Scott O. Trerotola
LAS VEGAS — In patients with dysfunctional hemodialysis arteriovenous fistulae, adding a drug-coated balloon to treatment with percutaneous transluminal angioplasty was safe and improved patency, a researcher reported at VIVA 17.
Researchers randomly assigned 285 patients at 23 centers with dysfunctional hemodialysis arteriovenous fistulae, all of whom received PTA, to further treatment with the DCB (Lutonix 035, Bard Peripheral Vascular) or a control balloon of similar design but without a drug.
The DCB in late August received FDA approval for this indication.
Scott O. Trerotola, MD, FACR, the Stanley Baum Professor of Radiology, associate chair and chief of interventional radiology at the Perelman School of Medicine at the University of Pennsylvania, presented the interim 18-month results.
The primary efficacy endpoint was target lesion primary patency at 6 months. The primary safety endpoint was freedom from serious adverse events related to the arteriovenous access circuit at 30 days.
At 6 months, target lesion primary patency was 71.4% in the DCB arm, and the DCB group required 32.6% fewer interventions to maintain target lesion patency vs. the control group, according to the results. At 30 days, the primary safety endpoint was met and “the curves were superimposed,” Trerotola said during a press conference.
A Kaplan-Meier analysis of the primary safety endpoint showed a trend in favor of the DCB arm at 18 months (difference in event-free rate, 11.6%; 95% CI, –0.9 to 24.2), Trerotola said.
“The curves begin to separate at about 60 days and remain separated all the way up to 18 months,” he said.
Target lesion primary patency at the interim of 18 months was 36.8% better in the DCB arm than the control arm (P = .038), he said, noting that “out to 18 months, there’s a sustained effectiveness benefit.”
Patients will be followed through 2 years, according to Trerotola.
“This is the first large, multicenter study to show that a technology is better than plain balloon angioplasty in fistulae,” he said during the press conference. – by Erik Swain
Trerotola SO, et al. Late-Breaking Clinical Trials. Presented at: VIVA 17; Sept. 11-14, 2017; Las Vegas.
Disclosures: The study was funded by Bard Peripheral Vascular. Trerotola reports he receives honoraria from Bard Peripheral Vascular and consults for Bard Peripheral Vascular, B. Braun, Cook Medical, Lutonix and Teleflex.