Optimal Timing of Staged Complete Revascularization in STEMI With Multivessel Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: In-hospital staged complete revascularization, Out-of-hospital staged complete revascularization.
- Who it may be relevant to
- Registry conditions: Myocardial Infarction (MI). Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
OPtimal TIming of Fractional Flow Reserve-Guided Complete RevascularizatiON for Non-Infarct Related Artery in ST-Segment Elevation Myocardial Infarction With Multivessel Disease: The OPTION-STEMI2 Trial
Overview
This prospective, multicenter, open-label, superiority trial will enroll patients with ST-segment elevation myocardial infarction (STEMI) and multivessel disease. Following successful percutaneous coronary intervention (PCI) of the infarct-related artery (IRA), patients who meet the eligibility criteria will be randomized in a 1:1 ratio to either in-hospital staged complete revascularization with PCI of non-IRA lesions performed on a separate day during hospitalization, at least 72 hours after PCI of the IRA, or out-of-hospital staged complete revascularization with PCI of non-IRA lesions performed after discharge between 15 and 45 days of randomization. In both groups, non-IRA lesions with 50-69% stenosis will be evaluated using FFR.
Detailed description
* Study Objectives: To determine the optimal timing of staged complete revascularization guided by fractional flow reserve (FFR) (in-hospital staged complete revascularization vs. out-of-hospital staged complete revascularization) in patients with ST-segment elevation myocardial infarction (STEMI) and multivessel disease. * Study Background: Approximately half of patients with STEMI have multivessel coronary artery disease, which is associated with worse clinical outcomes than single vessel disease. Complete revascularization has become the standard interventional strategy for the management of these patients. Regarding the timing of complete revascularization, two recent randomized clinical trials demonstrated that immediate complete revascularization was non-inferior to staged complete revascularization in patients with STEMI. In this context, the 2023 European guidelines give a class IA recommendation for complete revascularization, either during the index procedure or within 45 days. The 2025 American guidelines recommend immediate complete revascularization with a class IIb recommendation for hemodynamically stable patients with STEMI and low-complex anatomy. However, in these trials, planned staged revascularization in the staged group was performed after hospital discharge rather than during the index admission. In those previous trials, the timing of staged revascularization was median 15 days (IQR 4-28) in the BIOVASC trial and median 37 days (IQR 30-43) in the MULTISTARS AMI trial, and most clinical events in the staged group (mainly due to unplanned revascularization and myocardial infarction) had occurred during the early phase after the index procedure with the possibility of progression of a non-infarct related artery (non-IRA) lesion before the staged procedure. Greater inflammatory status during the acute phase of myocardial infarction might be associated with these findings. The OPTION-STEMI trial, which compared immediate and staged complete revascularization during index hospitalization, failed to demonstrate non-inferiority for the primary endpoint at 1 year (13% in the immediate complete revascularization group and 11% in the staged complete revascularization group; hazard ratio 1.24; 95% confidence interval 0.86-1.79; P for non-inferiority = 0.024). Therefore, it remains unclear whether the treatment effect differs between in-hospital and out-of-hospital staged complete revascularization in patients with STEMI and multivessel disease. The investigators designed a prospective, open-label, multicenter, superiority trial to evaluate the efficacy and safety of in-hospital staged complete revascularization compared with out-of-hospital staged complete revascularization in patients with STEMI and multivessel disease. Non-IRA lesions with 50-69% stenosis will be assessed using FFR, whereas those with ≥ 70% stenosis will undergo revascularization without FFR assessment. The investigators hypothesize that in-hospital staged complete revascularization may mitigate the risk of early progression of non-IRA lesions, compared with out-of-hospital staged complete revascularization, without increasing the procedural risk associated with immediate complete revascularization. * Study Hypothesis: In-hospital staged complete revascularization would reduce the risk of the primary composite endpoint (a composite of all-cause death, non-fatal myocardial infarction, or all unplanned revascularization) at 12 months compared with out-of-hospital staged complete revascularization in patients with STEMI and multivessel disease.
Interventions
- Procedure In-hospital staged complete revascularization
PCI of non-IRA lesions will be performed on a separate day during the index hospitalization, at least 72 hours after PCI of the IRA. Non-IRA lesion which have equal or more than 70% diameter stenosis by visual estimation will be revascularized without 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 will be deferred without PCI. If FFR value was equal or less than 0.8, non-IRA - Procedure Out-of-hospital staged complete revascularization
PCI of non-IRA lesions will be performed after discharge and between 15 and 45 days of randomization. Non-IRA lesion which have equal or more than 70% diameter stenosis by visual estimation will be revascularized without 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 will be deferred without PCI. If FFR value was equal or less than 0.8, non-IRA lesion will be revascularized.
Primary outcome measures
- Composite of all-cause death, nonfatal myocardial infarction, or all unplanned revascularization [Time frame: At 12 months after randomization]
Secondary outcome measures (12)
- Composite of all-cause death, nonfatal myocardial infarction, or all unplanned revascularization [Time frame: At 1, 6, 24, 36, 48, and 60 months after randomization]
- All-cause death [Time frame: At 1, 6, 12, 24, 36, 48, and 60 months after randomization]
- Nonfatal myocardial infarction [Time frame: At 1, 6, 12, 24, 36, 48, and 60 months after randomization]
- All unplanned revascularization [Time frame: At 1, 6, 12, 24, 36, 48, and 60 months after randomization]
- Cardiac death [Time frame: At 1, 6, 12, 24, 36, 48, and 60 months after randomization]
- Non-cardiac death [Time frame: At 1, 6, 12, 24, 36, 48, and 60 months after randomization]
- Nonfatal spontaneous myocardial infarction [Time frame: At 1, 6, 12, 24, 36, 48, and 60 months after randomization]
- Nonfatal procedure-related myocardial infarction [Time frame: At 1, 6, 12, 24, 36, 48, and 60 months after randomization]
- Target-lesion revascularization [Time frame: At 1, 6, 12, 24, 36, 48, and 60 months after randomization]
- Target-vessel revascularization [Time frame: At 1, 6, 12, 24, 36, 48, and 60 months after randomization]
- Non-target vessel revascularization [Time frame: At 1, 6, 12, 24, 36, 48, and 60 months after randomization]
- Hospitalization for unstable angina [Time frame: At 1, 6, 12, 24, 36, 48, and 60 months after randomization]
Eligibility criteria
Inclusion criteria
- Age ≥19 years
- ST-segment elevation myocardial infarction (STEMI): ST-segment elevation ≥ 0.1 mV in at least two contiguous leads, or New-onset left bundle branch block (LBBB)
- Primary PCI within 12 h after symptom development
- At least 1 non-infarct related artery (non-IRA) with diameter ≥ 2.5 mm and 50% stenosis by visual estimation
Exclusion criteria
- Cardiogenic shock at initial presentation or after infarct-related artery (IRA) treatment
- Thrombolysis in myocardial infarction flow at non-IRA ≤ 2
- Severe procedural complications during primary percutaneous coronary intervention that, in the judgement of the operator, preclude study enrollment
- Non-IRA lesion unsuitable for percutaneous coronary intervention (PCI) treatment that, in the judgement of the operator, preclude study enrollment
- Chronic total occlusion in a non-IRA
- History of anaphylaxis to contrast agent
- Pregnancy and lactation
- Life expectancy < 1 year
- Severe valvular heart disease
- History of coronary artery bypass grafting (CABG) or planned CABG
- Fibrinolysis therapy prior to admission
- Severe asthma
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
South Korea · 30 centers
- Bucheon Sejong Hospital — Bucheon-si
- Gyeongsang National University Changwon Hospital — Changwon
- Samsung Changwon Medical Center — Changwon
- Soon Chun Hyang University Hospital Cheonan — Cheonan
- Chungbuk National University Hospital — Cheongju-si
- Kangwon National University Hospital — Chuncheon
- Daegu Catholic University Medical Center — Daegu
- Keimyung University Dongsan Hospital — Daegu
- … and 22 more centers
Identifiers
NCT: NCT07741721 · CNUH-2026-258