First up, M. Boisiers presented on the ZILVERPASS study which compares the 5-year results of ZILVER PTX stents vs. bypass surgery in femoropopliteal lesions. The final 60-month results show at least non-inferiority of ZILVER PTX vs. prosthetic bypass surgery ATK rwith similar patency results, fewer complications, and shorter hospitalisation, as well as a clear cost benefit in favour of ZILVER PTX.
R. Langoff spoke on behalf of ROADSAVER study investigators, presenting 1-year outcomes of a dual-layer micromesh stent in endovascular carotid stenosis treatment. This study assesses the safety and efficacy of the Roadsaver DLMS in the treatment of carotid artery stenosis in unselected patients eligible for elective stenting; the study confirms the safety and efficacy of this treatment.
T. Chong presented results from the PRISTINE Registry which investigates the performance and safety of the SELUTION SLRTM sirolimus-eluting balloon for the treatment of complex occlusive lesions in chronic limb-threatening ischaemia (CLTI). SELUTION SLR has been demonstrated to be safe and efficacious in treating complex infrainguinal lesions in a frail cohort of CLTI patients with a high incidence of diabetes and kidney failure.
Insights from the SAVE randomized controlled trial were presented by K. Katsanos. The SAVE trial investigates the safety and efficacy of the novel SELUTION SLR™ 018 sirolimus-eluting balloon for the treatment of failed AVF in renal dialysis patients. This was the first report presenting the preliminary findings from the trial, which indicate improvements in minimal lumen diameter and flow rate after the procedure. The analysis of the 6-month follow-up cohort is currently ongoing.
M. Broadman spoke about the one-year results of the DEEPER LIMUS trial. The purpose of this study was to evaluate the safety of the Bare Temporary Spur Stent System for the treatment of infrapopliteal artery disease when used in conjunction with a commercially available Sirolimus coated balloon. The results suggest that this system in conjunction with a Sirolimus-coated DCB demonstrates safety and efficacy at 12 months.
Results from the BIONETIC-TRA feasibility study were summarized by M. Lichtenberg. This investigator-initiated trial evaluates the safety and feasibility of the DyNETIC-35 cobalt chromium balloon-expandable stent for the treatment of atherosclerotic iliac lesions via a transradial approach. Primary and secondary endpoint data were presented. The results from the study are expected to provide evidence that the DyNETIC-35 balloon expandable stent may be used to treat the Iliac artery via radial access with a low complication rate and reduced health care costs.