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

NCT05125367 | Completed

• 1 other identifier: AMCCV 2021-03
• Study Type: observational
• Target: 880
• Locations: 4 countries
• Sites: 24

Brief Summary

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.

Conditions

Multivessel Coronary Artery Disease

Keywords

multivessel coronary artery disease; percutaneous coronary intervention; coronary artery bypass graft

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

• Myocardial infarction

  10-year

• Stroke

  10-year

Study Arms (1)

multivessel coronary artery disease

From BEST trial study population\_NCT00997828

Procedure: coronary stent implantation; Procedure: bypass grafting

Interventions

coronary stent implantation PROCEDURE

coronary stent implantation using everolimus-eluting balloon expandable stents

multivessel coronary artery disease

bypass grafting PROCEDURE

coronary artery bypass graft

multivessel coronary artery disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Age 18 years or older
• 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.
• 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:

• 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).
• Planned simultaneous surgical procedure unrelated to coronary revascularization (e.g. valve repair/replacement, aneurysmectomy, carotid endarterectomy or carotid stent).
• Prior CABG surgery
• Prior PCI with DES implantation within 1 year
• Two or more chronic total occlusions in major coronary territories
• Acute ST-elevation myocardial infarction(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. When the cardiac enzyme is returned to normal, those can be enrolled.
• Previous stroke within 6 months or patients with stroke at more than 6 months with significant residual neurologic involvement.
• 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.

Sponsors & Collaborators

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

Study Sites (24)

Sir Run Run Shaw Hospital

Hangzhou, China

Location

Zhongshan Hospital

Shanghai, China

Location

Sarawak General Hospital

Kuching, Malaysia

Location

Asan Medical Center

Seoul, Songpa-gu, 138-736, South Korea

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 Service Ilsan Hospital

Ilsan, South Korea

Location

Gachon University Gil Hospital

Incheon, South Korea

Location

Inje University Pusan Paik Hospital

Pusan, South Korea

Location

Gangnam Severance Hospital

Seoul, South Korea

Location

Hanyang University Seoul Hospital

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

St.carollo Hospital

Suncheon, South Korea

Location

Wonju Severance Christian Hospital

Wŏnju, South Korea

Location

Pusan National University Yangsan Hospital

Yangsan, South Korea

Location

Siriraj Hospital

Bangkok, Thailand

Location

Related Publications (2)

• 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

• 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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine, CardioVascular Research Foundation, Korea

Study Record Dates

• First Submitted: November 8, 2021
• First Posted: November 18, 2021
• Study Start: May 1, 2022
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: August 5, 2022

Record last verified: 2022-08

Locations

MY (1); CN (2); TH (1); KR (20)