About this trial
This prospective, multicenter, open-label, superiority trial will enroll patients with ST-segment elevation myocardial infarction (STEMI) and multivessel disease. Following successful percutaneous coronary intervention (PCI) of the infarct-related artery (IRA), patients who meet the eligibility criteria will be randomized in a 1:1 ratio to either in-hospital staged complete revascularization with PCI of non-IRA lesions performed on a separate day during hospitalization, at least 48 hours after PCI of the IRA, or out-of-hospital staged complete revascularization with PCI of non-IRA lesions performed after discharge between 15 and 45 days of randomization. In both groups, non-IRA lesions with 50-69% stenosis will be evaluated using FFR.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥19 years
ST-segment elevation myocardial infarction (STEMI): ST-segment elevation ≥ 0.1 mV in at least two contiguous leads, or New-onset left bundle branch block (LBBB)
Primary PCI within 12 h after symptom development
At least 1 non-infarct related artery (non-IRA) with diameter ≥ 2.5 mm and 50% stenosis by visual estimation
Disqualifiers
Cardiogenic shock at initial presentation or after infarct-related artery (IRA) treatment
Thrombolysis in myocardial infarction flow at non-IRA ≤ 2
Severe procedural complications during primary percutaneous coronary intervention that, in the judgement of the operator, preclude study enrollment
Non-IRA lesion unsuitable for percutaneous coronary intervention (PCI) treatment that, in the judgement of the operator, preclude study enrollment
Trial design
Parallel
Treatments tested in this trial
In-hospital staged complete revascularization
Procedure/SurgeryPCI of non-IRA lesions will be performed on a separate day during the index hospitalization, at least 48 hours after PCI of the IRA. Non-IRA lesion which have equal or more than 70% diameter stenosis by visual estimation will be revascularized without FFR evaluation. Non-IRA lesion with diameter stenosis 50-69% by visual estimation will be evaluated using FFR device. In case of FFR value more than 0.8, non-IRA lesion will be deferred without PCI. If FFR value was equal or less than 0.8, non-IRA lesion will be revascularized.
Out-of-hospital staged complete revascularization
Procedure/SurgeryPCI of non-IRA lesions will be performed after discharge and between 15 and 45 days of randomization. Non-IRA lesion which have equal or more than 70% diameter stenosis by visual estimation will be revascularized without FFR evaluation. Non-IRA lesion with diameter stenosis 50-69% by visual estimation will be evaluated using FFR device. In case of FFR value more than 0.8, non-IRA lesion will be deferred without PCI. If FFR value was equal or less than 0.8, non-IRA lesion will be revascularized.
Treatment groups
Trial outcomes
Primary outcomes
Composite of all-cause death, nonfatal myocardial infarction, or all unplanned revascularization
Secondary outcomes
Composite of all-cause death, nonfatal myocardial infarction, or all unplanned revascularization
All-cause death
Nonfatal myocardial infarction
All unplanned revascularization
Sponsors and contacts
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