Abstract: SA-PO0471
Use of a Cell-Impermeable Endoprosthesis vs. Percutaneous Transluminal Angioplasty for De Novo and Restenotic Lesions
Session Information
- Dialysis: Vascular Access
November 08, 2025 | Location: Exhibit Hall, Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Dialysis
- 803 Dialysis: Vascular Access
Authors
- Roy-Chaudhury, Prabir, University of North Carolina Kidney Center, Chapel Hill, North Carolina, United States
- Razavi, Mahmood, St. Joseph Heart and Vascular Center, Orange, California, United States
- Balamuthusamy, Saravanan, Texas Research Institute, PPG Health, Fort Worth, Texas, United States
- Makris, Angelo N., Chicago Access Care, Westmont, Illinois, United States
- Hoggard, Jeffrey G., North Carolina Nephrology, Raleigh, North Carolina, United States
- Harduin, Leonardo Oliveira, University of Rio de Janeiro State, Rio de Janeiro, Brazil
- Jones, Robert, Queen Elizabeth Hospital Birmingham, Birmingham, England, United Kingdom
Group or Team Name
- WAVE Trial Investigators.
Background
A cell-impermeable endoprosthesis (CIE) was recently developed to help restore and extend functional patency within the peripheral venous outflow circuit of patients with stenosis in their arteriovenous fistula (AVF). However, evidence regarding the performance of the CIE versus percutaneous transluminal angioplasty (PTA) for treatment of de novo and restenotic lesions is needed.
Methods
This post-hoc analysis is based on data from the randomized-controlled arm of a prospective, multicenter, international trial conducted across 43 centers in the United States, South America, and the United Kingdom. The trial included patients with venous outflow stenosis or occlusion in their AVF. Patients were randomized 1:1 to treatment with the CIE or PTA. The target lesion primary patency (TLPP) and access circuit primary patency (ACPP) of patients treated with the CIE or PTA with de novo or restenotic lesions were compared at 6 and 12 months post-index procedure using the Z-test for the difference in proportions with pooled variance (two-group chi-square test) or Wilcoxon Rank Sum Test for continuous variables (threshold for significance: 0.05).
Results
A total of 245 patients were included in the trial (122 CIE; 123 PTA). For patients with de novo lesions, TLPP was significantly higher at 6 months for patients treated with the CIE vs. PTA (95% vs. 75%; p=0.007); however no significant difference was observed for ACPP (CIE: 86% vs. PTA: 69%; p=0.051). For patients with restenotic lesions at 6 months, TLPP was significantly higher for patients treated with the CIE vs. PTA (86% vs. 53%; p<0.001), but not ACPP (64% vs. 49%; p=0.07). At 12 months, the TLPP and ACPP for patients treated with the CIE vs. PTA were significantly higher for both de novo and restenotic lesions.
Conclusion
These results indicate that the CIE is generally associated with a greater clinical benefit than PTA at restoring and extending functional patency of patients’ dialysis access, regardless of whether lesions are de novo or restenotic.
Funding
- Other NIH Support – WL Gore, Medtronic, Becton Dickinson, Humacyte, Cormedix, Bayer, Astra Zeneca, Alexion, Panoramic Science, BMI Organ Bank, Boston Scientific and Vera