Ten-Year Outcomes of Randomized Comparison of Coronary Artery Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients With Multivessel Coronary Artery Disease (BEST Extended)

Ten-Year Outcomes of Randomized Comparison of Coronary Artery Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients With Multivessel Coronary Artery Disease: The BEST Extended 10 Y Follow-up

The primary objective of the BEST extended 10Y follow-up study is to compare the safety and effectiveness of coronary stent implantation using everolimus-eluting balloon-expandable stents with bypass grafting for the treatment of multivessel coronary artery disease at minimum of 10 years follow-up.

Study Overview

• Status: Completed
• Conditions: Multivessel Coronary Artery Disease
• Intervention / Treatment: Procedure: coronary stent implantation; Procedure: bypass grafting

• Study Type: Observational
• Enrollment (Actual): 880

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 Service Ilsan Hospital
  • Incheon, Korea, Republic of
    • Gachon University Gil Hospital
  • Pusan, Korea, Republic of
    • Inje University Pusan Paik Hospital
  • 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
    • Hanyang University Seoul Hospital
  • Seoul, Korea, Republic of
    • Inje University Sanggye Paik Hospital
  • Suncheon, Korea, Republic of
    • St.Carollo Hospital
  • Wonju, Korea, Republic of
    • Wonju Severance Christian Hospital
  • Yangsan, Korea, Republic of
    • Pusan National University Yangsan Hospital
  • Songpa-gu
    • Seoul, Songpa-gu, Korea, Republic of, 138-736
      • Asan Medical Center
• Malaysia
  • 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: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The BEST trial study population: patients with multivessel coronary artery disease treated by coronary stent implantation using everolimus-eluting balloon expandable stents or the bypass grafting

Description

Inclusion Criteria:

1. Age 18 years or older
2. Angiographically confirmed multivessel coronary artery disease [critical (>70%) lesions in at least two major epicardial vessels (≥ 2.0mm in diameter) at least two separate coronary artery territories (the right coronary artery (RCA), left circumflex artery (LCX) and left anterior descending (LAD)] and are expected to be equally treatable with PCI(Percutaneous Coronary Intervention) or CABG(coronary artery bypass graft) by interventionalists and surgeons at the investigating site.
3. Indication for revascularization based upon symptoms of angina and/or objective evidence of myocardial ischemia
4. Geographically accessible and willing to come in for required study visits
5. Signed informed consent.

Exclusion Criteria:

1. The patient has a known hypersensitivity or contraindication to any of the following medications:

   • Heparin
   • Aspirin
   • Both Clopidogrel and TIclopidine
   • Sirolimus, paclitaxel, ABT 578
   • Stainless steel and/or
   • Contrast media (patients with documented sensitivity to contrast which can be effectively pre-medicated with steroids and diphenhydramine [e.g. rash] may be enrolled. Patients with true anaphylaxis to prior contrast media, however, should not be enrolled).
2. Severe congestive heart failure (class III or IV according to New York Heart Association (NYHA) Functional Classification, or pulmonary edema) at the time of enrollment. The degree of left ventricular ejection fraction is not considered as an index of exclusion.
3. Planned simultaneous surgical procedure unrelated to coronary revascularization (e.g. valve repair/replacement, aneurysmectomy, carotid endarterectomy or carotid stent).
4. Prior CABG surgery
5. Prior PCI with DES implantation within 1 year
6. Two or more chronic total occlusions in major coronary territories
7. Acute ST-elevation myocardial infarction(Q-wave) within 72 hours prior to enrollment requiring revascularization.
8. Abnormal creatine kinase (CK > 2x normal) and/or abnormal CK-MB levels and/or elevated Troponin levels at time of randomization. When the cardiac enzyme is returned to normal, those can be enrolled.
9. Previous stroke within 6 months or patients with stroke at more than 6 months with significant residual neurologic involvement.
10. 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.
11. Prior history of significant bleeding (within the previous 6 months) that might be expected to occur during CABG or PCI/DES(drug eluting stent) related anticoagulation.
12. Contraindication either CABG or PCI/DES because of a coexisting clinical condition
13. Intolerance or contraindication to aspirin or both clopidogrel and ticlopidine
14. Suspected pregnancy.
15. Concurrent enrollment in another clinical trial
16. Left main stenosis (at least 50% diameter stenosis)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
multivessel coronary artery disease; From BEST trial study population_NCT00997828	Procedure: coronary stent implantation; coronary stent implantation using everolimus-eluting balloon expandable stents; Procedure: bypass grafting; coronary artery bypass graft

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major adverse cardiac event (MACE) including all-cause mortality, myocardial infarction, or target vessel revascularization (TVR)	A composite endpoint(MACE) is an endpoint that is a combination of multiple clinical endpoints. An event that is considered to have occurred if any one of several different events is observed. Definitions for primary and secondary clinical outcomes are consistent with those used in the original BEST trial protocol(NCT00997828).	10-year

Secondary Outcome Measures

Outcome Measure	Time Frame
Myocardial infarction	10-year
Composite of death, myocardial infarction, or stroke	10-year
Composite of death, myocardial infarction, stroke, or any repeat revascularization	10-year
All-cause death	10-year
Stroke	10-year
Target vessel revascularization (TVR)	10-year
Any repeat revascularization	10-year

Collaborators and Investigators

• Sponsor: Seung-Jung Park
• Collaborators: CardioVascular Research Foundation, Korea

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: November 8, 2021
• First Submitted That Met QC Criteria: November 8, 2021
• First Posted (Actual): November 18, 2021

Study Record Updates

• Last Update Posted (Actual): August 5, 2022
• Last Update Submitted That Met QC Criteria: August 3, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: percutaneous coronary intervention; coronary artery bypass graft; 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
• Other Study ID Numbers: AMCCV 2021-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No