6-Month Follow-Up of a Novel Biodegradable Drug-Eluting Stent Composed of Poly-L-Lactic Acid and Amorphous Calcium Phosphate Nanoparticles in Porcine Coronary Artery.
BACKGROUND
We reported previously, in porcine coronary arteries, that the novel biodegradable PowerStent Absorb paclitaxel-eluting stent had improved and sustained structural strength and functional performance at one month post-implantation.


OBJECTIVE
To report the stent performance at 6-month follow-up.


RESULTS
Six PowerStent Absorb and six TAXUS stents were randomly implanted in the left anterior descending and right coronary arteries of six Tibet miniature pigs. Quantitative coronary angiography (QCA) and intravascular ultrasound (IVUS) images were obtained at the time of implantation (T0) and at 6 months (T6). Two animals were sacrificed at T6 for histopathological evaluation. At T6, QCA showed that the mean luminal vascular diameter (mLD) between the PowerStent and the TAXUS stents were similar (2.36 ± 0.38 vs. 2.61 ± 0.31, respectively). Based on the IVUS analysis, the mLD and the mean lumen cross-sectional area (mCSA) in the PowerStent-treated arteries were similar between T0 and T6 (mLD: 2.74 ± 0.13 vs. 2.70 ± 0.20 and mCSA: 6.81 ± 0.62 mm2 vs. 6.68 ± 0.94 mm2). Histopathology showed that the PowerStent stents were well apposed to the vessel wall with no recoil, strut fracture and thrombus formation. The stents were fully covered with a layer of endothelial cells.


CONCLUSIONS
At six-month post-implantation, the PowerStent Absorb stents maintained their structural strength and functional performance. The development of restenosis was controlled, no stent thrombosis was observed and the stents were fully re-endothelialized. These results suggest the PowerStent Absorb stent is safe and effective for up to 6 months when implanted in porcine coronary arteries.
Jianmin
J
Xiao
Gaoke
G
Feng
Guanyang
G
Kang
Zhiyuan
Z
Lan
Tianshi
T
Liao
Edward
E
Kislauskis
Jiuhao
J
Chen
Jinxi
J
Xia
Zhimin
Z
Wang
Zhicheng
Z
Huo
Qun
Q
Wang
Tingfei
T
Xi
Stephen
S
McCarthy
Xuejun
X
Jiang
Tim
T
Wu
Roger
R
Laham
D020341:Absorbable Implants; D000818:Animals; D002130:Calcium Phosphates / Q000737:chemistry*; D023903:Coronary Restenosis / Q000473:pathology / Q000517:prevention & control*; D003331:Coronary Vessels / Q000187:drug effects / Q000473:pathology; D004343:Drug Implants / Q000008:administration & dosage / Q000737:chemistry; D054855:Drug-Eluting Stents; D005500:Follow-Up Studies; D019344:Lactic Acid / Q000737:chemistry*; D008137:Longitudinal Studies; D008422:Materials Testing; D053769:Nanocapsules / Q000008:administration & dosage* / Q000737:chemistry; D017239:Paclitaxel / Q000008:administration & dosage* / Q000737:chemistry; D011091:Polyesters; D011108:Polymers / Q000737:chemistry*; D013552:Swine
D002130:Calcium Phosphates; D004343:Drug Implants; D053769:Nanocapsules; D011091:Polyesters; D011108:Polymers; C519480:amorphous calcium phosphate; D019344:Lactic Acid; C033616:poly(lactide); D017239:Paclitaxel