An interventional study of Non-cardiac surgery followed by postoperative PCI and Preoperative PCI followed by delayed non-cardiac surgery ~3 months later in Coronary Artery Disease and Noncardiac Surgery, sponsored by First Affiliated Hospital of Wenzhou Medical University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-09-16.
Sponsored by First Affiliated Hospital of Wenzhou Medical University · Not applicable, Interventional, and Treatment
To compare the safety and efficacy of preoperative versus postoperative revascularization strategies in patients with coronary heart disease undergoing time-sensitive non-cardiac surgery.
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.
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.
Research materials and treatment strategies
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's planned enrollment of 140 is above the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →First Affiliated Hospital of Wenzhou Medical University is the lead sponsor of 82 studies on the registry; 56 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Diagnosis of coronary heart disease with non-emergent indication for PCI confirmed by coronary angiography：
Chronic coronary syndrome (CCS) with one of the following anatomical characteristics (see Appendix 1 for definition):
Exclusion Criteria:
Patients with malignant tumors undergoing non-palliative surgery who are in poor general condition, defined as meeting any of the following:
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.
Procedure: Preoperative PCI followed by delayed non-cardiac surgery ~3 months later
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.
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.
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.
Major Adverse Cardiovascular Events (MACE)
Composite of all-cause death, myocardial infarction, or repeat revascularization
Time frame: 180 days after the first invasive procedure (non-cardiac surgery or PCI)
Major Bleeding
Major bleeding defined as Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding.
Time frame: 180 days after the first invasive procedure (non-cardiac surgery or PCI)
All-Cause Mortality
Death from any cause within 180 days after the first invasive procedure (non-cardiac surgery or PCI)
Time frame: 180 days after the first invasive procedure (non-cardiac surgery or PCI)
Myocardial Infarction
Incidence of myocardial infarction defined according to the Fourth Universal Definition
Time frame: 180 days after the first invasive procedure (non-cardiac surgery or PCI)
Repeat Coronary Revascularization
Need for repeat PCI of target or non-target coronary arteries
Time frame: 180 days after the first invasive procedure (non-cardiac surgery or PCI)
Stroke or Transient Ischemic Attack (TIA)
Incidence of ischemic stroke or TIA confirmed by imaging and neurological evaluation.
Time frame: 180 days after the first invasive procedure (non-cardiac surgery or PCI)
New-Onset Acute Heart Failure
Acute onset of heart failure symptoms (e.g., dyspnea, edema, fatigue, palpitations) with clinical signs (including but not limited to displaced apical impulse, cardiac murmur, pulmonary rales, peripheral edema, hepatomegaly) and progressive elevation of BNP or NT-proBNP. Patients must require urgent treatment with intravenous diuretics and/or inotropes.
Time frame: 180 days after the first invasive procedure (non-cardiac surgery or PCI)
Myocardial Injury After Non-Cardiac Surgery (MINS)
For patients with normal preoperative cTnT: elevation of cTnT within 72 hours after surgery, with at least one value above the 99th percentile URL of the assay, showing a rise/fall pattern suggestive of acute injury; For patients with elevated preoperative cTnT: postoperative increase ≥20% or absolute increase ≥14 ng/L above baseline, or ≥5 ng/L increase above previous concentration, with a peak value \>20 ng/L, consistent with acute myocardial injury.
Time frame: 72 hours after non-cardiac surgery
Length of Hospital Stay
Total hospital stay during the study period, including intensive care unit stay, calculated from admission to discharge for the index hospitalization and any subsequent readmissions.
Time frame: 180 days after the first invasive procedure (non-cardiac surgery or PCI)
Duke Activity Status Index (DASI)
Comparison of DASI scores at baseline and at 6 months. The score ranges from 0 to 58.2, with higher scores indicating better functional status.
Time frame: Baseline and 180±30 days after the first invasive procedure
Fried Frailty Index
Comparison of Fried scores at baseline and at 6 months. Scoring criteria: 1 point is assigned for each criterion met; a total score ≥3 indicates frailty; 1-2 points indicate a pre-frail state; and 0 points indicate a robust (non-frail) health status.
Time frame: Baseline and 180±30 days after the first invasive procedure
New York Heart Association (NYHA) classification
The New York Heart Association (NYHA) classification is a widely used system for grading the severity of heart failure symptoms, ranging from Class I (no limitation of physical activity) to Class IV (symptoms present even at rest, with severe limitations). In this study, we compared the distribution of NYHA classes at baseline and at the 6-month follow-up to evaluate changes in patients' functional status over time.
Time frame: Baseline and 180±30 days after the first invasive procedure
Patient Health Questionnaire-9 (PHQ-9) depression score.
The total score of the PHQ-9 can be used to assess the severity of depressive symptoms: 0-4 indicates no depression, 5-9 mild, 10-14 moderate, and ≥15 severe. Comparison of PHQ-9 scores at baseline and at 6 months reflects either the progression or improvement of depressive symptoms in patients.
Time frame: Baseline and 180±30 days after the first invasive procedure
Plan to share: Undecided
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First Affiliated Hospital of Wenzhou Medical University