Non-ST-elevation Acute Coronary Syndrome, NSTE-ACS (NSTEMI and UA), NSTEMI, NSTEMI - Non-ST Segment Elevation MI
Conditions
Keywords
NSTEMI, FUTURE II
Brief summary
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.
Interventions
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).
DEVICEStaged Complete Revascularization
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.
Sponsors
RenJi Hospital
People's Hospital of Xinjiang Uygur Autonomous Region
LanZhou University
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 or older. 2. Patients with intermediate-to-high risk NSTE-ACS who meet the diagnostic criteria specified in current guideline, complicated by multivessel coronary artery disease, and have successfully undergone PCI for the culprit vessel. 3. PCI within 72 hours of diagnosis. 4. Accompanied by multivessel disease: defined as at least one non-culprit artery that meets the following conditions: a diameter of ≥2.5 mm by visual inspection, which can be successfully subjected to PCI, and the most severe diameter stenosis rate by visual inspection is at least 70% or positive coronary physiology testing. 5. Sign an informed consent form before participating in the study.
Exclusion criteria
1. Have received thrombolytic treatment. 2. Cardiogenic shock or SBP\< 90 mmHg. 3. Patients in whom the culprit vessel cannot be clearly identified. 4. Left main coronary artery lesion, non-infarct-related arteries are CTO lesions or severely calcified lesions, complex lesions that require the use of special devices such as rotational ablation/laser. 5. Previous PCI within the past 1 month or previous coronary artery bypass graft (CABG). 6. Accompanied by other diseases that lead to an expected survival time of ≤ 12 months. 7. Patients with other serious diseases such as severe renal insufficiency (creatinine clearance value \<30ml/min), hepatic insufficiency, thrombocytopenia (≤50\*109/L). 8. Patients with severe valvular disease, hypertrophic cardiomyopathy, restrictive cardiomyopathy, and primary pulmonary hypertension. 9. Not suitable for clinical study: 1. Have enrolled in the other clinical studies that may affect the outcome assessment of this study. 2. Pregnant and lactating women. 3. Known allergy to the drugs that may be used in the study. 4. Unable to comply with the trial protocol or follow-up requirements; or the investigator believes that participation in the trial may put the patient at greater risk.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major adverse cardiovascular and cerebrovascular event (MACCE) | at 1 year after randomization | defined as a composite of all-cause death, non-fatal myocardial infarction, unplanned ischemia-driven revascularization, and stroke |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major adverse cardiovascular and cerebrovascular event (MACCE) | 1 month, 6 months, 2 years, 3 years after randomization | defined as a composite of all-cause death, non-fatal myocardial infarction, unplanned ischemia-driven revascularization, and stroke |
| All-cause death | 1 month, 6 months, 1 year, 2 years, 3 years after randomization | cardiovascular, non-cardiovascular, death of undetermined cause |
| Cardiac death | 1 month, 6 months, 1 year, 2 years, 3 years after randomization | — |
| Myocardial infarction | 1 month, 6 months, 1 year, 2 years, 3 years after randomization | target vessel related, non-target vessel related |
| Target vessel revascularization | 1 month, 6 months, 1 year, 2 years, 3 years after randomization | ischemia-driven, non-ischemia-driven |
| Any coronary revascularization | 1 month, 6 months, 1 year, 2 years, 3 years after randomization | ischemia-driven, non-ischemia-driven |
| ARC-2 defined stent thrombosis | 1 month, 6 months, 1 year, 2 years, 3 years after randomization | including confirmed and possible stent thrombosis in acute, subacute, and late time frames |
| Stroke | 1 month, 6 months, 1 year, 2 years, 3 years after randomization | ischaemia, hemorrhage |
| Contrast agent-related acute kidney injury | 1 month after randomization | — |
| Major bleeding | 1 month, 6 months, 1 year, 2 years, 3 years after randomization | BARC grades 3 and 5 |
Contacts
CONTACTJun Pu, MD, PhD
PRINCIPAL_INVESTIGATORJun Pu, MD, PhD
RenJi Hospital
PRINCIPAL_INVESTIGATORYining Yang, MD, PhD
People's Hospital of Xinjiang Uygur Autonomous Region
PRINCIPAL_INVESTIGATORMing Bai, MD, PhD
LanZhou University
Outcome results
None listed