Midterm Results of Drug-Coated Balloon Alone or Combined with Rotarex Thrombectomy Device for Treatment of Subacute Femoropopliteal Artery Thrombotic Occlusion.

BACKGROUND

This retrospective multicenter study aimed to compare the midterm results of the Rotarex rotational thrombectomy device combined with drug-coated balloon (DCB) and DCB-alone for the treatment of subacute femoropopliteal artery thrombotic occlusion.

METHODS

All patients (74, aged 70.1 ± 9.3 years) were nonrandomized and divided into 2 groups based on treatment strategy between 2018 and 2020. Intraoperative technical success (defined as <30% residual stenosis), dissection types and bailout-stenting rates were assessed. Ankle-brachial index (ABI), primary patency (PP, restenosis <50%) and freedom from clinically driven target lesion reintervention (CD-TLR) were documented at follow-up.

RESULTS

Among them, 35 patients were treated with the Rotarex catheter combined with DCB while 39 patients underwent DCB-alone. The-overall technical success rate was 100%. Patients in the Rotarex + DCB group showed lower rate of bailout stenting than those in the DCB alone group (22.9% vs. 59.0%; P = 0.01). ABI at discharge was significantly higher in both groups. Mean follow-up time was 18.5 ± 3.4 months; 62 patients completed Doppler ultrasound investigation while 12 patients were censored. According to Kaplan-Meier analysis, the estimated PP was 82.0 ± 6.7% in the Rotarex + DCB group, whereas a significantly lower rate in the DCB alone group (60.9 ± 8.3%, P = 0.04). In addition, the freedom from CD-TLR rate was 82.9 ± 6.4% in the Rotarex + DCB group and 61.5 ± 7.8% in the DCB-alone group (P = 0.04).

CONCLUSIONS

These initial data indicate that the Rotarex thrombectomy device combined with DCB is an effective choice for the treatment of subacute femoropopliteal artery thrombotic occlusion compared to DCB-alone. The combined procedure had superior midterm results.