Comparison of "One-stop" Hybrid Coronary Revascularization Versus Percutaneous Coronary Intervention for the Treatment of Multi-vessel Coronary Artery Disease
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 480
- 试验地点
- 2
- 主要终点
- Composite of major adverse cardiac or cerebrovascular events (MACCE) including death, myocardial infarction, stroke and/or repeat revascularization.
研究概览
简要总结
The "one-stop" hybrid coronary revascularization combines minimally invasive direct coronary artery bypass (MIDCAB) and PCI to be performed in the hybrid operating suite, an enhanced operating room equipped with radiographic capability. This study is to compare 1-year clinical outcomes of "one-stop" hybrid coronary revascularization with percutaneous coronary intervention (PCI) in selected patients with multivessel coronary artery disease.
详细描述
Rationale and purpose of this study:
"One-stop" (also named simultaneous) hybrid coronary revascularization has emerged as a novel, safe and feasible minimally invasive approach in selected patients with multivessel coronary artery disease (CAD). The benefits of "one-stop" hybrid procedure compared with conventional PCI are unclear, however.
This study is a single center randomized clinical trial to compare the safety and efficacy of "one-stop" hybrid procedure with conventional PCI in the treatment of selected patients with multivessel CAD requiring revascularization with suitable coronary anatomy.
Sample size:
We examined the results of SYNTAX trial and of the hybrid procedures published previously. The 1-year MACCE rate (the primary endpoint) is estimated as being 18% for PCI/stenting and 8% for the hybrid group. The sample calculated for this trial is 480 patients.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Two- or three-vessel disease, left main disease, or LM equivalent with 2 or 3-vessel disease (left anterior descending [LAD], left circumflex [LCX], right coronary artery [RCA] territory)
- •Denovo lesions of LAD , with obstruction >=70%, especially chronic totally occlusion (CTO), severe calcification or bifurcation lesion of the LM;
- •Angiographic characteristics of non-LAD lesion(s) amiable to PCI/stenting;
- •Chronic stable or unstable angina pectoris of CCS 2 or greater (symptoms of angina and/or objective evidence of myocardial ischemia);
- •Evaluated by both cardiac surgeon and cardiologist together.
排除标准
- •Need for emergent CABG;
- •Prior CABG;
- •Prior PCI with stenting within 6 months of study entry;
- •Stroke with 6 months of study entry;
- •Overt congestive heart failure;
- •Need for a concomitant operation (i.e. valve repair or replacement, Maze surgery);
- •Hemodynamic instability;
- •Situations in which complete revascularization is not possible served;
- •Allergy to radiographic contrast, aspirin or clopidogrel.
- •Contradictions to PCI: Occluded coronary vessels, PVD, Unable to achieve access, Fresh thrombus, Vessels <1.5mm; Intolerance to aspirin or both clopidogrel and ticlopidine;
- •Cannot undergo either CABG or PCI/DES because of a coexisting medical condition
- •History of significant bleeding; Significant leukopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis.
结局指标
主要结局
Composite of major adverse cardiac or cerebrovascular events (MACCE) including death, myocardial infarction, stroke and/or repeat revascularization.
时间窗: 1 year
次要结局
- Overall MACCE rate.(30 days after procedure and 2 years after enrollment)
- Cardiac death.(30 days after procedure, 1 and 2 years after enrollment)
- Documented myocardial infarction.(30 days after procedure, 1 and 2 years after enrollment)
- Target lesion revascularization.(30 days after procedure, 1 and 2 years after enrollment)
- Recurrence of Angina.(1 and 2 years after enrollment)
- Cost-effectiveness analysis.(1 and 2 years after enrollment)
- Quality of life.(6 months, 1 and 2 years after enrollment)
- Rehospitalization.(6 months, 1 and 2 years after enrollment)
- Stent thrombosis.(30 days after procedure, 6 months, 1 and 2 years after enrollment)