Paclitaxel-coated balloons or stents | North Bristol NHS Trust

This page is for patients whose vascular surgeon or interventional radiologist thinks they would benefit from treating a narrowing in their blood vessel with special balloon or stent coated with a drug called paclitaxel. We hope to following information will answer some of the questions you may have about this procedure.

What is paclitaxel?

Paclitaxel is a drug used to prevent the smooth muscle cells in your blood vessel from growing. If these cells were to grow, it could cause another blockage in your blood vessel.

Research studies show that balloons and stents coated with paclitaxel increase the chance that the treated blood vessel will remain open after your treatment. This could lower the likelihood that you will need a repeat procedure to re-open the vessel in the future.

Are there any risks or complications associated with paclitaxel-coated balloons or stents?

The risks of having an angioplasty or a stent insertion are outlined in the angiography and angioplasty patient information leaflet which you have also received. There are potentially additional risks with having a paclitaxel-coated balloon or stent.

Based on the result of a single study published in 2018¹ there is a possibility that the use of balloons and stents coated with paclitaxel may increase your chance of death about 2 years after treatment.

When compared to treatment with uncoated balloons or bare metal stents there is also information that suggests that the use of these balloons and stents coated with paclitaxel may increase your chance of death over the next 2-5 years.²

This study¹ has several limitations, its results are widely debated, and further research is still ongoing.

Your doctors believe that the benefit of using a balloon or stent coated with paclitaxel would outweigh the potential increased risk of death shown in the previously mentioned research paper. This is by improving the likelihood that your vessel remains open after the treatment for longer, either because:

Other treatment options without paclitaxel have already been tried and failed.
Other treatment options, including bypass surgery, would not be technically possible or would be even riskier for you.
Not treating the narrowing in your blood vessel would likely cause you significant permanent damage or a condition that would threaten your limb or even your life.

Are there any other options?

There may be other options for the treatment of your symptoms including medications, exercise, balloons, stents or other devices that do not contain paclitaxel and surgery. You should discuss with your doctor the possible risks and benefits of all treatments to identify those options that are best for you.

References

(1) Katsanos K, Spiliopoulos S, Kitrou P, Krokidis M, Karnabatidis D. Risk of death following application of paclitaxel-coated balloons and stents in the femoropopliteal artery of the leg: a systematic review and meta-analysis of randomized controlled trials. J Am Heart Assoc 2018;7(24):e011245-e011245.

(2) MHRA statement : Paclitaxel drug-coated balloons (DCBs) or drug-eluting stents (DESs): Reconfirmed position on use in patients with intermittent claudication and critical limb ischaemia (DSI/2021/001) Paclitaxel drug-coated balloons (DCBs) or drug-eluting stents (DESs): Reconfirmed position on use in patients with intermittent claudication and critical limb ischaemia (DSI/2021/001) - GOV.UK (www.gov.uk)