NCT05831085招募中不适用
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)
Duk-Woo Park, MD52 个研究点 分布在 14 个国家目标入组 1,500 人开始时间: 2024年6月14日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,500
- 试验地点
- 52
- 主要终点
- The event rate of major adverse cardiac or cerebrovascular events
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Coronary-Artery Bypass Grafting
Active Comparator
干预措施: standard CABG (Procedure)
Imaging- and Physiology-Guided State-of-the-Art Percutaneous Coronary Intervention
Experimental
干预措施: State-of-the-Art Percutaneous Coronary Intervention (Procedure)
结局指标
主要结局
The event rate of major adverse cardiac or cerebrovascular events
时间窗: 2 years
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.
次要结局
- The event rate of death from any cause(5 years)
- The event rate of rehospitalization(7 days)
- The event rate of myocardial infarction(5 years)
- The event rate of repeat revascularization(5 years)
- The event rate of stroke(5 years)
- The event rate of composite of death from any causes, cardiovascular causes, or noncardiovascular causes(5 years)
- The event rate of composite of death or myocardial infarction(5 years)
- The event rate of composite of death, myocardial infarction, stroke or repeat revascularization(5 years)
- The event rate of stent thrombosis(5 years)
- The event rate of symptomatic graft occlusion or stenosis(5 years)
- The event rate of bleeding complications(5 years)
- The event rate of rehospitalization(7 days)
- The change of functional class(1, 6, 12, 18, 24, 36, 60 months)
- The event rate of death from any cause(5 years)
- The event rate of myocardial infarction(5 years)
- The event rate of composite of death, myocardial infarction, stroke or repeat revascularization(5 years)
- The event rate of periprocedural major adverse events(5 years)
- The event rate of repeat revascularization(5 years)
- The event rate of composite of death from any causes, cardiovascular causes, or noncardiovascular causes(5 years)
- The event rate of composite of death or myocardial infarction(5 years)
- The event rate of symptomatic graft occlusion or stenosis(5 years)
- The event rate of bleeding complications(5 years)
- The event rate of stroke(5 years)
- The event rate of stent thrombosis(5 years)
- Length of hospital stay(7 days)
- The change of angina-related quality of life index by the Seattle Angina Questionnaire [SAQ](1, 12, 24, 36, 60 months)
- The change of angina-related quality of life index by the EQ-5D(1, 12, 24, 36, 60 months)
- The number of anti-anginal medications used(1, 6, 12, 18, 24, 36, 60 months)
- Total healthcare costs and cost-effectiveness assessed using total medical expenditures and incremental cost-effectiveness ratio (ICER)(1, 6, 12, 18, 24, 36, 60 months)
研究者
Duk-Woo Park, MD
Professor, Cardiology, Asan Medical Center Heart Institute, Valvular Heart Disease Center, Ischemic Heart Disease Center
Asan Medical Center
研究点 (52)
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