The Cardiovascular and Interventional Radiological Society of Europe (CIRSE) has released a statement on the use of paclitaxel-coated balloons and stents in the treatment of peripheral arterial disease (PAD) following the paper published late last year by Konstantinos Katsanos (Patras, Greece) and colleagues in the Journal of the American Heart Association.
The statement from CIRSE reads:
“Recent debates at various global meetings, corrections to original papers and an FDA [US Food and Drug Administration] 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 randomised controlled trials (975 patients with five-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.
“Clearly, these results are preliminary and should be interpreted with caution. The trials involved mainly claudicants, and involved exclusively femoropopliteal lesions and not below-the-knee 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:
- In the majority of patients undergoing lower limb recanalisation therapies, alternatives to drug-eluting devices should be used.
- 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.
- Drug-eluting devices should only be used after a full informed consent process that has discussed the mortality implications from the Katsanos meta-analysis.
- All patients who have already received paclitaxel-eluting devices should be followed up to assess for a potential effect on mortality.”
Update from the SVS paclitaxel safety task force
In response to the updated letter to healthcare providers from the US Food and Drug Administration (FDA), the Society for Vascular Surgery (SVS) also released the a letter, signed by the SVS president, Michel Makaroun, and Kim Hodgson, chair of the SVS paclitaxel safety task force and president-elect of the SVS. The Society formed the paclitaxel safety task force earlier this year.
The SVS letter states that since their initial communication announcing the formation of the task force, “two additional developments regarding paclitaxel-delivering devices have prompted this member update.”
The developments are outlined here.