Clinical Outcomes of Medical Treatment for Patients With Significant Unprotected Left Main Coronary Artery Disease
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 4,600
- 试验地点
- 1
- 主要终点
- Major adverse cardiac and cerebrovascular events (MACCE) which is defined as a composite of death of any cause, myocardial infarction (MI), stroke, or urgent revascularization
研究概览
简要总结
Left main coronary artery (LMCA) is a major branch of coronary artery and supplies a large bulk of myocardium.
Revascularization by either surgical coronary bypass grafting (CABG) or percutaneous coronary intervention (PCI) is recommended for significant unprotected LMCA disease, with CABG being preferred if there is significant involvement in other coronary arteries1,2. CABG has been demonstrated to confer survival benefit over medical therapies patients with LMCA in earlier clinical trials3,4,5. However, these trials were performed before the wide adoption of modern medical therapies such as antiplatelet and statin. Antiplatelet agents, for example, was only used in 32% of all patients in the Coronary Artery Surgery Study3. Modern day medical treatment for stable coronary artery diseases have been shown to be non-inferior to revascularization in both the COURAGE and ISCHEMIA trials6,7. However, patients with LMCA involvement were mostly excluded from both of these studies. In Hong Kong, the average waiting time for an elective CABG for stable patients with LMCA is around 18 months, during which time the patients are treated with modern medical therapies including high-intensity statin and antiplatelet.
详细描述
Left main coronary artery (LMCA) is a major branch of coronary artery and supplies a large bulk of myocardium.
Revascularization by either surgical coronary bypass grafting (CABG) or percutaneous coronary intervention (PCI) is recommended for significant unprotected LMCA disease, with CABG being preferred if there is significant involvement in other coronary arteries1,2. CABG has been demonstrated to confer survival benefit over medical therapies patients with LMCA in earlier clinical trials3,4,5. However, these trials were performed before the wide adoption of modern medical therapies such as antiplatelet and statin. Antiplatelet agents, for example, was only used in 32% of all patients in the Coronary Artery Surgery Study3. Modern day medical treatment for stable coronary artery diseases have been shown to be non-inferior to revascularization in both the COURAGE and ISCHEMIA trials6,7. However, patients with LMCA involvement were mostly excluded from both of these studies. In Hong Kong, the average waiting time for an elective CABG for stable patients with LMCA is around 18 months, during which time the patients are treated with modern medical therapies including high-intensity statin and antiplatelet.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with significant LMCA disease who were on the waitlist for CABG since 1st January 2000 to 31st December
- •The decision for CABG over PCI as a mode of revascularization for the patients on this waitlist were collectively made by the HEART team
排除标准
- •patients with co-existing significant valvular heart disease requiring concomitant surgical intervention, and unstable patients in whom urgent surgical intervention was performed
结局指标
主要结局
Major adverse cardiac and cerebrovascular events (MACCE) which is defined as a composite of death of any cause, myocardial infarction (MI), stroke, or urgent revascularization
时间窗: 1 year
Major adverse cardiac and cerebrovascular events (MACCE) which is defined as a composite of death of any cause, myocardial infarction (MI), stroke, or urgent revascularization
Death of any cause.
时间窗: 1 year
Death of any cause.
次要结局
未报告次要终点
研究者
GuangMing Tan
Assistant professor
Chinese University of Hong Kong