The U.S. Food and Drug Administration (FDA) issued a second notification to health-care providers Friday stating that its preliminary analysis of long-term 5-year follow-up data from pivotal pre-market randomized trials of paclitaxel-coated products (paclitaxel-coated balloons (DCB) and paclitaxel-eluting stents (PES)) for peripheral artery disease identifies a concerning signal of increased mortality in patients treated with these devices.
The FDA’s internal data pooled three randomized controlled trials of 975 patients and showed an approximate 50% increase in mortality risk for the DCB-treated patients (crude 5-year rate: 20.1% vs 13.4%) compared to control patients.
Although the FDA did say that these data should be “interpreted with caution,” the communication states, “… 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 FDA said it will convene an Advisory Committee of the Circulatory System Devices Panel in the near future to discuss the magnitude of a long-term mortality signal and guide regulatory actions.
The communication states that, based on these preliminary data, health-care providers should consider the following until more information is provided: 1) Diligently follow patients treated with either paclitaxel-coated balloons or paclitaxel-eluting stents; 2) Add to the consent process for treatment recommendation the increased rate of long-term mortality in patients treated with paclitaxel-coated balloons or paclitaxel-eluting stents; 3) Discuss the alternative treatment for DCB and PES during the risk-benefit review with patient; 4) For patients who have high risk for restenosis, paclitaxel products’ benefit may outweigh the risk; and 5) Ensure optimal medical therapy for this patient cohort.
This communication comes 10 days after a daylong Drug-Coated Balloon Safety Town Hall at Cardiovascular Research Technologies (CRT) 2019 in Washington, D.C., which included representatives from the FDA and industries along with clinicians and a patient advocate. At that town hall meeting, panelists agreed that there was a strong safety signal for paclitaxel-coated devices used in the femoral and popliteal arteries and that physicians recommending the use of these devices should discuss this safety signal with patients.