Extensive arterial repair one year after paclitaxel-coated nitinol drug-eluting stent vs. bare-metal stent implantation in the superficial femoral artery

Abstract

Arterial repair differences between paclitaxel-coated nitinol drug-eluting stent (DES) vs. bare-metal stent (BMS) up to 1 year after implantation in the superficial femoral artery (SFA) have not been well characterized. We compared angioscopic findings 1 year after implantation in the SFA of 22 DES in 18 patients and 12 BMS in 9 patients (follow-up period 354 ± 49 vs. 383 ± 81 days, P = 0.20). Neointimal coverage (NIC) was graded as: 0, stent struts exposed; 1, struts bulged into the lumen, although covered; 2, struts embedded by the neointima, but translucent; and 3, struts fully embedded and invisible. NIC was defined as heterogeneous when NIC grade variation was ≥1. Presence of thrombus and yellow plaques (YP) was assessed. Baseline patient and lesion characteristics were similar between the groups. In terms of procedural characteristics, stent diameter was smaller in DES than in BMS (6.5 ± 0.5 vs. 7.4 ± 0.8 mm, P = 0.0020). Both DES (grade 2 5 %, grade 3 95 %) and BMS (grade 3 100 %) revealed dominant NIC grades of 2 or 3 (P = 0.46), however, DES showed greater NIC heterogeneity than BMS (91 vs. 42 %, P = 0.004). Both thrombus and YP were more frequently observed in DES than in BMS (64 vs. 17 %, P = 0.001; 95 vs. 67 %, P = 0.042, respectively). In conclusion, although arterial repair was limited after DES implantation in the SFA, it was extensive at 1 year.

Angioscopic Evaluation of Vascular Response After Fluoropolymer-Based Drug-Eluting Stent Implantation for Femoropopliteal Artery Lesions

“…Previous angioscopic studies reported that yellow plaque was less frequently observed 12 months after implantation of a bare nitinol stent in femoropopliteal lesions than at 3 months. 11, 13 However, in the present study, the maximum yellow color grade was not significantly different among the 3 groups after FP-DES implantation. This may be attributed to the this study.…”

“…This result differs from the findings of a previous angioscopy report evaluating intravascular status 12 months after PF-DCS implantation. 13 In that study, the grade of dominant neointimal coverage 12 months after PF-DCS implantation was mostly Grade 3. 13 This difference could be explained by differences in the duration of paclitaxel elution.…”

“…13 In that study, the grade of dominant neointimal coverage 12 months after PF-DCS implantation was mostly Grade 3. 13 This difference could be explained by differences in the duration of paclitaxel elution. PF-DCS does not contain a polymer, and the elution period of paclitaxel is approximately 2 months.…”

Zilver PTX Post-market Surveillance Study of Paclitaxel-Eluting Stents for Treating Femoropopliteal Artery Disease in Japan: 2-Year Results

“…Previous studies have typically only reported thrombosis rates through 1 year. Angioscopic observations in Japan have reported some evidence of thrombus with possible incomplete endothelial coverage at 2 months, but adequate healing at 1 year [ 13 , 14 ]. Based on these observations, the continuation of dual antiplatelet therapy could be important to minimize the incidence of stent thrombosis.…”

Impact of Angioscopic Evaluation for Femoropopliteal In-Stent Restenosis Before and After Excimer Laser Atherectomy

“…On the other hand, recently, it has been reported that angioscopy, which was usually used for evaluation of coronary arterial healing following stenting, [1][2][3][4] could be applied to evaluate the characterization of inside the vessel during and after endovascular therapy (EVT) including stent implantation in the femoropopliteal lesions. [5][6][7] Angioscopy can directly visualize the grade in the femoropopliteal lesions. Therefore, we report 2 cases who showed direct visualization of effect of ELA for femoropopliteal ISR lesions using angioscopy.…”