Many patients with non-ST-segment elevation myocardial infarction (NSTEMI) have multivessel coronary artery disease (MVD), which is associated with poor clinical outcomes. However, there have been few studies regarding revascularization strategy in patients with NSTEMI and MVD. Therefore, we planned to perform prospective, open-label, randomized trial to evaluate the efficacy and safety of immediate complete revascularization (percutaneous coronary intervention \[PCI\] for both infarct-related artery \[IRA\] and non-IRA during index PCI) compared to staged PCI strategy of non-IRA (PCI for IRA followed by non-IRA PCI after several days). PCI procedure at non-IRA with diameter stenosis between 50 and 69% should be conducted with the aid of fractional flow reserve (FFR), and non-IRA with diameter stenosis ≥ 70% will be revascularized without FFR.
Age ≥ 19 years old
Non-ST-segment elevation myocardial infarction
Angina pectoris or equivalent ischemic chest discomfort with at least 1 of 3 features and,
occurs at rest, usually lasting > 10 minutes
Cardiogenic shock at initial presentation or after treatment of IRA
TIMI flow at non-IRA ≤ 2
Severe procedural complications (e.g. persistent no-reflow phenomenon, coronary artery perforation) which restricts study enrollment by operators' decision
Non-IRA lesion not suitable for PCI treatment by operators' decision
Parallel
Staged in-hospital complete revascularization
Procedure/SurgeryPatients with non-ST-segment elevation myocardial infarction and multivessel disease will be randomized after percutaneous coronary intervention (PCI) for infarct-related artery (IRA). All patients will be randomized to immediate complete revascularization group or staged revascularization group by 1:1 fashion. Staged in-hospital complete revascularization group will receive staged PCI for non-IRA in other day (during hospitalization) after PCI for IRA. Non-IRA lesion which have equal or more than 70% diameter stenosis by visual estimation will be revascularized without fractional flow reserve (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 wll be deferred without PCI. If FFR value was equal or less than 0.8, non-IRA lesion will be revascularized.
Immediate complete revascularization
Procedure/SurgeryPatients with non-ST-segment elevation myocardial infarction and multivessel disease will be randomized after percutaneous coronary intervention (PCI) for infarct-related artery (IRA). All patients will be randomized to immediate complete revascularization group or staged revascularization group by 1:1 fashion. Immediate complete revascularization group will receive simultaneous PCI for both IRA and non-IRA during index PCI. Non-IRA lesion which have equal or more than 70% diameter stenosis by visual estimation will be revascularized without fractional flow reserve (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 wll be deferred without PCI. If FFR value was equal or less than 0.8, non-IRA lesion will be revascularized.
Cumulative incidence rate of all-cause death, non-fatal myocardial infarction, or all unplanned revascularization
Composite endpoint of all-cause death, non-fatal myocardial infarction, or all unplanned revascularization at 1 year from baseline
Rate of contrast-induced nephropathy
Rate of contrast-induced nephropathy during initial hospitalization
Cumulative incidence rate of all unplanned revascularization
Cumulative incidence rate of all unplanned revascularization at each visit
Cumulative incidence rate of target-lesion revascularization
Cumulative incidence rate of target-lesion revascularization at each visit
Cumulative incidence rate of target-vessel revascularization
Cumulative incidence rate of target-vessel revascularization at each visit
Click on the lead sponsor to view all of their trials.
