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

torstai 13. elokuuta 2026 päivittänyt: 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.

Tutkimuksen yleiskatsaus

Tila

Ei vielä rekrytointia

Ehdot

Interventio / Hoito

Yksityiskohtainen kuvaus

  • 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.

Opintotyyppi

Interventio

Ilmoittautuminen (Arvioitu)

1252

Vaihe

  • Ei sovellettavissa

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskeluyhteys

Opiskelupaikat

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

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

  • Aikuinen
  • Vanhempi Aikuinen

Hyväksyy terveitä vapaaehtoisia

Ei

Kuvaus

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

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Hoito
  • Jako: Satunnaistettu
  • Inventiomalli: Rinnakkaistehtävä
  • Naamiointi: Ei mitään (avoin tarra)

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
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.
Menettely: 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.
Kokeellinen: 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.
Menettely: 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.

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

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

Toissijaiset tulostoimenpiteet

Tulosmittaus
Aikaikkuna
Composite of all-cause death, nonfatal myocardial infarction, or all unplanned revascularization
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: At hospital discharge (up to 30 days)
At hospital discharge (up to 30 days)

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

Chonnam National University Hospital

Tutkijat

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

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

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