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 (DEFINE-DM)

Duk-Woo Park, MD

Status

Enrolling

Conditions

Coronary Artery Stenosis

Treatments

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

Procedure: standard CABG

Study type

Interventional

Funder types

Other

Identifiers

NCT05831085

AMCCV2023-03

Details and patient eligibility

About

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).

Enrollment

1,500 estimated patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

The subject must be ≥20 years of age with angina and/or evidence of myocardial ischemia.
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]).
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.
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

Unprotected left main coronary artery disease.
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).
Recent ST-elevation myocardial infarction(<5 days prior to randomization).
Cardiogenic shock and/or need for mechanical/pharmacologic hemodynamic support.
Severe left ventricular dysfunction (ejection fraction <30%).
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.
Contraindication or inability to take aspirin or P2Y12 inhibitors (clopidogrel, ticagrelor, or prasugrel) for at least 6 months.
Prior CABG.
Extremely calcified or tortuous vessels precluding FFR measurement or intracoronary imaging evaluation.
More than one major epicardial vessel which is chronically occluded; enrollment of 1 Chronic total occlusion lesion is allowed.
Subjects requiring or who may require additional surgery (cardiac or noncardiac) within 1 year.
End-stage renal disease requiring renal replacement therapy.
Liver cirrhosis.
Pregnant and/or lactating women.
Concurrent medical condition with a limited life expectancy of less than 2 years.
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.