Efficacy and safety of a novel nano-porous polymer-free sirolimus-eluting stent in pigs / 中华医学杂志(英文版)
Chinese Medical Journal
;
(24): 4731-4735, 2013.
Article
in English
| WPRIM
| ID: wpr-341749
ABSTRACT
<p><b>BACKGROUND</b>Drug-eluting stents represent a major advance in interventional cardiology. However, the current drug-eluting stents have significant limitations. One of the major problems is very late stent thrombosis, which is likely caused by inflammation and a hypersensitivity reaction related to a polymer on the stent. A polymer-free sirolimus-eluting stent with a unique nano-porous surface has been developed. This study aimed to evaluate this novel polymer-free sirolimus-eluting stent for its efficacy and safety in a pig model.</p><p><b>METHODS</b>Stents were directly coated with sirolimus (a drug concentration of 2.2 µg/mm(2) on the stent surface). The polymer-free sirolimus-eluting stents (PFSES) were compared to standard polymer-coated sirolimus-eluting stents (PCSES) and bare-metal stents (BMS) in 18 pigs.</p><p><b>RESULTS</b>At one month the degree of neointimal hyperplasia was similar between the two sirolimus-eluting stent groups and was significantly less compared to BMS ((1.93 ± 0.51) mm(2), (1.57 ± 0.69) mm(2) vs. (4.45 ± 1.05) mm(2), P < 0.05) At three months, PFSES maintained the low level of neointima ((2.41 ± 0.99) mm(2) vs. (4.32 ± 1.16) mm(2), P < 0.05), whereas PCSES had developed significant neointimal proliferation similar to BMS. The inflammation level was significantly higher in PCSES when compared with BMS three months post-implantation (2.50 ± 0.55 vs. 0.83 ± 0.75, P < 0.05) whereas PFSES showed a low level of inflammation comparable to PCSES (1.33 ± 0.52 vs. 2.50 ± 0.55, P < 0.05).</p><p><b>CONCLUSION</b>The PFSES is effective and safe, and appears to be superior to standard PCSEs.</p>
Full text:
Available
Index:
WPRIM (Western Pacific)
Main subject:
Polymers
/
Swine
/
Chemistry
/
Sirolimus
/
Therapeutic Uses
/
Drug-Eluting Stents
/
Neointima
Limits:
Animals
Language:
English
Journal:
Chinese Medical Journal
Year:
2013
Type:
Article
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