Abstract 10891: Optical Coherence Tomography Assessment of Novel Fully Bioabsorbable Salicylate-Based Sirolimus-Eluting Stent 540 Days after implantation in Pig Coronary Artery
Background: Fully biodegradable stent is an attractive alternative strategy for current permanent metallic stents. The BTI stent is synthesized entirely from salicylic acid bioabsorbable polymer derivates coated with a bioabsorbable salicylate-based polymer. We evaluated a novel, fully bioabsorbable sirolimus-eluting stent (8.3μg sirolimus/mm stent) with optical coherence tomography (OCT) 540 days after inplantation in pig coronary models.
Methods: Bioabsorbable balloon-expandable stents (n=93) were implanted in pig coronaries using QCA to optimize stent apposition. Animals underwent restudy at 1 month (1M), 3 month (3M), 6 month (6M), 9 month (9M), 12 month (12M), 15 month (15M) and 18 month (18M). Stent area, lumen area, struts thickness and strut area were measured by OCT.
Results: Though stent strut area could not be measured due to nearly disappearance of stent struts after 12M, stent struts maintained sufficient area up to 12M (1M: 6.50 mm2 vs 3M: 6.40 mm2, P=0.76, 3M vs 6M: 6.55mm2, P=0.62, 6M vs 9M: 6.76mm2, P=0.52, 9M vs 12M: 5.96mm2, P=0.05). In contrast lumen area was significantly increased from 3M to 6M (3M: 2.58mm2 vs 6M: 3.29mm2 P<0.05) and then maintaind sufficient area over time (6M vs 9M: 3.74mm2, P=0.13, 9M vs 12M: 3.39mm2, P=0.30, 12M vs 15M: 3.97mm2, P=0.08, 15M vs 18M: 4.25mm2, P=0.44). Average strut thickness and area measured by OCT at 1M was similar to post implantation (implant: 0.25mm, 0.14mm2, 1M: 0.26mm, 0.121mm2), then gradually decreased over time (3M: 0.23mm and 0.093mm2; 6M: 0.19mm and 0.070mm2, 9M: 0.18mm and 0.066mm2, 12M: 0.16mm and 0.055mm2, 15M: 0.15mm and 0.053mm2, 18M: 0.13mm and 0.021mm2, respectively, P<0.05)
Conclusions: A novel fully bioabsorbable salicylate-based stent maintain the lumen area and didn't show acute and chronic recoils during follow up terms. Furthermore, OCT demonstrated the degradation of BTI stent which was remarkably decreased from 1M to 18M.
- © 2010 by American Heart Association, Inc.