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

A regiszterben nem jelölt feltételek

• (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)
  • ※ 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.
  • (2) 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-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.