Drug-coated balloons show benefits for patients with dysfunctional dialysis fistulas
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Compared with a standard balloon, treatment with a drug-coated balloon led to improved outcomes for patients on hemodialysis who had a dysfunctional arteriovenous fistula.
Additional findings from the randomized trial showed safety was comparable between the two forms of treatment.
“Standard percutaneous transluminal angioplasty is the current recommended treatment for dysfunctional hemodialysis fistulas, yet long-term outcomes of this treatment are poor,” Robert A. Lookstein, MD, of Icahn School of Medicine at Mount Sinai, and colleagues wrote. “Drug-coated balloons delivering the antirestenotic agent paclitaxel may improve outcomes.”
These improved outcomes could lead to longer periods of “successful and uninterrupted dialysis,” while also reducing catheter use and the incidence of related adverse events, according to the researchers.
For the study, 330 patients with new or restenotic lesions in native upper-extremity arteriovenous fistulas were randomized to treatment with either a drug-coated or standard balloon. Efficacy was assessed by whether patients achieved freedom from clinically driven target-lesion revascularization or access circuit thrombosis in the 6 months following the procedure (termed here as target-lesion primary patency). Safety was determined by the number of serious adverse events involving the arteriovenous access circuit within 30 days.
During the 6 months after the procedure, Lookstein and colleagues found target-lesion primary patency was maintained more often in patients who had been treated with a drug-coated balloon than in those who had been treated with a standard balloon (82.2% vs. 59.5%).
Regarding safety, drug-coated balloons were deemed noninferior to standard balloons. More specifically, an analysis of the percentage of patients who experienced a serious adverse event within 30 days was 4.2% for those treated with the drug-coated balloon and 4.4% for those treated with the standard balloon. Further findings showed that, during 12 months, mortality was 9.4% for those treated with the drug-coated balloon and 9.6% of those treated with standard balloon.
According to the researchers, these findings are promising and demonstrate a potential short-term benefit of treatment with drug-coated balloons.
“In defining the benefits of this therapy, it is notable that dialysis circuit stenoses have indirect consequences that go far beyond local hemodynamic effects,” Lookstein and colleagues added. “If a patient has a dysfunctional arteriovenous fistula, placement of a central venous catheter is often used as an alternative form of dialysis.”
Emphasizing that catheter-based dialysis confers poor outcomes — including higher risk for mortality from cardiovascular and infectious causes — they contended that utilizing drug-coated balloons for treating dysfunctional AV fistulas could have a significant and positive impact.
“Any treatment method that has the potential to offer patients with end-stage renal disease uninterrupted hemodialysis can dramatically affect patients over the course of their lives,” the researchers concluded.
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