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Paclitaxel-coated peripheral artery devices are not associated with increased mortality.

Authors
  • Kumins, Norman H1
  • King, Alexander H2
  • Ambani, Ravi N2
  • Thomas, Jones P2
  • Bose, Saideep2
  • Shishehbor, Mehdi H2
  • Li, Jun2
  • Wong, Virginia L2
  • Harth, Karem C2
  • Cho, Jae S2
  • Kashyap, Vikram S2
  • 1 Harrington Heart and Vascular Institute, University Hospitals, Cleveland Medical Center and Case Western Reserve University, Cleveland, Ohio. Electronic address: [email protected]
  • 2 Harrington Heart and Vascular Institute, University Hospitals, Cleveland Medical Center and Case Western Reserve University, Cleveland, Ohio.
Type
Published Article
Journal
Journal of vascular surgery
Publication Date
Sep 01, 2020
Volume
72
Issue
3
Pages
968–976
Identifiers
DOI: 10.1016/j.jvs.2019.10.100
PMID: 31917036
Source
Medline
Keywords
Language
English
License
Unknown

Abstract

Long-term safety concerns have been raised that the use of paclitaxel-coated balloons and stents is linked to excess mortality. Our objective was to compare outcomes in patients treated with paclitaxel vs uncoated devices and to analyze long-term mortality. We conducted a retrospective single-institution review of 1170 consecutive patients who underwent femoropopliteal percutaneous revascularization by angioplasty, atherectomy, stent placement, or combination between 2011 and 2018. The primary outcome measure was all-cause mortality. Groups were divided into patients who received paclitaxel (n = 652) and those who did not (n = 518). Categorical variables were assessed using χ2 analysis and continuous variables with the Wilcoxon signed rank test. A multivariable analysis was performed using multivariable logistic regression models. Mortality was compared using Kaplan-Meier survival analysis. Demographics, risk factors, and Rutherford class were similar between the groups, except that the paclitaxel group was more likely to have diabetes (60.9% vs 55.0%; P = .04), was less likely to be on dialysis (10.7% vs 14.9%; P = .04), and had lower average creatinine concentration (1.6 ± 1.8 mg/dL vs 2.0 ± 2.3 mg/dL; P = .003). There were no differences in all-cause mortality through 2 years between paclitaxel and no-paclitaxel cohorts (25.5% vs 30.3%; log-rank, P = .098). At 3 years and 3.5 years, mortality was significantly lower in the paclitaxel group: year 3, 32.1% vs 39.4% (log-rank, P = .041); year 3.5, 35.2% vs 43.9% (log-rank, P = .027). Survival rates were not significantly different in examining subgroups by diabetes, chronic kidney disease, presence of chronic limb-threatening ischemia, or paclitaxel-coated balloon manufacturer. Multivariable analysis demonstrated that age, dialysis, chronic limb-threatening ischemia, chronic kidney disease, and congestive heart failure were independent risk factors for mortality, whereas paclitaxel use was associated with lower mortality. The use of paclitaxel-coated balloons and stents does not increase mortality compared with uncoated devices out to 3.5 years. Paclitaxel-coated devices can be used with continued caution, especially in patients at increased risk of restenosis. Further long-term studies are needed to determine the risk of late mortality. Copyright © 2019 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.

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