Drug-coated balloon angioplasty benefits dysfunctional dialysis fistulas patients: NEJM
USA: Treatment with a drug-coated balloon is beneficial over standard angioplasty for the treatment of stenotic lesion in patients on hemodialysis who had a dysfunctional arteriovenous fistula, according to a recent study in NEJM.
The current recommended treatment for dysfunctional hemodialysis fistulas is standard percutaneous transluminal angioplasty but the long-term outcomes of this treatment are poor. Delivery of antirestenotic agent paclitaxel via drug-coated balloons may be associated with improved outcomes. Robert A. Lookstein, Icahn School of Medicine at Mount Sinai, and colleagues conducted a prospective, single-blinded, 1:1 randomized trial, and enrolled 330 participants at 29 international sites.
The study included patients with new or restenotic lesions in native upper-extremity arteriovenous fistulas. A total of 330 participants were randomly assigned to receive treatment with a drug-coated balloon (n=170) or a standard balloon (n=160) after successful high-pressure percutaneous transluminal angioplasty.
The primary effectiveness endpoint was target-lesion primary patency, defined as freedom from clinically driven target-lesion revascularization or access-circuit thrombosis during the 6 months after the index procedure. The primary safety endpoint, serious adverse events involving the arteriovenous access circuit within 30 days, was assessed in a noninferiority analysis (margin of noninferiority, 7.5 percentage points).
Key findings of the study include:
- During the 6 months after the index procedure, target-lesion primary patency was maintained more often in participants who had been treated with a drug-coated balloon than in those who had been treated with a standard balloon (82.2% [125 of 152] vs. 59.5% [88 of 148]; difference in risk, 22.8 percentage points).
- Drug-coated balloons were noninferior to standard balloons with respect to the primary safety endpoint (4.2% [7 of 166] and 4.4% [7 of 158], respectively; difference in risk, −0.2 percentage points).
- Sensitivity analyses confirmed the results of the primary analyses.
"Drug-coated balloon angioplasty was superior to standard angioplasty for the treatment of stenotic lesions in dysfunctional hemodialysis arteriovenous fistulas during the 6 months after the procedure and was noninferior with respect to access circuit–related serious adverse events within 30 days," concluded the authors.
The study, "Drug-Coated Balloons for Dysfunctional Dialysis Arteriovenous Fistulas," is published in the New England Journal of Medicine