Efficacy Evaluation of Rotarex Thrombectomy and Drug-Coated Balloons for the Treatment of Long Tosaka Class III Femoropopliteal In-Stent Restenosis.

BACKGROUND: This study aimed to assess the efficacy and safety of combining drug-coated balloon (DCB) with Rotarex thrombectomy for treating long Tosaka class III femoropopliteal in-stent restenosis (FP-ISR).

METHODS: A retrospective analysis of clinical data from patients with long Tosaka class III FP-ISR between June 2018 and June 2023 was conducted. Primary end points included primary patency and freedom from clinically driven target lesion revascularization (FCD-TLR) at 6, 12, and 24 months. Secondary outcomes comprised embolization rate, amputation rate, and all-cause mortality.

RESULTS: A total of 90 patients were included; 39 were treated with Rotarex, 28 with DCB, and 23 with Rotarex plus DCB. The combined group exhibited significantly higher primary patency rates at 6, 12, and 24 months compared to the thrombectomy and DCB groups (95.7% vs. 66.7% vs. 67.9%, 71.7% vs. 27.2% vs. 35.7%, and 33.5% vs. 21.5% vs. 26.8%, P = 0.04). FCD-TLR rates were also superior in the Combined group (95.7% vs. 71.1% vs. 67.9%, 78.7% vs. 44.4% vs. 42.9%, and 64.1% vs. 32.8% vs. 35.7%, P = 0.024). The combined group had lower bailout stenting rates (4.3% vs. 15.4% vs. 25%, P = 0.047) with no significant differences in embolization, amputation, or all-cause mortality at 24 months.

CONCLUSION: Combining DCB and Rotarex thrombectomy in long Tosaka class III FP-ISR showed reduced bailout stenting and improved 2-year FCD-TLR. Further randomized trials and additional data are required.