Journal of the Korean Society of Radiology (대한영상의학회지)

The Korean Society of Radiology (대한영상의학회)
권호 표지
DOI QR코드

DOI QR Code

Efficacy and Safety of a Newly Developed Self-Expanding Open-Cell Type Nitinol Stent for Peripheral Arteries: A Preclinical Study in Minipigs

새로 개발된 말초동맥용 자가팽창성 개방형 니티놀 스텐트의 유효성 및 안전성 평가: 미니피그 전임상실험

  • Min Uk Kim (Department of Radiology, Seoul Metropolitan Government-Seoul National University Boramae Medical Center) ;
  • Jae Hwan Lee (Department of Radiology, Seoul National University Bundang Hospital) ;
  • Chang Jin Yoon (Department of Radiology, Seoul National University Bundang Hospital) ;
  • Won Seok Choi (Department of Radiology, Seoul National University Bundang Hospital) ;
  • Saebeom Hur (Department of Radiology, Seoul National University Hospital, Seoul National University College of Medicine) ;
  • Jin Wook Chung (Department of Radiology, Seoul National University Hospital, Seoul National University College of Medicine)
  • 김민욱 (서울특별시립 보라매병원 영상의학과) ;
  • 이재환 (분당서울대학교병원 영상의학과) ;
  • 윤창진 (분당서울대학교병원 영상의학과) ;
  • 최원석 (분당서울대학교병원 영상의학과) ;
  • 허세범 (서울대학교 의과대학 서울대학교병원 영상의학과) ;
  • 정진욱 (서울대학교 의과대학 서울대학교병원 영상의학과)
  • Received : 2020.02.17
  • Accepted : 2020.03.31
  • Published : 2020.07.01
Download PDF
⟨ Previous Next ⟩

Abstract

Purpose To evaluate the safety and efficacy of the newly designed open-cell type self-expandable nitinol stent (NiTi-stent) for peripheral arteries. Materials and Methods Twenty-eight limbs of 14 minipigs were randomly assigned to the NiTistent group or conventional nitinol stent group. Stents were symmetrically implanted into the iliac arteries of each animal using carotid artery approach and were observed for 1 month (n = 5) and 6 months (n = 9). The angiographic lumen diameter (ALD), late lumen loss, angiographic stenosis, histomorphometric lumen area, neointimal area, and area stenosis were analyzed and compared between the groups. Results Stent migration, stent fracture, or thrombus formation were not observed in either group. At the 1-month follow-up, the neointimal area (p = 0.008) and area stenosis (p = 0.016) were significantly smaller in the NiTi-stent group than in the control group. At the 6-months followup, the NiTi-stent group showed significantly larger ALD (p = 0.014), less late lumen loss (p = 0.019), less angiographic stenosis (p = 0.014), larger lumen area (p = 0.040), and smaller neointimal area and area stenosis (p = 0.004 and p = 0.014, respectively) compared with the control group. Conclusion The NiTi-stent is as safe and effective as the conventional nitinol stent and induces less neointimal hyperplasia in a minipig iliac artery model.

목적 얇고 새로운 구조로 개발된 말초동맥용 자가팽창성 개방형 니티놀 스텐트의 유효성 및 안전성을 기존에 사용하는 스텐트와 비교 평가하였다. 대상과 방법 미니피그 14마리를 대상으로 실험군과 대조군 스텐트를 무작위배정 후 각 개체의 장골동맥에 대칭적으로 삽입하여 1개월(n = 5) 및 6개월(n = 9) 추적관찰하였다. 혈관조영술로 혈관 직경, 후기 내강 손실 및 협착 정도를 평가하고 조직계측학적으로 내탄력층 면적, 내강 면적, 신생 내막 면적 및 협착 정도를 분석하였다. 추적기간 중 모든 실험 개체에 대하여 매일 임상적 평가 및 식이 정도를 추적관찰하였다. 결과 모든 개체는 추적관찰 기간 중 생존하였으며 중대한 유해 반응을 보이지 않았다. 혈관조영술상 6개월 추적관찰군에서 실험군의 내강 직경이 유의하게 컸으며(p = 0.014), 후기 내강 손실이 적었고(p = 0.019), 협착 정도가 낮았다(p = 0.014). 조직학적으로 1개월 추적관찰군에서 실험군이 신생 내막 면적 및 면적 협착이 유의하게 낮았다(각, p = 0.008, p = 0.016). 6개월 추적관찰군에서는 실험군이 대조군에 비하여 내강 면적이 유의하게 넓었으며(p = 0.040), 내탄력층 면적, 신생 내막 면적 및 면적 협착이 통계적으로 유의하게 낮았다(각, p = 0.004, p = 0.008, p = 0.014). 결론 새로 개발된 말초혈관용 자가팽창성 개방형 니티놀 스텐트는 기존에 사용하는 스텐트와 비교하여 안전하며 신생 내막 증식의 정도가 적었다.

Keywords

Acknowledgement

This work was supported by Korea Health Technology R&D Project (HI18C0493) funded by the Ministry of Health & Welfare.

References

  1. Becker GJ, Katzen BT, Dake MD. Noncoronary angioplasty. Radiology 1989;170:921-940
  2. Rees CR, Palmaz JC, Garcia O, Roeren T, Richter GM, Gardiner G Jr, et al. Angioplasty and stenting of completely occluded iliac arteries. Radiology 1989;172:953-959
  3. Long AL, Page PE, Raynaud AC, Beyssen BM, Fiessinger JN, Ducimetiere P, et al. Percutaneous iliac artery stent: angiographic long-term follow-up. Radiology 1991;180:771-778
  4. Sabeti S, Schillinger M, Amighi J, Sherif C, Mlekusch W, Ahmadi R, et al. Primary patency of femoropopliteal arteries treated with nitinol versus stainless steel self-expanding stents: propensity score-adjusted analysis. Radiology 2004;232:516-521
  5. Krankenberg H, Zeller T, Ingwersen M, Schmalstieg J, Gissler HM, Nikol S, et al. Self-expanding versus balloon- expandable stents for iliac artery occlusive disease: the randomized ICE trial. JACC Cardiovasc Interv 2017;10:1694-1704
  6. Sidawy AN, Perler BA. Rutherford's vascular surgery and endovascular therapy (E-Book). 9th ed. Amsterdam: Elsevier 2019:767-768
  7. Zhao HQ, Nikanorov A, Virmani R, Jones R, Pacheco E, Schwartz LB. Late stent expansion and neointimal proliferation of oversized Nitinol stents in peripheral arteries. Cardiovasc Intervent Radiol 2009;32:720-726
  8. Saguner AM, Traupe T, Raber L, Hess N, Banz Y, Saguner AR, et al. Oversizing and restenosis with self-expanding stents in iliofemoral arteries. Cardiovasc Intervent Radiol 2012;35:906-913
  9. Schwartz RS, Huber KC, Murphy JG, Edwards WD, Camrud AR, Vlietstra RE, et al. Restenosis and the proportional neointimal response to coronary artery injury: results in a porcine model. J Am Coll Cardiol 1992;19:267-274
  10. Grenacher L, Rohde S, Ganger E, Deutsch J, Kauffmann GW, Richter GM. In vitro comparison of self-expanding versus balloon-expandable stents in a human ex vivo model. Cardiovasc Intervent Radiol 2006;29:249-254
  11. Serruys PW, Rutsch W, Heyndrickx GR, Danchin N, Mast EG, Wijns W, et al. Prevention of restenosis after percutaneous transluminal coronary angioplasty with thromboxane A2-receptor blockade. A randomized, double-blind, placebo-controlled trial. Coronary Artery Restenosis Prevention on Repeated Thromboxane- Antagonism Study (CARPORT). Circulation 1991;84:1568-1580
  12. Byrne RA, Iijima R, Mehilli J, Pinieck S, Bruskina O, Schomig A, et al. Durability of antirestenotic efficacy in drug-eluting stents with and without permanent polymer. JACC Cardiovasc Interv 2009;2:291-299
  13. Windecker S, Serruys PW, Wandel S, Buszman P, Trznadel S, Linke A, et al. Biolimus-eluting stent with biodegradable polymer versus sirolimus-eluting stent with durable polymer for coronary revascularisation (LEADERS): a randomised non-inferiority trial. Lancet 2008;372:1163-1173
  14. Gunther RW, Vorwerk D, Bohndorf K, Peters I, El-Din A, Messmer B. Iliac and femoral artery stenoses and occlusions: treatment with intravascular stents. Radiology 1989;172:725-730
  15. Kichikawa K, Uchida H, Yoshioka T, Maeda M, Nishimine K, Kubota Y, et al. Iliac artery stenosis and occlusion: preliminary results of treatment with Gianturco expandable metallic stents. Radiology 1990;177:799-802