Temporal course of vascular response after fluoropolymer paclitaxel-eluting stent implantation for femoropopliteal artery lesions

Background Limited data is available regarding the vascular response after fluoropolymer paclitaxel-eluting stent (FP-PES) implantation. We sought to assess the vascular response at 6- and 12-month after FP-PES implantation for femoropopliteal artery lesions using serial optical coherence tomography (OCT) examination. Methods and results From the IMPERIAL trial, this study evaluated 10 de novo femoropopliteal lesions treated with FP-PES. The primary study endpoint was neointimal tissue coverage at 6- and 12-month follow-up as assessed by serial OCT examination. The incidence of peri-strut low-intensity area (PLIA) and extra-stent lumen (ESL) was also assessed. A total of 203 matched cross-sectional images were evaluated at 6- and 12-month (5,615 and 5,763 struts, respectively). From 6 to 12 months, the mean neointimal thickness tended to increase from 198 μm to 233 μm with a significant reduction in the incidence of malapposed struts (0.59% vs. 0.28%, p=0.039). Conversely, uncovered struts and PLIA were more frequently observed at 12 months (4.4% vs. 7.8%, p=0.01; 12.7% vs. 21.0%, p Conclusions Neointimal proliferation was markedly inhibited from 6 to 12 months after FP-PES implantation, whereas the incidence of uncovered struts and PLIA significantly increased over time with the enlargement of ESL. Funding Acknowledgement Type of funding sources: None.