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
NCT ID: NCT05125367
Last Updated: 2022-08-05
Study Results
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Basic Information
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COMPLETED
880 participants
OBSERVATIONAL
2022-05-01
2022-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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multivessel coronary artery disease
From BEST trial study population\_NCT00997828
coronary stent implantation
coronary stent implantation using everolimus-eluting balloon expandable stents
bypass grafting
coronary artery bypass graft
Interventions
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coronary stent implantation
coronary stent implantation using everolimus-eluting balloon expandable stents
bypass grafting
coronary artery bypass graft
Eligibility Criteria
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Inclusion Criteria
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
* 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)
18 Years
ALL
No
Sponsors
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CardioVascular Research Foundation, Korea
OTHER
Seung-Jung Park
OTHER
Responsible Party
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Seung-Jung Park
Professor, Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine, CardioVascular Research Foundation, Korea
Locations
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Sir Run Run Shaw Hospital
Hangzhou, , China
Zhongshan Hospital
Shanghai, , China
Sarawak General Hospital
Kuching, , Malaysia
Asan Medical Center
Seoul, Songpa-gu, South Korea
Gangwon National Univ. Hospital
Chuncheon, , South Korea
Keimyung University Dongsan Medical Center
Daegu, , South Korea
Yeungnam University Medical Center
Daegu, , South Korea
Konyang University Hospital
Daejeon, , South Korea
Chonnam National University Hospital
Gwangju, , South Korea
Inje University Ilsan Paik Hospital
Ilsan, , South Korea
National Health Insurance Service Ilsan Hospital
Ilsan, , South Korea
Gachon University Gil Hospital
Incheon, , South Korea
Inje University Pusan Paik Hospital
Pusan, , South Korea
Gangnam Severance Hospital
Seoul, , South Korea
Hanyang University Seoul Hospital
Seoul, , South Korea
Inje University Sanggye Paik Hospital
Seoul, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
Severance Hospital
Seoul, , South Korea
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul, , South Korea
St.carollo Hospital
Suncheon, , South Korea
Wonju Severance Christian Hospital
Wŏnju, , South Korea
Pusan National University Yangsan Hospital
Yangsan, , South Korea
Siriraj Hospital
Bangkok, , Thailand
Countries
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References
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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.
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.
Other Identifiers
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AMCCV 2021-03
Identifier Type: -
Identifier Source: org_study_id
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