Optimal Timing of Staged Complete Revascularization in STEMI With Multivessel Disease (OPTION-STEMI2)

OPtimal TIming of Staged Complete RevascularizatiON in ST-Segment Elevation Myocardial Infarction With Multivessel Disease: The OPTION-STEMI2 Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Myocardial Infarction (MI)
• Intervention / Treatment: Procedure: Out-of-hospital staged complete revascularization; Procedure: In-hospital staged complete revascularization

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.

• Study Type: Interventional
• Enrollment (Estimated): 1252
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Min Chul Kim, MD, PhD; Phone Number: 82-10-4606-2643; Email: kmc3242@hanmail.net

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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.
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Composite of all-cause death, nonfatal myocardial infarction, or all unplanned revascularization	At 12 months after randomization

Secondary Outcome Measures

Outcome Measure	Time Frame
Composite of all-cause death, nonfatal myocardial infarction, or all unplanned revascularization	At 1, 6, 24, 36, 48, and 60 months after randomization
All-cause death	At 1, 6, 12, 24, 36, 48, and 60 months after randomization
Nonfatal myocardial infarction	At 1, 6, 12, 24, 36, 48, and 60 months after randomization
All unplanned revascularization	At 1, 6, 12, 24, 36, 48, and 60 months after randomization
Cardiac death	At 1, 6, 12, 24, 36, 48, and 60 months after randomization
Non-cardiac death	At 1, 6, 12, 24, 36, 48, and 60 months after randomization
Nonfatal spontaneous myocardial infarction	At 1, 6, 12, 24, 36, 48, and 60 months after randomization
Nonfatal procedure-related myocardial infarction	At 1, 6, 12, 24, 36, 48, and 60 months after randomization
Target-lesion revascularization	At 1, 6, 12, 24, 36, 48, and 60 months after randomization
Target-vessel revascularization	At 1, 6, 12, 24, 36, 48, and 60 months after randomization
Non-target vessel revascularization	At 1, 6, 12, 24, 36, 48, and 60 months after randomization
Hospitalization for unstable angina	At 1, 6, 12, 24, 36, 48, and 60 months after randomization
Hospitalization for heart failure	At 1, 6, 12, 24, 36, 48, and 60 months after randomization
Stent thrombosis	At 1, 6, 12, 24, 36, 48, and 60 months after randomization
Stroke	At 1, 6, 12, 24, 36, 48, and 60 months after randomization
Major bleeding	At 1, 6, 12, 24, 36, 48, and 60 months after randomization
Contrast-induced nephropathy	At hospital discharge (up to 30 days)

Collaborators and Investigators

• Sponsor: Chonnam National University Hospital
• Investigators: Principal Investigator: Youngkeun Ahn, MD, PhD, Chonnam National University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): July 31, 2031
• Study Completion (Estimated): July 31, 2035

Study Registration Dates

• First Submitted: July 26, 2026
• First Submitted That Met QC Criteria: July 30, 2026
• First Posted (Actual): August 3, 2026

Study Record Updates

• Last Update Posted (Actual): August 17, 2026
• Last Update Submitted That Met QC Criteria: August 13, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Timing; Complete revascularization; Multivessel coronary artery disease; ST-segment myocardial infarction
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Infarction; Necrosis; Myocardial Ischemia; Ischemia; Pathological Conditions, Signs and Symptoms; Myocardial Infarction
• Other Study ID Numbers: CNUH-2026-258

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No