This is a prospective, multi-center, randomized controlled, open-label, blinded endpoint assessment study. The objective is to compare the 1-year incidence of major adverse cardiovascular and cerebrovascular events (MACCE) between two treatment strategies-immediate complete revascularization and staged complete revascularization-in NSTE-ACS patients with multivessel disease (MVD). NSTE-ACS patients who meet other the inclusion and exclusion criteria will be randomized into the following two groups after signing an informed consent form: Intervention group Immediate Complete Revascularization: Emergency PCI for the culprit vessel is performed successfully, and simultaneous PCI is conducted for non-culprit vessels that meet the defined criteria (visually estimated diameter ≥2.5 mm, eligible for successful PCI, and visually estimated maximum diameter stenosis ≥ 70% or positive coronary physiology testing). Control group During emergency intervention, PCI is performed only on the culprit vessel. Elective PCI is then conducted for non-culprit vessels that meet the defined criteria (visually estimated diameter ≥ 2.5 mm, eligible for successful PCI, and visually estimated maximum diameter stenosis ≥ 70% or positive coronary physiology testing)-either during the current emergency hospitalization or within 6 weeks after the culprit vessel PCI.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
1,904
Immediate Complete Revascularization: Emergency PCI for the culprit vessel is performed successfully, and simultaneous PCI is conducted for non-culprit vessels that meet the defined criteria (visually estimated diameter ≥2.5 mm, eligible for successful PCI, and visually estimated maximum diameter stenosis ≥ 70% or positive coronary physiology testing).
During emergency intervention, PCI is performed only on the culprit vessel. Elective PCI is then conducted for non-culprit vessels that meet the defined criteria (visually estimated diameter ≥ 2.5 mm, eligible for successful PCI, and visually estimated maximum diameter stenosis ≥ 70% or positive coronary physiology testing)-either during the current emergency hospitalization or within 6 weeks after the culprit vessel PCI.
Major adverse cardiovascular and cerebrovascular event (MACCE)
defined as a composite of all-cause death, non-fatal myocardial infarction, unplanned ischemia-driven revascularization, and stroke
Time frame: at 1 year after randomization
Major adverse cardiovascular and cerebrovascular event (MACCE)
defined as a composite of all-cause death, non-fatal myocardial infarction, unplanned ischemia-driven revascularization, and stroke
Time frame: 1 month, 6 months, 2 years, 3 years after randomization
All-cause death
cardiovascular, non-cardiovascular, death of undetermined cause
Time frame: 1 month, 6 months, 1 year, 2 years, 3 years after randomization
Cardiac death
Time frame: 1 month, 6 months, 1 year, 2 years, 3 years after randomization
Myocardial infarction
target vessel related, non-target vessel related
Time frame: 1 month, 6 months, 1 year, 2 years, 3 years after randomization
Target vessel revascularization
ischemia-driven, non-ischemia-driven
Time frame: 1 month, 6 months, 1 year, 2 years, 3 years after randomization
Any coronary revascularization
ischemia-driven, non-ischemia-driven
Time frame: 1 month, 6 months, 1 year, 2 years, 3 years after randomization
ARC-2 defined stent thrombosis
including confirmed and possible stent thrombosis in acute, subacute, and late time frames
Time frame: 1 month, 6 months, 1 year, 2 years, 3 years after randomization
Stroke
ischaemia, hemorrhage
Time frame: 1 month, 6 months, 1 year, 2 years, 3 years after randomization
Contrast agent-related acute kidney injury
Time frame: 1 month after randomization
Major bleeding
BARC grades 3 and 5
Time frame: 1 month, 6 months, 1 year, 2 years, 3 years after randomization
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