NCT07175870

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

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)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: First Affiliated Hospital of Wenzhou Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
PROCEDURE	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.
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.

Timeline

• Start date: 2025-10-01
• Primary completion: 2029-08-01
• Completion: 2029-08-01
• First posted: 2025-09-16
• Last updated: 2025-09-16

Locations

1 site across 1 country: China