Combination of Rotarex Thrombectomy and Drug-Coated Balloon for the Treatment of Femoropopliteal Artery In-Stent Restenosis

Background: The optimal treatment method for femoropopliteal (FP) artery in-stent restenosis (ISR) remains controversial. We assess the efficacy and safety of combination of Rotarex thrombectomy and drug-coated balloon (DCB) for the treatment of FP ISR. Methods: From June 2016 to July 2017, 32 patients with FP ISR who underwent combination of Rotarex thrombectomy and DCB angioplasty were included in a prospective registry. The primary end point was primary patency of the target lesion defined as a peak systolic velocity ratio <2.4 documented by duplex ultrasound at 12 months without clinically driven target lesion revascularization (CD-TLR). The secondary outcome measure was the rate of major adverse limb events. The primary functional end point was assessed using the Walking Impairment Questionnaire (WIQ). Results: Twenty-nine (90.6%) patients completed 12-month follow-up. Mean ankle-brachial index was 0.45 +/- 0.14 at baseline and 0.84 +/- 0.12 at 12 months (P < 0.05). The WIQ score was 30.45 +/- 21.14 at baseline and 52.68 +/- 29.75 at 12 months (P < 0.05). The Kaplan-Meier estimate of the primary patency rate at 12 months was 86.2% (25/29), and freedom from CD-TLR rate at 12 months was 89.7% (26/29). Conclusions: The data suggest that combination of Rotarex thrombectomy and DCB for treatment of FP ISR is safe and effective with satisfying primary patency rate and freedom from CD-TLR rate at 12-month follow-up.