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

NCT ID: NCT07175870

Last Updated: 2025-09-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-31
• Study Completion Date: 2029-08-31

Brief Summary

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

Detailed 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.

Conditions

Coronary Artery Disease; Noncardiac Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

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

Intervention Type: PROCEDURE

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.

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.

Group Type: ACTIVE_COMPARATOR

Non-cardiac surgery followed by postoperative PCI

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital of Wenzhou Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

the First Affiliated Hospitalof Wenzhou Medical University

Wenzhou, Zhejiang, China

Countries

China

Central Contacts

Hao Zhou

Role: CONTACT

wyzh66@126.com

+86 13968801939

KEN LIN

Role: CONTACT

linken1999@126.com

+86 18967760021

Facility Contacts

Huiqing Xu

Role: primary

wyyyclinical@126.com

0577-55578055

Other Identifiers

KY2025-304

Identifier Type: -

Identifier Source: org_study_id