The IN.PACT AV Access study, recently published in the New England Journal of Medicine (NEJM), showed that drug-coated balloons are superior for the treatment of stenotic lesions in arteriovenous fistulas for dialysis compared with conventional balloons.
Dialysis fistulas are an unknown territory for paclitaxel-eluting balloons, since the formal recommendation in the guidelines is conventional angioplasty (which, by the way, has rather poor outcomes).
The IN.PACT AV Access was a prospective, single-blinde trial including 330 patients at 29 international sites.
Patients with new or restenotic lesions in native upper-limb arteriovenous fistulas were eligible for participation. After successful angioplasty with high-pressure balloons, participants were randomly assigned to receive treatment with a drug-coated balloon or a standard balloon.
The primary endpoint was lesion patency, defined as freedom from new revascularization or access-circuit thrombosis within 6 months from the index procedure.
After a 6-month follow-up, patency in participants who had been treated with a drug-coated balloon was 82.2% vs. 59.5% for those treated with conventional angioplasty (p < 0.001). Drug-coated balloons were non-inferior as regards the safety endpoint.
Drug-coated balloons are superior to standard angioplasty for the treatment of stenotic lesions in dysfunctional hemodialysis arteriovenous fistulas.
Original Title: Drug-Coated Balloons for Dysfunctional Dialysis Arteriovenous Fistulas.
Reference: Robert A. Lookstein et al. N Engl J Med 2020;383:733-42. DOI: 10.1056/NEJMoa1914617.
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