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

13 agosto 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

  • 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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

1252

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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.
Procedura: 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.
Sperimentale: 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.
Procedura: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
Composite of all-cause death, nonfatal myocardial infarction, or all unplanned revascularization
Lasso di tempo: At 12 months after randomization
At 12 months after randomization

Misure di risultato secondarie

Misura del risultato
Lasso di tempo
Composite of all-cause death, nonfatal myocardial infarction, or all unplanned revascularization
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: At hospital discharge (up to 30 days)
At hospital discharge (up to 30 days)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Chonnam National University Hospital

Investigatori

  • Investigatore principale: Youngkeun Ahn, MD, PhD, Chonnam National University Hospital

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 settembre 2026

Completamento primario (Stimato)

31 luglio 2031

Completamento dello studio (Stimato)

31 luglio 2035

Date di iscrizione allo studio

Primo inviato

26 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

30 luglio 2026

Primo Inserito (Effettivo)

3 agosto 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

17 agosto 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

13 agosto 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CNUH-2026-258

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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