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).