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Basic science
Original research
Preclinical in vitro and in vivo results of the new silk vista flow diverter with P8RI coating
  1. Jonathan Cortese1,2,3,
  2. Géraud Forestier3,4,
  3. Sylvia M Bardet3,5,
  4. Marie-Laure Perrin3,
  5. Maxime Baudouin3,4,
  6. Alexis Belgacem3,
  7. Romain Chauvet3,6,
  8. Voahirana Ratsimbazafy7,8,
  9. Gregory Sasselina3,
  10. Daphnée Chandellier3,
  11. Jérémy Mounier3,
  12. Claude Couquet3,
  13. Florence Bosselut3,
  14. Laurent Spelle1,2,
  15. Charbel Mounayer3,4,
  16. Faraj Terro3,9,
  17. Aymeric Rouchaud3,4
    1. 1NEURI -Brain vascular center- Interventional Neuroradiology, Bicetre University-Hospital, Le Kremlin-Bicetre, France
    2. 2INSERM U1195, Paris-Saclay University, Le Kremlin-Bicêtre, France
    3. 3XLIM UMR CNRS, University of Limoges, Limoges, France
    4. 4Neuroradiology department, University Hospital of Limoges, Limoges, Limousin, France
    5. 5UMR CNRS no 7252, XLIM, Limoges, Aquitaine, France
    6. 6Vascular Surgery, Limoges University-Hospital, Limoges, Nouvelle-Aquitaine, France
    7. 7Pharmacy department, Limoges University-Hospital, Limoges, France
    8. 8IFR 145 GEIST, Institut d’Epidemiologie Neurologique et de Neurologie Tropicale, INSERM, UMR, University of Limoges, Limoges, France
    9. 9Cell Biology, Limoges University, Limoges, Nouvelle-Aquitaine, France
    1. Correspondence to Dr Jonathan Cortese, NEURI -Brain vascular center- Interventional Neuroradiology, Bicetre University-Hospital, Le Kremlin-Bicetre 94275, France; jonathan.cortese{at}aphp.fr

    Abstract

    Background Flow diverting stents (FDS) have transformed the treatment of intracranial aneurysms; however, their metallic structure associated with their intra-luminal positioning hamper angiographic and clinical outcomes. Therefore, there is a need to develop FDS with optimized surfaces that reduce thrombogenicity while promoting the healing process and endothelialization.

    Methods P8RI, a peptide mimicking the CD31 protein, was previously developed and grafted onto Silk Vista (SV) FDS. P8RI-SV and bare-SV were used in vitro in a blood loop model to test their hemocompatibility using human whole blood and in vivo using the rabbit elastase model for optical coherence tomography (OCT) comparisons of neointimal formation at day 5 and day 28.

    Results After blood loop incubation, P8RI-SV showed significant reduction in fibrin binding (p=0.004) and platelet adhesion (p=0.041) compared with bare-SV. Similarly, derivative markers measured in blood, thromboxane B2 (platelet activation) and Thrombin-Antithrombin III complexes (coagulation activation), were also significantly reduced in the P8RI-SV group (both p=0.002). In vivo, complete or near-complete occlusion was reached in all aneurysms (n=6) at day 28. Excellent rate of stent-coverage ratio was obtained at day 5 (89.3% (79.1%–98.7%)) comparable to the observation at day 28 (91.8% (79.1%–100%); p=0.44). These rates were significantly higher compared with bare-SV at day 5 (77.8% (58.3%–86.8%); p<0.001) and at day 28 (67.7% (52.6%–88.9%); p<0.0001).

    Conclusion In vitro results confirm enhanced hemocompatibility with a significant anti-thrombotic effect of the P8RI-SV. In vivo results provide evidence of rapid neo-intimal growth reaching near-complete tissue healing as early as day 5 in a rabbit model.

    • Aneurysm
    • Flow Diverter
    • Platelets

    Data availability statement

    Data may be obtained from a third party and are not publicly available.

    https://doi.org/10.1136/jnis-2024-021694

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      Data availability statement

      Data may be obtained from a third party and are not publicly available.

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      Footnotes

      • Contributors JC, GF, SMB, MB, FT and AR contributed to the conception and design of the studies. JC, GF, MB, MLP, AB, RC, VR, GS, FB, DC, JM, FT and AR contributed to acquisition of the data, the interpretation of the data. JC, GF, SMB, CC, LS, CM, FT and AR drafted the work and revised it for significant intellectual content. All authors approved the final version of the manuscript; agree to be accountable for all aspects of the work, including its accuracy and integrity. JC is the guarantor.

      • Funding Balt sponsored the study. JC is supported by the French Society of Neuroradiology (SFNR – Bourse de recherche Anne Bertrand), by the French Society of Radiology (SFR – Bourse de recherche Alain Rahmouni) and by the Philippe Foundation.

      • Competing interests JC received an educational grant from Medtronic, Phenox and Microvention; and received honoraria for lectures from Balt. LS is a consultant for Microvention, Balt, Phenox, Stryker, Medtronic. AR received honoraria for lectures from Balt. CM received honoraria for lectures from Balt.

      • Provenance and peer review Not commissioned; externally peer reviewed.