The Medicines and Healthcare Products Regulatory Agency (MHRA) has established an expert advisory group to review the safety of paclitaxel drug-coated balloon catheters and drug-eluting stents.
The decision follows the publication of findings suggesting an increased risk for death following application of paclitaxel‐coated balloons and stents in the femoropopliteal artery of the lower limbs.
The review and meta-analysis of 28 randomised controlled trials, published in Journal of the American Heart Association late last year, investigated the safety of paclitaxel‐coated devices in the femoral and/or popliteal arteries. It found that all‐cause death at two years was significantly increased with paclitaxel versus non-coated balloons or bare metal stents (risk ratio [RR], 1.68; 95% CI, 1.15-2.47). All‐cause death up to five years increased further with paclitaxel (RR, 1.93; 95% CI, 1.27-2.93).
The MHRA says that the expert advisor group toxicology has already begun the process of reviewing the available “but highly complex information on these medical devices”. The group has been asked to consider whether the publication’s findings and device-specific clinical study results are statistically robust and whether there is any evidence of a causal relationship between the paclitaxel and increased mortality.
“The aim is to provide a greater understanding of the potential benefits and risks to patients and will help to guide any possible future MHRA action,” the agency said. The group is expected to complete the review within the next few months.
Additionally, the MHRA is collaborating with major clinical and regulatory stakeholders, including the British Society of Interventional Radiology, the UK Basil-3 trial and National Institute for Health and Care Excellence, as well as other European and global regulatory authorities.