A recent analysis of over 270,000 Medicare fee-for-service beneficiaries has found an increase in adverse outcomes and death after a US Food and Drug Administration (FDA) warning led to decreased use of paclitaxel-coated devices for peripheral revascularisation procedures.
Writing in the Journal of the American College of Cardiology (JACC), a team of researchers from the Richard A and Susan F Smith Center for Outcomes Research at the Beth Israel Deaconess Medical Center (Boston, USA) begin by stating that peripheral revascularisation has faced “intense scrutiny” in the past decade.
The authors—Joseph M Kim and colleagues—first cite the impact of a 2018 meta-analysis associating paclitaxel-coated devices with increased mortality when used for peripheral revascularisation. The paper led the FDA to warn against routine use of such devices. It was not until 2023, the authors add, that the FDA reversed its warning following the publication of several further studies showing no mortality signal.
COVID-19 also impacted peripheral revascularisation, Kim et al continue, noting that the pandemic “complicated peripheral arterial disease (PAD) management by reducing access to patient care”.
To assess the impact of these events, the researchers conducted a study to evaluate trends in femoropopliteal revascularisation from 2016 to 2023 and to analyse safety outcomes during three key time periods: 1) before the paclitaxel safety concern; 2) after the onset of the paclitaxel safety concern; and 3) during and after the COVID-19 pandemic.
Kim and colleagues detail that their study included all Medicare fee-for-service beneficiaries aged ≥66 years who underwent femoropopliteal revascularisation by International Classification of Diseases-10th Revision codes between 1 January 2016 and 31 December 2023.
Regarding statistical analysis, the authors state that they examined trends of femoropopliteal artery revascularisation procedures by quarter year across the eight-year study period. Endovascular revascularisation procedures were stratified by percutaneous transluminal angioplasty (PTA) alone, drug-coated balloon (DCB) alone, bare metal stent (BMS) alone, or drug-eluting stent (DES) alone.
The study’s primary outcome was the composite of major amputation and all-cause mortality.
“During the study period, the number of endovascular revascularisation procedures declined 38.2%; the number of surgical revascularisation procedures declined 59.7%,” Kim et al report in JACC.
The authors share that PTA was the primary method (27.72%) used for endovascular revascularisation before the onset of the paclitaxel-coated device safety concern, followed closely by DCB (24.91%). After the paclitaxel safety concern, the use of DCBs declined to a low of 17.89% by 2019, with a proportional increase in the use of uncoated PTA (34.52%).
In addition, Kim and colleagues write that the proportion of DCB use increased after the onset of COVID-19. “By the time of the FDA’s reversal of its warning against routine use of drug-coated devices in 2023,” the authors continue, “DCB use had reached 23.46%.” They go on to note that the use of uncoated PTA stabilised at a proportion higher than was seen before the safety concern.
Furthermore, Kim et al reveal that revascularisations performed between the paclitaxel safety concern and the COVID-19 pandemic were associated with a higher rate of the primary outcome compared with procedures performed before the paclitaxel safety concern. They note that this was driven by increased risk of all-cause mortality.
“By contrast,” Kim and colleagues report, “there were lower rates of major amputation after the paclitaxel safety concern.”
“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,” the authors write in their discussion. “The use of DCBs 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 their routine use.”
Regarding limitations to their study, Kim et al recognise that claims data lack detailed anatomical and procedural information, and that the Medicare population “may not represent the US population at large, including those who are younger, are of minority background, or are privately insured”.
Eric Secemksy, senior author of the study, remarks on the significance of the findings: “This analysis is critical in informing how external events impact patient care. Between device safety concerns and the COVID-19 pandemic, treatment approaches changed dramatically for lower extremity interventions and patient outcomes were negatively impacted. How we approach existential threats to peripheral vascular care will require thought and caution, as informed by these novel data that were generously supported by the SCAI [Society for Cardiovascular Angiography and Interventions] Early Career Research Grant.”
