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

13 augustus 2026 bijgewerkt door: Min Chul Kim, Chonnam National University Hospital

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

  • 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.

Studietype

Ingrijpend

Inschrijving (Geschat)

1252

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: 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.
Experimenteel: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Composite of all-cause death, nonfatal myocardial infarction, or all unplanned revascularization
Tijdsspanne: At 12 months after randomization
At 12 months after randomization

Secundaire uitkomstmaten

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Chonnam National University Hospital

Onderzoekers

  • Hoofdonderzoeker: Youngkeun Ahn, MD, PhD, Chonnam National University Hospital

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 september 2026

Primaire voltooiing (Geschat)

31 juli 2031

Studie voltooiing (Geschat)

31 juli 2035

Studieregistratiedata

Eerst ingediend

26 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

30 juli 2026

Eerst geplaatst (Werkelijk)

3 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

17 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

13 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • CNUH-2026-258

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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