Mortality is not associated with paclitaxel-coated devices usage in peripheral arterial disease of lower extremities

Dai Sik Ko,Jin Mo Kang,Jaehun Jung,Sang Tae Choi,Gi Hwan Bae

doi:10.1038/s41598-021-97675-9

Dai Sik Ko, Jin Mo Kang + Show 3 more

Open Access

https://doi.org/10.1038/s41598-021-97675-9

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Abstract

A recent meta-analysis addressed increased risk of death following revascularization with paclitaxel-coated devices in femopopliteal artery. We evaluated differences in all-cause mortality and amputation free survival between peripheral arterial disease (PAD) patients who were treated with paclitaxel-coated devices and non-paclitaxel-coated devices. This was retrospective population-based cohort study from the National Health Insurance Service claims in South Korea from 2015 to 2019. Multivariate Cox regression analyses after propensity score matching were applied to identify all-cause mortality and amputation-free survival. After propensity score matching, there were 6090 patients per group. The median follow-up days was 580 days (interquartile range [IQR] 240–991 days) and 433 days (IQR 175–757 days) for the non-paclitaxel-coated device group and paclitaxel-coated device group, respectively. Multivariate analysis adjusted for age, sex, diabetes, hypertension, warfarin, and new oral anticoagulants showed that the mortality rate associated with paclitaxel-coated devices was not significantly higher than non-paclitaxel-coated devices (hazard ratio [HR] 0.992; 95% CI 0.91–1.08). The rate of amputation events was higher in patients with paclitaxel-coated devices than those with non-paclitaxel-coated devices (HR 1.614; 95% CI 1.46–1.78). In this analysis, the mortality rate in patients with PAD was not associated with the use of paclitaxel-coated devices, despite a higher amputation rate.

Highlights

A recent meta-analysis addressed increased risk of death following revascularization with paclitaxelcoated devices in femopopliteal artery
A potential long-term safety concern was raised during a recent meta-analysis by Katsanos et al.They identified an increased mortality rate associated with the use of paclitaxel devices for femoropopliteal PAD8
This study included a total of 28,390 patients with health insurance claims who had been diagnosed with atherosclerosis of native arteries in the extremities (I702) and treated with four interventional modalities (PBA, bare metal stent (BMS), drugeluting balloons (DEBs), and drug-eluting stents (DES)) after September 2015

Summary

Introduction

A recent meta-analysis addressed increased risk of death following revascularization with paclitaxelcoated devices in femopopliteal artery. We evaluated differences in all-cause mortality and amputation free survival between peripheral arterial disease (PAD) patients who were treated with paclitaxel-coated devices and non-paclitaxel-coated devices. This was retrospective populationbased cohort study from the National Health Insurance Service claims in South Korea from 2015 to 2019. Endovascular intervention has gained global acceptance as the primary approach of revascularization for patients with PAD; post-procedural restenosis is common From this perspective, paclitaxel-coated devices have become increasingly popular in the treatment of PAD in reducing the high restenosis r ate[3,4]. A potential long-term safety concern was raised during a recent meta-analysis by Katsanos et al.They identified an increased mortality rate associated with the use of paclitaxel devices for femoropopliteal PAD8. A real-world clinical data could be a practical alternative for all-cause mortality analysis

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