IN.PACT AV ACCESS | Drug-Coated Balloons for Dialysis Fistulas

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.

Balones farmacológicos en fístulas para diálisis

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.


Read also: 2 Year Outcomes of Lutonix Drug Coated Balloon in Superficial Femoral Arteries.


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.

Conclusion

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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