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

Conditions

Multivessel Coronary Artery Disease

Keywords

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

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.

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.

2025-09-111 citations

10.1136/heartjnl-2024-325107

Everolimus-Eluting Stents or Bypass Surgery for Multivessel Disease in Diabetics: The BEST Extended Follow-Up Study.

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.

2023-10-014 citations

10.1016/j.jcin.2023.07.028

Everolimus-Eluting Stents or Bypass Surgery for Multivessel Coronary Artery Disease: Extended Follow-Up Outcomes of Multicenter Randomized Controlled BEST Trial.

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.

2022-09-1922 citations

10.1161/circulationaha.122.062188

Interventions

PROCEDUREcoronary stent implantation

coronary stent implantation using everolimus-eluting balloon expandable stents

PROCEDUREbypass grafting

coronary artery bypass graft

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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)

Design outcomes

Primary

Measure	Time frame	Description
Major adverse cardiac event (MACE) including all-cause mortality, myocardial infarction, or target vessel revascularization (TVR)	10-year	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).

Secondary

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

Countries

China, Malaysia, South Korea, Thailand

Outcome results

None listed