Efficacy of Immediate Versus Staged Complete Revascularization in Patients With NSTE-ACS and Multivessel Disease (FUTURE II)

Overview

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

• Device Immediate Complete Revascularization
  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).
• Device Staged 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.

Primary outcome measures

• Major adverse cardiovascular and cerebrovascular event (MACCE) [Time frame: at 1 year after randomization]

Secondary outcome measures (10)

• Major adverse cardiovascular and cerebrovascular event (MACCE) [Time frame: 1 month, 6 months, 2 years, 3 years after randomization]
• All-cause death [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 [Time frame: 1 month, 6 months, 1 year, 2 years, 3 years after randomization]
• Target vessel revascularization [Time frame: 1 month, 6 months, 1 year, 2 years, 3 years after randomization]
• Any coronary revascularization [Time frame: 1 month, 6 months, 1 year, 2 years, 3 years after randomization]
• ARC-2 defined stent thrombosis [Time frame: 1 month, 6 months, 1 year, 2 years, 3 years after randomization]
• Stroke [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 [Time frame: 1 month, 6 months, 1 year, 2 years, 3 years after randomization]

Eligibility criteria

Inclusion criteria

• Age: 18 years or older.
• 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.
• PCI within 72 hours of diagnosis.
• 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.
• Sign an informed consent form before participating in the study.

Exclusion criteria

• Have received thrombolytic treatment.
• Cardiogenic shock or SBP< 90 mmHg.
• Patients in whom the culprit vessel cannot be clearly identified.
• 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.
• Previous PCI within the past 1 month or previous coronary artery bypass graft (CABG).
• Accompanied by other diseases that lead to an expected survival time of ≤ 12 months.
• Patients with other serious diseases such as severe renal insufficiency (creatinine clearance value <30ml/min), hepatic insufficiency, thrombocytopenia (≤50\*109/L).
• Patients with severe valvular disease, hypertrophic cardiomyopathy, restrictive cardiomyopathy, and primary pulmonary hypertension.
• Not suitable for clinical study:

• Have enrolled in the other clinical studies that may affect the outcome assessment of this study.
• Pregnant and lactating women.
• Known allergy to the drugs that may be used in the study.
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07343076 · FUTURE II

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗