April 11, 2019

CIRSE Position Statement Addresses the Use of Paclitaxel-Coated Devices in PAD

April 12, 2019—The Cardiovascular and Interventional Radiological Society of Europe (CIRSE) announced an updated CIRSE Position Statement on the use of paclitaxel-coated balloons and stents in treating peripheral artery disease (PAD).

The document is the society's initial response to the findings from a meta-analysis of randomized controlled trials (RCTs) of these device that were published online in December 2018 in Journal of the American Heart Association (JAHA), as well as the subsequent debates at various global meetings, corrections to original papers, and a United States FDA update that suggest there is a safety signal associated with the use of paclitaxel-coated balloons and stents in patients with PAD.

As noted by CIRSE, on March 15, the FDA published its update advising health care providers that the agency's preliminary review of three pivotal RCTs (975 patients with 5-year follow-up data) of these devices confirmed a higher mortality in patients treated with paclitaxel products, with an approximate 50% increased crude risk of mortality in patients treated with paclitaxel products. The FDA also announced that it will convene an Advisory Committee meeting of the Circulatory System Devices Panel, with details to be provided shortly.

CIRSE advised that these results are preliminary and should be interpreted with caution. The society noted that the trials involved mainly claudicants and involved exclusively femoropopliteal lesions and not below-the-knee lesions. Moreover, a specific cause and mechanism of the increased mortality are unknown, few trials have long term follow-up data, and it will take more time and possibly new trials to determine the veracity of the increased safety signal.

Until more information is available, CIRSE's position includes the following:

  • In the majority of patients undergoing lower limb recanalization therapies, alternatives to drug-eluting devices should be used.
  • For some individual patients at particularly high risk for restenosis, clinicians may decide that the benefits of using a paclitaxel-coated device may outweigh the risks.
  • Drug-eluting devices should only be used after a fully informed consent process that has discussed the mortality implications from the JAHA meta-analysis.
  • All patients who have already received paclitaxel-eluting devices should be followed up to assess for a potential effect on mortality.

For all news related to the ongoing controversy regarding paclitaxel use in PAD, please visit Endovascular Today's comprehensive continuing coverage page.


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