UK Regulator Appoints Expert Advisory Group to Review Paclitaxel Devices in PAD
March 20, 2019—The United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) announced the formation of an independent Expert Advisory Group (EAG) to review paclitaxel-coated balloon catheters and paclitaxel-eluting stents used to treat patients with peripheral artery disease (PAD), particularly in the femoropopliteal artery.
The action is a response to the findings of a systematic review and meta‐analysis of randomized controlled trials evaluating paclitaxel‐coated balloons and stents in the femoral and/or popliteal arteries, concluding that there is an increased risk of death after application of these devices in this anatomy. Konstantinos Katsanos, MD, et al published the original study online in the Journal of the American Heart Association (JAHA).
According to the agency, the EAG has begun the process of reviewing the available but highly complex information on these medical devices. The group is composed of leading United Kingdom clinicians from specialist societies, including interventional radiology, vascular surgery, and scientists with toxicology, medicine, and statistical expertise.
The devices in question have valid CE Mark approval and remain commercially available in the United Kingdom. The investigation will determine if new advice is required or if MHRA needs to undertake any other regulatory action.
The MHRA stated that the Katsanos et al study suggests a possible increased mortality rate from 2 to 5 years in patients with PAD treated with paclitaxel-coated balloons and paclitaxel-eluting stents compared with patients treated with noncoated balloons or bare-metal stents. The agency noted that a causal relationship for this observation has not been identified and may reflect limitations in the way the data were analyzed, but this has yet to be determined. MHRA acknowledged that there are a number of other publications that produced different results and opinions taking into account other factors such as the overall health of the patient.
The EAG has been asked to consider whether the JAHA 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.
MHRA advised that it has provided the EAG with the full spectrum of source material available to the agency, together with all relevant published information the agency has gathered. The aim is to provide a greater understanding of the potential benefits and risks to patients and to help guide any possible future MHRA action. The EAG has agreed to undertake and complete their review, including reporting their findings to MHRA, within the next few months.
The agency is collaborating with the major clinical and regulatory stakeholders, including the British Society of Interventional Radiology, the United Kingdom's BASIL-3 trial, and the National Institute for Health and Care Excellence, as well as other European and global regulatory authorities.
For links to all of Endovascular Today's coverage and other key documents on the continuing discussion regarding paclitaxel in PAD, please visit this page.