U.K. medtech regulators have recommended a ban on routine use of paclitaxel drug-coated balloons (DCBs) and drug-eluting stents in patients with intermittent leg cramps, but held back on recommending the same for patients with critical limb ischemia.
U.S., U.K. and French regulators began raising concerns about the risk of increased long-term mortality in people with peripheral artery disease who were treated with paclitaxel-coated devices compared to those treated with bare devices following the December publication of a meta-analysis of patient outcomes.
U.K. and French regulators began investigations in March after the FDA told doctors that a preliminary review of long-term follow-up data found a “potentially concerning signal” of increased long-term mortality in people with peripheral artery disease who were treated with paclitaxel-coated devices.
In January, the FDA said that it plans to assess long-term follow-up data from studies that supported the approval of paclitaxel-coated balloons or paclitaxel-eluting stents in the U.S. The agency is focusing on causes of death within these studies, paclitaxel dose delivered and patient characteristics.
U.K. regulators said the risk of mortality from using the paclitaxel-coated balloons and stents in leg-cramp patients “generally outweighs the benefits,” while the benefits outweigh the risk of using the devices in critical limb ischemia patients. “This is because these patients generally have a higher risk of irreversible ischemic damage resulting from restenosis, and a lower life expectancy,” the Medicines and Healthcare Products Regulatory Agency (MHRA) said in a news release.
The MHRA also recommended that healthcare providers assess the relative risks on an individual patient basis, provide informed consent, “enhanced life-long follow-up” and report any serious adverse events and cause of death.
The FDA and French regulators are continuing to investigate the possibility of a link between the use of paclitaxel-coated balloons and stents and increased mortality over two to five years. MHRA said it will review the need to update its advice as further evidence emerges.
