Optimal Timing of Staged Complete Revascularization in STEMI With Multivessel Disease (OPTION-STEMI2)
2026년 8월 13일 업데이트: 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.
연구 개요
상태
아직 모집하지 않음
정황
상세 설명
- 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.
연구 유형
중재적
등록 (추정된)
1252
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Min Chul Kim, MD, PhD
- 전화번호: 82-10-4606-2643
- 이메일: kmc3242@hanmail.net
연구 장소
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Bucheon-si, 대한민국
- Bucheon Sejong Hospital
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Changwon, 대한민국
- Gyeongsang National University Changwon Hospital
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Changwon, 대한민국
- Samsung Changwon Medical Center
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Cheonan, 대한민국
- Soon Chun Hyang University Hospital Cheonan
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Cheongju-si, 대한민국
- Chungbuk National University Hospital
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Chuncheon, 대한민국
- Kangwon National University Hospital
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Daegu, 대한민국
- Keimyung University Dongsan Hospital
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Daegu, 대한민국
- Kyungpook National University Hospital
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Daegu, 대한민국
- Daegu Catholic University Medical Center
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Daegu, 대한민국
- Yeongnam University Medical Center
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Daejeon, 대한민국
- Chungnam National University Hospital
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Gwangju, 대한민국
- Chonnam National University Hospital
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Gwangju, 대한민국
- Chosun University Hospital
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Gwangju, 대한민국
- Gwangju Veterans Hospital
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Gwangju, 대한민국
- Kwangju Christian Hospital
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Gwangmyeong, 대한민국
- Chung-Ang University Gwangmyeong Hospital
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Jeju City, 대한민국
- Jeju National University Hospital
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Jeonju, 대한민국
- Jeonbuk National University Hospital
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Jeonju, 대한민국
- Presbyterian Medical Center
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Jinju, 대한민국
- Gyeongsang National University Hospital
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Pusan, 대한민국
- Pusan National University Hospital
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Pusan, 대한민국
- Inje University Haeundae Paik Hospital
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Pusan, 대한민국
- Inje University Busan Paik Hospital
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Pusan, 대한민국
- Kosin University Gospel Hospital
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Seoul, 대한민국
- Korea University Anam Hospital
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Seoul, 대한민국
- Koera University Guro Hospital
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Seoul, 대한민국
- Yonsei University Health System, Gangnam Severance Hospital
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Suncheon, 대한민국
- St. Carollo General Hospital
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Suwon, 대한민국
- Ajou University Hospital
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Yangsan, 대한민국
- Pusan National University Yangsan Hospital
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: 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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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Composite of all-cause death, nonfatal myocardial infarction, or all unplanned revascularization
기간: At 12 months after randomization
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At 12 months after randomization
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Composite of all-cause death, nonfatal myocardial infarction, or all unplanned revascularization
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: At hospital discharge (up to 30 days)
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At hospital discharge (up to 30 days)
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Youngkeun Ahn, MD, PhD, Chonnam National University Hospital
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 9월 1일
기본 완료 (추정된)
2031년 7월 31일
연구 완료 (추정된)
2035년 7월 31일
연구 등록 날짜
최초 제출
2026년 7월 26일
QC 기준을 충족하는 최초 제출
2026년 7월 30일
처음 게시됨 (실제)
2026년 8월 3일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 8월 17일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 13일
마지막으로 확인됨
2026년 8월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- CNUH-2026-258
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .