Multivessel Coronary Artery DiseaseBEST ExtendedNCT05125367
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
An observational study of Multivessel Coronary Artery Disease, run by Seung-Jung Park at 24 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multivessel Coronary Artery Disease
- What is being tested?
- coronary stent implantation and bypass grafting
- Type of treatment
- Surgery or procedure
- How many people
- 880 participants
- Where
- 24 sitesin 4 countries
- Study dates
- 1 May 2022to 30 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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
Show all 22Show fewer
- 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).
- 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.
- 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.
- 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.
- Contraindication either CABG or PCI/DES because of a coexisting clinical condition
- Intolerance or contraindication to aspirin or both clopidogrel and ticlopidine
- Suspected pregnancy.
- Concurrent enrollment in another clinical trial
- Left main stenosis (at least 50% diameter stenosis)
Trial locations and contacts
24 sites in 4 countries.
24 sites in 4 countries
South Korea20 sites
Gangwon National Univ. Hospital
Chuncheon
Keimyung University Dongsan Medical Center
Daegu
Yeungnam University Medical Center
Daegu
Konyang University Hospital
Daejeon
Chonnam National University Hospital
Gwangju
Inje University Ilsan Paik Hospital
Ilsan
National Health Insurance Service Ilsan Hospital
Ilsan
Gachon University Gil Hospital
Incheon
Inje University Pusan Paik Hospital
Pusan
Asan Medical Center
Seoul, Songpa-gu, 138-736
Gangnam Severance Hospital
Seoul
Hanyang University Seoul Hospital
Seoul
Inje University Sanggye Paik Hospital
Seoul
Korea University Anam Hospital
Seoul
Korea University Guro Hospital
Seoul
Severance Hospital
Seoul
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul
St.carollo Hospital
Suncheon
Wonju Severance Christian Hospital
Wŏnju
Pusan National University Yangsan Hospital
Yangsan
About this study
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
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
- Being tested
- coronary stent implantation, bypass grafting
- Keywords
- multivessel coronary artery disease, percutaneous coronary intervention, coronary artery bypass graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coronary stent implantationProcedure or surgery
coronary stent implantation using everolimus-eluting balloon expandable stents
bypass graftingProcedure or surgery
coronary artery bypass graft
| Study group | Role | What they receive |
|---|---|---|
| multivessel coronary artery disease | From BEST trial study population_NCT00997828 Receives: Procedure: coronary stent implantation; Procedure: bypass grafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 10-year
Secondary outcomes (7)
Composite of death, myocardial infarction, or stroke
Measured: 10-year
Composite of death, myocardial infarction, stroke, or any repeat revascularization
Measured: 10-year
All-cause death
Measured: 10-year
Myocardial infarction
Measured: 10-year
Stroke
Measured: 10-year
Target vessel revascularization (TVR)
Measured: 10-year
Any repeat revascularization
Measured: 10-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2021
- Study start1 May 2022
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Multivessel Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 880 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seung-Jung Park
- Sponsor type
- University, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea
- Responsible party
- Sponsor-investigator, Seung-Jung Park, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05125367
- Sponsor's protocol ID
- AMCCV 2021-03
- Acronym
- BEST Extended
- Status last verified
- Aug 2022
- First submitted
- 8 Nov 2021
- Last updated
- 5 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 40368452Ahn 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.
PubMed 36121700
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05125367
- Acronym / sponsor ID
- BEST Extended / AMCCV 2021-03
- Conditions
- Multivessel Coronary Artery Disease
- Keywords
- multivessel coronary artery disease, percutaneous coronary intervention, coronary artery bypass graft
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 880 participants (actual)
- Lead sponsor
- Seung-Jung ParkUniversity, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea
- Study start
- 1 May 2022 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 18 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| multivessel coronary artery disease | – | Procedure: coronary stent implantation, Procedure: bypass graftingFrom BEST trial study population_NCT00997828 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (22 listed)
- The patient has a known hypersensitivity or contraindication to any of the following medications:
- 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.
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| coronary stent implantationcoronary stent implantation using everolimus-eluting balloon expandable stents | Procedure or surgery | multivessel coronary artery disease |
| bypass graftingcoronary artery bypass graft | Procedure or surgery | multivessel coronary artery disease |
Primary outcome
Major adverse cardiac event (MACE) including all-cause mortality, myocardial infarction, or target vessel revascularization (TVR)
Time frame: 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).
7 secondary outcomes
Composite of death, myocardial infarction, or stroke
Time frame: 10-year
Composite of death, myocardial infarction, stroke, or any repeat revascularization
Time frame: 10-year
All-cause death
Time frame: 10-year
Myocardial infarction
Time frame: 10-year
Stroke
Time frame: 10-year
Target vessel revascularization (TVR)
Time frame: 10-year
Any repeat revascularization
Time frame: 10-year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2022.
- Derived from this study: PubMed 40368452Lee 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.
- Derived from this study: PubMed 36121700Ahn 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.
- Individual participant dataSharing planned: Undecided
Related trials for Multivessel Coronary Artery Disease
Recruiting
Multivessel Balloon Occlusion to Investigate Obstructive Coronary Artery Disease and aNgina
Stable Angina, Multivessel Coronary Artery Disease
Recruiting
Optimal Timing of Staged Complete Revascularization in STEMI With Multivessel Disease (OPTION-STEMI2)
Myocardial Infarction (MI)
Active, not recruiting
Physiology-guided vs Angiography-guided Non-culprit Lesion Complete Revascularization for Acute MI & Multivessel Disease
Acute Myocardial Infarction, Coronary Artery Disease
Recruiting
Clinical Impact of DCB-based Versus DES-based Intervention in Patients With MVCAD
Multi Vessel Coronary Artery Disease, Percutaneous Coronary Intervention
Active, not recruiting
Medical Management vs Partial Revascularization in Diffuse Multivessel Coronary Artery Disease
Multi Vessel Coronary Artery Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
24 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multivessel Coronary Artery Disease, run by Seung-Jung Park at 24 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in South Korea, China, Malaysia, Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiac event (MACE) including all-cause mortality, myocardial infarction, or target vessel revascularization (TVR) (time frame: 10-year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05125367, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2022.