Optimal Timing of Staged Complete Revascularization in STEMI With Multivessel Disease (OPTION-STEMI2)
2026年8月13日 更新者：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.
調査の概要
状態
まだ募集していません
条件
詳細な説明
- 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.
研究の種類
介入
入学 (推定)
1252
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Min Chul Kim, MD, PhD
- 電話番号：82-10-4606-2643
- メール：kmc3242@hanmail.net
研究場所
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Bucheon-si、韓国
- Bucheon Sejong Hospital
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Changwon、韓国
- Gyeongsang National University Changwon Hospital
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Changwon、韓国
- Samsung Changwon Medical Center
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Cheonan、韓国
- Soon Chun Hyang University Hospital Cheonan
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Cheongju-si、韓国
- Chungbuk National University Hospital
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Chuncheon、韓国
- Kangwon National University Hospital
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Daegu、韓国
- Keimyung University Dongsan Hospital
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Daegu、韓国
- Kyungpook National University Hospital
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Daegu、韓国
- Daegu Catholic University Medical Center
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Daegu、韓国
- Yeongnam University Medical Center
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Daejeon、韓国
- Chungnam National University Hospital
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Gwangju、韓国
- Chonnam National University Hospital
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Gwangju、韓国
- Chosun University Hospital
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Gwangju、韓国
- Gwangju Veterans Hospital
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Gwangju、韓国
- Kwangju Christian Hospital
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Gwangmyeong、韓国
- Chung-Ang University Gwangmyeong Hospital
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Jeju City、韓国
- Jeju National University Hospital
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Jeonju、韓国
- Jeonbuk National University Hospital
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Jeonju、韓国
- Presbyterian Medical Center
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Jinju、韓国
- Gyeongsang National University Hospital
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Pusan、韓国
- Pusan National University Hospital
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Pusan、韓国
- Inje University Haeundae Paik Hospital
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Pusan、韓国
- Inje University Busan Paik Hospital
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Pusan、韓国
- Kosin University Gospel Hospital
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Seoul、韓国
- Korea University Anam Hospital
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Seoul、韓国
- Koera University Guro Hospital
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Seoul、韓国
- Yonsei University Health System, Gangnam Severance Hospital
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Suncheon、韓国
- St. Carollo General Hospital
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Suwon、韓国
- Ajou University Hospital
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Yangsan、韓国
- Pusan National University Yangsan Hospital
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：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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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
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Composite of all-cause death, nonfatal myocardial infarction, or all unplanned revascularization
時間枠：At 12 months after randomization
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At 12 months after randomization
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Composite of all-cause death, nonfatal myocardial infarction, or all unplanned revascularization
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：At hospital discharge (up to 30 days)
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At hospital discharge (up to 30 days)
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Youngkeun Ahn, MD, PhD、Chonnam National University Hospital
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年9月1日
一次修了 (推定)
2031年7月31日
研究の完了 (推定)
2035年7月31日
試験登録日
最初に提出
2026年7月26日
QC基準を満たした最初の提出物
2026年7月30日
最初の投稿 (実際)
2026年8月3日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月17日
QC基準を満たした最後の更新が送信されました
2026年8月13日
最終確認日
2026年8月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。