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

13 sierpnia 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

  • 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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

1252

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: 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.
Eksperymentalny: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Ramy czasowe
Composite of all-cause death, nonfatal myocardial infarction, or all unplanned revascularization
Ramy czasowe: At 12 months after randomization
At 12 months after randomization

Miary wyników drugorzędnych

Miara wyniku
Ramy czasowe
Composite of all-cause death, nonfatal myocardial infarction, or all unplanned revascularization
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: At hospital discharge (up to 30 days)
At hospital discharge (up to 30 days)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Chonnam National University Hospital

Śledczy

  • Główny śledczy: Youngkeun Ahn, MD, PhD, Chonnam National University Hospital

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 września 2026

Zakończenie podstawowe (Szacowany)

31 lipca 2031

Ukończenie studiów (Szacowany)

31 lipca 2035

Daty rejestracji na studia

Pierwszy przesłany

26 lipca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

30 lipca 2026

Pierwszy wysłany (Rzeczywisty)

3 sierpnia 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

17 sierpnia 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

13 sierpnia 2026

Ostatnia weryfikacja

1 sierpnia 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • CNUH-2026-258

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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