Mortality with paclitaxel-coated devices in peripheral artery disease

Research output: Contribution to journalArticle


BACKGROUND The results of a recent meta-analysis aroused concern about an increased risk of death associated with the use of paclitaxel-coated angioplasty balloons and stents in lower-limb endovascular interventions for symptomatic peripheral artery disease. METHODS We conducted an unplanned interim analysis of data from a multicenter, randomized, open-label, registry-based clinical trial. At the time of the analysis, 2289 patients had been randomly assigned to treatment with drug-coated devices (the drug-coated-device group, 1149 patients) or treatment with uncoated devices (the uncoated-device group, 1140 patients). Randomization was stratified according to disease severity on the basis of whether patients had chronic limb-threatening ischemia (1480 patients) or intermittent claudication (809 patients). The single end point for this interim analysis was all-cause mortality. RESULTS No patients were lost to follow-up. Paclitaxel was used as the coating agent for all the drug-coated devices. During a mean follow-up of 2.49 years, 574 patients died, including 293 patients (25.5%) in the drug-coated-device group and 281 patients (24.6%) in the uncoated-device group (hazard ratio, 1.06; 95% confidence interval, 0.92 to 1.22). At 1 year, all-cause mortality was 10.2% (117 patients) in the drug-coated-device group and 9.9% (113 patients) in the uncoated-device group. During the entire follow-up period, there was no significant difference in the incidence of death between the treatment groups among patients with chronic limb-threatening ischemia (33.4% [249 patients] in the drug-coated-device group and 33.1% [243 patients] in the uncoated-device group) or among those with intermittent claudication (10.9% [44 patients] and 9.4% [38 patients], respectively). CONCLUSIONS In this randomized trial in which patients with peripheral artery disease received treatment with paclitaxel-coated or uncoated endovascular devices, the results of an unplanned interim analysis of all-cause mortality did not show a difference between the groups in the incidence of death during 1 to 4 years of follow-up.


  • Joakim Nordanstig
  • Stefan James
  • Manne Andersson
  • Mattias Andersson
  • Peter Danielsson
  • Peter Gillgren
  • Martin Delle
  • Jan Engström
  • Maher Hamoud
  • Anna Hilbertson
  • Patrik Johansson
  • Lars Karlsson
  • Björn Kragsterman
  • Karin Ludwigs
  • Stefan Mellander
  • Niklas Nyman
  • Henrik Renlund
  • Birgitta Sigvant
  • Per Skoog
  • Gustaf Tegler
  • Asko Toivola
  • Maria Truedson
  • Carl Magnus Wahlgren
  • Jonas Wallinder
  • Andreas Öjersjö
  • Mårten Falkenberg
External organisations
  • Linköping University
  • Ryhov County Hospital, Jönköping
  • Sunderby Hospital
  • Halmstad County Hospital
  • Karolinska Institutet
  • Södersjukhuset
  • Karolinska University Hospital
  • Skåne University Hospital
  • Skaraborg Hospital
  • Central Hospital Kristianstad
  • Växjö Central Hospital
  • Gävle Hospital
  • Uppsala University
  • Helsingborg Hospital
  • NU Hospital Group
  • Karlstad Hospital
  • University of Gothenburg
  • Västerviks sjukhus
  • Örebro University Hospital
  • Umeå University
  • Kalmar County Hospital
  • South Elfsborg Hospital
  • Sundsvall Hospital
  • Uppsala University Hospital
Research areas and keywords

Subject classification (UKÄ) – MANDATORY

  • Cardiac and Cardiovascular Systems
Original languageEnglish
Pages (from-to)2538-2546
Number of pages9
JournalNew England Journal of Medicine
Issue number26
Publication statusPublished - 2020
Publication categoryResearch