Two-Year RENOVA Results Compare Stent Graft Versus PTA to Treat Arteriovenous Graft Anastomotic Stenosis

July 7, 2016—The final 2-year results of the RENOVA study were published by Ziv J. Haskal, MD, et al online ahead of print in the Journal of Vascular and Interventional Radiology (JVIR).

RENOVA is a prospective, randomized, concurrently controlled study comparing an expanded polytetrafluoroethylene stent graft (SG) versus percutaneous transluminal angioplasty (PTA) for the treatment of arteriovenous graft (AVG) anastomotic stenosis. 

As summarized in JVIR, the RENOVA study enrolled 270 patients at 28 sites in the United States. All patients had malfunctioning AVG anastomotic stenoses of ≥ 50%. In the study, 138 patients underwent SG placement, and 132 underwent PTA alone. Follow-up imaging and intervention were event driven. The study was completed by 191 patients (97 SG, 94 PTA). Five patients were lost to follow-up or withdrew, and 74 patients died during the study (38 SG, 36 PTA). 

The investigators reported that at 12 months for SG versus PTA, respectively, treatment area primary patency (TAPP) was 47.6% versus 24.8% (P < .001), access circuit primary patency (ACPP) was 24% versus 11% (P = .007), and index of patency function (IPF) was 5.2 ± 4.1 months/intervention versus 4.4 ± 3.5months/intervention (P = .009). 

At 24 months, TAPP was 26.9% versus 13.5% (P < .001), ACPP was 9.5% versus 5.5% (P = .01), and IPF was 7.1 ± 7 months/intervention versus 5.3 ± 5.2 months/intervention. The estimated number of reinterventions before graft abandonment was 3.4 for SG patients versus 4.3 for PTA patients. There were no significant differences in adverse events (P > .05) except for restenosis requiring reintervention rates of 82.6% in PTA patients versus 63% in SG patients (P < .001).

The investigators concluded that at 2 years, SG use provided a sustained, more than twofold advantage over PTA in treatment area and overall access patency. Additionally, time to subsequent intervention was longer in the SG group, advised the investigators in JVIR.