Industry concerns over paclitaxel-coated devices may have put PAD patients at risk
Safety concerns related to the use of paclitaxel-coated devices to treat peripheral artery disease (PAD) resulted in a significant decrease in the utilization of drug-coated balloons and drug-eluting stents, according to new data published in the Journal of the American College of Cardiology.[1] This trend appears to have been at least partially responsible for a rise in all-cause mortality among patients undergoing endovascular revascularization procedures.
Looking back at recent safety concerns related to paclitaxel-coated devices
Back in December 2018, a meta-analysis published in the Journal of the American Heart Association found that paclitaxel-coated balloons and paclitaxel-eluting stents were associated with a heightened mortality risk.[2] This created a bit of controversy at the time and even influenced the U.S. Food and Drug Administration (FDA) to issue a warning in 2019 that alternative treatments other than paclitaxel-coated devices should be considered in the future.
As the years went on, however, it became clear that the findings from that 2018 meta-analysis were not being seen in other studies. In 2023, the FDA officially reversed its stance on paclitaxel-coated balloons and paclitaxel-eluting stents, highlighting their ability to “improve blood flow to the legs and decrease the need for repeat procedures.”
Tracking utilization before and after safety concerns
For this new analysis, researchers hoped to track how the use of paclitaxel-coated devices had been impacted by the years of uncertainty and the FDA’s warning. The group explored data from more than 275,000 Medicare fee-for-service beneficiaries who underwent femoropopliteal revascularization from 2016 to 2023. Overall, the number of endovascular procedures revascularization procedures decreased by 38.2% over the course of the study. From 2016 to 2018, percutaneous transluminal angioplasty (PTA) with bare stents was the most common treatment (27.7%) used during these procedures, followed closely by drug-coated balloons (24.9%). By 2019, however, PTA utilization was up to 34.5% and drug-coated balloons utilization was down to 17.9%.
By the end of the study, researchers added, the use of uncoated PTA had “stabilized” at 31.4%, notably higher than it had been before the FDA issued its warning. Meanwhile, all-cause mortality had increased.
“The paclitaxel safety concern sparked a rapid shift away from the use of paclitaxel-coated devices and toward the use of uncoated devices, particularly PTA,” wrote first author Joseph M. Kim, MD, a cardiology fellow with Beth Israel Deaconess Medical Center, and colleagues. “The use of drug-coated balloons has only recently regained some ground since its nadir in 2019, but their use remains remarkably low relative to PTA despite evidence supporting their superior efficacy and the FDA’s reversal of its warning against routine use.”
Kim et al. also wrote that the COVID-19 pandemic likely played a role in patient mortality, but this trend was already underway before the pandemic, “suggesting that alternative factors played a role.”
This study was funded in part by a grant from the Society for Cardiovascular Angiography and Interventions (SCAI).
“This analysis is critical in informing how external events impact patient care,” co-author Eric Secemsky, MD, MSc, director of vascular interventions at Beth Israel Deaconess Medical Center, said in a separate statement put out by SCAI. “Between device safety concerns and the COVID-19 pandemic, treatment approaches changed dramatically for lower extremity interventions and patient outcomes were negatively impacted.”
Click here to read the full analysis.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.