Predictors of Recurrence Based on Intravascular Ultrasound Findings after EluviaTM Placement in Symptomatic Peripheral Arterial Disease

Abstract

Abstract Background Polymer-coated drug-eluting stents (Eluvia™) have shown favorable clinical outcomes in real-world registries. Predictors of recurrence after Eluvia™ placement have been identified among clinical parameters. However, there are no reports on predictors of recurrence after Eluvia™ placement based on intravascular ultrasound (IVUS) findings. Materials and Methods We analyzed clinical data from the ASIGARU PAD registry, a retrospective, multi-center, observational study that enrolled patients who underwent endovascular therapy (EVT) for superficial femoral and proximal popliteal arteries lesions using Eluvia™ or drug-coated balloon. The primary outcome was the identification of predictors of recurrence, including IVUS parameters at 12 months. The rate of target lesion recurrence was also assessed. Results IVUS images were obtained in 54 of 65 cases. Seven recurrence cases (13.0%) were observed within 12 months. The random survival forest method presented eight predictive variables of recurrence: Clinical Frailty Scale (CFS), distal stent edge area, distal plaque burden, age, sex, distal external elastic membrane (EEM) area, minimum stent area (MSA), and distal lumen area. Furthermore, the partial dependence plot showed that frailty (CFS ≥ 6), smaller distal stent edge area, higher and lower distal plaque burden, older and younger age, female sex, smaller distal EEM area, smaller MSA, and smaller and larger distal lumen area predicted recurrence after Eluvia™ placement within 12 months. Conclusion CFS, distal stent edge area, distal plaque burden, age, sex, distal EEM area, MSA, and distal lumen area were significant predictors of recurrence after Eluvia™ placement.