Twelve month results of the RENOVA trial: a prospective multicenter randomized, concurrently-controlled comparison of the Flair® endovascular stent graft vs. balloon angioplasty in dialysis access grafts

Abstract

Purpose A prior randomized trial demonstrated 6-month primary patency superiority of an ePTFE stent graft (Flair®, Bard Peripheral Vascular) over PTA alone for primary treatment of venous anastomotic in hemodialysis access grafts (p 1 . This report presents the 12-month results of the 2-year RENOVA study, conducted to compare long term use of the Flair® stent-graft compared to PTA alone. Materials and Methods 28 U.S. study sites enrolled 270 patients in this registered trial. Inclusion required patent but failing upper extremity arteriovenous grafts with ≥ 50% venous anastomotic stenoses associated with hemodynamic, functional, or clinical abnormalities. 138 patients were randomized to stent grafts vs.132 to the PTA group. Patency, graft function, and subsequent access interventions were recorded. Primary outcome measures (intent-to-treat basis) included Access Circuit Primary Patency (ACPP), Index of Patency Function (IPF) defined as the average number of months between interventions, and adverse events(AEs). Results There were no significant differences in demographics or baseline criteria between the groups. The mean deployed stent-graft length was 45 mm (SD 4.9 mm). 12-month ACPP for the stent graft group was significantly better than the PTA group, 24.1% vs. 10.3% (p=0.005), respectively. 12-month IPF for the stent-graft group was significantly better than for the PTA group, 5.3 ± 4.1 months/intervention vs. 4.4 ± 3.5 months/intervention (p=0.008), respectively. There were no significant differences in AEs between groups (96.2% PTA and 92.8% stent graft group experienced at least 1 AE), with the exception of stenosis requiring intervention which occurred significantly more frequently in the PTA group, 82.6%, (n=109/132) vs.stent graft group, 60.1% (n=83/138), p Conclusion Mid-term 12-month results of the RENOVA trial demonstrated both statistically significantly better ACPP (>2x superiority) in the Flair® stent-graft group compared to PTA alone, and IPF, resulting in fewer follow up interventions per unit time per patient. References 1). Haskal ZJ, Trerotola S, Dolmatch B, et al. Stent Graft versus Balloon Angioplasty for Failing Dialysis-Access Grafts. New England J Med 2010;362:494-503.