Preoperative vs Postoperative Revascularization in Coronary Heart Disease Patients Undergoing Time-Sensitive Non-Cardiac Surgery (CHRONOS-PCI)

Официальное название

Comparison of Clinical Outcomes Between Preoperative and Postoperative Revascularization in Coronary Heart Disease Patients With Time-Sensitive NOn-Cardiac Surgery: A Multicenter Pragmatic Randomized Controlled Trial (CHRONOS-PCI)

Обзор

To compare the safety and efficacy of preoperative versus postoperative revascularization strategies in patients with coronary heart disease undergoing time-sensitive non-cardiac surgery.

Подробное описание

1. Study overview This study is a prospective, open-label, randomized, multicenter trial to evaluate the safety and efficacy of preoperative versus postoperative revascularization strategies in patients with coronary heart disease undergoing time-sensitive non-cardiac surgery.

The primary hypothesis is that the postoperative (surgery-first) revascularization strategy will show a non-inferior rate of major adverse cardiovascular events (MACE) at 180 days after randomization compared with the preoperative (revascularization-first) strategy. 2. Study population and sample size calculation Based on previous data, the 180-day incidence of MACE was approximately 5.5% in patients undergoing postoperative revascularization and 5.7% in those undergoing preoperative revascularization. Using a non-inferiority margin (delta) of 4%, a two-sided type I error rate (α) of 0.05, and a power of 78%, a total of 140 patients (70 in each group) will be enrolled. An attrition rate of 10% was considered.

* Primary endpoint: MACE at 180 days after randomization, defined as a composite of all-cause death, myocardial infarction, and any repeat revascularization. * Design: Non-inferiority, delta = 4%. * Sampling ratio: 1:1 (surgery-first vs. revascularization-first). * Type I error (α): Two-sided 0.05. * Accrual time: 3 years. * Total time: 3.5 years (3 years accrual + 6 months follow-up). * Assumption: MACE 5.5% vs. 5.7% in surgery-first and revascularization-first groups, respectively. * Statistical power (1-β): 78%. * Primary statistical method: Farrington-Manning non-inferiority test for binary outcomes. * Potential withdrawal rates: 10%. * Stratification in randomization: Randomization will be stratified according to (1) the estimated cardiovascular risk of the non-cardiac surgery and (2) the bleeding risk of the surgery. 3. Research materials and treatment strategies

* Surgery-first group: Patients will undergo the time-sensitive non-cardiac surgery first. Coronary revascularization (PCI) will be performed after surgery. * Revascularization-first group: Patients will undergo coronary revascularization (PCI) prior to the non-cardiac surgery, according to guideline-based recommendations and operator judgment.

Вмешательства

• Процедура Non-cardiac surgery followed by postoperative PCI
  Patients undergo the planned time-sensitive non-cardiac surgery first in a hybrid operating room, with PCI standby available in case of an intraoperative acute coronary event. If such an event occurs, immediate PCI will be performed. Additional PCI will be performed postoperatively if clinically indicated.
• Процедура Preoperative PCI followed by delayed non-cardiac surgery ~3 months later
  Patients undergo PCI first. The planned non-cardiac surgery will then be performed approximately 3 months after PCI, in accordance with current guideline recommendations for the timing of non-cardiac surgery following PCI.

Первичные конечные точки

• Major Adverse Cardiovascular Events (MACE) [Срок оценки: 180 days after the first invasive procedure (non-cardiac surgery or PCI)]

Вторичные конечные точки (12)

• Major Bleeding [Срок оценки: 180 days after the first invasive procedure (non-cardiac surgery or PCI)]
• All-Cause Mortality [Срок оценки: 180 days after the first invasive procedure (non-cardiac surgery or PCI)]
• Myocardial Infarction [Срок оценки: 180 days after the first invasive procedure (non-cardiac surgery or PCI)]
• Repeat Coronary Revascularization [Срок оценки: 180 days after the first invasive procedure (non-cardiac surgery or PCI)]
• Stroke or Transient Ischemic Attack (TIA) [Срок оценки: 180 days after the first invasive procedure (non-cardiac surgery or PCI)]
• New-Onset Acute Heart Failure [Срок оценки: 180 days after the first invasive procedure (non-cardiac surgery or PCI)]
• Myocardial Injury After Non-Cardiac Surgery (MINS) [Срок оценки: 72 hours after non-cardiac surgery]
• Length of Hospital Stay [Срок оценки: 180 days after the first invasive procedure (non-cardiac surgery or PCI)]
• Duke Activity Status Index (DASI) [Срок оценки: Baseline and 180±30 days after the first invasive procedure]
• Fried Frailty Index [Срок оценки: Baseline and 180±30 days after the first invasive procedure]
• New York Heart Association (NYHA) classification [Срок оценки: Baseline and 180±30 days after the first invasive procedure]
• Patient Health Questionnaire-9 (PHQ-9) depression score. [Срок оценки: Baseline and 180±30 days after the first invasive procedure]

Критерии участия

Критерии включения

• Age ≥18 years
• Diagnosis of coronary heart disease with non-emergent indication for PCI confirmed by coronary angiography：

• Non-ST-elevation acute coronary syndrome (NSTE-ACS) at low or intermediate ischemic risk
• Chronic coronary syndrome (CCS) with one of the following anatomical characteristics (see Appendix 1 for definition):

• Moderate or severe stenosis of the left main coronary artery
• Multivessel disease involving the ostium of the left anterior descending artery
• Three-vessel disease with ≥70% stenosis in each major epicardial vessel
• Indication for time-sensitive non-cardiac surgery
• Planned non-cardiac surgery under general anesthesia in the following surgical departments: thoracic surgery, gastrointestinal surgery, colorectal surgery, hepatobiliary and pancreatic surgery, or gynecology
• For patients with malignant tumors requiring time-sensitive surgery: written informed consent confirming understanding and acceptance that, if randomized to the "PCI-first" group, their tumor surgery will be delayed until 90±14 days after PCI, with acknowledgement of potential risks (e.g., tumor progression, change in resectability)
• Ability to understand the study requirements and sign written informed consent in the language provided by the research team

Критерии исключения

• Age >80 years
• Severe thrombocytopenia (platelet count <50×10⁹/L)
• Cardiogenic shock, severe heart failure (NYHA class IV, Killip class IV, or LVEF ≤35%), malignant arrhythmias (including cardiac arrest, asystole, ventricular fibrillation, or sustained ventricular tachycardia), or other life-threatening conditions requiring resuscitation
• Moderate-to-severe valvular heart disease, high-grade atrioventricular block, or other severe cardiac/pulmonary dysfunction incompatible with the planned surgery
• Planned surgery with extremely high bleeding risk (e.g., intracranial surgery, spinal surgery, retinal surgery)
• Patients with malignant tumors undergoing non-palliative surgery who are in poor general condition, defined as meeting any of the following:

• Karnofsky performance score <60
• Eastern Cooperative Oncology Group (ECOG) performance status >2
• Disease stage beyond surgical indications or estimated life expectancy <1 year
• Patients requiring emergency or urgent surgery due to critical illness
• Severe renal dysfunction: serum creatinine >442 μmol/L, GFR ≤30 mL/min/1.73 m², or currently on renal replacement therapy
• Severe hepatic dysfunction: Child-Pugh class C or higher
• Severe uncontrolled systemic infection
• Advanced dementia with significant decline in quality of life requiring full-time care and support
• Systemic thromboembolic disease (e.g., pulmonary embolism) making surgery unsuitable
• Women who are pregnant, breastfeeding, or planning pregnancy during the study period
• Severe, uncontrolled comorbid conditions continuously impairing physiological or psychological function
• Participation in another clinical study within 3 months prior to enrollment
• Any condition judged by the investigator to interfere with participation or study conduct

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

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• the First Affiliated Hospitalof Wenzhou Medical University — Wenzhou

Идентификаторы

NCT: NCT07175870 · KY2025-304

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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