화학공학소재연구정보센터
홈 로그인 로그아웃 연락처 사이트맵
Macromolecular Research, Vol.25, No.7, 730-738, July, 2017
DOI10.1007/s13233-017-5067-z  Export Citation
Long-Term Preclinical Evaluation of Bioabsorbable Polymer-Coated Drug-Eluting Stent in a Porcine Model
Kyung Seob Lim1, 2, Jun-Kyu Park3, Myung Ho Jeong1, 2, †, Jae-Woon Nah4, In Ho Bae1, 2, Dae Sung Park2, 5, Jae Won Shim2, 5, Jung Ha Kim2, 5, Hyun Kuk Kim2, 5, Sung Soo Kim2, 5, Doo Sun Sim2, 5, Young Joon Hong2, 5, Ju Han Kim2, 5, and Youngkeun Ahn2, 5
  • 1Korea Cardiovascular Stent Institute, Jangsung, Jeonnam 57248, Korea
  • 2Cardiovascular Convergence Research Center, Nominated by the Korea Ministry of Health and Welfare, Gwangju 61469, Korea
  • 3CGBio. Co. Ltd, Jangseong-gun, Jeonnam 57248, Korea
  • 4Department of Polymer Science and Engineering, Sunchon National University, Sunchon, Jeonnam 57940, Korea
  • 5Cardiovascular Research Center, Chonnam National University Hospital, Gwangju 61469, Korea
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Bioabsorbable polymer-based drug-eluting stents have been shown to be effective and safe in the actual practice. The objective of the present study was to evaluate a biodegradable poly-L-lactic acid (PLLA)-based sirolimus-coated stent in comparison with a commercial everolimus-eluting stent with a permanent polymer in a porcine coronary restenosis model on a short-, mid-, and long-term basis. Pigs were randomized into eight groups in which the coronary arteries (36 pigs with 72 coronary arteries) had either a sirolimus-eluting stent with PLLA (SES, n=24, follow-up after 4, 12, and 24 weeks), bare metal stent (BMS, n=12, follow-up after 4 weeks), PLLA-coated stent without a drug (PCS, n=12, follow-up after 4 weeks), or commercial everolimus-eluting stent with a permanent polymer (EES, Promus PREMIER®, n=24, follow-up after 4, 12, and 24 weeks). Histopathological analysis was performed at 4, 12, or 24 weeks after stenting. The surface morphology of the SES, visualized using an optical microscope and a scanning electron microscope, was smooth and uniform with virtually no defects. Sirolimus was released slowly over 60 days. There was no significant difference in the percent area stenosis between the SES and EES at any of the follow- up time points (13.0±8.10% in SES vs. 14.1±9.12% in EES at 4 weeks, 23.1±8.63% in SES vs. 21. ±7.92% in EES at 12 weeks, 28.2±8.20% in SES vs. 25.1±8.51% in EES at 24 weeks, each p=NS). The percent area stenosis using micro-computed tomography and intravenous ultrasound demonstrated similar restenosis rates with histopathological stenosis between the SES and EES. The SES with a biodegradable polymer was as effective as the commercial EES with a permanent polymer in inhibiting neointima proliferation at 4, 12, and 24 weeks in a porcine coronary restenosis model.
Keywords:stents;percutaneous coronary intervention;restenosis;inflammation
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