The study aims to compare a preventive percutaneous coronary intervention (PCI) plus optimal medical treatment (OMT) strategy vs. OMT for treatment of non-functionally significant non-culprit lesions presenting with optical coherence tomography (OCT) findings indicative of vulnerable plaque, in patients with ST-elevation myocardial infarction (STEMI) and multivessel disease.
Patients > 18 years.
Successful revascularization of the culprit lesion in patients undergoing coronary angiography due to ST-segment elevation (> 1mm in > 2 contiguous leads, new left bundle branch block, or true posterior MI with ST depression of >1mm in >2 contiguous anterior leads) in the first 72 hours of the symptom's onset.
Multivessel coronary disease with non-culprit lesions located in different vessels than the culprit lesion and ranging from 40 to 69% of DS (visual estimated diameter stenosis ) by visual estimate planned for FFR-guided revascularization in staged procedure (>24 hours and <60 days after PCI of the culprit lesion).
Non-culprit lesions should be suitable for functional assessment with pressure wire and OCT catheter and should be suitable to be treated with a single 2.0 to 4.5 mm EES (everolimus-eluting stent ).
Inability to provide informed consent.
Female of childbearing potential (age <50 years and last menstruation within the last 12 months), who did not undergo tubal ligation, ovariectomy or hysterectomy.
Known intolerance to aspirin, heparin, everolimus, contrast material.
Unresolved mechanical complication or cardiogenic shock at the staged procedure.
Parallel
FFR>0.80+ OCT with findings indicative of vulnerable plaque
Other interventionPatients received OPTIMAL MEDICAL TREATMENT (OMT)+PCI
FFR>0.80+ OCT with findings indicative of vulnerable plaque
Other interventionOPTIMAL MEDICAL TREATMENT (OMT)
Target Vessel Failure (TVF)
TVF as a composite of : Cardiovascular Death Target-vessel related MI Clinically and physiologically-oriented Target vessel revascularization
Cardiac death
To compare Cardiac death between both groups in the randomized arm death.
All-cause Death
To compare all death between both groups in the randomized arm death.
All Myocardial Infarctions
To compare Myocardial Infarctions between both groups in the randomized arm death. death
Target-Vessel Myocardial Infarction
To compare target-vessel myocardial infarction between both groups in the randomized arm.
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Fundación EPIC
Lead sponsor
Abbott
Collaborator
