Antiplatelet Agents in Patients With Intermediate Coronary Artery Stenosis and Negative Fractional Flow Reserve
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4,657
- 试验地点
- 1
- 主要终点
- Major adverse cardiac and cerebrovascular events
研究概览
简要总结
There is no specific recommendation regarding pharmacologic treatment as primary prevention for patients with intermediate coronary artery stenosis whose revascularization was deferred based on negative fractional flow reserve (FFR).
Current nationwide cohort study conducted using Korean National Health Insurance Service database evaluated the safety and efficacy of antiplatelet therapy in patients with intermediate coronary artery stenosis with deferred revascularization based on negative FFR (FFR>0.80).
详细描述
This study was nationwide cohort study conducted using Korean National Health Insurance Service database. From 2013 to 2020, reimbursement criteria of FFR were patients with no previous evidence of myocardial ischemia and intermediate coronary artery stenosis (50-70%). Patients who were evaluated by coronary angiography and FFR but did not undergo revascularization were selected and classified according to the use of antiplatelet agents after index procedure. Patients with previous history of atherosclerotic cardiovascular disease were excluded. Eligible patients were matched using propensity score in a 1:1 ratio. Primary efficacy outcome was major adverse cardiac and cerebrovascular events a composite of all-cause death, myocardial infarction, unplanned revascularization, and stroke at 5-year. Primary safety outcome was gastrointestinal bleeding, regardless of the need of transfusion.
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 50-70% intermediate stenosis by quantitative coronary angiography in a vessel greater than 2.5 mm
- •Patients who underwent invasive coronary angiography and FFR measurement
- •Patients whose revascularization was deferred based on FFR>0.80
排除标准
- •Patients who underween FFR measurement after expansion of reimbursement criteria of FFR (since 2021)
- •Patients with history of any bleeding with blood transfusion
- •Patients with use of non-vitamin K antagonist oral anticoagulants (NOAC) or warfarin
- •Patients with previous atherosclerotic cardiovascular disease
- •Patients with already on antiplatelet agents including dual antiplatelet agents
研究组 & 干预措施
Antiplatelet agents
Among patients with intermediate coronary artery stenosis (50-70% diameter stenosis by quantitative coronary angiography) but who did not undergo PCI based on negative FFR, those who were taking antiplatelet agents (aspirin or clopidogrel) are classified into this group.
干预措施: Antiplatelet Agents (Drug)
结局指标
主要结局
Major adverse cardiac and cerebrovascular events
时间窗: at 5 years from index procedure
Primaey efficacy ouotcome (MACCE, a composite of all-cause death, myocardial infarction, unplanned revascularization, and stroke)
Gastrointestinal bleeding
时间窗: at 5 years from index procedure
Primary safety outcome (any gastrointestinal bleeding, regardless of the need of transfusion)
次要结局
- All-cause death(at 5 years from index procedure)
- Gastrointestinal bleeding necessitated hospitalization without documented transfusion(at 5 years from index procedure)
- Myocardial infarction(at 5 years from index procedure)
- Unplanned revascularization(at 5 years from index procedure)
- Stroke(at 5 years from index procedure)
- Major bleeding(at 5 years from index procedure)
- Intracranial hemorrhage(at 5 years from index procedure)
研究者
Joo Myung Lee
Associate Professor
Samsung Medical Center