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

Multivessel Coronary Artery Disease Clinical Trial

— BEST Extended  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05125367
• Other study ID #: AMCCV 2021-03
• Status: Completed
• Start date: May 1, 2022
• Est. completion date: June 30, 2022

Study information

• Verified date: August 2022
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 880
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Multivessel Coronary Artery Disease
• Myocardial Ischemia

Intervention

Procedure:
• coronary stent implantation
coronary stent implantation using everolimus-eluting balloon expandable stents
• bypass grafting
coronary artery bypass graft

Locations

Country	Name	City	State
China	Sir Run Run Shaw Hospital	Hangzhou
China	Zhongshan Hospital	Shanghai
Korea, Republic of	Gangwon National Univ. Hospital	Chuncheon
Korea, Republic of	Keimyung University Dongsan Medical Center	Daegu
Korea, Republic of	Yeungnam University Medical Center	Daegu
Korea, Republic of	Konyang University Hospital	Daejeon
Korea, Republic of	Chonnam National University Hospital	Gwangju
Korea, Republic of	Inje University Ilsan Paik Hospital	Ilsan
Korea, Republic of	National Health Insurance Service Ilsan Hospital	Ilsan
Korea, Republic of	Gachon University Gil Hospital	Incheon
Korea, Republic of	Inje University Pusan Paik Hospital	Pusan
Korea, Republic of	Asan Medical Center	Seoul	Songpa-gu
Korea, Republic of	Gangnam Severance Hospital	Seoul
Korea, Republic of	Hanyang University Seoul Hospital	Seoul
Korea, Republic of	Inje University Sanggye Paik Hospital	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	Severance Hospital	Seoul
Korea, Republic of	The Catholic University of Korea Seoul St. Mary's Hospital	Seoul
Korea, Republic of	St.carollo Hospital	Suncheon
Korea, Republic of	Wonju Severance Christian Hospital	Wonju
Korea, Republic of	Pusan National University Yangsan Hospital	Yangsan
Malaysia	Sarawak General Hospital	Kuching
Thailand	Siriraj Hospital	Bangkok

Sponsors (2)

Lead Sponsor	Collaborator
Seung-Jung Park	CardioVascular Research Foundation, Korea

Countries where clinical trial is conducted

China,  Korea, Republic of,  Malaysia,  Thailand, 

Outcome

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