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Coronary Artery DiseaseBESTNCT00997828

Bypass Surgery Versus Everolimus-Eluting Stent Implantation for Multivessel Coronary Artery Disease (BEST)

A study testing everolimus-eluting stent and coronary artery bypass graft surgery in people with Coronary Artery Disease, run by Seung-Jung Park at 27 sites in 4 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

The purpose of this study is to determine whether the safety and efficacy of coronary stent implantation using Everolimus-Eluting Coronary Stent System (Abbott, Boston Scientific) is not inferior to coronary artery bypass grafting (CABG) for the treatment of patient with multivessel coronary artery disease (CAD). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
everolimus-eluting stent and coronary artery bypass graft surgery
Could I receive a placebo?
No, everyone receives an active treatment
How many people
888 participants
Where
27 sitesin 4 countries
Study dates
28 Jul 2008to 5 Apr 2019
Phase
Interventional
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18 years of older
  • Angiographically confirmed multivessel CAD [critical (>70%) lesions in at least two major epicardial vessels and in at least two separate coronary artery territories (LAD, LCX, RCA)] and amenable to either PCI or CABG.
  • 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

  • Severe congestive heart failure (class III or IV according to NYHA, or pulmonary edema) at the time of enrollment.
  • Planned simultaneous surgical procedure unrelated to coronary revascularization (e.g. valve repair/replacement, aneurysmectomy, carotid endarterectomy or carotid stent).
  • In-stent restenosis of a target vessel
  • Prior CABG surgery
  • Prior PCI with stent implantation within 1 year
  • Two or more chronic total occlusions in major coronary territories
Show all 17Show fewer
  • Acute ST-elevation MI(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
  • Previous stroke within 6 months or patients with stroke at more than 6 months with significant residual neurologic involvement, as reflected in a Rankin Score > 1
  • Dementia with a Mini Mental Status Examination (MMSE) score of ≤ 20
  • 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 related anticoagulation.
  • Contraindication either CABG or PCI/DES because of a coexisting clinical condition
  • Significant leucopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis
  • Intolerance or contraindication to aspirin or both clopidogrel and ticlopidine
  • Suspected pregnancy. A pregnancy test (urine or serum) will be administered prerandomization to all women not clearly menopausal
  • Concurrent enrollment in another clinical trial

Trial locations and contacts

27 sites in 4 countries.

27 sites in 4 countries

South Korea22 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 Corporation Ilsan Hospital

    Ilsan

  • Gachon University Gil Hospital

    Incheon

  • Inje University Pusan Paik Hospital

    Pusan

  • Pusan National University Yangsan Hospital

    Pusan

  • Asan Medical Center

    Seoul

  • Gangnam Severance Hospital

    Seoul

  • Hanyang National University Medical Center

    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

  • The Catholic University of Korea, Yeouido St. Mary's Hospital

    Seoul

  • St.carollo Hospital

    Suncheon

  • Ulsan University Hospital

    Ulsan

  • Wonju Christian Hospital

    Wŏnju

Other trials in South Korea

China2 sites

  • Sir Run Run Shaw Hospital

    Hangzhou

  • Zhongshan Hospital

    Shanghai

Other trials in China

Malaysia2 sites

  • National Heart Institue

    Kuala Lumpur

  • Sarawak General Hospital

    Kuching

Other trials in Malaysia

Thailand1 site

  • Siriraj Hospital

    Bangkok

Other trials in Thailand

About this study

Official title: Randomized Comparison of Coronary Artery Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients With Multivessel Coronary Artery Disease (BEST)

The purpose of this study is to determine whether the safety and efficacy of coronary stent implantation using Everolimus-Eluting Coronary Stent System (Abbott, Boston Scientific) is not inferior to coronary artery bypass grafting (CABG) for the treatment of patient with multivessel coronary artery disease (CAD).

Read the detailed description

The primary purpose of the BEST Study is to determine whether the safety and efficacy of coronary stent implantation using everolimus-eluting balloon expandable stents is not inferior to coronary artery bypass grafting for the treatment of multivessel coronary artery disease.

Being tested
everolimus-eluting stent, coronary artery bypass graft surgery
Keywords
Coronary Artery Disease, stent, coronary artery bypass graft surgery, multivessel coronary artery disease
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • everolimus-eluting stentDevice

    Also called everolimu-eluting stent

    Xience V stent

  • coronary artery bypass graft surgeryProcedure or surgery

    coronary artery bypass graft surgery

Study groups in NCT00997828
Study groupRoleWhat they receive
everolimus-eluting stentExperimentaleverolimus-eluting stent
Receives: Device: everolimus-eluting stent
coronary artery bypass graft surgeryActive comparatorcoronary artery bypass graft surgery
Receives: Procedure: coronary artery bypass graft surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. the composite of death, nonfatal myocardial infarction, and ischemia-driven target vessel revascularization (TVR)

    Death includes all cause mortality. MI includes both Q wave and non Q wave, per protocol definition. TVR should be defined by the protocol.

    Measured: at 2 years

Secondary outcomes (29)

  1. the composite of death, myocardial infarction, and any target vessel revascularization

    Measured: at 2years

  2. Ischemic MACCE (The composite of death, MI, stroke and ischemia-driven TVR)

    Measured: at 2 years

  3. MACCE (The composite of death, MI, stroke and any TVR)

    Measured: at 2 years

  4. the composite of death, MI, and any TVR

    Measured: at 30 days and yearly to 5 years

  5. ischemic MACE(the composite of death, MI, and any TVR)

    Measured: at 30 days and yearly to 5 years

  6. MACCE (The composite of death, MI, stroke and ischemia-driven TVR)

    Measured: at 30 days and yearly to 5 years

  7. ischemic MACCE(The composite of death, MI, stroke and ischemia-driven TVR)

    Measured: at 30 days and yearly to 5 years

  8. all cause death

    Measured: at 30 days and yearly to 5 years

  9. cardiac death

    Measured: at 30 days and yearly to 5 years

  10. myocardial infarction

    Measured: at 3o days and yearly to 5 years

  11. stroke

    Measured: at 30 days and yearly to 5 years

  12. ischemic-driven TVR

    Measured: at 30 days and yearly to 5 years

  13. any target vessel revascularization

    Measured: at 30 days and yearly to 5 years

  14. any target vessel revascularization or target lesion revascularization

    Measured: at 30 days and yearly to 5 years

  15. non-target vessel revascularization

    Measured: at 30 days and yearly to 5 years

  16. stent thrombosis for the percutaneous coronary intervention arm; acute, subacute, and late

    Measured: at 30 days and yearly to 5 years

  17. analysis segment and in-stent binary restenosis

    Measured: at 9 months angiographic follow-up

  18. analysis segment and in-stent late loss

    Measured: at 9 months angiographic follow-up

  19. angina status

    Measured: at 2 years

  20. Follow-up in-stent, in-segment neointimal hyperplasia volume by IVUS

    Measured: at 9 months angiographic follow-up

  21. Incidence of stent malapposition, strut fracture, and peri-stent remodeling by IVUS

    Measured: at 9 months angiographic follow-up

  22. Graft patency in subjects undergoing CABG (defined as: stenosis [DS>50%] in any of the grafts from touch-down to touch-down point)

    Measured: at 9 months angiographic follow up

  23. Cardiac re-hospitalizations

    Measured: at 1 years and yearly to 5 years

  24. Quality of life measurements

    Measured: at 1 year

  25. use of cardiac medications

    Measured: at 1 year and yearly to 5 years

  26. Dialysis/hemofiltration

    Measured: at 30 days and yearly to 5 years

  27. Infectious complications

    Measured: at 30 days

  28. duration of hospitalization related to the target procedure

    Measured: at every event time

  29. 2-year MACE according to the use of FFR-guided multivessel PCI

    Measured: at 2 years after index procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2009 (estimated)
  2. Study start28 Jul 2008
  3. Primary completionApr 2016
  4. Study completion5 Apr 2019

Why it stopped: Problem with recruitment of subjects

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
888 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00997828
Sponsor's protocol ID
2008-0272
Acronym
BEST
Status last verified
May 2019
First submitted
18 Oct 2009
Last updated
10 May 2019
Results posted
No
Data monitoring committee
Yes

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 40368452

  • 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. Everolimus-Eluting Stents or Bypass Surgery for Multivessel Disease in Diabetics: The BEST Extended Follow-Up Study. JACC Cardiovasc Interv. 2023 Oct 9;16(19):2412-2422. doi: 10.1016/j.jcin.2023.07.028.

    PubMed 37821187

  • 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.

    PubMed 36121700

  • Takahashi K, Serruys PW, Fuster V, Farkouh ME, Spertus JA, Cohen DJ, Park SJ, Park DW, Ahn JM, Onuma Y, Kent DM, Steyerberg EW, van Klaveren D; SYNTAX, BEST, and FREEDOM Trial investigators. External Validation of the FREEDOM Score for Individualized Decision Making Between CABG and PCI. J Am Coll Cardiol. 2022 Apr 19;79(15):1458-1473. doi: 10.1016/j.jacc.2022.01.049.

    PubMed 35422242

  • Sotomi Y, Onuma Y, Cavalcante R, Ahn JM, Lee CW, van Klaveren D, de Winter RJ, Wykrzykowska JJ, Farooq V, Morice MC, Steyerberg EW, Park SJ, Serruys PW. Geographical Difference of the Interaction of Sex With Treatment Strategy in Patients With Multivessel Disease and Left Main Disease: A Meta-Analysis From SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery), PRECOMBAT (Bypass Surgery Versus Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease), and BEST (Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients With Multivessel Coronary Artery Disease) Randomized Controlled Trials. Circ Cardiovasc Interv. 2017 May;10(5):e005027. doi: 10.1161/CIRCINTERVENTIONS.117.005027.

    PubMed 28495897

  • Cavalcante R, Sotomi Y, Zeng Y, Lee CW, Ahn JM, Collet C, Tenekecioglu E, Suwannasom P, Onuma Y, Park SJ, Serruys PW. Coronary bypass surgery versus stenting in multivessel disease involving the proximal left anterior descending coronary artery. Heart. 2017 Mar;103(6):428-433. doi: 10.1136/heartjnl-2016-309720. Epub 2016 Sep 20.

    PubMed 27651390

  • Sotomi Y, Cavalcante R, van Klaveren D, Ahn JM, Lee CW, de Winter RJ, Wykrzykowska JJ, Onuma Y, Steyerberg EW, Park SJ, Serruys PW. Individual Long-Term Mortality Prediction Following Either Coronary Stenting or Bypass Surgery in Patients With Multivessel and/or Unprotected Left Main Disease: An External Validation of the SYNTAX Score II Model in the 1,480 Patients of the BEST and PRECOMBAT Randomized Controlled Trials. JACC Cardiovasc Interv. 2016 Aug 8;9(15):1564-72. doi: 10.1016/j.jcin.2016.04.023.

    PubMed 27491605

  • Park SJ, Ahn JM, Kim YH, Park DW, Yun SC, Lee JY, Kang SJ, Lee SW, Lee CW, Park SW, Choo SJ, Chung CH, Lee JW, Cohen DJ, Yeung AC, Hur SH, Seung KB, Ahn TH, Kwon HM, Lim DS, Rha SW, Jeong MH, Lee BK, Tresukosol D, Fu GS, Ong TK; BEST Trial Investigators. Trial of everolimus-eluting stents or bypass surgery for coronary disease. N Engl J Med. 2015 Mar 26;372(13):1204-12. doi: 10.1056/NEJMoa1415447. Epub 2015 Mar 16.

    PubMed 25774645

Questions about this trial

What is this clinical trial studying?

A study testing everolimus-eluting stent and coronary artery bypass graft surgery in people with Coronary Artery Disease, run by Seung-Jung Park at 27 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 17 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: stopped early, as of the sponsor's last update on 10 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 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 was stopped early (reason given: Problem with recruitment of subjects). Results are not available in the source record.

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?

the composite of death, nonfatal myocardial infarction, and ischemia-driven target vessel revascularization (TVR) (time frame: at 2 years). 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 NCT00997828, which also lists 8 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 10 May 2019.

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