Safety and Efficacy of Rotational Thrombectomy and Drug Coated Balloon Angioplasty in Patients with In Stent Re-stenosis and Occlusions: A Prospective, Two Centre Study

Abstract

Objective: Rotational thrombectomy using a Rotarex S device aids the removal of organised thrombus and soft atherosclerotic material in complex femoropopliteal lesions. The aim of this study was to assess the safety and efficacy of the Rotarex S device in combination with drug coated balloon (DCB) angioplasty for the treatment of in stent re-stenosis (ISR).

Methods: The Rotarex S (Straub Medical) was used in combination with DCB for the treatment of patients with lower limb ISR and stent occlusions (Tasaka II or III) who presented with subacute or chronic symptoms. Primary endpoints were freedom from clinically driven target lesion revascularisation (CD-TLR) and patency at 12 month follow up. The secondary procedural endpoint was procedural success. Secondary safety endpoints were perforation and peripheral embolisation.

Results: Between January 2017 and August 2023, 215 consecutive patients were enrolled, comprising 84 (39.1%) with claudication, 79 (36.7%) with ischaemic rest pain, and 52 (24.2%) with ischaemic ulcerations due to femoropopliteal lesions (popliteal artery involved in 42.8% of cases). The median patient age was 73.0 years (interquartile range [IQR] 68.0, 77.0), 59.1% were male, and 44.7% had diabetes mellitus. Tosaka III lesions (total occlusions) were present in 165 patients (76.7%). The median lesion length was 22.0 cm (IQR 17.0, 27.0). There were no perforations, whereas three (1.4%) peripheral embolisations were noted (all three with a subacute presentation and total stent occlusion). All complications were treated within the index procedure by manual catheter aspiration without requiring surgery or lysis. After one year, 28 patients (13.0%) underwent CD-TLR, whereas primary patency was maintained in 156 patients (79.2%).

Conclusion: Rotarex S thrombectomy can be safely used for debulking and removal of organised thrombus in subacute and chronic ISR lesions and occlusions. Additional DCB after debulking provides clinically acceptable CD-TLR and patency rates in this complex patient cohort.

Keywords: CLTI; Duplex ultrasound; In stent re-stenosis; Patency rate; Peripheral arterial disease; Rotational thrombectomy.