RENOVA Results Support Stenting to Improve Access for Dialysis Patients

April 15, 2013—The Society of Interventional Radiology (SIR) announced that 12-month data from the RENOVA trial indicate that kidney failure patients on dialysis derive long-term benefit from the minimally invasive placement of a stent that improves the function of dialysis access grafts. RENOVA is a prospective, multicenter, randomized, and concurrently controlled comparison of the Flair endovascular stent graft (Bard Peripheral Vascular, Tempe, AZ) versus balloon angioplasty in dialysis access grafts. The results were revealed in Abstract 237—named SIR’s Abstract of the Year—at the society’s 38th Annual Scientific Meeting held in New Orleans, April 13–18, 2013. This abstract is available online at the meeting’s Web site, www.SIRmeeting.org.

“Results of the study exceeded our expectations, and that is a boon for dialysis patients,” commented the study’s principal investigator, Ziv J. Haskal, MD, in SIR’s press release. “Dialysis is very demanding, and anything that prevents access sites from failing and reduces the need for invasive treatments of surgery will dramatically improve patients’ quality of life—while reducing health care costs.” Dr. Haskal is Professor of Vascular and Interventional Radiology at the University of Maryland School of Medicine in Baltimore; he is also Editor of SIR’s Journal of Vascular and Interventional Radiology

According to SIR, the 12-month data from the RENOVA trial show that dialysis sites can be successfully kept open using stent grafts for far longer than previously reported. In the study, 270 dialysis patients treated for collapsed access sites at 28 centers in the United States were randomized and 138 subjects received stent grafts while the remaining 132 patients had balloon angioplasty. After 12-month follow-up, the investigators found that two-and-half times more patients in the stent graft group were able to continue to use their dialysis access grafts than those who were being treated by balloon angioplasty alone (without invasive interim procedures). Before these data were known, grafts have been considered short-term solutions, with 75% requiring invasive interventions in under a year, noted Dr. Haskal in the SIR announcement.

“This area where the graft is sewn in, that allows blood to flow back up the arm toward the heart, has particular turbulence,” stated Dr. Haskal. “That turbulence, like a river bend, tends to incite tissue growth at the sides. Just like a river depositing sediment along a bend, these veins thicken and narrow. More than 100,000 angioplasties are performed a year due to this narrowing. What this stent method does is not only reopen the vein, but turn the graft into an inline flow, so that the blood enters the vein at a more natural angle.”

Dr. Haskal added, “It was a wholly foreign concept when we started. People told me it was crazy. Anecdotally, we now have patients who have these stent grafts that are still open after 3 years. That is practically unheard of. This controlled study proves that we can achieve durable long-term solutions for these patients, reducing their invasive procedures and thus improving their quality of life.”