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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.

Abstract
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 +/- 410.49% 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.
AuthorsZhiyuan Lan, Yongnan Lyu, Jianmin Xiao, Xiaoxin Zheng, Suyuan He, Gaoke Feng, Yipei Zhang, Shihang Wang, Edward Kislauskis, Jiuhao Chen, Stephen McCarthy, Roger Laham, Xuejun Jiang, Tim Wu
JournalJournal of biomedical nanotechnology (J Biomed Nanotechnol) Vol. 10 Issue 7 Pg. 1194-204 (Jul 2014) ISSN: 1550-7033 [Print] United States
PMID24804540 (Publication Type: Journal Article, Research Support, N.I.H., Extramural)
Chemical References
  • Biocompatible Materials
  • Calcium Phosphates
  • Polyesters
  • Polymers
  • amorphous calcium phosphate
  • Lactic Acid
  • poly(lactide)
  • Paclitaxel
Topics
  • Animals
  • Biocompatible Materials (chemistry)
  • Calcium Phosphates (chemistry)
  • Calorimetry, Differential Scanning
  • Coronary Artery Disease (diagnostic imaging, pathology, physiopathology, therapy)
  • Coronary Vessels (drug effects, pathology, physiopathology)
  • Drug-Eluting Stents
  • Female
  • Lactic Acid (chemistry)
  • Male
  • Materials Testing
  • Nanoparticles (chemistry, ultrastructure)
  • Paclitaxel (pharmacology)
  • Polyesters
  • Polymers (chemistry)
  • Radiography
  • Swine
  • Swine, Miniature

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