Following a review, the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) has updated guidance on the use of paclitaxel-coated devices stating that such devices can be considered for the treatment of peripheral arterial disease (PAD), including intermittent claudication and critical limb-threatening ischemia (CLTI).
The MHRA had previously issued a statement in April 2022 on the use of paclitaxel drug-coated-balloons or drug-eluting stents in patients with CLTI which stated that they should only be used in patients where ‘the benefits may outweigh the risks’. The parameters for use outlined that exposure should be kept to a minimum, which referred to using the lowest dose device available and avoiding/reducing repeated exposure to a device. Furthermore, the 2022 guidelines noted that paclitaxel devices should not be used in the routine treatment of patients with intermittent claudication due to the reported risk of longer-term increased mortality.
The updated guidance has been issued following an extensive review of the most recent published literature alongside the MHRA’s request for the advice of the Interim Devices Working Group (IDWG) and other invited experts. The IDWG advised that the new studies did not support a statistically significant increased risk of harm associated with the use of paclitaxel-coated devices in patients with PAD, irrespective of disease type or severity.
In this update, the MHRA make reference to the 2023 evaluation of numerous randomized controlled trials and real-world studies which compared paclitaxel-coated devices versus control devices in a patient-level pooled analysis. Led by Sahil A. Parikh, MD, an interventional cardiologist at Columbia University Irving Medical Center in New York City, the analysis included a total of 2,666 participants with a median follow-up of 4.9 years. Their results showed that no significant increase in deaths were observed for patients treated with paclitaxel-coated devices, providing reassurance to patients, physicians and regulators on the safety of said devices.
Subsequently, the MHRA has removed its previous restrictions on indication, dose and repeated exposure for paclitaxel-coated devices for both intermitted claudication and CLTI.
