Timing of heart artery procedures in heart attack patients with several blocked arteries
Compares treating all blocked heart arteries at once with staging the treatment in adults.
Plain-language title generated from the registry record
Registry title: Timing of FFR-guided PCI for Non-IRA in NSTEMI and MVD (OPTION-NSTEMI)
Key facts
- Where
- Gwangju, South KoreaSee the site
Where in South Korea
- Chonnam National University HospitalGwangju, South KoreaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Chonnam National University Hospital
- Trial code
- NCT04968808
- Record updated
- 28 July 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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.
Exclusion: Severe procedural complications (e.g. persistent no-reflow phenomenon, coronary artery perforation) which restricts study enrollment by operators' decision; History of anaphylaxis to contrast agent; Severe valvular disease; History of CABG, or planned CABG; Cardiogenic shock at initial presentation or after treatment of IRA; TIMI flow at non-IRA ≤ 2; Non-IRA lesion not suitable for PCI treatment by operators' decision; Chronic total occlusion at non-IRA; Pregnancy and lactation; Life expectancy < 1-year; Fibrinolysis before admission.