Drug-coated balloon angioplasty maintains patency better than standard balloon angioplasty in patients with dysfunctional hemodialysis (HD) arteriovenous fistulas (AVF), according to new study findings published in the New England Journal of Medicine.

In the international, multicenter, single-blind, IN.PACT AV Access trial (NCT03041467), investigators randomly assigned 330 HD patients with new or restenotic lesions in upper-extremity AVFs undergoing high-pressure percutaneous transluminal angioplasty to treatment with a paclitaxel-coated balloon (dose 3.5 μg/mm2 with a urea excipient) or a standard balloon.

This trial evaluated the effectiveness and safety of a distinct drug-coated balloon with a different paclitaxel dose and excipient to treat stenoses within dysfunctional HD arteriovenous fistulas, Robert A. Lookstein, MD, of Mount Sinai in New York, New York, and colleagues explained.

Over 6 months, significantly more patients treated with the paclitaxel-coated balloon had target-lesion primary patency: 82.2% vs 59.5% (P <.001). Approximately half the patients in the paclitaxel-coated than the standard balloon group required revascularization during the 6 months following the index procedure: 16.3% vs 39.9%, respectively (P <.001). In addition, treatment rates for access-circuit thrombosis did not differ significantly between groups: 2.0% vs 3.4%, respectively.


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With respect to safety, similar proportions of patients treated with the drug-coated and standard balloons experienced serious adverse events involving the arteriovenous access circuit within 30 days: 4.2% vs 4.4%, respectively (P =.002 for noninferiority).

“The six-month data demonstrate that with IN.PACT AV DCB, we can cut the number of reinterventions required to maintain vessel patency in half. This technology may positively impact patients’ quality of life, and demonstrate meaningful reductions in projected costs to the healthcare system,” Dr Lookstein stated in a press release from Medtronic. “Right now, this is very important for [end stage kidney disease] patients on hemodialysis, who are at especially high risk of acquired infections. This technology may have the potential to allow these patients to experience continued, uninterrupted access to life-saving dialysis care, including fewer hospital visits to get their access sites maintained.”

Future studies are needed to evaluate the safety and effectiveness of drug-coated balloons for the treatment of central vein obstruction, in-stent restenosis, and arteriovenous graft stenosis.

Disclosure: This clinical trial was supported by Medtronic. Please see the original reference for a full list of authors’ disclosures.

References

Lookstein RA, Haruguchi H, Ouriel K, et al. Drug-coated balloons for dysfunctional dialysis arteriovenous fistulas. N Engl J Med. 383:733-42. doi:10.1056/NEJMoa1914617

Study Published in The New England Journal of Medicine Demonstrates Patients Experience Fewer Disruptions to Dialysis Therapy When Treated with Medtronic Drug-Coated Balloon [press release]. Dublin. Medtronic; August 19, 2020.