RECRUITINGINTERVENTIONAL

Timing of FFR-guided PCI for Non-IRA in NSTEMI and MVD (OPTION-NSTEMI)

OPtimal TIming of Fractional Flow Reserve-Guided Complete RevascularizatiON in Non-ST-Segment Elevation Myocardial Infarction (OPTION-NSTEMI)

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Age ≥ 19 years old 2. 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 3. PCI within 72 hours after symptom development 4. Multivessel disease: Non-IRA with at least 2.5 mm diameter and 50% diameter stenosis by visual estimation 5. Patient's or protector's agreement about study design and the risk of PCI Who Should NOT Join This Trial: 1. Cardiogenic shock at initial presentation or after treatment of IRA 2. TIMI flow at non-IRA ≤ 2 3. Severe procedural complications (e.g. persistent no-reflow phenomenon, coronary artery perforation) which restricts study enrollment by operators' decision 4. Non-IRA lesion not suitable for PCI treatment by operators' decision 5. Chronic total occlusion at non-IRA 6. History of anaphylaxis to contrast agent 7. Pregnancy and lactation 8. Life expectancy \< 1-year 9. Severe valvular disease 10. History of CABG, or planned CABG 11. Fibrinolysis before admission Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: 1. Age ≥ 19 years old 2. 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 3. PCI within 72 hours after symptom development 4. Multivessel disease: Non-IRA with at least 2.5 mm diameter and 50% diameter stenosis by visual estimation 5. Patient's or protector's agreement about study design and the risk of PCI Exclusion Criteria: 1. Cardiogenic shock at initial presentation or after treatment of IRA 2. TIMI flow at non-IRA ≤ 2 3. Severe procedural complications (e.g. persistent no-reflow phenomenon, coronary artery perforation) which restricts study enrollment by operators' decision 4. Non-IRA lesion not suitable for PCI treatment by operators' decision 5. Chronic total occlusion at non-IRA 6. History of anaphylaxis to contrast agent 7. Pregnancy and lactation 8. Life expectancy \< 1-year 9. Severe valvular disease 10. History of CABG, or planned CABG 11. Fibrinolysis before admission

Treatments Being Tested

PROCEDURE

Staged in-hospital complete revascularization

Patients 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.

PROCEDURE

Immediate complete revascularization

Patients 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.

Locations (1)

Chonnam National University Hospital

Gwangju, South Korea