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
- Conditions
- Diseases of the circulatory system
- Registration Number
- KCT0009077
- Lead Sponsor
- Asan Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 1360
Inclusion Criteria: subject must have met all of the following criteria to be eligible for treatment in the study:
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]) (17).
3.Significant multivessel CAD (defined as = 50% diameter stenosis [DS] 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.
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 or Ethical Committee of the respective clinical site.
Exclusion Criteria: Subjects were to be excluded from the study if any of the following criteria were met:
1.Unprotected left main coronary artery disease requiring revascularization
2.The presence of complex CAD 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 STEMI (<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 clopidogrel) 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 CTO 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, except for observational registries
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome was the rate of major adverse cardiac or cerebrovascular events (MACCE) at 2 years.
- Secondary Outcome Measures
Name Time Method 1)Each individual component of primary composite outcome;Death from any causes, cardiovascular causes, or noncardiovascular causes;MI (any, spontaneous or procedural);Composite of death or MI;Composite of death, MI, stroke or repeat revascularization;Stent thrombosis (ARC definition) ;Symptomatic graft occlusion or stenosis;Bleeding complications (BARC criteria);Periprocedural major adverse events (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);Length of hospital stay;Rehospitalization (any, cardiac, or noncardiac causes);Functional class (assessed by the CCS Classification) at each time point;Angina-related quality of life index (by the Seattle Angina Questionnaire [SAQ]) or health-related quality of life index (by the EQ-5D) at each time point;Number of anti-anginal medications used at each time point