FDA NewsPerspective

FDA recommends temporary halt to use of paclitaxel-coated devices in most patients with PAD

The FDA warned that using paclitaxel-coated products in the treatment of peripheral arterial disease in the femoropopliteal artery may increase mortality risk, according to a letter released Friday.

The letter is a follow-up to one from January and gives expanded evidence on the potential risks of using paclitaxel-coated sleeves and stents. The warning is based on analysis of three trials with 5-year follow-up data in which a 50% increase in mortality risk was observed in those with peripheral arterial disease who were treated with these products.

The FDA announced at a special forum in early March that its own preliminary analysis had also found a mortality signal associated with paclitaxel-coated devices.

“Because of this concerning safety signal, we believe alternative treatment options should generally be used for most patients while we continue to further evaluate the increased long-term mortality signal and its impact on the overall benefit-risk profile of these devices,” the agency wrote in the letter.

The FDA advised health care providers to monitor patients who have already been given these treatments and consider alternatives for those who have not, except in circumstances such as high restenosis risk.

The FDA said it will continue to analyze this issue and consider the biological causes, risks and benefits of these treatments. This analysis will include convening the FDA’s Circulatory System Devices Panel to provide advice.

The FDA warned that using paclitaxel-coated products in the treatment of peripheral arterial disease in the femoropopliteal artery may increase mortality risk, according to a letter released Friday.

The letter is a follow-up to one from January and gives expanded evidence on the potential risks of using paclitaxel-coated sleeves and stents. The warning is based on analysis of three trials with 5-year follow-up data in which a 50% increase in mortality risk was observed in those with peripheral arterial disease who were treated with these products.

The FDA announced at a special forum in early March that its own preliminary analysis had also found a mortality signal associated with paclitaxel-coated devices.

“Because of this concerning safety signal, we believe alternative treatment options should generally be used for most patients while we continue to further evaluate the increased long-term mortality signal and its impact on the overall benefit-risk profile of these devices,” the agency wrote in the letter.

The FDA advised health care providers to monitor patients who have already been given these treatments and consider alternatives for those who have not, except in circumstances such as high restenosis risk.

The FDA said it will continue to analyze this issue and consider the biological causes, risks and benefits of these treatments. This analysis will include convening the FDA’s Circulatory System Devices Panel to provide advice.

    Perspective
    Krishna Rocha-Singh

    Krishna Rocha-Singh

    As cardiologists, we understand that the FDA is tasked with the safety of medical devices, and they saw a statistical safety signal, so I think they are well within their purview to recommend against using paclitaxel-coated devices in most patients with PAD until we learn more. I do think it’s a bit hyperbolic, however, to suggest that insurance agencies will stop reimbursing for use of these devices and that medicolegal issues should drive the issue as to whether physicians chose to use these devices in the best interest of their patients.

    Now, the die is cast, and we have to work together to best evaluate the cause of the mortality link. VIVA Physicians is aligning itself with all major industry stakeholders, have engaged an independent statistician expert in meta-analyses and have a statistical plan in the works. The FDA will review it and comment on this plan, but not necessarily endorse it, and then we will move forward very quickly with our patient-level data meta-analysis.

    The bottom line is that we need to define a signal with causation. We need to find the smoking gun, if there is one. And we need to do it very quickly.

    In the interim, doctors should follow data-driven guidelines and follow their ethical obligations to the best care of their patients. Personally, I would suggest we defer the interventional care of claudicants with these devices until the causation of the safety signal is defined. For patients with critical limb ischemia, however, we have to balance the potential, yet-to-be-defined risk for mortality with the best care of these high-risk patients. We have to move together quickly with the FDA and industry to define the potential safety signal with causation as soon as possible.

    • Krishna Rocha-Singh, MD, FACC, FAHA
    • Chief Scientific Officer
      Prairie Heart Institute of Illinois at St. John’s Hospital, Springfield, Illinois
      Board Member, VIVA Physicians

    Disclosures: Rocha-Singh reports he is a consultant for Medtronic.