Treating Native Arteries, Bypasses and In-Stent-restenosis with Rotational Athero-Thrombectomy - Two-Year Results from the Rotarex-PMCF Trial.

Background: Atherectomy devices have become a widely used tool to treat peripheral vessels in a variety of clinical situations. This trial assesses the efficacy, safety and clinical success of the Rotarex Catheter, a rotational athero-thrombectomy system, for the treatment of acute, subacute and chronic occlusions in peripheral arteries including native arteries, bypasses and in-stent restenosis, used alone or as an adjunctive tool. Patients and methods: 220 patients were enrolled in this prospective, multicentre, single-arm study in Europe. Procedural success was measured after the index procedure. Freedom from major adverse events (MAEs), was collected through 30 days. Primary patency was collected at 1, 6, 12, and 24 months. Secondary outcomes included safety events, freedom from target lesion and vessel revascularization (TLR and TVR) and quality of life improvement. Results: Procedural success of Rotarex with an adjunctive treatment was 94.1%. Primary patency was 87.2%, 68.1%, 57.8% and 49.1% at 1, 6, 12 and 24 months, respectively. Freedom from MAEs through 30 days was 96.3%. The MAE rate was 21.0%, 31.0% and 41.1% at 6, 12 and 24 months. Freedom from TLR was 97.7%, 81.0%, 72.0% and 64.3% at 1, 6, 12 and 24 months. Freedom from TVR was 95.8%, 79.0%, 69.9% and 62.3% at 1, 6, 12 and 24 months. Most subjects showed improvement in Rutherford Class and in the quality-of-life measures. Conclusions: These results show that Rotarex performs effectively and safely when it is being used as an adjunctive treatment in acute, subacute and chronic occlusions of native arteries, ISR and bypass.