OPtimal TIming of Fractional Flow Reserve-Guided Complete RevascularizatiON in Non-ST-Segment Elevation Myocardial Infarction (OPTION-NSTEMI)
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
∙ severe and new onset (within the prior 4-6 weeks)
∙ crescendo pattern
⁃ Elevated cardiac biomarkers and,
• ≥ 99% value of high-sensitivity cardiac troponin
⁃ No ST-segment elevation ≥ 0.1 mV in ≥ 2 contiguous leads or newly developed left bundle branch block on 12-lead electrocardiogram
• PCI within 72 hours after symptom development
• Multivessel disease: Non-IRA with at least 2.5 mm diameter and 50% diameter stenosis by visual estimation
• Patient's or protector's agreement about study design and the risk of PCI