One-month vessel healing after BioFreedom polymer-free drug-coated stent versus Xience drug-eluting stent in heart attack patients with high bleeding risk

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

We'll use very detailed optical imaging to see if the polymer-free BioFreedom stent leads to faster or better vessel healing than the Xience stent in people with a recent heart attack who are at high bleeding risk.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: China National Center for Cardiovascular Diseases (Government)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07230847 on ClinicalTrials.gov

What this trial studies

This interventional study enrolls acute coronary syndrome patients at high bleeding risk who receive either the BioFreedom polymer-free drug-coated stent or the Xience drug-eluting stent during PCI. Participants will undergo ultra-high-resolution optical coherence tomography (OCT) about one month after implantation to measure neointimal transformation, strut coverage, and other markers of vascular healing. The trial compares OCT-derived quantitative measures between the two stent types to characterize early healing patterns in this high-risk population. Results aim to inform stent selection and post-PCI antiplatelet strategies for patients with ACS and elevated bleeding risk.

Who should consider this trial

Good fit: Adults (≥18) with acute coronary syndrome undergoing PCI who meet ARC-HBR criteria for high bleeding risk and have no contraindication to coronary artery bypass grafting are ideal candidates.

Not a fit: People without ACS, those at low bleeding risk, or patients who cannot undergo OCT imaging or return for the one-month follow-up are unlikely to benefit from the study's results.

Why it matters

Potential benefit: If successful, this could identify a stent that promotes quicker vessel healing and help guide shorter or safer antiplatelet therapy for high-bleeding-risk heart attack patients.

How similar studies have performed: Prior clinical trials have shown favorable outcomes for the BioFreedom stent in high-bleeding-risk populations, but direct OCT comparisons of early neointimal coverage versus Xience at one month remain limited.

Eligibility criteria

Inclusion Criteria:

1. Age ≥18 years
2. Male or non-pregnant female
3. Acute coronary syndrome (ACS) patients requiring percutaneous coronary intervention (PCI)
4. No contraindications for coronary artery bypass grafting (CABG)
5. 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
6. Capable of understanding trial objectives and providing informed consent

Angiographic Inclusion Criteria:

1. Target lesion must be primary native coronary artery lesion
2. Target lesion with ≥70% diameter stenosis (visual estimate), or 50-70% diameter stenosis (visual estimate) with ischemic evidence
3. ≥1 non-target lesion requiring intervention
4. Non-target lesions eligible for elective treatment within 1 month

Exclusion Criteria:

General Exclusion Criteria:

1. 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)
2. Cardiogenic shock patients
3. Known allergies to: Aspirin / clopidogrel / ticagrelor / heparin, Contrast agents/drugs used in drug-eluting stents or contraindications to aspirin/ clopidogrel / ticagrelor
4. Life expectancy \<12 months or factors potentially compromising clinical follow-up
5. Participation in other drug/medical device trials prior to enrollment without reaching primary endpoint timelines
6. History of substance abuse (alcohol/cocaine/heroin, etc.)
7. Severe arrhythmias (e.g., high-risk ventricular premature contractions/ ventricular tachycardia)
8. Other medical conditions deemed unsuitable by investigators

Angiographic Exclusion Criteria:

1. Left main coronary artery disease
2. Bypass graft lesions
3. Evidence of extensive thrombus in target vessel

Where this trial is running

Beijing, Beijing Municipality

• Fuwai hospital, CAMS&PUMC — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Yongjian Wu

Conditions Coronary Heart Disease; Acute Coronary Syndrome