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

Wenzhou Medical University

Status: Not yet enrolling

Conditions: Coronary Artery Disease; Noncardiac Surgery

Treatments: Procedure: Non-cardiac surgery followed by postoperative PCI; Procedure: Preoperative PCI followed by delayed non-cardiac surgery ~3 months later

Study type: Interventional

Funder types: Other

Identifiers

NCT07175870

KY2025-304

Details and patient eligibility

About

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

Full description

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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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):

    1. Moderate or severe stenosis of the left main coronary artery
    2. Multivessel disease involving the ostium of the left anterior descending artery
    3. 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

Exclusion criteria

• 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:

  1. Karnofsky performance score <60
  2. 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

Surgery-First Strategy (Postoperative Revascularization)

Experimental group

Description:

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.

Treatment:

Procedure: Preoperative PCI followed by delayed non-cardiac surgery ~3 months later

PCI-First Strategy (Preoperative PCI with Delayed Surgery)

Active Comparator group

Description:

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.

Treatment:

Procedure: Non-cardiac surgery followed by postoperative PCI