When blood vessels stay open, blood flows smoothly and the body stays healthy, with fewer clinical symptoms.
- Stenosis or blockage of the leg arteries impairs blood flow: leg pain and numbness after walking a short distance (intermittent claudication).
- Stenosis of the dialysis access impairs blood flow, raises pressure and makes the access more prone to blockage.
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Minimally invasive (uncoated) balloon angioplasty is currently the main treatment.
A balloon is passed through a puncture in the skin into the vessel lumen and positioned at the narrowed segment. Inflating the balloon widens the narrowed vessel.
After balloon angioplasty, a certain proportion of vessels recoil over time and narrow again.
Repeated balloon angioplasty is therefore needed from time to time to keep the vessel open.
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Drug-coated balloon (DCB)
Offers another option: the effect of the drug helps maintain or improve vessel patency.
How it works
A drug-coated balloon has a layer of drug (usually paclitaxel) on its surface. During angioplasty, the balloon expands to open the narrowed vessel while the drug is released onto the vessel wall, inhibiting the proliferation of vascular smooth muscle cells, reducing the chance of re-narrowing and extending the life of the access.
Strengths
Compared with conventional balloon angioplasty, a drug-coated balloon can significantly reduce the rate of re-narrowing and extend the life of the access.
Disadvantages
Drug-coated balloons cost more (when used for dialysis access they are self-paid).
Re-narrowing is still possible, although less likely than with conventional balloon angioplasty.
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Several studies have now shown that drug-coated balloons can reduce re-narrowing of dialysis access.
Drug-coated balloons and conventional balloons differ clearly in treating vessel stenosis in dialysis patients. According to studies, the drug-coated balloon (DCB) is better than plain balloon angioplasty (PBA) at preventing re-narrowing. Patency at one year is higher, the re-narrowing rate is lower, and the need for repeat intervention (that is, repeat balloon angioplasty) is reduced.
With a drug-coated balloon, the risk of re-narrowing fell by about 20–30% on average, and one-year patency rose by about 15–20%. This means that drug-coated balloons offer a marked improvement over conventional balloons in keeping vessels open.
For patients who need long-term dialysis, the drug-coated balloon provides a more effective way of maintaining the vessel, helping to extend the useful life of the access and reduce complications and the need for repeat procedures.
The following are the latest developments on drug-coated balloon treatment for dialysis access, presented in 2024 at the Charing Cross International Symposium in the United Kingdom (an international vascular symposium held in London every year for nearly 50 years, and an important benchmark meeting in vascular therapy).
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What do the latest studies say? (Updated 2026)
In 2026, two leading vascular surgery journals published three studies on drug-coated balloons. The results are not entirely consistent and are summarized below:
- Meta-analysis (EJVES 2026): pooled 26 randomized controlled trials and 2,930 patients. Compared with a plain balloon, the odds ratio for loss of patency within 12 months with a drug-coated balloon was 0.54 (95% confidence interval 0.44–0.66), meaning roughly one repeat access intervention avoided for about every 7 drug-coated balloon angioplasties. The certainty of evidence for this result was rated “high”, but the certainty of evidence for access thrombosis and access abandonment remained “low”. (PubMed 41933692)
- French ABISS randomized trial (EJVES 2026): 145 patients with native fistula stenosis were randomized to a drug-coated balloon or a placebo balloon. The primary endpoint, loss of patency at 6 months, was 31% vs 42%, a difference that did not reach statistical significance; the difference was clear at 3 months (4.2% vs 22.5%), and at 12 months the two groups were similar (58.6% vs 57.7%). (PubMed 42379345)
- US Medicare real-world study (JVS 2026): 64,140 native fistula angioplasties; the cumulative 12-month reintervention rates were similar in the two groups (57.7% vs 56.9%), but the drug-coated balloon group needed retreatment later by about 8 days on average. This was a non-randomized analysis of claims data. (PubMed 42331153)
In short: overall, the studies suggest that drug-coated balloons may reduce the chance of retreatment within a year, but the effect may diminish over time, and the results of individual studies are not entirely the same. Whether a drug-coated balloon is suitable depends on the location and length of the stenosis and how often it has needed treatment in the past; please discuss it with your care team. Study results are statistics for groups of patients and do not predict the treatment outcome of an individual patient.
References:
- Drug-Coated Balloons: What’s Their Role in AV Access? – Endovascular Today: https://evtoday.com/articles/2015-june/drug-coated-balloons-whats-their-role-in-av-access
- Drug-Coated Balloon for Arteriovenous Access Stenosis in Hemodialysis Patients – MDPI: https://www.mdpi.com/2673-8236/1/1/4
- The Role of Drug-Coated Balloon in Haemodialysis Arteriovenous Fistula Stenosis Management https://pubmed.ncbi.nlm.nih.gov/37414842/