GAITHERSBURG, MD. – There was sufficient evidence of a late mortality signal seen at 2-5 years post procedurally for paclitaxel-eluting stents and coated balloons to warrant a label change for the devices, the Food and Drug Administration’s Circulatory System Devices Panel unanimously agreed after 2 days of deliberation.
That signal was brought to light in a meta-analysis published last December by Konstantinos Katsanos, MD, of Patras University Hospital, Rion, Greece, and colleagues (). Although there were concerns about the quality of the industry data used in the study, the caliber of the analysis itself and the subsequent data presented by the FDA to the panel were deemed sufficient to recommend a warning of concern to patients and providers.
Much of the new data from industry and large database registries presented to the panel, which was chaired by, indicated a lessening to no evidence of the mortality effect. But this evidence was deemed insufficient to counter the evidence of the randomized controlled trials individually and collectively as presented in the Katsanos meta-analysis and subsequent information presented by the FDA that examined various parameters in a variety of sensitivity analyses that confirmed the late mortality signal. There was also concern that the industry and the registry analyses presented were not peer reviewed.
However, the panel also determined that it would be inappropriate to pull the devices from the market and from general use for several reasons.
One key reason was that, according to the panel, there was no mechanistic cause apparent for the late mortality. In addition, no convincing dose-response data could be teased from the preclinical and clinical trials studied because of their variability of devices, application methods, and lack of appropriate tissue analysis across studies.