Thrombogenicity of the p48 and anti-thrombogenic p48 hydrophilic polymer coating low-profile flow diverters in an in vitro human thrombin generation model.

Abstract

The implantation of flow diverters, or stents in general, necessitates the use of dual anti-platelet treatment with typical regimes including aspirin and a P2Y12 inhibitor. This carries an inherent risk of haemorrhage. We sought to compare the thrombogenicity of the anti-thrombogenic p48 hydrophilic polymer coating compared to the standard uncoated p48 flow diverter using an in vitro thrombogenicity assay. To evaluate the thrombin generation influenced by the different stent types the stents were placed in wells of a 24-well plate with the addition of plasma from healthy volunteers the thrombin calibrator respectively the PPP-reagent was added. Subsequently, the thrombin substrate was added and the thrombin generation was analysed every 60 s using a thrombinoscope. The assay is calibrated using samples containing a known amount of active thrombin in PPP. Thrombin activity is proportional to the change in fluorescence. The p48 hydrophilic polymer coating shows a significantly lower peak thrombin concentration (1.13 ± 0.21 vs. 1.41 ± 0.22) and longer time to peak thrombin concentration (0.96 ± 0.04 vs. 0.74 ± 0.07) compared to the uncoated p48 device (p < 0.01). The responses of the p48 hydrophilic polymer coating were similar to that of the negative control. The hydrophilic polymer coating surface modification significantly reduces the thrombogenicity of the p48 flow diverter. These results corroborate the findings from previous in vitro studies.