Poor below Knee Runoff Impacts Femoropopliteal Stent Failure and Fluoropolymer Antithrombotic Effect in Healthy Swine Model

Objective: Poor below knee (BTK) runoff is a predictor of stent failure after endovascular femoropopliteal artery treatment; however, lack of pathological evaluation has prevented characterisation of stent failure. The study aimed to investigate the impact of poor BTK runoff and the antithrombotic effect of the polymer of fluoropolymer coated paclitaxel eluting stents (FP-PESs) in a healthy swine femoropopliteal artery model. Methods: FP-PESs and bare metal stents (BMSs) and FP-PES and polymer free paclitaxel coated stents (PF-PCSs) were implanted in the bilateral femoral arteries of healthy swine (n = 6, respectively) following coil embolisation in both tibial arteries to induce poor BTK runoff. Histological assessment and intravascular imaging device evaluation were performed at one month. The Japanese Association for Laboratory Animal Science approved the study protocol (reference number: IVT22-90). Results: Optical coherence tomography showed significantly lower percent area stenosis in FP-PES compared with BMS (37.3%, [interquartile range (IQR), 25.6 - 54.3] % vs. 92.5% [IQR, 75.5 - 96.1] %, respectively, p = .031), and PF-PCS (8.3% [IQR, 4.5 - 27.0] % vs. 31.2% [IQR, 23.3 - 52.2] %, respectively, p = .031). Histopathological evaluation demonstrated that thin fibrin attachment without re-stenosis was the most dominant neointimal tissue characteristic in FP-PES. On the other hand, neointimal tissue characteristics with significant restenosis of BMS and PF-PCS were mainly organising or organised thrombus. Conclusion: Organising and or organised thrombus attachment due to poor BTK runoff was the main cause of in stent restenosis of the swine femoral artery. FP-PES demonstrated the least percent area stenosis, suggesting the importance of the antithrombotic effect of polymer.