Fractional Flow Reserve Guided Primary Multivessel Percutaneous Coronary Intervention to Improve Guideline Indexed Actual Standard of Care for Treatment of ST-elevation Myocardial Infarction in Patients With Multivessel Coronary Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 885
- 试验地点
- 36
- 主要终点
- Number of Participants With Death From Any Cause
研究概览
简要总结
The Compare-Acute trial is a prospective randomised trial in patients with multivessel disease, who are admitted into hospital with a ST-elevation Myocardial Infarction. The purpose of the study is to compare a FFR guided multivessel PCI taking place during the primary PCI with a primary PCI of the culprit vessel only.
Patients will be enrolled after successful revascularisation of the culprit vessel. Patients that have at least one lesion with a diameter of stenosis of more than 50% on visual estimation, feasible (operators judgement) for treatment with PCI in a non-infarct related artery, will be randomised either to the FFR guided complete revascularisation arm or staged revascularisation by proven ischemia or persistence of symptoms of angina.
Approximately 885 patients will be entered in the study.
Study hypothesis: FFR-guided complete percutaneous revascularisation of all flow-limiting stenoses in the non-IRA performed within the same procedure as the primary PCI or within the same hospitalisation will improve clinical outcomes compared to the staged revascularisation, guided by prove of ischemia or clinical judgment, as recommended from the guidelines.
详细描述
Background of the study: At the moment the general opinion is divided over the way the non culprit lesions in patients presenting with STEMI should be treated. While the previous guidelines stead that these lesions should be treated in a second time ( ie not during the primary intervention) the actual guidelines do not touch this argument. The reason is that the studies where the previous guidelines were based are old. Meanwhile small sized randomised trials from EU region have proven favourable outcomes with NON infarct related artery during the primary procedure while registers (non randomised trials) from USA still recommend the staged treatment. For this reason we have decided to perform a randomised study to address this issue incorporating the state of the art diagnosis and treatment, as well as the new medical therapy and PCI techniques.
Objective of the study: FFR-guided complete percutaneous revascularisation of all flow-limiting stenoses in the non-IRA performed within the same procedure as the primary PCI or within the same hospitalisation will improve clinical outcomes compared to the staged revascularisation, guided by prove of ischemia or clinical judgment, as recommended from the guidelines
Study design: Prospective, 1: 2 randomisation. FFR guided revascularisation during primary PCI (1) versus following actual guidelines (2)
Study population: All STEMI patients between 18-85 years who will be treated with primary PCI in < 12 h (more than 12 hr if persisting pain allowed) after the onset of symptoms and have at least one stenosis of >50% in a non-IRA judged feasible for treatment with PCI.
Intervention (if applicable): FFR-guided complete percutaneous revascularisation of all flow-limiting stenoses in the non-IRA performed within the same procedure as the primary PCI or within the same hospitalisation will improve clinical outcomes compared to the staged revascularisation, guided by prove of ischemia or clinical judgment, as recommended from the guidelines
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients between 18-85 years presenting with STEMI who will be treated with primary PCI in < 12 h after the onset of symptoms* and have at least one stenosis of >50% in a non-IRA on QCA or visual estimation of baseline angiography and judged feasible for treatment with PCI by the operator.
- •Patients with symptoms for more than 12 hr but ongoing angina complaints can be randomised
排除标准
- •Left main stem disease (stenosis > 50%)
- •STEMI due to in-stent thrombosis
- •Chronic total occlusion of a non-IRA
- •Severe stenosis with TIMI flow ≤ II of the non-IRA artery.
- •Non-IRA stenosis not amenable for PCI treatment (operators decision)
- •Complicated IRA treatment, with one or more of the following;
- •Extravasation,
- •Permanent no re-flow after IRA treatment (TIMI flow 0-1),
- •Inability to implant a stent
- •Known severe cardiac valve dysfunction that will require surgery in the follow-up period.
- •Killip class III or IV already at presentation or at the completion of culprit lesion treatment.
- •Life expectancy of < 2 years.
- •Intolerance to Aspirin, Clopidogrel, Prasugrel, Ticagrelor, Heparin, Bivaluridin, or Everolimus and known true anaphylaxis to prior contrast media of bleeding diathesis or known coagulopathy.
- •Gastrointestinal or genitourinary bleeding within the prior 3 months,
- •Planned elective surgical procedure necessitating interruption of thienopyridines during the first 6 months post enrolment.
- •Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
- •Pregnancy or planning to become pregnant any time after enrolment into this study.
- •Inability to obtain informed consent.
- •Expected lost to follow-up.
结局指标
主要结局
Number of Participants With Death From Any Cause
时间窗: 12 months
Number of participants with all cause mortality at 12 months between groups
Number of Participants With Spontaneous MI
时间窗: 12 months
Number of participants with Spontaneous Myocardial Infarction at 12 months between groups
Number of Participants With the Composite Endpoint of MACCE
时间窗: 12 months
Number of participants with the composite endpoint of all cause mortality non-fatal Myocardial Infarction, any Revascularisation and Cerebrovascular Events (MACCE) at 12 months between groups
Number of Participants With Revascularization - CABG
时间窗: 12 months
Number of participants with revascularization CABG at 12 months between groups
Number of Participants With Periprocedural MI
时间窗: 12 months
Number of participants with Periprocedural Myocardial Infarction at 12 months between groups
Number of Participants With Cerebrovascular Event
时间窗: 12 months
Number of participants with Cerebrovascular event at 12 months between groups
Number of Participants With Revascularization - PCI
时间窗: 12 months
Number of participants with revascularization PCI at 12 months between groups
Number of Participants With Cardiac Death
时间窗: 12 months
Number of participants with Cardiac mortality at 12 months between groups
次要结局
- Number of Participants With Death From Any Cause or MI(3 year)
- Number of Participants With Major Bleeding(12 months)
- Number of Participants With Any Bleeding at 12 Months(12 months)
- Number of Participants With Any Bleeding at 48 Hours(48 hours)
- Number of Participants With Revascularization(12 months)
- Number of Participants With Elective Revascularization at 3 Year(3 year)
- Number of Participants With Any Bleeding at 3 Year(3 year)
- Number of Participants With Hospitalization(3 year)
- Number of Participants With Primary Endpoint Outcome MACCE (Any First Event) at 3 Year(3 year)
- Number of Participants With All Cause Death at 3 Year(3 year)
- Number of Participants With Peri-procedural MI at 3 Year(3 year)
- Number of Participants With Major Bleeding at 3 Year(3 year)
- Number of Participants With Stent Thrombosis at 3 Year(3 year)
- Number of Participants With Composite Endpoint of NACE (Any First Event)(12 months)
- Number of Participants With Cardiac Death at 3 Year(3 year)
- Number of Participants With Cerebrovascular Event(3 year)
- Number of Participants With Hospitalization at 3 Year(3 year)
- Number of Participants With Stent Thrombosis(12 months)
- Number of Participants With Urgent Revascularization at 3 Year(3 year)
- Number of Participants With Composite Endpoint of NACE (Any First Event) at 3 Year(3 years)
- Number of Participants With Spontaneous MI at 3 Year(3 year)