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KMID : 1011220140010020059
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Clinical & Experimental Thrombosis and Hemostasis
2014 Volume.1 No. 2 p.59 ~ p.65
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Biodegradable Polymer-Based Sirolimus Coating Stent in a Porcine Coronary Restenosis Model
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Lim Kyung-Seob
Park Jun-Kyu
Jeong Myung-Ho
Bae In-Ho
Nah Jae-Woon
Park Dae-Sung
Kim Jong-Min
Kim Jung-Ha
Lee So-Yeon
Jang Eun-Jae
Kim Nan-Yeol
Sim Doo-Sun
Park Keun-Ho
Hong Young-Joon
Ahn Young-Keun
Kang Jung-Chaee
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Abstract
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Purpose: Biolimus A9 is a highly lipophilic derivative of sirolimus. The aim of this study was to compare a sirolimus- and a biolimus A9-eluting stent using the same biodegradable polymer (PLA, poly-L-lactic acid) in a porcine coronary overstretch restenosis model.
Methods: Pigs were randomized into three groups in which the coronary arteries (15 pigs, 10 coronaries in each group) had either sirolimus-eluting stents with PLA (SEP, n = 10), biolimus A9-eluting stents with PLA (BEP, n = 10), or PLA-coated stents (PCS, n = 10). Histopathologic analysis was performed at 28 days after stenting.
Results: In the release profiles, approximately 40% of the sirolimus and 50% of the biolimus A9 were released from the stent for 32 days. There were no significant differences in the injury score and the internal elastic lamina. Among the three groups, there were significant differences in the lumen area (3.2±0.91 mm2 in SEP vs. 3.1±1.10 mm2 in BEP vs. 0.5±0.56 mm2 in PCS, P<0.0001), in the neointimal area (1.7±0.56 mm2 in SEP vs. 1.9±0.95 mm2 in BEP vs. 4.3±0.63 mm2 in PCS, P<0.0001), in the percent area of stenosis (35.2±13.77% in SEP vs. 39.0±20.00% in BEP vs. 89.4±10.92% in PCS, P<0.0001), in the fibrin score [2.0 (range 1.0 to 3.0) in SEP vs. 2.0 (range 2.0 to 3.0) in BEP vs. 1.0 (range 1.0 to 2.0) in PCS, P<0.0001], and in the inflammation score [1.0 (range 1.0 to 2.0) in SEP vs. 1.0 (range 1.0 to 3.0) in BEP vs. 3.0 (range 2.0 to 3.0) in PCS, P<0.0001]. The percent area of stenosis using micro-computed tomography demonstrated similar restenosis rates with histopathological stenosis between SEP and BEP (36.7±13.77% in SEP vs. 41.2±20.00% in BEP vs. 86.5±10.92% in PCS).
Conclusion: SEP and BEP showed a superior neointima suppressive effect compared to PCS at one month after stenting in a porcine coronary restenosis model. Therefore, sirolimus with biodegradable polymers can be a useful and selective drug for coating the coronary stent to inhibit neointimal hyperplasia.
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KEYWORD
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Stents, Percutaneous coronary intervention, Restenosis, Inflammation
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