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

Korábbi kezelés

• Participation in another clinical study within 3 months prior to enrollment

Más betegség

• 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:
  • Karnofsky performance score <60
  • 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 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
• Severe, uncontrolled comorbid conditions continuously impairing physiological or psychological function
• Any condition judged by the investigator to interfere with participation or study conduct

Laborértékek

• 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
• Severe renal dysfunction: serum creatinine >442 μmol/L, GFR ≤30 mL/min/1.73 m², or currently on renal replacement therapy

Életkor

• Age >80 years

Egyéb

• Severe hepatic dysfunction: Child-Pugh class C or higher
• Women who are pregnant, breastfeeding, or planning pregnancy during the study period

• 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):
  • Moderate or severe stenosis of the left main coronary artery
  • Multivessel disease involving the ostium of the left anterior descending artery
  • 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