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Patients with STEMI (ST-segment elevation myocardial infarction) with multivessel disease which have PCI (percutaneous coronary intervention)-suitable non-IRA (infarct related artery) will be randomized to immediate complete revascularization group or staged revascularization group by 1:1 fashion. Non-IRA lesion which have equal or more than 70% diameter stenosis by visual estimation will be revascularized without FFR (fractional flow reserve) evaluation. Non-IRA lesion with diameter stenosis 50-70% by visual estimation will be evaluated using FFR device. In case of FFR value more than 0.8, non-IRA lesion wll be deferred without PCI. If FFR value was equal or less than 0.8, non-IRA lesion will be revascularized.
Study objectives:
To determine the optimal timing of non-infarct related artery (IRA) percutaneous coronary intervention (PCI) with the aid of FFR (fractional flow reserve) (immediate complete revascularization during primary angioplasty vs. staged procedure for non-IRA PCI) in patients with ST-segment elevation myocardial infarction with multivessel disease (MVD).
Study hypothesis:
Complete revascularization (CR) at index procedure is not inferior to staged in-hospital CR in patients with STEMI and MVD who undergoing FFR-guided revascularization for non-IRA.
Background:
Multivessel coronary artery disease (MVD) is a common clinical condition, about 40-65% of all primary angioplasty, encountered by interventional cardiologists in ST-segment elevation myocardial infarction (STEMI), and it is associated with poorer clinical outcomes than single-vessel disease. Older guidelines recommended culprit-vessel only revascularization (CVR) during primary angioplasty, except in patient that are hemodynamically unstable. Several recent studies have reported improved clinical outcomes in these patients with multivessel percutaneous coronary intervention (PCI), and others reported promising results from CVR followed by elective second-stage PCI at non-infarct related artery (non-IRA) with significant stenosis. However, there has been no consensus of optimal revascularization strategy in this circumstance.
Recently, several large-scaled randomized controlled trials were conducted about this issue, and confirmed the benefit of immediate complete revascularization during primary angioplasty compared to CVR. Furthermore, fractional flow reserve (FFR)-guided PCI at non-IRA was more effective than angiography-guided PCI at non-IRA for reducing repeat revascularization by either immediate multivessel PCI strategy or staged PCI strategy in the other trials.
Although FFR is a well-known tool to evaluate significant ischemia of moderate stenosis, the most studies regarding FFR enrolled patients without acute myocardial infarction (AMI). Timing of non-IRA PCI is also uncertain. After promising results of above-mentioned randomized trials, current guideline recommendation of multivessel PCI (immediate or staged) was upgraded. However, current guidelines simply mentioned about the timing of non-IRA PCI which recommends complete revascularization during initial hospitalization by either of immediate of staged PCI strategy.
Therefore, the investigators planned to perform prospective, open-label, multicenter, non-inferiority trial to evaluate the efficacy and safety of immediate complete revascularization (PCI for both IRA and non-IRA during primary angioplasty) compared to staged PCI strategy of non-IRA (primary angioplasty for IRA followed by non-IRA PCI after several days). PCI procedure at non-IRA with diameter stenosis between 50 and 70% should be conducted with the aid of FFR, and non-IRA with diameter stenosis ≥ 70% will be revascularized without FFR.
Study procedure:
Patients will be randomized after primary PCI for 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 50-70% by visual estimation will be evaluated using FFR device. In case of FFR value more than 0.8, non-IRA lesion wll be deferred without PCI. If FFR value was equal or less than 0.8, non-IRA lesion will be revascularized.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Staged in-hospital CR (complete revascularization) | Active Comparator | Non-infarct related artery (IRA) will be revascularized in other day (during hospitalization) after PCI for 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 50-70% by visual estimation will be evaluated using FFR device. In case of FFR value more than 0.8, non-IRA lesion wll be deferred without PCI. If FFR value was equal or less than 0.8, non-IRA lesion will be revascularized. |
|
| Immediate CR (complete revascularization) | Experimental | Non-infarct related artery (IRA) will be revascularized immediately after PCI for IRA (during primary PCI). 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 50-70% by visual estimation will be evaluated using FFR device. In case of FFR value more than 0.8, non-IRA lesion wll be deferred without PCI. If FFR value was equal or less than 0.8, non-IRA lesion will be revascularized. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Staged in-hospital or Immediate complete revascularization | Procedure | Patients with ST-segment elevation myocardial infarction and multivessel disease will be randomized after primary PCI for IRA. All patients will be randomized to immediate complete revascularization group or staged revascularization group by 1:1 fashion. 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 50-70% by visual estimation will be evaluated using FFR device. In case of FFR value more than 0.8, non-IRA lesion wll be deferred without PCI. If FFR value was equal or less than 0.8, non-IRA lesion will be revascularized. |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative incidence rate of all-cause death, non-fatal myocardial infarction, or all unplanned revascularization at 1 year from baseline | Composite endpoint of all-cause death, non-fatal myocardial infarction, or all unplanned revascularization at 1 year after index percutaneous coronary intervention | Index admission to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of contrast-induced nephropathy during index admission | Rate of contrast-induced nephropathy during index admission | During index admission |
| Cumulative incidence rate of all unplanned revascularization at each visit |
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Inclusion Criteria:
Age ≥ 19 years old
ST-segment elevation myocardial infarction
Primary PCI within 12 hours after symptom development
Multivessel disease: Non-IRA with at least 2.5 mm diameter and 50% diameter stenosis by visual estimation
Patient's or protector's agreement about study design and the risk of PCI
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Youngkeun Ahn, MD | Chonnam National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Catholic University of Korea, Bucheon St. Mary's Hospital | Bucheon-si | South Korea | ||||
| Gyeongsang National University Changwon Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40902612 | Derived | Kim MC, Ahn JH, Hyun DY, Lim Y, Cho KH, Lee SH, Park S, Oh S, Sim DS, Hong YJ, Kim JH, Jeong MH, Cho JH, Lee SR, Kang DO, Hwang JY, Youn YJ, Lee JH, Jeong YH, Ahn JH, Kim DB, Choo EH, Kim CJ, Kim W, Rhew JY, Park JI, Yoo SY, Ahn Y; OPTION-STEMI Investigators. Immediate versus staged complete revascularisation during index admission in patients with ST-segment elevation myocardial infarction and multivessel disease (OPTION-STEMI): a multicentre, non-inferiority, open-label, randomised trial. Lancet. 2025 Sep 6;406(10507):1032-1043. doi: 10.1016/S0140-6736(25)01529-6. Epub 2025 Aug 31. | |
| 38641031 |
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|
Cumulative incidence rate of all unplanned revascularization at each visit
| Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months |
| Cumulative incidence rate of target-lesion revascularization at each visit | Cumulative incidence rate of target-lesion revascularization at each visit | Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months |
| Cumulative incidence rate of target-vessel revascularization at each visit | Cumulative incidence rate of target-vessel revascularization at each visit | Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months |
| Cumulative incidence rate of non-target vessel revascularization at each visit | Cumulative incidence rate of non-target vessel revascularization at each visit | Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months |
| Cumulative incidence rate of all-cause death at each visit | Cumulative incidence rate of all-cause death at each visit | Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months |
| Cumulative incidence rate of cardiac death at each visit | Cumulative incidence rate of cardiac death at each visit | Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months |
| Cumulative incidence rate of non-cardiac death at each visit | Cumulative incidence rate of non-cardiac death at each visit | Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months |
| Cumulative incidence rate of non-fatal myocardial infarction at each visit | Cumulative incidence rate of non-fatal myocardial infarction at each visit | Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months |
| Cumulative incidence rate of hospitalization for unstable angina at each visit | Cumulative incidence rate of hospitalization for unstable angina at each visit | Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months |
| Cumulative incidence rate of hospitalization for heart failure at each visit | Cumulative incidence rate of hospitalization for heart failure at each visit | Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months |
| Cumulative incidence rate of definite or probable stent thrombosis at each visit | Cumulative incidence rate of definite or probable stent thrombosis at each visit | Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months |
| Cumulative incidence rate of ischemic and hemorrhagic stroke at each visit | Cumulative incidence rate of ischemic and hemorrhagic stroke at each visit | Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months |
| Cumulative incidence rate of major bleeding (BARC definitions type 3 or 5) at each visit | Cumulative incidence rate of major bleeding (BARC definitions type 3 or 5) at each visit | Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months |
| Cumulative incidence rate of all-cause death, non-fatal myocardial infarction, or all unplanned revascularization at 1 year from baseline | Composite endpoint of all-cause death, non-fatal myocardial infarction, or all unplanned revascularization at 1 year after index percutaneous coronary intervention | Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months |
| Changwon |
| South Korea |
| Yeongnam University Medical Center | Daegu | South Korea |
| GangNeung Asan Hospital | Gangneung | South Korea |
| Chonnam National University Hospital | Gwangju | South Korea |
| Chonbuk National University Hospital | Jeonju | South Korea |
| Presbyterian Medical Center | Jeonju | South Korea |
| Gyeongsang National University Hospital | Jinju | South Korea |
| Koera University Guro Hospital | Seoul | South Korea |
| Kyung Hee University Hospital | Seoul | South Korea |
| The Catholic University of Korea, Seoul St. Mary's Hospital | Seoul | South Korea |
| St. Carollo General Hospital | Suncheon | South Korea |
| The Catholic University of Korea, Uijeongbu St. Mary's Hospital | Uijeongbu-si | South Korea |
| Yonsei University, Wonju Severance Christian Hospital | Wŏnju | South Korea |
| Derived |
| Kim MC, Ahn JH, Hyun DY, Lim Y, Lee SH, Oh S, Cho KH, Sim DS, Hong YJ, Kim JH, Jeong MH, Cho JH, Lee SR, Kang DO, Hwang JY, Youn YJ, Jeong YH, Park Y, Kim DB, Choo EH, Kim CJ, Kim W, Rhew JY, Lee JH, Yoo SY, Ahn Y; OPTION-STEMI Investigators. Timing of fractional flow reserve-guided complete revascularization in patients with ST-segment elevation myocardial infarction with multivessel disease: Rationale and design of the OPTION-STEMI trial. Am Heart J. 2024 Jul;273:35-43. doi: 10.1016/j.ahj.2024.03.017. Epub 2024 Apr 18. |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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