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Monday, August 1, 2016

Results from the RENOVA study show superiority of stent graft to balloon angioplasty in the treatment of arteriovenous graft stenosis


A national team of researchers led by Dr. Ziv Haskal of the University of Virginia have recently published their 2-yr results from the Prospective, Randomized, Concurrently-Controlled Study of an ENdOVAscular Stent Graft. The RENOVA trial, was conducted at 28 clinical sites in the U.S. and was designed to compare the use of an ePTFE stent graft to PTA alone for the revision of AV access graft-venous anastomotic stenosis through 2 years. A total of 270 patients were enrolled with malfunctioning AVG anastomotic stenoses of ≥50%. 138 patients underwent placement of a stent graft (SG) and 132 received angioplasty (PTA) alone. At 12 months, treatment area primary patency (TAPP) was: SG 47.6% vs. PTA 24.8% (p< 0.001) and access circuit primary patency (ACPP) was SG 24% vs. PTA 11% (p=0.007). At 24 months, TAPP was: SG 26.9% vs. PTA 13.5% (p<0.001) and ACPP was SG 9.5% vs. PTA 5.5% (p=0.01). The estimated number of re-interventions before graft abandonment was 3.4 for the SG group vs. 4.3 for PTA group. There were no significant differences in the adverse events (p>0.05) excepting restenosis requiring reintervention rates of 82.6% in PTA patients vs. 63.0% in SG (p<0.001). The authors concluded that at 2 years, Stent graft use provided a “sustained, greater than two-fold advantage over angioplasty in treatment area and overall access patency.”

Discussion


The FLAIR trial from 2010 showed 6-month superiority of the SG for both prolonging uninterrupted access function and patency of the target stenosis and led to FDA approval of the device. The RENOVA study has replicated and affirmed the pivotal trial results, extending the follow up to 2 years, and establishing the long-term superiority of this stent-graft for revision of failing anastomoses in prosthetic grafts as compared to repeated PTA. As detailed in the paper, the healthcare costs of maintaining a failed AV access are substantial. Further, given the burden associated repeat interventions upon patients, the use of SGs in this clinical scenario may offer significant advantages to the dialysis patient population and to the healthcare system as a whole.

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Haskal, Ziv J., et al. "Prospective, Randomized, Concurrently-Controlled Study of a Stent Graft versus Balloon Angioplasty for Treatment of Arteriovenous Access Graft Stenosis: 2-Year Results of the RENOVA Study." Journal of Vascular and Interventional Radiology 27.8 (2016): 1105-1114.

Post Author:
Luke R. Wilkins, MD
University of Virginia

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