The primary purpose of the study was to determine whether the 2-year probability of major adverse cardiac events (primary composite outcome) differed significantly between patients who underwent angiography-guided Percutaneous Coronary Intervention(PCI) and those who underwent Fractional Flow Reserve(FFR)-guided PCI in patients with Left Main Coronary Artery disease(LMCA).
The subject must be ≥20 years of age with angina and/or evidence of myocardial ischemia.
Significant de novo LMCA disease, defined as ≥ 50% diameter stenosis by visual estimation with or without concomitant non-left main major epicardial coronary artery disease, amenable to PCI with drug-eluting stent(DES) implantation.
The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.
left anterior descending coronary artery (LAD) or left circumflex coronary artery (LCx) chronic total occlusion (CTO)
Extremely calcified or tortuous vessels precluding FFR measurement.
The presence of complex coronary disease anatomy or lesion characteristics or other cardiac condition(s) which leads the participating interventional cardiologist to believe that PCI is not suitable (i.e. the subject should be managed with coronary artery bypass graft or medical therapy alone).
Recent ST Elevation Myocardial Infarction(<7 days prior to randomization).
Parallel
FFR-Guided PCI
Procedure/SurgeryFractional Flow Reserve-Guided PCI
Angiography-Guided PCI
Procedure/SurgeryAngiography-Guided PCI
The composite event rate
Composite event consists of death from any causes, myocardial infarction, or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest, or repeat revascularization. A composite endpoint is an endpoint that is a combination of multiple clinical endpoints. An event is considered to have occurred if any one of several different events is observed.
The event rate of death from any causes
The event rate of myocardial infarction
any, spontaneous or procedural myocardial infarction
The event rate of hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest
The event rate of repeat revascularization
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Seung-Jung Park
Lead sponsor
Asan Medical Center
Sponsor institution
CardioVascular Research Foundation, Korea
Collaborator
