New England Journal of Medicine publishes first study to show minimally invasive interventional radiology approach for end-stage kidney disease patients 'superior' in treating blocked access
A randomized multicenter study of 190 patients at 13 medical centers shows-- for the first time-- the "superior" benefit of stent grafts over balloon angioplasty for maintaining function of dialysis access grafts in kidney failure patients who undergo dialysis. Until now, no other therapy has proven more effective than angioplasty. At six months, the stent grafts allowed dialysis patients to continue life-saving treatment with significantly fewer interruptions and invasive procedures, according to a study published in the Feb. 11 issue of the New England Journal of Medicine. Hemodialysis is the leading treatment for more than 340,000 patients in the United States with end-stage renal disease or kidney failure.
"Stent grafts are a game changer for dialysis patients, especially for those who suffer due to the repeated need for invasive procedures to maintain their ability to get dialysis," said Ziv J Haskal, M.D., FSIR, vice chair of strategic development and chief of vascular and interventional radiology at the University of Maryland Medical Center in Baltimore, Md.
"This study-- the first large prospective controlled study of its kind-- shows that this novel therapy (stent grafts) provides clear improvement over balloon angioplasty by prolonging the function of a patient's bypass without surgery-- helping individuals avoid additional invasive procedures and time in the hospital," noted Haskal, who is also professor of radiology and surgery at the University of Maryland School of Medicine. "Stent grafts overwhelmingly performed better than balloon angioplasty for maintaining access in dialysis patients, providing superior patency and freedom from repeat interventions," added the lead investigator and co-author of "Stent Graft Versus Balloon Angioplasty for Failing Dialysis-access Grafts." He noted, "What we've done is arguably supersede the results of surgery by improving the flow dynamics beyond those achievable with an operation."
Thirteen participating sites-- including academic, community-based, inpatient and freestanding outpatient dialysis centers-- enrolled 190 patients (69 men, 121 women) with failing arteriovenous (AV) grafts in this study, said Haskal. Ninety-seven patients received stent grafts, with 93 undergoing balloon angioplasty (percutaneous transluminal angioplasty or PTA). There were no significant differences between graft and PTA groups with respect to demographics or relevant medical history. Nearly 51 percent of dialysis accesses treated with stent grafts remained open at six months, as compared to just 23 percent of those treated with balloon angioplasties. Treating physicians had a nearly 94 percent success rate at implanting the stent grafts. There were no differences in adverse events between the two approaches.