Comparison of arterial wall integration of different flow diverters in rabbits: The CICAFLOW study.

BACKGROUND AND PURPOSE

New coated flow diverters (FDs) claim antithrombotic properties and increased arterial wall integration. The aim of this study is to compare in vivo endothelial coverage of coated and uncoated FD in the context of different antiplatelet regimens.

METHODS

Different FDs (Silk Vista - SV, Pipeline with Shield technology - PED shield and Surpass Evolve - SE) were implanted in the aorta of rabbits, all 3 in each animal with 3 different antiplatelet regimens: no antiplatelet therapy, aspirin alone, or aspirin and ticagrelor. Four weeks after FD implantation, angiography, flat-panel CT, and optical coherence tomography (OCT) were performed before harvesting the aorta. Extensive histopathology analyses were performed including environmental scanning electron microscopy (ESEM), multiphoton microscopy (MPM) and histological staining with qualitative and/or quantitative assessment of device coverage.

RESULTS

All 23 FDs that were implanted remained patent without hyperplasia. Qualitative stent coverage assessment revealed that there were no statistically significant differences between the FD groups (p = 0.19, p = 0.45, p = 0.40, and p = 0.84 for OCT, ESEM, MPM and histology, respectively). Quantitative neointimal measurement of histological sections also showed similar results in all 3 FD groups (p = 0.70). However, there were significant differences between the 3 groups of antiplatelet regimens (p = 0.07) with a higher rate in the no antiplatelet group (p = 0.05 versus aspirin alone and p = 0.03 versus aspirin and ticagrelor).

CONCLUSION

Our study provides evidence that FD integration into the arterial wall is similar with coated (PED shield) and uncoated devices (SV, SE), regardless of the antiplatelet regimen. FD integration with specific surface coverage should be promoted.

TRIAL REGISTRATION

APAFIS #2022011215518538.