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

Обзор

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.

Вмешательства

• Устройство 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).
• Устройство 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.

Первичные конечные точки

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

Вторичные конечные точки (10)

• Major adverse cardiovascular and cerebrovascular event (MACCE) [Срок оценки: 1 month, 6 months, 2 years, 3 years after randomization]
• All-cause death [Срок оценки: 1 month, 6 months, 1 year, 2 years, 3 years after randomization]
• Cardiac death [Срок оценки: 1 month, 6 months, 1 year, 2 years, 3 years after randomization]
• Myocardial infarction [Срок оценки: 1 month, 6 months, 1 year, 2 years, 3 years after randomization]
• Target vessel revascularization [Срок оценки: 1 month, 6 months, 1 year, 2 years, 3 years after randomization]
• Any coronary revascularization [Срок оценки: 1 month, 6 months, 1 year, 2 years, 3 years after randomization]
• ARC-2 defined stent thrombosis [Срок оценки: 1 month, 6 months, 1 year, 2 years, 3 years after randomization]
• Stroke [Срок оценки: 1 month, 6 months, 1 year, 2 years, 3 years after randomization]
• Contrast agent-related acute kidney injury [Срок оценки: 1 month after randomization]
• Major bleeding [Срок оценки: 1 month, 6 months, 1 year, 2 years, 3 years after randomization]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07343076 · FUTURE II

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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