DCB versus PTA in AVF

Comparison of Clinical Effectiveness and Safety of Drug-Coated Balloons versus Percutaneous Transluminal Angioplasty in Arteriovenous Fistulae: A Review of Systematic Reviews and Updated Meta-Analysis

Clinical question

What does the most updated meta-analysis say about the safety and clinical effectiveness of drug-coated balloons versus percutaneous transluminal angioplasty for arteriovenous fistula stenosis?

Take away point

Drug eluting ballons have been shown to have consistent benefits in treating arteriovenous fistulae compared to percutaneous transluminal angioplasty in both primary patency and target lesion revascularization at 6 and 12 months, without increased mortality.

Reference

Lee, H., Choi, H., Han, E. and Kim, Y.J., 2024. Comparison of Clinical Efficacy and Safety of Drug-Coated Balloons versus Percutaneous Transluminal Angioplasty in Arteriovenous Fistulas: A Review of Systematic Reviews and Updated Meta-Analysis. Journal of Vascular and Interventional Radiology.

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Study design

Systematic review and meta-analysis

Funding Source

None reported

Setting

Academic

Figure

Figure 3. Forest plot of primary patency at 12 months. Pooled effect with 95% CI were estimated using a Mantel–Haenszel (M-H) random-effects model. DCB = drug-coated balloon; df = degree of freedom; PTA = percutaneous transluminal angioplasty.

Summary

Arteriovenous fistulae are primarily created for hemodialysis in patients with end-stage renal disease due to their lower infection risk and better maintenance compared to other types of access. However, they are usually plagued by stenosis and an eventual loss of patency. Percutaneous transluminal angioplasty is the conventional treatment, with drug-coated balloon emerging as a promising treatment option recently. Despite several systematic reviews and meta-analyses assessing the clinical effectiveness and safety of drug-coated balloons for arteriovenous fistulas and arteriovenous grafts, the results remain controversial. A comprehensive review of existing evidence and an updated meta-analysis were conducted to evaluate the clinical effectiveness and safety of drug-coated balloons compared to percutaneous transluminal angioplasty for arteriovenous fistula stenosis.

This study conducted a systematic review and meta-analysis following PRISMA guidelines, with a protocol registered in PROSPERO. An extensive search of MEDLINE, Embase, and Cochrane Library databases up to April 2023 used keywords related to "arteriovenous fistula," "drug-coated balloon," "angioplasty," and "hemodialysis." Studies were included if they involved patients with arteriovenous fistula stenosis, compared drug-coated balloon to standard or high-pressure percutaneous transluminal angioplasty, and reported primary patency, target lesion revascularization, or mortality. Only systemic reviews of randomized controlled trials, nonrandomized studies, or cohort studies were considered, excluding low-quality studies. Quality was evaluated using AMSTAR and appropriate bias assessment tools for original studies. Data synthesis involved narrative and quantitative analyses, with subgroup and sensitivity analyses to address heterogeneity and potential biases, using Revman 5.4 for meta-analysis and funnel plots for publication bias.

The results of this systematic review and meta-analysis are based on an extensive literature search that identified 257 systematic reviews, of which 11 were included. These reviews, published between 2019 and 2022, focused on patients with arteriovenous fistula stenosis undergoing angioplasty, comparing drug-coated balloon to standard or high-pressure balloon treatments. The primary outcome, primary patency, was assessed in 9 reviews, showing a general trend favoring drug-coated balloon at 6 and 12 months, with significant results in 7 outcomes and nonsignificant differences in 3 outcomes. Target lesion revascularization was reported in 3 reviews, indicating significantly lower target lesion revascularization rates for drug-coated balloon at 6 months and mixed results at 12 months. Mortality was reported in 4 reviews, showing no significant difference between drug and percutaneous transluminal angioplasty at 6 and 12 months. A meta-analysis update included 23 studies, revealing significantly more favorable primary patency for drug-coated balloon at 6 and 12 months but not at 24 months, and a lower risk of target lesion revascularization at 6 and 12 months. Mortality rates showed no significant difference at any time point. Subgroup analyses confirmed favorable primary patency for drug-coated balloon at 12 months across various device brands, study funding sources, and designs, with no evident publication bias.

The study highlighted the variability in outcomes due to heterogeneity among included studies, differences in study design, and various methodological factors. Despite these inconsistencies, the overall findings suggest that drug-coated balloon is more effective than percutaneous transluminal angioplasty in maintaining arteriovenous fistula patency without increasing mortality risk, although further well-designed studies are needed to confirm these results and address long-term outcomes and cost-effectiveness.

Commentary

This article provides a comprehensive and meticulous synthesis of current evidence on the use of drug-coated balloons compared to percutaneous transluminal angioplasty for treating arteriovenous fistula stenosis. By analyzing multiple systematic reviews and updating previous meta-analyses, the authors highlight the clinical benefits of drug-coated balloons, particularly in improving primary patency and reducing target lesion revascularization rates at 6 and 12 months. However, the study also underscores the variability and heterogeneity among the included studies, which pose challenges in drawing definitive conclusions. Notably, the review confirms that drug-coated balloons do not increase mortality risk, aligning with previous findings. Despite some limitations, including the need for more long-term data and consideration of cost-effectiveness, this article provides updated level 1 (SIR-A) evidence for drug-coated balloon’s efficacy and safety in the context of arteriovenous fistula stenosis. Further well-designed research may resolve existing discrepancies and provide better insights regarding longer-term clinical outcomes.