Paclitaxel-coated devices may prevent death in people undergoing endovascular revascularization

Exposure to paclitaxel-coated devices (PCDs) does not appear to increase the risk of death among patients who are undergoing endovascular revascularization for lower limb peripheral artery disease, suggest the results of DETECT, a nationwide, retrospective cohort study. In contrast, exposure to PADs may even help lower the risk of mortality.

DETECT used medico-administrative data from the French National Healthcare System representing >99 percent of the population. The main inclusion criterion was the first procedure of interest: endovascular revascularization for lower limb peripheral artery disease involving one or more balloon and/or stent performed between 1 October 2011 and 31 December 2019.

Finally, the research team compared patients with or without PCDs for all-cause mortality until 31 December 2021.

Overall, 259,137 patients met the eligibility criteria for analysis. Of these, 20,083 (7.7 percent) received treatment with at least one PCD.

A total of 5,386 deaths per 73,923 person-years (PY) and 109,844 deaths per 1,060,513 PY occurred in the PCD and control groups, respectively, after a median follow-up of 4.1 years.

In multivariable Cox analysis, adjusted for confounding factors, PCD treatment significantly correlated with reduced risk of death (hazard ratio, 0.86, 95 percent confidence interval [CI], 0.84‒0.89; p<0.001). These results persisted when using propensity score matching approaches based on either nearest-neighbour or exact matching.

“In a nationwide analysis based on large-scale real-world data, exposure to PCDs was not associated with a higher risk of mortality in patients undergoing endovascular revascularization for lower limb peripheral artery disease,” the researchers said.