ST Elevation Myocardial Infarction
Conditions
Keywords
STEMI, Coronary Artery Disease, Coronary Syndrome
Brief summary
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
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: 1. Age ≥ 18 years 2. Patients presenting STEMI and multivessel coronary disease successful primary PCI of the culprit lesion (including those who still have ischemic symptoms within 48 hours) 3. 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 4. Sign an informed consent form before participating in the study Exclusion Criteria: 1. Received thrombolytic therapy 2. Cardiac shock or SBP\<90mmHg; 3. History of old myocardial infarction; 4. Left main artery lesion, non infarct related vessels are CTO lesions; 5. PCI in the previous 30 days or Previous CABG 6. Patients who cannot give informed consent or have a life expectancy of less than 1 year 7. Patients combined with other serious diseases such as severe renal dysfunction (creatinine clearance value\<30ml/min;), liver dysfunction and thrombocytopenia 8. Patients with severe valve disease, hypertrophic cardiomyopathy, restrictive cardiomyopathy, and primary pulmonary hypertension; 9. Not suitable for clinical research: 1. . Currently participating in another study that may affect the primary endpoint 2. . Pregnant and lactating women; 3. . Known allergy to drugs that may be used in the study; 4. . 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.
Interventions
DEVICEPCI-immediate complete revascularisation
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.
DEVICEPCI-staged complete revascularisation
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.
Sponsors
RenJi Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years 2. Patients presenting STEMI and multivessel coronary disease successful primary PCI of the culprit lesion (including those who still have ischemic symptoms within 48 hours) 3. 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 4. Sign an informed consent form before participating in the study
Exclusion criteria
1. Received thrombolytic therapy 2. Cardiac shock or SBP\<90mmHg; 3. History of old myocardial infarction; 4. Left main artery lesion, non infarct related vessels are CTO lesions; 5. PCI in the previous 30 days or Previous CABG 6. Patients who cannot give informed consent or have a life expectancy of less than 1 year 7. Patients combined with other serious diseases such as severe renal dysfunction (creatinine clearance value\<30ml/min;), liver dysfunction and thrombocytopenia 8. Patients with severe valve disease, hypertrophic cardiomyopathy, restrictive cardiomyopathy, and primary pulmonary hypertension; 9. Not suitable for clinical research: 1. Currently participating in another study that may affect the primary endpoint 2. Pregnant and lactating women; 3. Known allergy to drugs that may be used in the study; 4. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MACCE | At 1 year after the index procedure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality | At 1 months, 6 months, 1, 2 and 3 years after the index procedure | All-cause mortality (cardiovascular death, non- cardiovascular death, undetermined cause of death) |
| Cardiovascular death | At 1 months, 6 months, 1, 2 and 3 years after the index procedure | Cardiovascular death |
| Myocardial Infarction | At 1 months, 6 months, 1, 2 and 3 years after the index procedure | Myocardial Infarction (Q-wave and non Q-wave MI) |
| TVR: Target vessel revascularization | At 1 months, 6 months, 1, 2 and 3 years after the index procedure | TVR: Target vessel revascularization(Ischemia driven revascularization, or Non ischemic driven revascularization) |
| Any coronary revascularization | At 1 months, 6 months, 1, 2 and 3 years after the index procedure | Any coronary revascularization (ischemic driven, non ischemic driven) |
| MACCE | At 1 months, 6 months, 2 and 3 years after the index procedure | 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. |
| Stroke (Ischemic\hemorrhagic) | At 1 months, 6 months, 1, 2 and 3 years after the index procedure | Stroke (Ischemic\\hemorrhagic) |
| Hospitalization for heart failure | At 1 months, 6 months, 1, 2 and 3 years after the index procedure | Hospitalization for heart failure |
| Contrast-induced acute kidney injury | At 1 months after the index procedure | Contrast-induced acute kidney injury |
| Major bleeding | At 1 months, 6 months, 1, 2 and 3 years after the index procedure | Major bleeding (BARC 3-5) |
| Stent Thrombosis | At 1 months, 6 months, 1, 2 and 3 years after the index procedure | ARC-2 defines Stent Thrombosis: including confirmed and possible stent thrombosis within acute, subacute, and advanced time ranges |
Countries
China
Contacts
Primary ContactJun Pu, MD, PhD
Outcome results
None listed