The Endovascular Therapy Using Excimer Laser Atherectomy for Complex Femoropopliteal In-Stent Restenosis Lesions

Purpose: The guidelines recommend excimer laser atherectomy (ELA) for in-stent restenosis (ISR) lesions in femoropopliteal arteries. However, its efficacy is still unknown in ISR related to scaffolds other than bare-metal stent (BMS). This study aimed to evaluate the 1-year clinical outcomes in patients with femoropopliteal ISR lesions treated with endovascular therapy (EVT) using ELA. Materials and Methods: This retrospective multicenter registry analyzed patients who presented with peripheral artery disease caused by femoropopliteal ISR lesions undergoing EVT with ELA between 2020 and 2024. The primary outcome was re-restenosis 1-year following EVT. Results: Overall, consecutive 166 patients with femoropopliteal ISR lesions were enrolled. The rates of in-stent occlusion and ISR related to scaffolds other than BMS were found in 88.6% and 52.4% of the lesions, respectively. Technical success was achieved in 83.7%. The 1-year Kaplan–Meier estimate of freedom from re-restenosis was 67.6% (95% confidence interval [CI] 60.0-75.5). The primary-assisted patency and secondary patency rate was 72.7% (95% CI 65.8-80.3) and 81.5% (95% CI 76.6-88.0), respectively. In the multivariate analysis, slow flow observed in the completion angiography of EVT (adjusted hazard ratio, 2.32; P = .024) and chronic renal failure requiring dialysis (1.72; P = .036) were independently associated with re-restenosis risk. The accumulation of these factors was associated with a lower rate of freedom from re-restenosis; Kaplan–Meier estimates of the rates were 46.6% in subgroups with 1 or 2 risk factors, whereas it was 77.8% in the absence of risk factors. The Kaplan–Meier estimate shows a comparable primary patency rate between ISR related to BMS and drug-eluting stent at 1 year. Conclusion: ELA provided acceptable technical success in current femoropopliteal ISR lesions; however, the long-term result was clinically suboptimal. Clinical Impact This retrospective multicenter registry enrolled 166 patients with in-stent restenosis/in-stent occlusion lesions in femoropopliteal arteries treated with endovascular therapy using excimer laser atherectomy. The technical success rate was acceptable at 83.7%; however, 1-year estimate of freedom from restenosis was clinically suboptimal at 67.6%. The multivariate analysis showed incomplete antegrade blood flow and dialysis-dependent chronic renal failure were independently associated with re-restenosis risk.