BioFreedom™ is the world's first polymer-free drug-coated stent (DCS), utilizing a proprietary microstructured surface technology. Its abluminal microporous surface directly carries BA9™ (a sirolimus derivative) with high lipophilicity. This design mitigates inflammatory responses while promoting early vascular healing and reducing thrombotic risk. Extensive clinical evidence has validated BioFreedom™'s superior performance in high-bleeding-risk (HBR) populations. However, comprehensive assessments of neointimal coverage and quantitative neointimal transformation post-implantation remain insufficient. With advancements in ultra-high-resolution optical coherence tomography (OCT), detailed evaluation of coronary stent healing has become feasible. This study will employ OCT to comparatively assess vascular healing patterns-including neointimal transformation and strut coverage-in ACS patients with HBR receiving either the commercially available BioFreedom™ DCS or Xience drug-eluting stent system. The findings will provide multidimensional insights into the devices' post-implantation efficacy and safety profiles.
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)
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)
Cardiogenic shock patients
Parallel
BioFreedom™
DeviceBioFreedom™ Drug-Coated Coronary Stent Intervention
Xience
DeviceXience Drug-Eluting Coronary Stent System Intervention
OCT-Detected Neointimal Strut Coverage at 1-Month Post-Procedure
Neointimal strut coverage was defined as: Covered strut proportion =Number of struts covered by neointima / Total number of analyzable struts A strut is considered covered when both its luminal surface and lateral sides demonstrate continuous neointimal tissue encapsulation.
Neointimal thickness at 1-month post-procedure
Strut neointimal thickness (NIT) will be analysed every 1 mm at 1-month post-procedure OCT follow-up
Neointimal area at 1-month post-procedure
Lumen area and stent area will be analysed every 1 mm at 1-month post-procedure OCT follow-up, neointimal area (NIA) will be calculated as stent minus lumen area.
Neointimal volume at 1-month post-procedure
Neointimal volume (NIV) and stent volume will be calculated using Simpson's rule and reported as total NIV, mean NIV (total NIV divided by length), and percent NIV (NIV divided by stent volume)
Incidence of Major Adverse Cardiac Events (MACE) within 12 Months Post-Procedure
MACE is defined as a composite of cardiac death, myocardial infarction, and target vessel revascularization (TVR).
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