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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
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.
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.
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, China
RECRUITINGMACCE
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.
Time frame: At 1 year after the index procedure
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.
Time frame: 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)
Time frame: At 1 months, 6 months, 1, 2 and 3 years after the index procedure
Cardiovascular death
Cardiovascular death
Time frame: 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)
Time frame: 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)
Time frame: 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)
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SINGLE
Enrollment
840
Time frame: 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
Time frame: At 1 months, 6 months, 1, 2 and 3 years after the index procedure
Stroke (Ischemic\hemorrhagic)
Stroke (Ischemic\\hemorrhagic)
Time frame: At 1 months, 6 months, 1, 2 and 3 years after the index procedure
Hospitalization for heart failure
Hospitalization for heart failure
Time frame: At 1 months, 6 months, 1, 2 and 3 years after the index procedure
Contrast-induced acute kidney injury
Contrast-induced acute kidney injury
Time frame: At 1 months after the index procedure
Major bleeding
Major bleeding (BARC 3-5)
Time frame: At 1 months, 6 months, 1, 2 and 3 years after the index procedure