Updated Updated CIRSE Position Statement on the use of paclitaxel-coated balloons and stents in peripheral arterial disease (PAD)

Recent debates at various global meetings, corrections to original papers and an FDA update suggest that there is a safety signal associated with the use of paclitaxel-coated balloons and stents in PAD patients. A preliminary review by the FDA of the three pivotal RCTs (975 patients with 5-year follow-up data) comparing paclitaxel-coated balloons or stents with standard balloon angioplasty or uncoated stents has confirmed a higher mortality in patients treated with paclitaxel products. There was an approximate 50% increased crude risk of mortality in patients treated with paclitaxel products.

The latest FDA update can be found on this link

Clearly, these results are preliminary and should be interpreted with caution. The trials involved mainly claudicants, and involved exclusively femoropopliteal lesions and not BTK lesions.

Moreover, a specific cause and mechanism of the increased mortality is unknown, few trials have long term follow-up data and it will take more time and possibly new trials to determine the veracity of the increased safety signal.

In the meantime, and until more information is available, CIRSE sees no alternative but to take the position that:

1. In the majority of patients undergoing lower limb recanalization therapies, alternatives to drug eluting devices should be used.
2. For some individual patients at particularly high risk for restenosis, clinicians may decide that the benefits of using a paclitaxel-coated device may outweigh the risks.
3. Drug-eluting devices should only be used after a full informed consent process that has discussed the mortality implications from the Katsanos meta-analysis (1).
4. All patients who have already received paclitaxel-eluting devices should be followed up to assess for a potential effect on mortality.

(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

Updated CIRSE Position Statement

Updated CIRSE Position Statement on the use of paclitaxel-coated balloons and stents in peripheral arterial disease

Dear IRSA members

IRSA would like to draw your attention to the following updated CIRSE press release regarding Paclitaxel coated and

eluting devices in the treatment of peripheral vascular disease. Further information can be found here.



FDA Update

UPDATE: Treatment of Peripheral Arterial Disease with Paclitaxel-Coated Balloons and Paclitaxel-Eluting Stents Potentially Associated with Increased Mortality - Letter to Health Care Providers

IRSA would like to draw the attention of its members to the following press reserve from the FDA regarding the use of paclitaxel coated balloons and eluting stents in peripheral vascular disease. 

FDA Update

Interventional Radiology White Paper

Dear IRSA members,

The college has recently released an Interventional Radiology white paper for consultation link here

This is an important document as this details the college’s plans for IR moving forwards in Australia and New Zealand.

IRSA encourages members to read the document and to provide feedback either to the college directly, IRSA or both.  

The IRSA executive will be formulating a response to the white paper in due course.

Kind regards,

Gerard Goh

IRSA president

Important information regarding Drug eluting Technology

Paclitaxel coated balloons IRSA Statement


IRSA would like to draw members attention to a recently published meta-analysis on paclitaxel drug coated balloons, which has raised some controversy in the use of these devices.
See the full article here

Our partner Organisation, CIRSE, has issued a statement, which was sent to all IRSA members. The situation is evolving and IRSA will keep members informed of any developments as they arise.

Link ro CIRSE statement here

John Vrazas
Tim Buckenham