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