Immediate Versus Staged Complete Myocardial Revascularization in Patients With STEMI With Multivessel Disease

Sponsor

RenJi Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05967663

Collaborator

(none)

1,608

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
ST Elevation Myocardial Infarction	Device: PCI	N/A

Detailed Description

Objectives: The purpose of this study is to compare the strategy of immediate complete revascularisation and staged complete revascularisation 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 coronary arteries with a diameter of 2.5 mm or more and a maximum diameter at least 70% stenosis by visual estimation or a maximum diameter stenosis rate of 70%, without prior stent implantation, PCI can be successfully implemented.
Sign an informed consent form before participating in the study The standard for acute myocardial infarction follows the "Fourth Edition of the General Definition of Acute ST Segment Elevated Myocardial Infarction" released by ESC/ACC/AHA/WHF in 2018. STEMI is defined as: 1) typical ischemic symptoms; 2) On the adjacent two leads, the ST segment elevation at the newly detected J-point is accompanied by a cutoff point: ≥ 2mm on all leads except for the V2-V3 lead; In the V2-V3 lead, the following cutoff points are used: ≥ 2mm (males ≥ 40 years old), ≥ 2.5 mm (males < 40 year old); Women regardless of age ≥ 1.5 mm; 3) Troponin increased, and the measured value was greater than the upper reference limit of 99th percentile at least once.

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; Or the researcher believes that the inclusion of the subject may affect the special evaluation of the experiment.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1608 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Immediate Versus Staged Complete Revascularisation in ST-segment-elevation Myocardial Infarction Patients With Multivessel Coronary Disease: a Prospective, Open-label, Non-inferiority, Randomised Trial

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2026

Anticipated Study Completion Date :

Dec 1, 2028

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention group Immediate complete revascularisation	Device: PCI 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 45 days after the index procedure.
Active Comparator: Control group Staged complete revascularisation	Device: PCI 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 45 days after the index procedure.

Arm

Intervention/Treatment

Experimental: Intervention group

Immediate complete revascularisation

Device: PCI

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 45 days after the index procedure.

Active Comparator: Control group

Staged complete revascularisation

Device: PCI

Outcome Measures

Primary Outcome Measures

MACCE [At 1 year after the index procedure]
The composite of all-cause mortality, myocardial infarction, any unplanned ischaemia-driven revascularisation, or cerebrovascular events

Secondary Outcome Measures

MACCE [At 1 months, 6 months, 2 and 3 years after the index procedure]
The composite of all-cause mortality, myocardial infarction, any unplanned ischaemia-driven revascularisation, or cerebrovascular events
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)
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
Cerebrovascular events [At 1 months, 6 months, 1, 2 and 3 years after the index procedure]
Cerebrovascular events (Ischemic\hemorrhagic)
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 coronary arteries with a diameter of 2.5 mm or more and a maximum diameter at least 70% stenosis by visual estimation or a maximum diameter stenosis rate of 70%, without prior stent implantation, PCI can be successfully implemented.
Sign an informed consent form before participating in the study

The standard for acute myocardial infarction follows the "Fourth Edition of the General Definition of Acute ST Segment Elevated Myocardial Infarction" released by ESC/ACC/AHA/WHF in 2018. STEMI is defined as: 1) typical ischemic symptoms; 2) On the adjacent two leads, the ST segment elevation at the newly detected J-point is accompanied by a cutoff point: ≥ 2mm on all leads except for the V2-V3 lead; In the V2-V3 lead, the following cutoff points are used: ≥ 2mm (males ≥ 40 years old), ≥ 2.5 mm (males < 40 year old); Women regardless of age ≥ 1.5 mm; 3) Troponin increased, and the measured value was greater than the upper reference limit of 99th percentile at least once.

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; Or the researcher believes that the inclusion of the subject may affect the special evaluation of the experiment.