Optimal Timing of Staged Complete Revascularization in STEMI With Multivessel Disease (OPTION-STEMI2)
13 августа 2026 г. обновлено: 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.
Обзор исследования
Статус
Еще не набирают
Условия
Подробное описание
- 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.
Тип исследования
Интервенционный
Регистрация (Оцененный)
1252
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
- Имя: Min Chul Kim, MD, PhD
- Номер телефона: 82-10-4606-2643
- Электронная почта: kmc3242@hanmail.net
Места учебы
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Bucheon-si, Южная Корея
- Bucheon Sejong Hospital
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Changwon, Южная Корея
- Gyeongsang National University Changwon Hospital
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Changwon, Южная Корея
- Samsung Changwon Medical Center
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Cheonan, Южная Корея
- Soon Chun Hyang University Hospital Cheonan
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Cheongju-si, Южная Корея
- Chungbuk National University Hospital
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Chuncheon, Южная Корея
- Kangwon National University Hospital
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Daegu, Южная Корея
- Keimyung University Dongsan Hospital
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Daegu, Южная Корея
- Kyungpook National University Hospital
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Daegu, Южная Корея
- Daegu Catholic University Medical Center
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Daegu, Южная Корея
- Yeongnam University Medical Center
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Daejeon, Южная Корея
- Chungnam National University Hospital
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Gwangju, Южная Корея
- Chonnam National University Hospital
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Gwangju, Южная Корея
- Chosun University Hospital
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Gwangju, Южная Корея
- Gwangju Veterans Hospital
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Gwangju, Южная Корея
- Kwangju Christian Hospital
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Gwangmyeong, Южная Корея
- Chung-Ang University Gwangmyeong Hospital
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Jeju City, Южная Корея
- Jeju National University Hospital
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Jeonju, Южная Корея
- Jeonbuk National University Hospital
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Jeonju, Южная Корея
- Presbyterian Medical Center
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Jinju, Южная Корея
- Gyeongsang National University Hospital
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Pusan, Южная Корея
- Pusan National University Hospital
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Pusan, Южная Корея
- Inje University Haeundae Paik Hospital
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Pusan, Южная Корея
- Inje University Busan Paik Hospital
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Pusan, Южная Корея
- Kosin University Gospel Hospital
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Seoul, Южная Корея
- Korea University Anam Hospital
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Seoul, Южная Корея
- Koera University Guro Hospital
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Seoul, Южная Корея
- Yonsei University Health System, Gangnam Severance Hospital
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Suncheon, Южная Корея
- St. Carollo General Hospital
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Suwon, Южная Корея
- Ajou University Hospital
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Yangsan, Южная Корея
- Pusan National University Yangsan Hospital
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Нет
Описание
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
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Активный компаратор: 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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Экспериментальный: 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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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Временное ограничение |
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Composite of all-cause death, nonfatal myocardial infarction, or all unplanned revascularization
Временное ограничение: At 12 months after randomization
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At 12 months after randomization
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Вторичные показатели результатов
Мера результата |
Временное ограничение |
|---|---|
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Composite of all-cause death, nonfatal myocardial infarction, or all unplanned revascularization
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: At hospital discharge (up to 30 days)
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At hospital discharge (up to 30 days)
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Следователи
- Главный следователь: Youngkeun Ahn, MD, PhD, Chonnam National University Hospital
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Оцененный)
1 сентября 2026 г.
Первичное завершение (Оцененный)
31 июля 2031 г.
Завершение исследования (Оцененный)
31 июля 2035 г.
Даты регистрации исследования
Первый отправленный
26 июля 2026 г.
Впервые представлено, что соответствует критериям контроля качества
30 июля 2026 г.
Первый опубликованный (Действительный)
3 августа 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
17 августа 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
13 августа 2026 г.
Последняя проверка
1 августа 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- CNUH-2026-258
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
НЕТ
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .