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)
Coronary Artery Stenosis
About this trial
This is an interventional treatment trial for Coronary Artery Stenosis focused on measuring Multivessel Coronary Artery Disease, state of the art, State-of-the-Art Percutaneous Coronary Intervention, Coronary-Artery Bypass Grafting, Diabetes Mellitus
Eligibility Criteria
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]) (17). Significant multivessel CAD (defined as ≥ 50% diameter stenosis by visual estimation) of major epicardial vessels with LAD involvement and amenable to revascularization (equally suitable) by both PCI and CABG as determined by the Heart Team. 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 requiring revascularization 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 clopidogrel) 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, except for observational registries
Sites / Locations
- Asan Medical Center
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Imaging- and Physiology-Guided State-of-the-Art Percutaneous Coronary Intervention
Coronary-Artery Bypass Grafting