Comparing heart procedures for diabetes patients with blocked arteries

A Comparison of Imaging- and Physiology-Guided State-of-the-Art Percutaneous Coronary Intervention and Coronary-Artery Bypass Grafting in Patients With Diabetes and Three-Vessel Coronary Artery Disease: DEFINE-DM Trial (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)

This study is testing whether a new heart procedure or a traditional surgery works better for people with diabetes who have blocked arteries and chest pain.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 1500 (estimated)
• Ages: 20 Years and up
• Sex: All
• Sponsor: Asan Medical Center (Academic / other)
• Locations: 27 sites (Palo Alto, California and 26 other locations)
• Trial ID: NCT05831085 on ClinicalTrials.gov

What this trial studies

This study aims to compare the outcomes of advanced percutaneous coronary intervention (PCI) with standard coronary artery bypass grafting (CABG) in patients who have diabetes and significant three-vessel coronary artery disease. It is a randomized trial that focuses on patients with angina or evidence of myocardial ischemia, assessing which intervention provides better results. The study will involve a Heart Team to determine the suitability of patients for either PCI or CABG based on their specific conditions.

Who should consider this trial

Good fit: Ideal candidates for this study are patients aged 20 and older with type 2 diabetes and significant three-vessel coronary artery disease.

Not a fit: Patients with less than three-vessel coronary artery disease or those not diagnosed with diabetes may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment strategies for diabetes patients with coronary artery disease, potentially enhancing their heart health outcomes.

How similar studies have performed: Other studies have shown promising results in comparing PCI and CABG in similar patient populations, indicating that this approach is supported by prior research.

Eligibility criteria

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:

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.

Where this trial is running

Palo Alto, California and 26 other locations

• Palo Alto VA Medical Center — Palo Alto, California, United States (Not_yet_recruiting)
• Fuwai Hospital, Chinese Academy of Medical Sciences (CAMS) — Beijing, China (Not_yet_recruiting)
• Second Affiliated Hospital of Zhejiang University School of Medicine — Hanzhou, China (Recruiting)
• Medanta - The Medicity — Gurugram, India (Recruiting)
• Fortis Escorts Heart Institute — New Delhi, India (Not_yet_recruiting)
• Sarawak Heart Centre — Kota Samarahan, Malaysia (Recruiting)
• University Clinical Center of Serbia — Belgrade, Serbia (Not_yet_recruiting)
• National Heart Centre Singapore (NHCS) — Singapore, Singapore (Not_yet_recruiting)
• Daegu Catholic University Medical Center — Daegu, South Korea (Not_yet_recruiting)
• Keimyung University Dongsan Medical Center — Daegu, South Korea (Recruiting)
• Yeungnam University Medical Center — Daegu, South Korea (Not_yet_recruiting)
• Chungnam National University Hospital — Daejeon, South Korea (Not_yet_recruiting)
• Konyang University Hospital — Daejeon, South Korea (Withdrawn)
• Gangneung Asan Hospital — Gangneung, South Korea (Not_yet_recruiting)
• Chonnam National University Hospital — Gwangju, South Korea (Recruiting)
• National Health Insurance Service Ilsan Hospital — Ilsan, South Korea (Recruiting)
• Gachon University Gil Hospital — Incheon, South Korea (Not_yet_recruiting)
• Dong-A Medical Center — Pusan, South Korea (Recruiting)
• Asan Medical Center — Seoul, South Korea (Recruiting)
• Hanyang University Seoul Hospital — Seoul, South Korea (Not_yet_recruiting)
• Samsung Medical Center — Seoul, South Korea (Recruiting)
• SNU Boramae Medical Center — Seoul, South Korea (Not_yet_recruiting)
• The Catholic University of Korea, St. Vincent's Hospital — Suwon, South Korea (Not_yet_recruiting)
• The Catholic University of Korea, Uijeongbu ST. Mary's Hospital — Uijeongbu-si, South Korea (Recruiting)
• Ulsan University Hospital — Ulsan, South Korea (Recruiting)
• National Taiwan University Hospital — Taipei, Taiwan (Not_yet_recruiting)
• Siriraj Hospital — Bangkok, Thailand (Recruiting)

Study contacts

• Study coordinator: Jung-hee Ham, Project manager

Conditions Coronary Artery Stenosis; Multivessel Coronary Artery Disease; state of the art; State-of-the-Art Percutaneous Coronary Intervention; Coronary-Artery Bypass Grafting; Diabetes Mellitus