Endovascular treatment of atherosclerotic lesions in the superficial femoral artery and proximal popliteal artery using the sinus-SuperFlex-635 stent: twelve-month results from the HERO Registry

Abstract

BACKGROUNDː The aim of the present article was to evaluate the safety and performance of the sinus-Superflex-635 self-expandable nitinol stent (Optimed GmbH) for the treatment of steno-occlusive lesions in the superficial femoral artery (SFA) and proximal popliteal artery (PPA).METHODSː The prospective, multicenter, observational HERO study recruited 117 eligible patients (83 men; mean age 69.4±9.7y) from 7 centers in Belgium. The patients presented with symptomatic ≥ 50% stenosis or chronic total occlusion (CTO) (30.6%). Mean length of the 121 lesions was 71±56.3 mm. Moderate to severe calcification was present in 83% of the lesions.RESULTSː A total of 129 stents were successfully deployed in 121 lesions in 117 patients (100%). Acute lesion success (<30% residual stenosis) was achieved in 96%. There were no in-hospital serious adverse events. Duplex ultrasound-driven primary patency at 12 months was recorded in 84 of 107 (79%) lesions. The overall TLR rate was 8.4% at 12 months; the TER rate was 4.7%. Clinical assessment at 12 months demonstrated improvement by at least 1 Rutherford class, without the need for TLR (i.e. primary sustained clinical improvement) in 84% of patients and with the need for TLR in 91% of patients (i.e. secondary sustained clinical improvement). CONCLUSIONSː Based on the high primary patency, low stent fracture rate and significant clinical improvement, combined with refined stent design and long stent availability, the sinus-Superflex-635 self-expandable nitinol stent proves its value in bail-out stenting after suboptimal drug-coated balloon (DCB) results for the treatment of long and complex femoropopliteal artery (FPA) lesions.