Optimal Timing of Staged Complete Revascularization in STEMI With Multivessel Disease (OPTION-STEMI2)
13 de agosto de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Descripción detallada
- 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 de estudio
Intervencionista
Inscripción (Estimado)
1252
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Min Chul Kim, MD, PhD
- Número de teléfono: 82-10-4606-2643
- Correo electrónico: kmc3242@hanmail.net
Ubicaciones de estudio
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Bucheon-si, Corea del Sur
- Bucheon Sejong Hospital
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Changwon, Corea del Sur
- Gyeongsang National University Changwon Hospital
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Changwon, Corea del Sur
- Samsung Changwon Medical Center
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Cheonan, Corea del Sur
- Soon Chun Hyang University Hospital Cheonan
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Cheongju-si, Corea del Sur
- Chungbuk National University Hospital
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Chuncheon, Corea del Sur
- Kangwon National University Hospital
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Daegu, Corea del Sur
- Keimyung University Dongsan Hospital
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Daegu, Corea del Sur
- Kyungpook National University Hospital
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Daegu, Corea del Sur
- Daegu Catholic University Medical Center
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Daegu, Corea del Sur
- Yeongnam University Medical Center
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Daejeon, Corea del Sur
- Chungnam National University Hospital
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Gwangju, Corea del Sur
- Chonnam National University Hospital
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Gwangju, Corea del Sur
- Chosun University Hospital
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Gwangju, Corea del Sur
- Gwangju Veterans Hospital
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Gwangju, Corea del Sur
- Kwangju Christian Hospital
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Gwangmyeong, Corea del Sur
- Chung-Ang University Gwangmyeong Hospital
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Jeju City, Corea del Sur
- Jeju National University Hospital
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Jeonju, Corea del Sur
- Jeonbuk National University Hospital
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Jeonju, Corea del Sur
- Presbyterian Medical Center
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Jinju, Corea del Sur
- Gyeongsang National University Hospital
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Pusan, Corea del Sur
- Pusan National University Hospital
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Pusan, Corea del Sur
- Inje University Haeundae Paik Hospital
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Pusan, Corea del Sur
- Inje University Busan Paik Hospital
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Pusan, Corea del Sur
- Kosin University Gospel Hospital
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Seoul, Corea del Sur
- Korea University Anam Hospital
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Seoul, Corea del Sur
- Koera University Guro Hospital
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Seoul, Corea del Sur
- Yonsei University Health System, Gangnam Severance Hospital
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Suncheon, Corea del Sur
- St. Carollo General Hospital
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Suwon, Corea del Sur
- Ajou University Hospital
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Yangsan, Corea del Sur
- Pusan National University Yangsan Hospital
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador activo: 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.
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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.
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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.
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Composite of all-cause death, nonfatal myocardial infarction, or all unplanned revascularization
Periodo de tiempo: At 12 months after randomization
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At 12 months after randomization
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
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Composite of all-cause death, nonfatal myocardial infarction, or all unplanned revascularization
Periodo de tiempo: At 1, 6, 24, 36, 48, and 60 months after randomization
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At 1, 6, 24, 36, 48, and 60 months after randomization
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All-cause death
Periodo de tiempo: At 1, 6, 12, 24, 36, 48, and 60 months after randomization
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At 1, 6, 12, 24, 36, 48, and 60 months after randomization
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Nonfatal myocardial infarction
Periodo de tiempo: At 1, 6, 12, 24, 36, 48, and 60 months after randomization
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At 1, 6, 12, 24, 36, 48, and 60 months after randomization
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All unplanned revascularization
Periodo de tiempo: At 1, 6, 12, 24, 36, 48, and 60 months after randomization
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At 1, 6, 12, 24, 36, 48, and 60 months after randomization
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Cardiac death
Periodo de tiempo: At 1, 6, 12, 24, 36, 48, and 60 months after randomization
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At 1, 6, 12, 24, 36, 48, and 60 months after randomization
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Non-cardiac death
Periodo de tiempo: At 1, 6, 12, 24, 36, 48, and 60 months after randomization
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At 1, 6, 12, 24, 36, 48, and 60 months after randomization
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Nonfatal spontaneous myocardial infarction
Periodo de tiempo: At 1, 6, 12, 24, 36, 48, and 60 months after randomization
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At 1, 6, 12, 24, 36, 48, and 60 months after randomization
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Nonfatal procedure-related myocardial infarction
Periodo de tiempo: At 1, 6, 12, 24, 36, 48, and 60 months after randomization
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At 1, 6, 12, 24, 36, 48, and 60 months after randomization
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Target-lesion revascularization
Periodo de tiempo: At 1, 6, 12, 24, 36, 48, and 60 months after randomization
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At 1, 6, 12, 24, 36, 48, and 60 months after randomization
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Target-vessel revascularization
Periodo de tiempo: At 1, 6, 12, 24, 36, 48, and 60 months after randomization
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At 1, 6, 12, 24, 36, 48, and 60 months after randomization
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Non-target vessel revascularization
Periodo de tiempo: At 1, 6, 12, 24, 36, 48, and 60 months after randomization
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At 1, 6, 12, 24, 36, 48, and 60 months after randomization
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Hospitalization for unstable angina
Periodo de tiempo: At 1, 6, 12, 24, 36, 48, and 60 months after randomization
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At 1, 6, 12, 24, 36, 48, and 60 months after randomization
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Hospitalization for heart failure
Periodo de tiempo: At 1, 6, 12, 24, 36, 48, and 60 months after randomization
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At 1, 6, 12, 24, 36, 48, and 60 months after randomization
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Stent thrombosis
Periodo de tiempo: At 1, 6, 12, 24, 36, 48, and 60 months after randomization
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At 1, 6, 12, 24, 36, 48, and 60 months after randomization
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Stroke
Periodo de tiempo: At 1, 6, 12, 24, 36, 48, and 60 months after randomization
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At 1, 6, 12, 24, 36, 48, and 60 months after randomization
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Major bleeding
Periodo de tiempo: At 1, 6, 12, 24, 36, 48, and 60 months after randomization
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At 1, 6, 12, 24, 36, 48, and 60 months after randomization
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Contrast-induced nephropathy
Periodo de tiempo: At hospital discharge (up to 30 days)
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At hospital discharge (up to 30 days)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Youngkeun Ahn, MD, PhD, Chonnam National University Hospital
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de septiembre de 2026
Finalización primaria (Estimado)
31 de julio de 2031
Finalización del estudio (Estimado)
31 de julio de 2035
Fechas de registro del estudio
Enviado por primera vez
26 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
30 de julio de 2026
Publicado por primera vez (Actual)
3 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
17 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
13 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CNUH-2026-258
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .