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Does paclitaxel-coated balloon angioplasty improve the patency of a malfunctioning arteriovenous fistula?

limited confidence  ·  Last reviewed October 12, 2026

For a failing arteriovenous fistula (an AVF, a surgically created vein-and-artery connection used for dialysis), a paclitaxel-coated balloon appears to help keep the treated area open longer than a standard plain balloon. The strongest evidence comes from a 2026 multicenter randomized controlled trial that compared a scoring paclitaxel-coated balloon (a balloon with a drug coating plus surface scoring elements) against conventional plain balloon angioplasty in adults with malfunctioning mature fistulas or grafts 9. At six months, the coated balloon kept the target lesion open in 78.9% of cases versus 57.3% with the plain balloon, a difference of about 21 percentage points that was statistically significant 9.

What the research says

The 2026 trial enrolled 219 treated participants across nine centers in China, randomly assigning them to either predilation-free scoring paclitaxel-coated balloon angioplasty or conventional plain balloon angioplasty 9. The primary endpoint was 6-month target lesion primary patency, meaning the treated segment stayed open without needing another intervention 9. The coated balloon group reached 78.9% patency versus 57.3% for the plain balloon group, with a center-adjusted absolute difference of 21.2 percentage points (95% CI 8.1 to 37.1; P = 0.004) 9.

At 12 months, the advantage narrowed and was no longer statistically significant: 63.5% versus 52.4%, an absolute difference of 11.1 percentage points (95% CI -2.2 to 24.4; P = 0.1043) 9. This suggests the benefit may be strongest in the first six months and may fade over time, though the trial was likely not powered to detect a smaller difference at one year 9. The trial also reported device success, procedural success, clinical success, mortality, and adverse events as secondary outcomes 9.

It is worth being clear about what the other available sources do and do not cover. Several sources in this set discuss paclitaxel in completely different contexts, such as treating breast cancer 23, nasopharyngeal carcinoma 8, triple-negative breast cancer 7, and mechanisms of paclitaxel resistance in solid tumors 5. None of those address arteriovenous fistula patency. Other sources cover AVF-related topics like physical therapy for pain 1 and self-management interventions 4, but neither evaluates paclitaxel-coated balloons. So the question of whether paclitaxel-coated balloon angioplasty improves AVF patency rests almost entirely on the single randomized trial 9.

What to ask your doctor

  • Ask whether a paclitaxel-coated balloon is an option for my specific fistula and whether it is covered by my insurance or available at my center.
  • Ask how the expected benefit (about 21 percentage points better patency at 6 months in the trial) compares with the risks and costs for my situation 9.
  • Ask what happens if the treated area narrows again, and what the plan would be at 6 months and 12 months.
  • Ask whether the benefit seen at 6 months but not clearly at 12 months in the trial matters for how often I might need repeat procedures 9.
  • Ask about any concerns with paclitaxel coating itself, given that this is a drug-coated device.

This question is drawn from common patient questions about Cardiology and answered using cited medical research. We do not provide individualized advice.