Comparing the 1-year clinical outcomes of polymer-based paclitaxel-eluting stent implantation between hemodialysis and non-hemodialysis patients: A prospective, observational, single-center study”.

Abstract Background: Previous studies have shown favorable clinical outcomes of polymer-based paclitaxel-eluting stents (PB-PESs) in patients with femoropopliteal artery (FPA) disease. However, the effectiveness of PB-PES in hemodialysis (HD) patients has not been reported. The aim of this study was to compare the clinical performance of PB-PESs between HD and non-HD patients with symptomatic FPA disease.Materials and Methods: Between January 2019 and February 2020, 52 consecutive patients (mean age: 75.5 years; 42 men) underwent PB-PES implantation for symptomatic FPA diseases. Of these, 29 patients received HD and were classified into the HD cohort. The remaining 23 patients were classified into the non-HD cohort. Clinical outcomes were compared between the two cohorts. The primary efficacy endpoint was the primary patency at 12 months, and the primary safety endpoint was the 12-month incidence of major adverse cardiovascular and limb events (MACLEs), which were defined as the composite of the incidence of all-cause death, major amputation, stent thrombosis, and clinically driven target lesion revascularization (CD-TLR).Results: The overall primary patency rate was 93.3%. No significant difference existed in primary patency between the HD and non-HD cohorts (91.7% vs. 95.0%, P=0.577). The overall incidence rate of MACLEs was 16.6%, and the incidence rate was not significantly different between the HD and non-HD cohorts (20.2% vs. 13.3%, P=0.954). The incidence of stent thrombosis was not different between the HD and non-HD cohorts (8.3% vs. 5.0%, P=0.956).Conclusion: PB-PESs have exceptional 1-year primary patency and acceptable safety in HD patients and non-HD patients.Level of Evidence: Level 3, nonrandomized, follow-up study