Clinical trial NCT05125367: 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multivessel Coronary Artery Disease
Keywords: multivessel coronary artery disease
percutaneous coronary intervention
coronary artery bypass graft
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: CardioVascular Research Foundation, Korea
First posted: 2021-11-18
Enrollment: 880
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Major adverse cardiac event (MACE) including all-cause mortality, myocardial infarction, or target vessel revascularization (TVR)
timeFrame: 10-year
Secondary outcomes:
measure: Composite of death, myocardial infarction, or stroke
timeFrame: 10-year
measure: Composite of death, myocardial infarction, stroke, or any repeat revascularization
timeFrame: 10-year
measure: All-cause death
timeFrame: 10-year
measure: Myocardial infarction
timeFrame: 10-year
measure: Stroke
timeFrame: 10-year
measure: Target vessel revascularization (TVR)
timeFrame: 10-year
measure: Any repeat revascularization
timeFrame: 10-year
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital
city: Shanghai
country: China
facility: Zhongshan Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Songpa-gu
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 Service 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: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Hanyang University Seoul Hospital
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: Suncheon
country: Korea, Republic of
facility: St.carollo Hospital
city: Wonju
country: Korea, Republic of
facility: Wonju Severance Christian Hospital
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
city: Kuching
country: Malaysia
facility: Sarawak General Hospital
city: Bangkok
country: Thailand
facility: Siriraj Hospital
Study officials:
References: