Prospective, Randomized Clinical Trial Evaluating Safety and Efficacy of Cobalt-Chromium Sirolimus- -Eluting Stent (PERS) Versus Cobalt-Chromium Stent (Neptun C) to Maintain Patency of Iliac Arteries in Patients Undergoing Peripheral Angioplasty
, 3, 3, 12, 3, 4
Abstract
Introduction: The study aimed to assess the safety and efficacy of the new cobalt-chromium sirolimus-eluting stent (PERS, Balton, Poland) compared to cobalt-chromium stent (Neptun C, Balton, Poland) in patients with symptomatic iliac artery disease undergoing endovascular revascularization. Materials and methods: This was a prospective, randomized clinical study. The primary endpoint was defined as the major adverse event rate (MAE defined as death associated with stent implantation or procedure surgery, amputation above the metatarsus in the treated limb due to vascular complications, or re-intervention in a treated lesion) at 12 months. The secondary endpoints were vessel patency; implantation, procedural and clinical success, change in ankle-brachial index (ABI), mortality rate, change in peak systolic velocity (PSV) and % diameter stenosis. (ClinicalTrials.gov NCT04323033). Results: 40 patients were included, 20 patients in the PERS group and 20 patients in the Neptun C group. Procedural and implantation success rates were 100% in both groups. MAE rates in both groups were 0% at 12 months. Vessel patency rates were 100% in all cases at every time point (30 days, 6 months and 12 months). Clinical success at 12-month follow-up was numerically higher in the PERS group than in the Neptun C group (94.44% vs 85%), but there were no statistically significant differences in ABI change between the groups. In an ultrasound examination, % diameter stenosis did not reach 20% in any of the study groups. Conclusions: The results showed a favourable safety profile of PERS stents, but the efficacy results were comparable between PERS and Neptun C stents.
Keywords: endovascular revascularizationperipheral artery diseasePADLEADlower extremity atherosclerotic disease
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