A Study Evaluating the Vascular Healing and Neointimal Transformation at 1 Month After Implantation of BioFreedom™ Drug-coated Stents and the Xience Drug-eluting Stent System in Patients With Acute Coronary Syndrome and High Bleeding Risk Using Optical Coherence Tomography

Prior treatment

• Participation in other drug/medical device trials prior to enrollment without reaching primary endpoint timelines

Other illness

• Known allergies to: Aspirin / clopidogrel / ticagrelor / heparin, Contrast agents/drugs used in drug-eluting stents or contraindications to aspirin/ clopidogrel / ticagrelor
• History of substance abuse (alcohol/cocaine/heroin, etc.)
• Severe arrhythmias (e.g., high-risk ventricular premature contractions/ ventricular tachycardia)
• Other medical conditions deemed unsuitable by investigators
  • Angiographic Exclusion Criteria:
• Left main coronary artery disease

Lab values

• Presence of ≥1 evidence of heart failure including:
  • NYHA Class III or higher, or
  • Killip classification ≥ Grade 2, or
  • Left ventricular ejection fraction (LVEF) ≤30% within 30 days pre-procedure (by echocardiography or intraoperative ventriculography)

Other

• General Exclusion Criteria:
• Cardiogenic shock patients
• Life expectancy \<12 months or factors potentially compromising clinical follow-up
• Bypass graft lesions
• Evidence of extensive thrombus in target vessel

• Age ≥18 years
• Male or non-pregnant female
• Acute coronary syndrome (ACS) patients requiring percutaneous coronary intervention (PCI)
• No contraindications for coronary artery bypass grafting (CABG)
• High bleeding risk (HBR) patients per ARC-HBR definition (meeting ≥1 major or 2 minor criteria):
  • Major Criteria:
  • Expected long-term oral anticoagulation
  • Severe/end-stage chronic kidney disease (eGFR \<30 mL/min)
  • Moderate/severe anemia (Hb \<110 g/L)
  • Spontaneous bleeding requiring hospitalization/transfusion within 6 months (or recurrent)
  • Chronic bleeding diathesis
  • Moderate/severe thrombocytopenia pre-PCI (platelet count \<100×10⁹/L)
  • Liver cirrhosis with portal hypertension
  • Active malignancy in past 12 months (excluding non-melanoma skin cancer; defined as diagnosis/treatment within 12 months)
  • History of spontaneous intracranial hemorrhage
  • Traumatic intracranial hemorrhage within 12 months
  • Known cerebral arteriovenous malformation
  • Moderate/severe ischemic stroke within 6 months
  • Major surgery/severe trauma within 30 days pre-PCI
  • Planned non-deferrable major surgery during dual antiplatelet therapy
  • Minor Criteria:
  • Age ≥75 years
  • Moderate chronic kidney disease (eGFR:30\~59 ml/min)
  • Mild anemia (male: Hb=110\~129 g/L; female: Hb=110\~119 g/L)
  • Spontaneous bleeding requiring hospitalization/transfusion within 6-12 months pre-PCI
  • Chronic NSAID/steroid use post-PCI
  • Ischemic stroke \>6 months pre-PCI
• Capable of understanding trial objectives and providing informed consent
  • Angiographic Inclusion Criteria:
• Target lesion must be primary native coronary artery lesion
• Target lesion with ≥70% diameter stenosis (visual estimate), or 50-70% diameter stenosis (visual estimate) with ischemic evidence
• ≥1 non-target lesion requiring intervention
• Non-target lesions eligible for elective treatment within 1 month