OPtimal TIming of Fractional Flow Reserve-Guided Complete RevascularizatiON for Non-Infarct Related Artery in ST-Segment Elevation Myocardial Infarction With Multivessel Disease (OPTION-STEMI)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 994
- 试验地点
- 22
- 主要终点
- Cumulative incidence rate of all-cause death, non-fatal myocardial infarction, or all unplanned revascularization at 1 year from baseline
研究概览
简要总结
Patients with STEMI (ST-segment elevation myocardial infarction) with multivessel disease which have PCI (percutaneous coronary intervention)-suitable non-IRA (infarct related artery) will be randomized to immediate complete revascularization group or staged revascularization group by 1:1 fashion. Non-IRA lesion which have equal or more than 70% diameter stenosis by visual estimation will be revascularized without FFR (fractional flow reserve) evaluation. Non-IRA lesion with diameter stenosis 50-70% by visual estimation will be evaluated using FFR device. In case of FFR value more than 0.8, non-IRA lesion wll be deferred without PCI. If FFR value was equal or less than 0.8, non-IRA lesion will be revascularized.
详细描述
Study objectives:
To determine the optimal timing of non-infarct related artery (IRA) percutaneous coronary intervention (PCI) with the aid of FFR (fractional flow reserve) (immediate complete revascularization during primary angioplasty vs. staged procedure for non-IRA PCI) in patients with ST-segment elevation myocardial infarction with multivessel disease (MVD).
Study hypothesis:
Complete revascularization (CR) at index procedure is not inferior to staged in-hospital CR in patients with STEMI and MVD who undergoing FFR-guided revascularization for non-IRA.
Background:
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 19 years old
- •ST-segment elevation myocardial infarction
- •ST-segment elevation in at least 2 contiguous leads or,
- •New onset left bundle branch block
- •Primary PCI within 12 hours after symptom development
- •Multivessel disease: Non-IRA with at least 2.5 mm diameter and 50% diameter stenosis by visual estimation
- •Patient's or protector's agreement about study design and the risk of PCI
排除标准
- •Cardiogenic shock at initial presentation or after treatment of IRA
- •Unprotected left main coronary artery disease with at least 50% diameter stenosis by visual estimation
- •TIMI (Thrombolysis in Myocardial Infarction) flow at non-IRA ≤ 2
- •Severe procedural complications (e.g. persistent no-reflow phenomenon, coronary artery perforation) which restricts study enrollment by operators' decision
- •Non-IRA lesion not suitable for PCI treatment by operators' decision
- •Chronic total occlusion at non-IRA
- •History of anaphylaxis to contrast agent
- •Pregnancy and lactation
- •Life expectancy < 1-year
- •Severe valvular disease
- •History of CABG (coronary artery bypass graft), or planned CABG
- •Fibrinolysis before admission
- •Severe asthma
- •Patient's refusal to participate in study
研究组 & 干预措施
Staged in-hospital CR (complete revascularization)
Non-infarct related artery (IRA) will be revascularized in other day (during hospitalization) after PCI for IRA. Non-IRA lesion which have equal or more than 70% diameter stenosis by visual estimation will be revascularized without FFR evaluation. Non-IRA lesion with diameter stenosis 50-70% by visual estimation will be evaluated using FFR device. In case of FFR value more than 0.8, non-IRA lesion wll be deferred without PCI. If FFR value was equal or less than 0.8, non-IRA lesion will be revascularized.
干预措施: Staged in-hospital or Immediate complete revascularization (Procedure)
Immediate CR (complete revascularization)
Non-infarct related artery (IRA) will be revascularized immediately after PCI for IRA (during primary PCI). Non-IRA lesion which have equal or more than 70% diameter stenosis by visual estimation will be revascularized without FFR evaluation. Non-IRA lesion with diameter stenosis 50-70% by visual estimation will be evaluated using FFR device. In case of FFR value more than 0.8, non-IRA lesion wll be deferred without PCI. If FFR value was equal or less than 0.8, non-IRA lesion will be revascularized.
干预措施: Staged in-hospital or Immediate complete revascularization (Procedure)
结局指标
主要结局
Cumulative incidence rate of all-cause death, non-fatal myocardial infarction, or all unplanned revascularization at 1 year from baseline
时间窗: Index admission to 12 months
Composite endpoint of all-cause death, non-fatal myocardial infarction, or all unplanned revascularization at 1 year after index percutaneous coronary intervention
次要结局
- Rate of contrast-induced nephropathy during index admission(During index admission)
- Cumulative incidence rate of non-target vessel revascularization at each visit(Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months)
- Cumulative incidence rate of all-cause death at each visit(Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months)
- Cumulative incidence rate of target-lesion revascularization at each visit(Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months)
- Cumulative incidence rate of target-vessel revascularization at each visit(Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months)
- Cumulative incidence rate of non-cardiac death at each visit(Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months)
- Cumulative incidence rate of non-fatal myocardial infarction at each visit(Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months)
- Cumulative incidence rate of ischemic and hemorrhagic stroke at each visit(Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months)
- Cumulative incidence rate of major bleeding (BARC definitions type 3 or 5) at each visit(Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months)
- Cumulative incidence rate of all-cause death, non-fatal myocardial infarction, or all unplanned revascularization at 1 year from baseline(Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months)
- Cumulative incidence rate of all unplanned revascularization at each visit(Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months)
- Cumulative incidence rate of hospitalization for heart failure at each visit(Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months)
- Cumulative incidence rate of definite or probable stent thrombosis at each visit(Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months)
- Cumulative incidence rate of cardiac death at each visit(Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months)
- Cumulative incidence rate of hospitalization for unstable angina at each visit(Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months)
研究者
Min Chul Kim
Associate Professor
Chonnam National University Hospital