First Affiliated Hospital of Wenzhou Medical University
Phase
Not applicable
Started
2025-10
Last updated
2025-09-16
Condition(s) studied
Coronary Artery DiseaseNoncardiac Surgery
Investigational drug(s) / intervention(s)
Non-cardiac surgery followed by postoperative PCIPreoperative PCI followed by delayed non-cardiac surgery ~3 months later
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.
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.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Major Adverse Cardiovascular Events (MACE) — 180 days after the first invasive procedure (non-cardiac surgery or PCI) Composite of all-cause death, myocardial infarction, or repeat revascularization
Trial sites (1)
Facility
City
Region
Status
the First Affiliated Hospitalof Wenzhou Medical University
Wenzhou
Zhejiang
More First Affiliated Hospital of Wenzhou Medical University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.