Drug-coated balloon angioplasty benefits dysfunctional dialysis fistulas patients: NEJM

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). 

"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

DOI: 10.1056/NEJMoa1914617