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RecruitingNCT05831085DEFINE-DMUpdated Jun 24, 2026

Diabetes-Centered Evaluation of Revascularization Strategy of Functional and Imaging-CombiNEd State-of-the-Art Percutaneous Coronary Intervention or Coronary-Artery Bypass Grafting in Patients With Diabetes Mellitus and Multivessel Coronary Artery Disease

An interventional study of State-of-the-Art Percutaneous Coronary Intervention and standard CABG in Coronary Artery Stenosis, sponsored by Duk-Woo Park, MD. Recruiting at 39 sites in 14 countries. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2026-06-24.

Sponsored by Duk-Woo Park, MD · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
1,500
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study summary

The objective of this randomized study was to compare outcomes of imaging-and physiology-guided state-of-the-art percutaneous coronary intervention (PCI) to coronary artery bypass grafting (CABG) in patients with diabetes and three-vessel CAD (not involving left main).

02

Conditions studied

  • Coronary Artery Stenosis

Keywords

  • Multivessel Coronary Artery Disease
  • state of the art
  • State-of-the-Art Percutaneous Coronary Intervention
  • Coronary-Artery Bypass Grafting
  • Diabetes Mellitus
03

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. The subject must be ≥20 years of age with angina and/or evidence of myocardial ischemia.
  2. Patients with type 2 diabetes based on the need for treatment with insulin or oral hypoglycemic drugs or a confirmed elevated blood glucose level (fasting plasma glucose elevation on >1 occasion of ≥126 mg/dL [7.0 mmol/L] or 2-h postprandial of ≥200 mg/dL [11.1 mmol/L] during oral glucose tolerance test or random plasma glucose of ≥200 mg/dL [11.1 mmol/L] with classic symptoms of hyperglycemia or hyperglycemic crisis or HbA1C ≥6.5% [48 mmol/mol]).
  3. Significant three-vessel CAD (defined as ≥ 50% diameter stenosis [DS] by visual estimation in each of the three major epicardial vessels or major side branches but not involving the left main coronary artery) and equivalently amenable to revascularization by means of either PCI or CABG as determined by the Heart Team at the trial site.
  4. The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.

Exclusion criteria

Exclusion Criteria:

  1. Unprotected left main coronary artery disease.
  2. The presence of complex coronary disease anatomy or lesion characteristics or other cardiac condition(s) which leads the participating interventional cardiologist to believe that PCI is not suitable (i.e. the subject should be managed with CABG or medical therapy alone).
  3. Recent ST-elevation myocardial infarction(\<5 days prior to randomization).
  4. Cardiogenic shock and/or need for mechanical/pharmacologic hemodynamic support.
  5. Severe left ventricular dysfunction (ejection fraction \<30%).
  6. Requirement for other cardiac or non-cardiac surgical procedure (e.g., valve replacement, aorta surgery, or carotid revascularization). However, a maze procedure or pulmonary vein isolation is allowed.
  7. Contraindication or inability to take aspirin or P2Y12 inhibitors (clopidogrel, ticagrelor, or prasugrel) for at least 6 months.
  8. Prior CABG.
  9. Extremely calcified or tortuous vessels precluding FFR measurement or intracoronary imaging evaluation.
  10. More than one major epicardial vessel which is chronically occluded; enrollment of 1 Chronic total occlusion lesion is allowed.
  11. Subjects requiring or who may require additional surgery (cardiac or noncardiac) within 1 year.
  12. End-stage renal disease requiring renal replacement therapy.
  13. Liver cirrhosis.
  14. Pregnant and/or lactating women.
  15. Concurrent medical condition with a limited life expectancy of less than 2 years.
  16. Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period. However, where at least one or more conditions are satisfied, it could be an exception according to an investigator's discretion;

1) Participated in the observational study expected no effect on the safety and/or effectiveness evaluation of this trial.

2) Screening failed before any interventional factor is involved.

3) Participated in academic trials like strategic comparison studies conducted under standard therapy provided that there is no additional risk or a specific procedure to a subject and no interference between this trial and other studies.

04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
1,500 participants (estimated)

Study arms

  • Experimental
    Imaging- and Physiology-Guided State-of-the-Art Percutaneous Coronary Intervention

    Procedure: State-of-the-Art Percutaneous Coronary Intervention

  • Active comparator
    Coronary-Artery Bypass Grafting

    Procedure: standard CABG

Interventions

  • ProcedureState-of-the-Art Percutaneous Coronary Intervention

    supported by intracoronary imaging (e.g., intravascular ultrasound \[IVUS\] or optical coherence tomography \[OCT\]), intracoronary physiology (e.g., fractional flow reserve \[FFR\] or instantaneous wave-free ratio \[iFR\]), contemporary metallic DES (durable polymer everolimus-eluting stents; XIENCE family stent system, Abbott Vascular), guideline-directed optimal medical therapy \[GDMT\] with advanced cardiovascular (e.g., high-dose statin and advanced strategy of antiplatelet regimens) and anti-diabetic medications \[e.g., a sodium-glucose cotransporter \[SGLT\]-2 inhibitors or Glucagon-like peptide-1 \[GLP-1\] agonists) in patients with type 2 diabetes and three-vessel coronary artery disease (CAD) (not involving left main)

  • Procedurestandard CABG

    Coronary-Artery Bypass Grafting

05

What researchers measure

Primary outcomes

  1. The event rate of major adverse cardiac or cerebrovascular events

    Major adverse cardiac or cerebrovascular events (MACCE) were defined as a composite of hard clinical endpoints of death from any causes, myocardial infarction, or stroke.

    Time frame: 2 years

Secondary outcomes

  1. The event rate of death from any cause

    Time frame: 5 years

  2. The event rate of myocardial infarction

    Time frame: 5 years

  3. The event rate of repeat revascularization

    Time frame: 5 years

  4. The event rate of stroke

    Time frame: 5 years

  5. The event rate of composite of death from any causes, cardiovascular causes, or noncardiovascular causes

    Time frame: 5 years

  6. The event rate of myocardial infarction

    any, spontaneous or procedural

    Time frame: 5 years

  7. The event rate of composite of death or myocardial infarction

    Time frame: 5 years

  8. The event rate of composite of death, myocardial infarction, stroke or repeat revascularization

    Time frame: 5 years

  9. The event rate of stent thrombosis

    by an Academic Research Consortium (ARC) definition

    Time frame: 5 years

  10. The event rate of symptomatic graft occlusion or stenosis

    Time frame: 5 years

  11. The event rate of bleeding complications

    BARC (Bleeding Academic Research Consortium) criteria

    Time frame: 5 years

  12. The event rate of periprocedural major adverse events

    Periprocedural major adverse events means major arrhythmia, any unplanned surgery or therapeutic radiologic procedure, development of acute renal failure, sternal wound dehiscence, infection requiring antibiotics, prolonged intubation (\>48 hours), post-pericardiotomy syndrome, etc.

    Time frame: 5 years

  13. Length of hospital stay

    Time frame: 7 days

  14. The event rate of rehospitalization

    any, cardiac, or noncardiac causes

    Time frame: 7 days

  15. The change of functional class

    Assessed by The Canadian Cardiovascular Society (CCS) Angina Score Classification. The minimum and maximum values are 1 and 4 respectively. A higher score of CCS angina score classification means severe exertional angina.

    Time frame: 1, 6, 12, 18, 24, 36, 60 months

  16. The change of angina-related quality of life index by the Seattle Angina Questionnaire [SAQ]

    The SAQ is a disease-specific patient-reported outcome (PRO) with 5 domains. The minimum and maximum values are 0 and 100 respectively. A lower score represents poor health status and a high score represents good health status.

    Time frame: 1, 12, 24, 36, 60 months

  17. The change of angina-related quality of life index by the EQ-5D

    EQ-5D is a standardised measure of health-related quality of life developed by the EuroQol Group. The minimum and maximum values are 5 and 15 respectively. A higher score of EQ-5D means a low quality of life.

    Time frame: 1, 12, 24, 36, 60 months

  18. The number of anti-anginal medications used

    Time frame: 1, 6, 12, 18, 24, 36, 60 months

  19. Total healthcare costs and cost-effectiveness assessed using total medical expenditures and incremental cost-effectiveness ratio (ICER)

    Total medical cost will be calculated using predefined cost components related to the index revascularization procedure (PCI or CABG) and subsequent healthcare utilization. The list of cost items includes (but is not limited to): diagnostic catheters, guide catheters, guidewires, balloons, stents, adjunctive devices (e.g., rotablation system, intravascular lithotripsy), professional procedure fees, CABG-related graft categories, hospitalization cost per day (Intensive care unit and ward), and non-invasive cardiac tests. Total costs will be aggregated for each participant and compared between study groups at each scheduled time point. Cost-effectiveness will be assessed using the incremental cost-effectiveness ratio (ICER), calculated as the difference in total costs divided by the difference in clinical effectiveness between the study groups.

    Time frame: 1, 6, 12, 18, 24, 36, 60 months

06

Study locations

31 of 39 sites recruiting
  • Palo Alto VA Medical Center
    Palo Alto, California 94304, United States
    • Fearon F. William, MD · Contact
    • Fearon F. William, MD · Principal investigator
    Recruiting
  • Victorian Heart Institute
    Clayton, Australia
    • James Sapontis, MD · Contact
    • James Sapontis, MD · Principal investigator
    Recruiting
  • Fuwai Hospital, Chinese Academy of Medical Sciences (CAMS)
    Beijing, China
    • Kefei Dou, MD · Contact
    • Kefei Dou, MD · Principal investigator
    Recruiting
  • Second Affiliated Hospital of Zhejiang University School of Medicine
    Hanzhou, China
    • Jian'an Wang, MD · Contact
    • Jian'an Wang, MD · Principal investigator
    Recruiting
  • Queen Mary Hospital
    Hong Kong, Hong Kong
    • Frankie CC Tam, MD · Contact
    • Frankie CC Tam, MD · Principal investigator
    Recruiting
  • Mody Harvard Cardiac Institute
    Bathinda, India
    • Rohit Mody, MD · Contact
    • Rohit Mody, MD · Principal investigator
    Recruiting
  • Medanta - The Medicity
    Gurugram, India
    • Rajneesh Kapoor, MD · Contact
    • Rajneesh Kapoor, MD · Principal investigator
    • Praveen Chandra, MD · Principal investigator
    Recruiting
  • Fortis Escorts Heart Institute
    New Delhi, India
    • Ashok Seth, MD · Contact
    • Ashok Seth, MD · Principal investigator
    Recruiting
  • Tsuchiura Kyodo Hospital
    Tsuchiura, Japan
    • Tsunekazu Kakuta, MD · Contact
    • Tsunekazu Kakuta, MD · Principal investigator
    Recruiting
  • Pauls Stradins Clinical University Hospital
    Riga, Latvia
    • Andrejs Erglis, MD · Contact
    • Andrejs Erglis, MD · Principal investigator
    Recruiting
  • Vilnius University Hospital Santaros Klinikos
    Vilnius, Lithuania
    • Giedrius Davidavicius, MD · Contact
    • Giedrius Davidavicius, MD · Principal investigator
    Recruiting
  • Sarawak Heart Centre
    Kota Samarahan, Malaysia
    • Alan Fong, MD · Contact
    • Alan Fong, MD · Principal investigator
    Recruiting
  • University Clinical Center of Serbia
    Belgrade, Serbia
    • Branko Beleslin, MD · Contact
    • Branko Beleslin, MD · Principal investigator
    Recruiting
  • National Heart Centre Singapore (NHCS)
    Singapore, Singapore
    • Tan Wei Chieh Jack, MD · Contact
    • Tan Wei Chieh Jack, MD · Principal investigator
    Recruiting
  • Bucheon Sejong Hospital
    Bucheon-si, South Korea
    • Young-jin Choi, MD · Contact
    • Young-jin Choi, MD · Principal investigator
    Recruiting
  • Daegu Catholic University Medical Center
    Daegu, South Korea
    • Jin-bae Lee, MD · Contact
    • Jin-bae Lee, MD · Principal investigator
    Not yet recruiting
  • Keimyung University Dongsan Medical Center
    Daegu, South Korea
    • Chul-hyun Lee, MD · Contact
    • Chul-hyun Lee, MD · Principal investigator
    Recruiting
  • Yeungnam University Medical Center
    Daegu, South Korea
    • Woong Kim, MD · Contact
    • Woong Kim, MD · Principal investigator
    Not yet recruiting
  • Chungnam National University Hospital
    Daejeon, South Korea
    • Jin-ok Jeong, MD · Contact
    • Jin-ok Jeong, MD · Principal investigator
    Recruiting
  • Konyang University Hospital
    Daejeon, South Korea
    Withdrawn
  • Gangneung Asan Hospital
    Gangneung, South Korea
    • Han-bit Park, MD · Contact
    • Han-bit Park, MD · Principal investigator
    Not yet recruiting
  • Chonnam National University Hospital
    Gwangju, South Korea
    • Young-keun Ahn, MD · Contact
    • Young-keun Ahn, MD · Principal investigator
    Recruiting
  • National Health Insurance Service Ilsan Hospital
    Ilsan, South Korea
    • Ji-yong Jang, MD · Contact
    • Ji-yong Jang, MD · Principal investigator
    Recruiting
  • Gachon University Gil Hospital
    Incheon, South Korea
    • Seung-hwan Han, MD · Contact
    • Seung-hwan Han, MD · Principal investigator
    Not yet recruiting
  • Dong-A Medical Center
    Pusan, South Korea
    • Yong-rak Cho, MD · Contact
    • Yong-rak Cho, MD · Principal investigator
    Recruiting
  • Seoul university Bundang hospital
    Seongnam-si, South Korea
    • Si-Hyuck Kang, MD · Contact
    • Si-Hyuck Kang, MD · Principal investigator
    Recruiting
  • Asan Medical Center
    Seoul, South Korea
    • Duk-woo Park, MD · Contact
    • Duk-woo Park, MD · Principal investigator
    Recruiting
  • Hanyang University Seoul Hospital
    Seoul, South Korea
    • Young-hyo Lim, MD · Contact
    • Young-hyo Lim, MD · Principal investigator
    Not yet recruiting
  • Samsung Medical Center
    Seoul, South Korea
    • Joo-yong Han, MD · Contact
    • Joo-yong Han, MD · Principal investigator
    Recruiting
  • SNU Boramae Medical Center
    Seoul, South Korea
    • Sang-hyun Kim, MD · Contact
    • Sang-hyun Kim, MD · Principal investigator
    Not yet recruiting
  • The Catholic Univ. of Korea Seoul St. Mary's hospital
    Seoul, South Korea
    • Byung-hee Hwang, MD · Contact
    • Byung-hee Hwang, MD · Principal investigator
    Recruiting
  • The Catholic University of Korea, St. Vincent's Hospital
    Suwon, South Korea
    • Sung-ho Hur, MD · Contact
    • Sung-ho Hur, MD · Principal investigator
    Not yet recruiting
  • The Catholic University of Korea, Uijeongbu ST. Mary's Hospital
    Uijeongbu-si, South Korea
    • Hyo-seok Ahn, MD · Contact
    • Hyo-seok Ahn, MD · Principal investigator
    Recruiting
  • Ulsan University Hospital
    Ulsan, South Korea
    • Eun-seok Shin, MD · Contact
    • Eun-seok Shin, MD · Principal investigator
    Recruiting
  • Pusan National University Yangsan Hospital
    Yangsan, South Korea
    • Jeong-cheon Choi, MD · Contact
    • Jeong-cheon Choi, MD · Principal investigator
    Recruiting
  • National Taiwan University Hospital
    Taipei, Taiwan
    • Paul Hsien Li Kao, MD · Contact
    • Paul Hsien Li Kao, MD · Principal investigator
    Recruiting
  • Siriraj Hospital
    Bangkok, Thailand
    • Karokoth Towashiraporn, MD · Contact
    • Karokoth Towashiraporn, MD · Principal investigator
    Recruiting
  • Siriraj Hospital
    Bangkok, Thailand
    • Korakoth Towashiraporn, MD · Contact
    • Korakoth Towashiraporn, MD · Principal investigator
    Recruiting
  • Srinagarind Hospital
    Khon Kaen, Thailand
    • Chaiyasith Wongvipaporn, MD · Contact
    • Chaiyasith Wongvipaporn, MD · Principal investigator
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05831085
Lead sponsor
Duk-Woo Park, MD
Collaborators
CardioVascular Research Foundation, Korea
Responsible party
Duk-Woo Park, MD (Professor, Cardiology, Asan Medical Center Heart Institute, Valvular Heart Disease Center, Ischemic Heart Disease Center, Asan Medical Center) — Sponsor-investigator
First posted
Apr 26, 2023
Start date
Jun 14, 2024
Primary completion
Dec 31, 2029 (estimated)
Completion
Dec 31, 2029 (estimated)
Last update
Jun 24, 2026

Study contacts

Jung-hee Ham, Project manager
Contact
cvcrc5@amc.seoul.kr
82-2-3010-4728
Seung-jung Park, MD
study chair · Asan Medical Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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