Fractional Flow Reserve Guided Immediate Versus Staged Complete Myocardial Revascularization in Patients With ST-segment Elevation Myocardial Infarction With Multivessel Disease (Future Study)

Study Overview
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Brief Summary
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It is a prospective, multicenter, randomised controlled, open-label, blinded endpoint assessment trial, to compare the strategy of immediate complete revascularisation and staged complete revascularisation in ST-segment-elevation myocardial infarction patients with multivessel coronary disease.

Detailed Description
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Objectives: The purpose of this study is to investigate whether FFR guided PCI strategy for non-culprit lesions should be attempted during the index procedure or staged in ST-segment-elevation myocardial infarction patients with multivessel coronary disease. Inclusion Criteria: Age ≥ 18 years Patients presenting STEMI and multivessel coronary disease successful primary PCI of the culprit lesion (including those who still have ischemic symptoms within 48 hours) Multivessel disease was defined at least one non-culprit coronary arteries with a diameter of 2.5 mm or more and a maximum diameter at least 50% stenosis by visual estimation, PCI can be successfully implemented Sign an informed consent form before participating in the study Exclusion Criteria: Received thrombolytic therapy Cardiac shock or SBP<90mmHg; History of old myocardial infarction; Left main artery lesion, non infarct related vessels are CTO lesions; PCI in the previous 30 days or Previous CABG Patients who cannot give informed consent or have a life expectancy of less than 1 year Patients combined with other serious diseases such as severe renal dysfunction (creatinine clearance value<30ml/min;), liver dysfunction and thrombocytopenia Patients with severe valve disease, hypertrophic cardiomyopathy, restrictive cardiomyopathy, and primary pulmonary hypertension; Not suitable for clinical research: . Currently participating in another study that may affect the primary endpoint . Pregnant and lactating women; . Known allergy to drugs that may be used in the study; . Unable to comply with the trial protocol or follow-up requirements; Or the researcher believes that participating in the trial may result in patients facing greater risks.

Official Title
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Fractional Flow Reserve Guided Immediate Versus Staged Complete Myocardial Revascularization in Patients With ST-segment Elevation Myocardial Infarction With Multivessel Disease (Future Study)

Conditions
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ST Elevation Myocardial Infarction

Intervention / Treatment
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* Device: PCI-immediate complete revascularisation
* Device: PCI-staged complete revascularisation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Patients presenting STEMI and multivessel coronary disease successful primary PCI of the culprit lesion (including those who still have ischemic symptoms within 48 hours) Multivessel disease was defined at least one non-culprit coronary arteries with a diameter of 2.5 mm or more and a maximum diameter at least 50% stenosis by visual estimation, PCI can be successfully implemented Sign an informed consent form before participating in the study Exclusion Criteria: Received thrombolytic therapy Cardiac shock or SBP<90mmHg; History of old myocardial infarction; Left main artery lesion, non infarct related vessels are CTO lesions; PCI in the previous 30 days or Previous CABG Patients who cannot give informed consent or have a life expectancy of less than 1 year Patients combined with other serious diseases such as severe renal dysfunction (creatinine clearance value<30ml/min;), liver dysfunction and thrombocytopenia Patients with severe valve disease, hypertrophic cardiomyopathy, restrictive cardiomyopathy, and primary pulmonary hypertension; Not suitable for clinical research: Currently participating in another study that may affect the primary endpoint Pregnant and lactating women; Known allergy to drugs that may be used in the study; Unable to comply with the trial protocol or follow-up requirements; Or the researcher believes that participating in the trial may result in patients facing greater risks.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Immediate complete revascularisation | Device: PCI-immediate complete revascularisation<br>* In patients allocated to the immediate complete revascularisation group, PCI of the culprit lesion was attempted first and followed by all other lesions deemed to be clinically significant by the operator during the index procedure.<br>|
| Active Comparator: Control group<br>Staged complete revascularisation | Device: PCI-staged complete revascularisation<br>* In the staged complete revascularisation group, only the culprit lesion was treated during the index procedure and PCI of all non-culprit lesions deemed to be clinically significant by the operator was planned at a later stage through an elective re-admission within 15-45 days after randomisation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACCE | The primary outcome was the composite of all-cause mortality, myocardial infarction, any unplanned ischemia-driven revascularization, stroke or hospitalization for heart failure at 1 year after the index procedure. | At 1 year after the index procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACCE | The primary outcome was the composite of all-cause mortality, myocardial infarction, any unplanned ischemia-driven revascularization, stroke or hospitalization for heart failure at 1 year after the index procedure. | At 1 months, 6 months, 2 and 3 years after the index procedure | 
| All-cause mortality | All-cause mortality (cardiovascular death, non- cardiovascular death, undetermined cause of death) | At 1 months, 6 months, 1, 2 and 3 years after the index procedure | 
| Cardiovascular death | Cardiovascular death | At 1 months, 6 months, 1, 2 and 3 years after the index procedure | 
| Myocardial Infarction | Myocardial Infarction (Q-wave and non Q-wave MI) | At 1 months, 6 months, 1, 2 and 3 years after the index procedure | 
| TVR: Target vessel revascularization | TVR: Target vessel revascularization(Ischemia driven revascularization, or Non ischemic driven revascularization) | At 1 months, 6 months, 1, 2 and 3 years after the index procedure | 
| Any coronary revascularization | Any coronary revascularization (ischemic driven, non ischemic driven) | At 1 months, 6 months, 1, 2 and 3 years after the index procedure | 
| Stent Thrombosis | ARC-2 defines Stent Thrombosis: including confirmed and possible stent thrombosis within acute, subacute, and advanced time ranges | At 1 months, 6 months, 1, 2 and 3 years after the index procedure | 
| Stroke (Ischemic\hemorrhagic) | Stroke (Ischemic\hemorrhagic) | At 1 months, 6 months, 1, 2 and 3 years after the index procedure | 
| Hospitalization for heart failure | Hospitalization for heart failure | At 1 months, 6 months, 1, 2 and 3 years after the index procedure | 
| Contrast-induced acute kidney injury | Contrast-induced acute kidney injury | At 1 months after the index procedure | 
| Major bleeding | Major bleeding (BARC 3-5) | At 1 months, 6 months, 1, 2 and 3 years after the index procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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STEMI, Coronary Artery Disease, Coronary Syndrome