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)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Major Adverse Cardiovascular Events (MACE)
研究概览
简要总结
To compare the safety and efficacy of preoperative versus postoperative revascularization strategies in patients with coronary heart disease undergoing time-sensitive non-cardiac surgery.
详细描述
- 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.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Surgery-First Strategy (Postoperative Revascularization)
Patients with coronary heart disease scheduled for time-sensitive non-cardiac surgery. The surgery will be performed in a hybrid operating room. If an acute coronary event occurs intraoperatively, standby PCI will be performed immediately. Elective PCI may also be performed postoperatively if clinically indicated.
干预措施: Preoperative PCI followed by delayed non-cardiac surgery ~3 months later (Procedure)
PCI-First Strategy (Preoperative PCI with Delayed Surgery)
Patients with coronary heart disease scheduled for time-sensitive non-cardiac surgery. Participants will undergo PCI first, followed by non-cardiac surgery approximately 3 months later, according to current guideline recommendations for elective surgery after PCI.
干预措施: Non-cardiac surgery followed by postoperative PCI (Procedure)
结局指标
主要结局
Major Adverse Cardiovascular Events (MACE)
时间窗: 180 days after the first invasive procedure (non-cardiac surgery or PCI)
Composite of all-cause death, myocardial infarction, or repeat revascularization
次要结局
- All-Cause Mortality(180 days after the first invasive procedure (non-cardiac surgery or PCI))
- Myocardial Infarction(180 days after the first invasive procedure (non-cardiac surgery or PCI))
- Major Bleeding(180 days after the first invasive procedure (non-cardiac surgery or PCI))
- Repeat Coronary Revascularization(180 days after the first invasive procedure (non-cardiac surgery or PCI))
- Stroke or Transient Ischemic Attack (TIA)(180 days after the first invasive procedure (non-cardiac surgery or PCI))
- New-Onset Acute Heart Failure(180 days after the first invasive procedure (non-cardiac surgery or PCI))
- Myocardial Injury After Non-Cardiac Surgery (MINS)(72 hours after non-cardiac surgery)
- Length of Hospital Stay(180 days after the first invasive procedure (non-cardiac surgery or PCI))
- Duke Activity Status Index (DASI)(Baseline and 180±30 days after the first invasive procedure)
- Fried Frailty Index(Baseline and 180±30 days after the first invasive procedure)
- New York Heart Association (NYHA) classification(Baseline and 180±30 days after the first invasive procedure)
- Patient Health Questionnaire-9 (PHQ-9) depression score.(Baseline and 180±30 days after the first invasive procedure)