Endovascular community response to mortality data in use of paclitaxel devices for peripheral vascular disease.

OBJECTIVE

We examined the endovascular community response to data demonstrating increased mortality in paclitaxel devices for the treatment of peripheral arterial disease in femoropopliteal lesions.

METHODS

A retrospective observational study using the Vascular Quality Initiative Peripheral Vascular Intervention registry dataset was performed to examine paclitaxel device use for peripheral arterial disease in femoropopliteal arteries treated from 2017 to 2019. A total of 41,707 patients and 52,208 procedures were analyzed during the study period. A post hoc analysis was performed to examine paclitaxel device use during selected periods in 2019.

RESULTS

The total number of femoropopliteal procedures in 2017, 2018, and 2019 were 17,458, 21,140, and 21,322, respectively. Paclitaxel devices were used for 8852 arteries in 2017, 10,691 in 2018, and 6732 in 2019, which was significantly reduced in 2019 compared with 2017 or 2018 (P < .0001) and 2019 compared with the 2018 and 2017 volumes combined (P < .0001). Post hoc analysis of selected periods in 2019 demonstrated variable use throughout 2019.

CONCLUSIONS

After the report of data with concerns of mortality associated with paclitaxel device use in 2018, a rapid reduction in overall paclitaxel device use was observed in 2019.