Mortality in patients undergoing revascularization with paclitaxel eluting devices for infrainguinal peripheral artery disease: Insights from a network meta-analysis of randomized trials

Catheter Cardiovasc Interv. 2020 Oct 1;96(4):E467-E478. doi: 10.1002/ccd.29125. Epub 2020 Jul 21.

Abstract

Objectives: We aimed to evaluate whether paclitaxel eluting devices increased the risk of death in patients undergoing revascularization for infrainguinal peripheral artery disease using network meta-analyses.

Methods: PUBMED and EMBASE were searched through April 2020 for randomized trials in patients with infrainguinal peripheral artery disease who underwent revascularization with or without a paclitaxel eluting device (balloon/stent). Short-term mortality defined as death at 6-12 months, and long-term mortality defined as death at >12 months after revascularization.

Results: Our search identified 57 eligible randomized controlled studies enrolling a total of 9,362 patients comparing seven revascularization strategies (balloon angioplasty vs. bare metal stent vs. covered stent vs. paclitaxel eluting stent vs. other drug eluting stent vs. paclitaxel-coated balloon vs. bypass surgery). Overall, paclitaxel eluting stent and paclitaxel-coated balloons did not increase short-term mortality (eg, vs. balloon angioplasty: paclitaxel-coated balloon OR [95% CI] 1.21 [0.88-1.66], p = .24; paclitaxel eluting stent OR [95%CI] 1.01 [0.63-1.63], p = .97, respectively). In addition, paclitaxel eluting stent did not show significant increase in long-term mortality (eg, vs. balloon angioplasty: OR [95%CI] 1.06 [0.70-1.59], p = .79). However, paclitaxel-coated balloon showed significant increase in long-term mortality compared to balloon angioplasty and bypass (vs. balloon angioplasty: OR [95% CI] 1.48 [1.06-2.07], p = .021; vs. bypass: OR [95%CI] 1.73 [1.05-2.84], p = .031, respectively).

Conclusions: In this meta-analysis of randomized trials, there was no significant increase in mortality with paclitaxel eluting stent, but there was increased risk of long-term mortality in paclitaxel-coated balloon for the treatment of infrainguinal peripheral artery disease.

Keywords: femopopliteal artery disease; infrainguinal artery disease; infrapopliteal artery disease; paclitaxel eluting stent; paclitaxel-coated balloon.

Publication types

  • Meta-Analysis
  • Systematic Review

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Cardiovascular Agents / administration & dosage*
  • Coated Materials, Biocompatible*
  • Drug-Eluting Stents*
  • Endovascular Procedures / adverse effects
  • Endovascular Procedures / instrumentation*
  • Endovascular Procedures / mortality
  • Female
  • Humans
  • Male
  • Middle Aged
  • Network Meta-Analysis
  • Paclitaxel / administration & dosage*
  • Peripheral Arterial Disease / diagnostic imaging
  • Peripheral Arterial Disease / mortality
  • Peripheral Arterial Disease / therapy*
  • Prosthesis Design
  • Randomized Controlled Trials as Topic
  • Risk Assessment
  • Risk Factors
  • Time Factors
  • Treatment Outcome
  • Vascular Access Devices*

Substances

  • Cardiovascular Agents
  • Coated Materials, Biocompatible
  • Paclitaxel