI
timeFrame: at 2 years after index procedure
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital
city: Shanghai
country: China
facility: Zhongshan Hospital
city: Chuncheon
country: Korea, Republic of
facility: Gangwon National Univ. Hospital
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Medical Center
city: Daejeon
country: Korea, Republic of
facility: Konyang University Hospital
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Ilsan
country: Korea, Republic of
facility: Inje University Ilsan Paik Hospital
city: Ilsan
country: Korea, Republic of
facility: National Health Insurance Corporation Ilsan Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Hospital
city: Pusan
country: Korea, Republic of
facility: Inje University Pusan Paik Hospital
city: Pusan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Hanyang National University Medical Center
city: Seoul
country: Korea, Republic of
facility: Inje University Sanggye Paik Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Seoul St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Yeouido St. Mary's Hospital
city: Suncheon
country: Korea, Republic of
facility: St.carollo Hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
city: Wonju
country: Korea, Republic of
facility: Wonju Christian Hospital
city: Kuala Lumpur
country: Malaysia
facility: National Heart Institue
city: Kuching
country: Malaysia
facility: Sarawak General Hospital
city: Bangkok
country: Thailand
facility: Siriraj Hospital
Study officials:
affiliation: Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine
name: Seung-Jung Park, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.