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

Summary

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.

Eligibility

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

Conditions4

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