FFR Versus Angiography-Guided Strategy for Management of AMI With Multivessel Disease

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    1292
  • sponsor
    Samsung Medical Center
Updated on 27 September 2021
angiography
stenosis
stemi
troponin
ischemia
q waves
bundle branch block

Summary

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.

Description

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 stentor procedure related complications, and enhance long-term prognosis of patients.

Therefore, the FRAME-AMI trial will compare 2-year 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.

Details
Condition Acute Myocardial Infarction
Treatment PCI using 2nd generation drug-eluting stent
Clinical Study IdentifierNCT02715518
SponsorSamsung Medical Center
Last Modified on27 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Subject age 19-85 years old
Acute ST-segment elevation myocardial infarction (STEMI)
STEMI : "ST-segment elevation 0.1 mV in 2 contiguous leads or documented newly developed left bundle-branch block
Acute non ST-segment elevation myocardial infarction (NSTEMI)
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 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 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

Exclusion Criteria

Severe stenosis with TIMI flow II of the non-IRA artery
Unprotected left main coronary artery disease (stenosis > 50% by visual estimation)
Non-culprit stenosis not amenable for PCI treatment by operators decision)
Cardiogenic shock (Killip class IV) already at presentation or the completion of culprit 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
or 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
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