Multicenter randomized controlled trial to assess the effectiveness of PASSEO-LUX DCB® drug coated balloon compared to plain balloon angioplasty of arteriovenous fistulae for hemodialysis: Two-years results

Abstract

Purpose: To compare primary patency after angioplasty with drug-coated balloon (DCB)-Passeo-18Lux, BIOTRONIK versus uncoated balloon in dysfunctional peripheral vascular access (PVA) for hemodialysis. Material and methods: A total of 133 patients from four hospitals were randomized to receive DCB or plain old balloon angioplasty (POBA) after satisfactory treatment (residual stenosis <30%) with high pressure balloon (HPB). The primary endpoint was clinical patency of PVA 2 years after angioplasty. Secondary endpoints included the relationship between the location of stenosis and patency and also, other covariates. Mortality at 2 years was compared between both groups. Results: Patency measured in days after angioplasty was higher in fistulae dilated with DCB than HPB. Kaplan-Meier survival curves showed the next percent of success (free time restenosis) after DCB versus POBA at 6 months—77.1% versus 58.2% (160.41–143.72 days until restenosis), 12 months—51.4% versus 44.3% (274.1–237.23), 18 months—38.6% versus 38% (350.74–305.18), and 24 months—37.1% versus 30.4% (419.04–369.1). At 6 months, this difference was statistically significant ( p = 0.018), but not at 12 ( p = 0.225), 18 ( p = 0.471), or 24 months ( p = 0.236). Mortality was similar in both groups. Conclusions: DCB angioplasty resulted in superior target lesion primary patency (TLPP)-free survival at 6 months of follow-up. No significant improvements in TLPP-free survival long term were observed. Mortality observed at 1 and 2 years was similar in DCB and POBA: there was no significant difference, and a safety study demonstrated no difference between the two groups (complications and mortality): DCB is safe to use in stenosis treatment in patients who are PVA carriers. Level of evidence: Level Ia, therapeutic study, RCT. EBM ratings will be based on a scale of 1–5.