Author + information
- Yanping Cheng1,
- Qing Wang2,
- Laura Perkins3,
- Richard Rapoza3,
- Jenn McGregor1,
- Gerard Conditt1,
- Greg Kaluza1 and
- Juan Granada1
The bioresorption process of the Absorb bioresorbable vascular scaffold (BVS) has been characterized in healthy swine model and clinical studies. This study aimed to evaluate the integration process of BVS in the familial hypercholesterolemic swine (FHS) model of spontaneous untreated atherosclerosis up to 4 years.
Twenty weeks following initial balloon injury, BVS were implanted in 26 coronary segments of 13 FHS. OCT was performed at 1 year (n=26), 2 (n=8), 3 (n=8) and 4 years (n=5) to assess the total cross sectional area of struts and integration by changes in light reflectivity as previously defined, every 1 mm of the scaffold.
At 1 year, the total strut area per BVS was 10.31±2.18mm2 and 95% of struts showed sharply defined, bright reflection borders, previously described as “preserved box”. At 2 years, the strut area was 10.77±2.23mm2 with 17% of struts preserved box appearance. At 3 years, recognizable strut area decreased to 5.81±2.26mm2 with 7% preserved box, 33% dissolved black box and 14% dissolved bright box appearance (Figure). At 4 years, the struts were not discernible in any implanted segments.
In the FHS model of spontaneous untreated atherosclerosis, fewer and fewer BVS struts are still discernible by OCT at 2 and 3 years after implantation, but none are visible at 4 years. This appears to confirm that the scaffold bioresorption/integration timeline defined in normal animals is not significantly altered by atherosclerotic disease and supports the predictive value of the FHS model for evaluation of BVS.
CORONARY: Bioresorbable Vascular Scaffolds