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Not yet recruitingNCT07741721OPTION-STEMI2Updated Aug 17, 2026

Optimal Timing of Staged Complete Revascularization in STEMI With Multivessel Disease

An interventional study of In-hospital staged complete revascularization and Out-of-hospital staged complete revascularization in Myocardial Infarction (MI), sponsored by Chonnam National University Hospital. Not yet recruiting at 30 sites in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-08-17.

Sponsored by Chonnam National University Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
1,252
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study summary

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 48 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.

Read the 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.
02

Conditions studied

  • Myocardial Infarction (MI)

Keywords

  • ST-segment myocardial infarction
  • Multivessel coronary artery disease
  • Complete revascularization
  • Timing
03

In context

Myocardial Infarction

2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.

This study's planned enrollment of 1,252 is above the median of 148 across 1,595 interventional studies indexed under Myocardial Infarction.

Browse Myocardial Infarction studies →

Lead sponsor

Chonnam National University Hospital is the lead sponsor of 70 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,252 participants (estimated)

Study arms

  • Experimental
    In-hospital staged complete revascularization

    In the in-hospital staged complete revascularization group, PCI of non-IRA lesions will be performed on a separate day during the index hospitalization, at least 48 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 lesion will be revascularized.

    Procedure: In-hospital staged complete revascularization

  • Active comparator
    Out-of-hospital staged complete revascularization

    In the out-of-hospital staged complete revascularization group, 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.

    Procedure: Out-of-hospital staged complete revascularization

Interventions

  • ProcedureIn-hospital staged complete revascularization

    PCI of non-IRA lesions will be performed on a separate day during the index hospitalization, at least 48 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 lesion will be revascularized.

  • ProcedureOut-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.

06

What researchers measure

Primary outcomes

  1. Composite of all-cause death, nonfatal myocardial infarction, or all unplanned revascularization

    Time frame: At 12 months after randomization

Secondary outcomes

  1. 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

  2. All-cause death

    Time frame: At 1, 6, 12, 24, 36, 48, and 60 months after randomization

  3. Nonfatal myocardial infarction

    Time frame: At 1, 6, 12, 24, 36, 48, and 60 months after randomization

  4. All unplanned revascularization

    Time frame: At 1, 6, 12, 24, 36, 48, and 60 months after randomization

  5. Cardiac death

    Time frame: At 1, 6, 12, 24, 36, 48, and 60 months after randomization

  6. Non-cardiac death

    Time frame: At 1, 6, 12, 24, 36, 48, and 60 months after randomization

  7. Nonfatal spontaneous myocardial infarction

    Time frame: At 1, 6, 12, 24, 36, 48, and 60 months after randomization

  8. Nonfatal procedure-related myocardial infarction

    Time frame: At 1, 6, 12, 24, 36, 48, and 60 months after randomization

  9. Target-lesion revascularization

    Time frame: At 1, 6, 12, 24, 36, 48, and 60 months after randomization

  10. Target-vessel revascularization

    Time frame: At 1, 6, 12, 24, 36, 48, and 60 months after randomization

  11. Non-target vessel revascularization

    Time frame: At 1, 6, 12, 24, 36, 48, and 60 months after randomization

  12. Hospitalization for unstable angina

    Time frame: At 1, 6, 12, 24, 36, 48, and 60 months after randomization

  13. Hospitalization for heart failure

    Time frame: At 1, 6, 12, 24, 36, 48, and 60 months after randomization

  14. Stent thrombosis

    Time frame: At 1, 6, 12, 24, 36, 48, and 60 months after randomization

  15. Stroke

    Time frame: At 1, 6, 12, 24, 36, 48, and 60 months after randomization

  16. Major bleeding

    Time frame: At 1, 6, 12, 24, 36, 48, and 60 months after randomization

  17. Contrast-induced nephropathy

    Time frame: At hospital discharge (up to 30 days)

07

Study locations

30 sites
  • Bucheon Sejong Hospital
    Bucheon-si, South Korea
  • Gyeongsang National University Changwon Hospital
    Changwon, South Korea
  • Samsung Changwon Medical Center
    Changwon, South Korea
  • Soon Chun Hyang University Hospital Cheonan
    Cheonan, South Korea
  • Chungbuk National University Hospital
    Cheongju-si, South Korea
  • Kangwon National University Hospital
    Chuncheon, South Korea
  • Daegu Catholic University Medical Center
    Daegu, South Korea
  • Keimyung University Dongsan Hospital
    Daegu, South Korea
  • Kyungpook National University Hospital
    Daegu, South Korea
  • Yeongnam University Medical Center
    Daegu, South Korea
  • Chungnam National University Hospital
    Daejeon, South Korea
  • Chonnam National University Hospital
    Gwangju, South Korea
  • Chosun University Hospital
    Gwangju, South Korea
  • Gwangju Veterans Hospital
    Gwangju, South Korea
  • Kwangju Christian Hospital
    Gwangju, South Korea
  • Chung-Ang University Gwangmyeong Hospital
    Gwangmyeong, South Korea
  • Jeju National University Hospital
    Jeju City, South Korea
  • Jeonbuk National University Hospital
    Jeonju, South Korea
  • Presbyterian Medical Center
    Jeonju, South Korea
  • Gyeongsang National University Hospital
    Jinju, South Korea
  • Inje University Busan Paik Hospital
    Pusan, South Korea
  • Inje University Haeundae Paik Hospital
    Pusan, South Korea
  • Kosin University Gospel Hospital
    Pusan, South Korea
  • Pusan National University Hospital
    Pusan, South Korea
  • Koera University Guro Hospital
    Seoul, South Korea
  • Korea University Anam Hospital
    Seoul, South Korea
  • Yonsei University Health System, Gangnam Severance Hospital
    Seoul, South Korea
  • St. Carollo General Hospital
    Suncheon, South Korea
  • Ajou University Hospital
    Suwon, South Korea
  • Pusan National University Yangsan Hospital
    Yangsan, South Korea
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07741721
Lead sponsor
Chonnam National University Hospital
Responsible party
Min Chul Kim (Professor, Chonnam National University Hospital) — Principal investigator
First posted
Aug 3, 2026
Start date
Sep 1, 2026 (estimated)
Primary completion
Jul 31, 2031 (estimated)
Completion
Jul 31, 2035 (estimated)
Last update
Aug 17, 2026

Study contacts

Min Chul Kim, MD, PhD
Contact
kmc3242@hanmail.net
82-10-4606-2643
Youngkeun Ahn, MD, PhD
principal investigator · Chonnam National University Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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