Percutaneous Mechanical Athero-Thrombectomy Using the Rotarex®S Device in Peripheral Artery In-Stent Restenosis or Occlusion: A French Retrospective Multicenter Study on 128 Patients

Objectives: To ascertain the safety and mid-term outcomes of Rotarex®S rotational atherectomy plus thrombectomy device (Straub Medical AG, Wangs, Switzerland) with or without adjunctive treatment (e.g., percutaneous transluminal angioplasty [PTA]/drug-coated balloon [DCB]/stenting) in patients with in-stent restenosis (ISR) or occlusion in the iliac and/or infrainguinal arteries. Methods: This was a French multicenter retrospective study of all patients treated by in-stent percutaneous mechanical debulking (PMD) of the lower limbs with Rotarex®S device between January 2013 and November 2018. Results: The cohort consisted of 128 patients (88 men and 40 women), aged 39–94 years (median, 66.7 years). All patients presented with cardiovascular risk factors. Overall, 51.5% of the patients had critical limb ischemia. The study demonstrated a technical success of 96.9% in the population with PMD and adjunctive PTA (95/128, 74.2%) or adjunctive DCB (16/128, 12.5%) or both (13/128, 10.2%). At 12-month follow-up, the primary patency rate was 92.3% and the secondary patency rate was 91.4%. The rate of limb salvage was 93.7%. We accounted for 32 (25%) re-interventions with mean time from Rotarex®S treatment to re-intervention of 7.1 ± 8.2 months. Target lesion revascularization (TLR) was 19.5% (25/128). Seven (5.5%) patients developed distal embolism that responded to endovascular treatment. At mean follow-up, major adverse events observed were death (18/128, 14.1%), myocardial infarction (9/128, 7.0%), stroke (2/128, 1.6%), and renal failure (3/128, 2.3%). Conclusion: Recanalization with Rotarex®S rotational atherectomy plus thrombectomy device is a treatment of choice for arterial ISR/occlusions of the iliac and/or infrainguinal arteries, regardless of the age of the thrombus, with satisfying TLR. Only adjunctive PTA is often necessary to further improve the recanalization.

Publication History

Article published online:
26 April 2021