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

Sci Rep. 2021 Sep 14;11(1):18214. doi: 10.1038/s41598-021-97675-9.

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.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Aged, 80 and over
  • Amputation, Surgical / statistics & numerical data
  • Angioplasty, Balloon / adverse effects*
  • Angioplasty, Balloon / methods
  • Comorbidity
  • Female
  • Humans
  • Leg
  • Male
  • Middle Aged
  • Paclitaxel / adverse effects*
  • Peripheral Arterial Disease / surgery*
  • Postoperative Complications / etiology
  • Postoperative Complications / mortality*
  • Postoperative Complications / surgery
  • Stents / adverse effects

Substances

  • Paclitaxel