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A head to head comparison of XINSORB bioresorbable sirolimus-eluting scaffold versus metallic sirolimus-eluting stent: 180 days follow-up in a porcine model

  • Li Shen
  • Yizhe Wu
  • Lei Ge
  • Yaojun Zhang
  • Qibing Wang
  • Juying Qian
  • Zhifen Qiu
  • Junbo Ge
Original Paper

Abstract

We aimed to investigate the safety and efficacy of XINSORB bioresorbable sirolimus-eluting scaffold in porcine model. XINSORB scaffolds and metallic Firebird2™ stents were randomly implanted into minipigs’ coronary arteries. Angiography, optical coherent tomography (OCT) and histopathological analyses were performed at post-procedure and 14-, 28-, 90-, 180-day follow-up. Thirty-two minipigs were enrolled. Eight XINSORB scaffolds and 8 Firebird2 stents were examined at each time point. Quantitative coronary angiography showed that in-scaffold late luminal loss (LLL) of XINSORB scaffold was 0.26 ± 0.13, 0.50 ± 0.16, 0.88 ± 0.29 and 0.43 ± 0.24 mm at 14-, 28, 90-, and 180-day follow-up respectively, and the corresponding diameter stenosis (DS) was 7.3 ± 4.7, 12.0 ± 9.5, 22.1 ± 8.0, and 16.0 ± 9.5%. Neither in-scaffold LLL nor DS of XINSORB scaffold was significantly different in comparison with Firebird2 stent. No difference of luminal area, device area, neointimal hyperplasia, and area stenosis was detected between two devices under OCT. Scaffold area of XINSORB remained steady through the observation. Histopathology revealed the similar findings. The greatest late recoil of XINSORB scaffold was about 4.12% at 90-day follow-up, which was comparable to Firebird2 stent. Both devices showed low injury or inflammation of vessel wall. XINSORB scaffold showed early neointimal coverage on struts within 28 days under scanning electron microscopy. XINSORB scaffold suppressed neointimal hyperplasia as effectively as Firebird2 did without obvious late device recoil during the 180 days follow-up. It is feasible to carry out clinical trial to investigate the safety and efficacy of XINSORB scaffold for patients with coronary artery diseases.

Keywords

Bioresorbable scaffold Restenosis Porcine model 

Notes

Acknowledgements

This work was supported by National Natural Science Foundation of China (Nos. 81370323 and 81670319) and the Specialized Research Fund for the Doctoral Program of Higher Education of China (No. 20130071120065).

Conflict of interest

All authors declare no conflicts of interest.

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Copyright information

© Springer Science+Business Media Dordrecht 2017

Authors and Affiliations

  • Li Shen
    • 1
  • Yizhe Wu
    • 1
  • Lei Ge
    • 1
  • Yaojun Zhang
    • 2
  • Qibing Wang
    • 1
  • Juying Qian
    • 1
  • Zhifen Qiu
    • 3
  • Junbo Ge
    • 1
  1. 1.Department of Cardiology, Shanghai Institute of Cardiovascular Diseases, Zhongshan HospitalFudan UniversityShanghaiChina
  2. 2.Department of Cardiology, Xuzhou Third People′s HospitalXuzhou Medical UniversityXuzhouChina
  3. 3.Department of CardiologyTengnan Hospital of ZaozhuangShandongChina

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