In December 2018 a study (Katsanos et al) published findings which raised concerns over the use of paclitaxel eluting balloons and stents in the treatment of patients with peripheral arterial disease (PAD) and in particular the femoropopliteal artery in the leg. These devices are used to treat patients in which a build-up of deposits in the arteries restricts blood supply to leg muscles, also known as peripheral vascular disease (PVD).
Following this publication, an independent Expert Advisory Group (EAG) was formed, made up of leading UK clinicians from specialist societies, including interventional radiology and vascular surgery, supported by MHRA scientists with toxicology, and statistical expertise, to advise the MHRA.
The EAG was 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 drug, paclitaxel, and increased mortality. It was also asked to provide recommendations to the MHRA on the benefits and risks of the use of these devices in the treatment of PAD.
The review concluded that the statistical analysis in the Katsanos paper is robust. The review also considers there is a possible dose dependent effect of the use of paclitaxel coated/eluting devices on mortality although no scientific or clinical explanation is currently available.
The EAG recommended that these devices are not used to treat patients with intermittent claudication (a pain in the leg caused by the lack of blood flow). This is a condition that may be treated effectively with other devices and therapies. The devices may still be considered in patients with critical limb ischaemia (severe obstruction of the arteries), where it is felt that the benefits outweigh the risks and taking NICE guidance into account. If these devices are to be used there should be enhanced patient follow-up.
After receiving the recommendations, the MHRA has acted to limit the future use of these devices in routine clinical care, until more is known on this issue.
If you think you’re affected, please contact your GP, vascular specialist or other healthcare professional.
The MHRA encourages anyone, patient, carer or healthcare professional, who is aware of a safety complication or adverse event associated with a medical device, to report to us via the Yellow Card scheme.
Patients requiring treatment for PAD can continue to be treated with alternative therapies and devices. However, for some patients, clinicians may consider using these devices if they believe this is the best option for the individual. The MHRA’s advice allows clinicians to consider all the benefits and risks on an individual patient basis to make the most appropriate treatment choice.
The EAG recommended that future research is undertaken to evaluate the causal relationship between these devices and mortality. In line with the EAG’s recommendations, the MHRA will consider the available evidence supporting the use of these devices for other conditions.
The US FDA is leading a review of patient-level data from clinical trials involving these devices. The MHRA will consider any further information concerning the safety of these devices. It will take any regulatory action and update its guidance where necessary.