Comparison of Clinical Outcomes Between Fractional Flow Reserve-guided Strategy and Angiography-guided Strategy in Treatment of Non-Infarction Related Artery Stenosis in Patients With Acute Myocardial Infarction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,292
- 试验地点
- 1
- 主要终点
- Patient-oriented composite outcome
研究概览
简要总结
The aim of the study is to compare clinical outcomes following fractional flow reserve (FFR)-guided versus angiography only guided strategy in treatment of non-infarction related artery (non-IRA) stenosis in patients with acute myocardial infarction (AMI) with multivessel disease
Prospective, open-label, randomized, multicenter trial to test the clinical outcomes following FFR-guided or angiography-guided strategy in treatment of non-IRA stenosis in patients with acute AMI with multivessel disease.
详细描述
The presence of ischemia is a prerequisite for the improvement of clinical outcomes with percutaneous coronary intervention (PCI). It is well-known that the discrepancy exists between angiographic stenosis severity and the presence of myocardial ischemia. This discrepancy cannot completely overcome with even more precise invasive imaging modalities such as intravascular ultrasound or optical coherence tomography.
Currently, fractional flow reserve (FFR) is regarded as a gold-standard invasive method to define lesion-specific ischemia and FFR-guided PCI has been proven to reduce unnecessary revascularization and to enhance patient's clinical outcomes. Therefore, current guidelines recommend FFR measurement for intermediate coronary stenosis when there is no definite evidence of lesion-specific ischemia.
However, previous evidences which well demonstrated the benefit of FFR-guided strategy were mostly generated from non-acute myocardial infarction patients.1, 3-5 Recently FAMOUS-NAMI trial evaluated 176 patients with acute non-ST elevation myocardial infarction (NSTEMI) with multivessel disease, and demonstrated feasibility of FFR measurement in acute NSTEMI patients and also presented that FFR-guided decision making for non-infarct related artery (IRA) stenosis was significantly reduced unnecessary stent implantation without any difference in major adverse cardiovascular events at 1-year as well as medical cost, compared with angiography-only guided decision making process.
Nevertheless, there have been no evidence in clinical setting of acute myocardial infarction (AMI). Since about 30-50% of patients with AMI possess multivessel disease, the ability to accurately assess the functional significance of non-IRA stenoses at the time of initial primary PCI would potentially facilitate revascularization decisions with potential for health and economic benefit. Moreover, avoiding unnecessary stent implantation for non-IRA stenoses in patients with AMI with multivessel disease would reduce the possibility of stent- or procedure related complications, and enhance long-term prognosis of patients.
Therefore, the FRAME-AMI trial will compare clinical outcomes after index primary PCI between FFR-guided strategy versus angiography only-guided strategy for management of non-IRA stenoses in AMI with multivessel disease 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
- Double (Investigator, Outcomes Assessor)
盲法说明
Clinical event adjudication and statistical analysis will be blindly performed by independent investigators.
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
- •(1) Inclusion Criteria
- •Subject must be at least 19 years of age
- •Acute ST-segment elevation myocardial infarction (STEMI) A. ※ STEMI: "ST-segment elevation ≥0.1 mV in ≥2 contiguous leads B. or documented newly developed left bundle-branch block "
- •Acute non-ST-segment elevation myocardial infarction (NSTEMI)
- •A. ※ NSTEMI: NSTEMI is defined as a combination of criteria with mandated elevation of a cardiac biomarker, preferably high-sensitive cardiac troponin with at least one value above 99th percentile of the upper reference limit and at least one of the following:
- •Symptoms of ischaemia.
- •New or presumed new significant ST-T wave changes
- •Development of pathological Q waves on electrocardiography (ECG).
- •Imaging evidence of new or presumed new loss of viable myocardium or regional wall motion abnormality.
- •Intracoronary thrombus detected on angiography.
- •Primary percutaneous coronary intervention (PCI) in < 12 h after the onset of symptoms for STEMI patients (In case of NSTEMI, PCI should be performed within 72 hours of symptom onset)
- •Multivessel disease (at least one stenosis of >50% in a non-culprit vessel ≥ 2.0 mm by visual estimation)
- •Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving invasive physiologic evaluation and PCI and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.
排除标准
- •Severe stenosis with TIMI flow ≤ II of the non-IRA artery
- •Unprotected left main coronary artery disease (stenosis > 50% by visual estimation)
- •Non-IRA stenosis not amenable for PCI treatment by operators' decision)
- •Chronic total occlusion in non-IRA
- •Cardiogenic shock (Killip class IV) already at presentation or the completion of IRA PCI
- •Intolerance to Aspirin, Clopidogrel, Plasugrel, Ticagrelor, Heparin, Bivaluridin, or Everolimus, Zotarolimus
- •Known true anaphylaxis to contrast medium (not allergic reaction but anaphylactic shock)
- •Pregnancy or breast feeding
- •Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
- •Other primary valvular disease with severe degree: severe mitral regurgitation, mitral stenosis, severe aortic regurgitation, or aortic stenosis
- •Patients with a history of Coronary Artery Bypass Graft (CABG) or treated with fibrinolytic Therapy
- •Unwillingness or inability to comply with the procedures described in this protocol.
研究组 & 干预措施
FFR-guided strategy arm
FFR measurement for non-IRA stenosis (>50% visual estimation) will be performed by continuous infusion of adenosine (140~180ug/kg/min) or intracoronary nicorandil (2mg bolus) injection. The FFR ≤ 0.80 will be targeted for PCI using 2nd generation drug-eluting stent. In case of non-IRA stenosis > 90%, we will judge FFR value of ≤ 0.80.
The evaluation of non-IRA stenosis by FFR will be recommended to perform during same intervention with primary PCI for IRA. However, exceptions can be made for complex lesions including ACC/AHA classification B2/C lesion where the operator estimates that the revascularization procedure will require significant contrast overload which may lead to deterioration of cardiac and renal function of the patient. Such procedures can be performed in a staged procedure during the same hospitalization.
干预措施: PCI using 2nd generation drug-eluting stent (Device)
Angiography-guided strategy arm
Non-IRA stenosis with > 50% stenosis will be the target of PCI using 2nd generation drug-eluting stent.
As for the angiography-guided strategy arm, PCI for non-IRA stenosis will be recommended during same procedure. However, exceptions can be made for complex lesions including ACC/AHA classification B2/C lesion where the operator estimates that the revascularization procedure will require significant contrast overload which may lead to deterioration of cardiac and renal function of the patient. Such procedures can be performed in a staged procedure during the same hospitalization.
干预措施: PCI using 2nd generation drug-eluting stent (Device)
结局指标
主要结局
Patient-oriented composite outcome
时间窗: 24 months
a composite of death, myocardial infarction, or repeat revascularization
次要结局
- Cardiac death(24 months)
- All-cause mortality(24 months)
- Any myocardial infarction without procedure-related myocardial infarction(24 months)
- Any myocardial infarction with periprocedural myocardial infarction(24 months)
- Non-IRA repeat revascularization(24 months)
- Stent thrombosis(24 months)
- Total amount of contrast use(1 week)
- All-cause death and myocardial infarction(24-month)
- Any revascularization(24 months)
- Infarct-related artery (IRA) repeat revascularization(24 months)
- Seattle Angina Questionnaires(24-month)
- Death, spontaneous myocardial infarction, or repeat revascularization(24-month)
- Stroke(24 months)
- Incidence of contrast-induced nephropathy(3 days)
- Seattle Angina Questionnaires(12-month)
研究者
Joo-Yong Hahn
Professor
Samsung Medical Center