1. Drug-coated balloon angioplasty was superior to standard angioplasty for stenotic lesion treatment in hemodialysis arteriovenous fistulas.
2. Drug-coated balloon angioplasty was shown to be noninferior to standard angioplasty for adverse events.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Arteriovenous (AV) fistulas are given preference over central venous hemodialysis catheters during hemodialysis treatment. The AV fistulas provide access for renal replacement therapy while maintaining low risk for infection. However, one limitation of AV fistulas are the high incidence of vascular stenoses within the fistula circuit known as dysfunction. As such, this study investigated whether a paclitaxel-coated balloon angioplasty improved outcome in patients with dysfunctional fistulas compared to standard angioplasty. The results of the study demonstrated that the drug-coated balloon angioplasty was superior for treatment of stenotic lesions in AV fistulas compared to standard angioplasty. This randomized trial was limited by its non-blinded study design, as the drug-coated balloon had a different appearance than the standard balloon. Nonetheless, the study found a potential solution for AV fistula dysfunction to widen the adoption of this type of access.
In-Depth [randomized controlled trial]: This randomized control trial enrolled 330 participants in a multicenter study at 29 sites in the Untied States, Japan, and New Zealand. Participants included in the study had a native AV fistula created at least 60 days before the procedure and used dialysis between 8 to 12 times in a four-week period. Participants with a history of access-circuit thrombosis or a previous stent in the access circuit were excluded from this study. The participants were randomized in a 1:1 ratio to receive drug-coated balloon angioplasty or standard (non-drug-coated) balloon angioplasty. The primary outcome was patency of the targeted stenotic lesion. Target-lesion patency was defined as the freedom from target-lesion revascularization or access-circuit thrombosis. During the six-month follow-up period, 82.2% (125 or 152) in the drug-coated balloon group and 59.5% (88 of 148) in the standard balloon group maintained target-lesion patency (risk difference, 22.8 percentage points; 95% confidence interval [CI], 12.8 to 32.8; P<0.001). At the end of the follow-up period, the percentage of participants with target-lesion patency was 81.4% in the drug-coated balloon group compared to 59.0% in the control group (hazard ratio, 0.39; 95% CI, 0.24 to 0.61). Additionally, there was no significant difference for the risk of access-circuit thrombosis between the two groups (drug-coated balloon group, 2.0%; standard-balloon group, 3.4%; risk difference, -1.4%; 95% CI, -5.1 to 2.3). Finally, the drug-coated balloon (4.2%) was shown to be noninferior to the standard balloon (4.4%) with respect to serious adverse events involving the AV access-circuit (risk difference, -0.2 percentage points; 95% CI, -5.5 to 5.0; P=0.002 for noninferiority). The most frequent adverse event was AV fistula site complication in both groups (drug-coated balloon group, 3.0%; standard balloon group, 2.5%). Taken together, the drug-coated balloon angioplasty was shown to be significantly superior to standard balloon angioplasty for the treatment of stenotic lesion in hemodialysis AV fistulas.
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