Two-Year Findings From RESCUE Study Support Bard’s Fluency Plus
August 10, 2016—Two-year findings from the RESCUE study were published online ahead of print by Abigail Falk, MD, in the Journal of Vascular and Interventional Radiology (JVIR). RESCUE assessed the safety and efficacy of the Fluency Plus (Bard Peripheral Vascular) expanded polytetrafluoroethylene endovascular stent graft versus balloon angioplasty for the treatment of in-stent restenosis in the venous outflow of hemodialysis access grafts and fistulae.
In the RESCUE trial, 275 patients at 23 sites in the United States were randomized to stent graft placement or percutaneous transluminal angioplasty (PTA). Primary study endpoints were access circuit primary patency (ACPP) at 6 months and safety through 30 days; secondary endpoints were evaluated through 24 months.
In JVIR, the RESCUE investigators reported that ACPP at 6 months was significantly higher in the stent graft group versus the PTA group (18.6% vs 4.5%; P < .001), and freedom from safety events (30 days) was comparable (stent graft, 96.9%; PTA, 96.4%; P = .003, noninferiority).
The investigators found that the separation in ACPP survival curves remained through 12 months (stent graft, 6.2%; PTA, 1.5%). Treatment area primary patency (TAPP) was superior for the stent graft group (66.4%) versus the PTA group (12.3%) at 6 months (P < .001), with a survivorship difference in favor of stent graft placement maintained through 24 months (stent graft, 15.6%; PTA, 2.2%).
ACPP and TAPP for the stent graft group were better than those for the PTA group when compared within central and peripheral vein subgroups (P < .001). In central veins, TAPP was 13.6% in the stent graft group versus 4.3% in the PTA group at 24 months (P < .001).
Stent graft use provided better ACPP and TAPP than PTA when treating in-stent restenosis in patients receiving dialysis with arteriovenous grafts and fistulae, concluded the investigators in JVIR.