Mechanical rotational thrombectomy with Rotarex system augmented with drug-eluting balloon angioplasty versus stenting for the treatment of acute thrombotic and critical limb ischaemia in the femoropopliteal segment.

Abstract

IntroductionMechanical thrombectomy is an alternative to local thrombolysis for the treatment of severe ischaemia in the femoropopliteal segment, but stent implantation is usually required after this procedure. The use of drug-eluting balloons (DEBs) may overcome long-term problems associated with stents, but it remains unclear how often such a treatment is technically feasible and efficient.AimThis post hoc single-centre study was aimed at assessment of the feasibility, safety and efficacy of mechanical thrombectomy followed by application of DEBs.Material and methodsFifty-one patients, aged 69.1 ±11.6 years, were managed for acute thrombotic or chronic critical ischaemia in the femoropopliteal segment using the Rotarex device. Following mechanical thrombectomy, on condition that there was no significant residual stenosis or dissection, lesions were managed with paclitaxel-coated DEBs, which was a desired strategy (24 patients). The remaining 25 patients underwent stent implantations, which was regarded as bailout treatment. Final follow-up was scheduled 12 months after the procedure.ResultsThe primary-assisted patency rate after mechanical rotational thrombectomy with additional balloon angioplasty and/or stenting was 97.1% (49 patients). The early mortality rate was 2.0% (1 patient) and the amputation rate was 4.1% (2 patients). There were no late mortalities or limb amputations at 12-month follow-up, but significant restenoses occurred in 13 (27.1%) patients. These restenoses were more frequent in patients who underwent stent implantation (45.5%) than those managed with DEBs (12.5%), and in patients managed for secondary lesions.ConclusionsIn selected patients mechanical rotational thrombectomy in the femoropopliteal segment followed by application of DEB is a safe, effective and long-lasting method of revascularisation.