A scientific article has raised concerns about paclitaxel-coated balloons and paclitaxel-eluting stents used in the treatment of peripheral arterial disease (PAD). In response, the Federal Agency for Medicines and Health Products (FAMHP) hereby makes its recommendations.
The article by Katsanos et al. focuses on patients with intermittent claudication (those with a narrowing or a blockage in the artery which takes blood to their leg) who have been treated with paclitaxel-coated balloons (DCBs) and paclitaxel-eluting stents (DESs). The meta-analysis shows a statistically significant increase in general mortality from 2 to 5 years after treatment.
Global concern
No causal relationship between paclitaxel DCBs and DESs in the treatment of PAV and increased mortality has been established yet. Nevertheless, the article has raised great concern worldwide about clinical practice and clinical trials using paclitaxel DCBs and DESs in patients for whom paclitaxel DCBs or DESs are not absolutely necessary. This concern was also voiced in recent discussions at the panel meeting organised by the US Food and Drug Administration (FDA).
Recommendations
While further investigation is in progress, the FAMHP takes this safety signal very seriously and makes the following recommendations (FR - NL) to healthcare professionals:
- Do not use paclitaxel DCBs or DESs as a preferred treatment for intermittent claudication until further notice. Carefully estimate the risks and benefits for each patient.
- Discuss the risks and benefits of all available treatment options for PAV with patients. Inform patients about the uncertainty of increased mortality.
- Ensure proper follow-up for patients who have already been treated with a paclitaxel DCB or DES.
- Report any adverse event involving a paclitaxel DCB or DES to FAMHP using our online adverse event form.
Patients who are worried or have any questions about these aids should talk to their attending physician.