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Novel Biodegradable Drug-Eluting Stent Composed of Poly-L-Lactic Acid and Amorphous Calcium Phosphate Nanoparticles Demonstrates Improved Structural and Functional Performance for Coronary Artery Disease

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Bioabsorbable drug-eluting stents (BDES) offer multiple advantages over a permanent bare metal stent (BMS) for coronary artery disease (CAD). However, current BDES remains two major issues: inferior radial strength and biocompatibility. PowerStent® Absorb BDES, fabricated by co-formulating amorphous calcium phosphate (ACP) nanoparticles with poly-L-lactic acid (PLLA/ACP, 98/2, w/w) and 2% Paclitaxel (PAX, w/w) was designed to address these issues. Two cohorts of 6 miniature pigs were each implanted with PLLA/PAX (control, 2% PAX, w/w) or PowerStent® Absorb BDES. After 1 month in-vivo study, histological analyses showed significantly reduced restenosis in the PowerStent® Absorb BDES cohort relative to the control cohort (44.49 ± 10.49% vs. 64.47±16.2%, p < 0.05). Stent recoil (21.57 ± 5.36% vs. 33.81 ± 11.49, P < 0.05) and inflammation (3.01 ± 0.62 vs. 4.07 ± 0.86, P < 0.01) were also obviously decreased. From in-vitro studies, PLLA/ACP/PAX stent tube maintained significantly greater radial strength than control group during 6 months in-vitro degradation (PLLA/ACP/PAX vs. PLLA/PAX: before hydrolysis: 82.4 ± 1.9 N vs.74.8 ± 3.8 N; 6 weeks: 73.9 ± 1.8 N vs. 68.0 ± 5.3 N; 3 months: 73.5 ± 3.4 N vs.67.2 ± 3.8 N; 6 months: 56.3 ± 8.1 N vs. 57.5 ± 4.9 N). Moreover, ACP facilitated the hydrolytic degradation of PLLA compared with control one (62.6% vs. 49.8%), meanwhile, it also increased the crystallinity of PLLA (58.4% vs. 50.7%) at 6 months. From SEM observations, ACP created nanometer pores that enlarge gradually to a micrometer scale as degradation proceeds. The changes of the porosity may result in greatly promoting re-endothelialization.
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Keywords: AMORPHOUS CALCIUM PHOSPHATE (ACP) NANOPARTICLES; BIOCOMPATIBILITY; BIODEGRADABLE DRUG-ELUTING STENT (BDES); DEGRADATION; POLY-L-LACTIC ACID (PLLA); PORCINE CORONARY ARTERY IMPLANTATION; RADIAL STRENGTH

Document Type: Research Article

Publication date: July 1, 2014

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  • Journal of Biomedical Nanotechnology (JBN) is a peer-reviewed multidisciplinary journal providing broad coverage in all research areas focused on the applications of nanotechnology in medicine, drug delivery systems, infectious disease, biomedical sciences, biotechnology, and all other related fields of life sciences.
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