Skip to main content

Lund University Publications

LUND UNIVERSITY LIBRARIES

Mortality with paclitaxel-coated devices in peripheral artery disease

Nordanstig, Joakim ; James, Stefan ; Andersson, Manne ; Andersson, Mattias ; Danielsson, Peter ; Gillgren, Peter ; Delle, Martin ; Engström, Jan ; Fransson, Torbjörn LU orcid and Hamoud, Maher , et al. (2020) In New England Journal of Medicine 383(26). p.2538-2546
Abstract

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... (More)

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.

(Less)
Please use this url to cite or link to this publication:
author
; ; ; ; ; ; ; ; and , et al. (More)
; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; and (Less)
organization
publishing date
type
Contribution to journal
publication status
published
subject
in
New England Journal of Medicine
volume
383
issue
26
pages
9 pages
publisher
Massachusetts Medical Society
external identifiers
  • scopus:85098653068
  • pmid:33296560
ISSN
0028-4793
DOI
10.1056/NEJMoa2005206
language
English
LU publication?
yes
id
a03cac1e-3d61-4b3d-a149-3b1c0c2b85b9
date added to LUP
2021-01-14 13:31:55
date last changed
2024-04-18 00:02:52
@article{a03cac1e-3d61-4b3d-a149-3b1c0c2b85b9,
  abstract     = {{<p>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.</p>}},
  author       = {{Nordanstig, Joakim and James, Stefan and Andersson, Manne and Andersson, Mattias and Danielsson, Peter and Gillgren, Peter and Delle, Martin and Engström, Jan and Fransson, Torbjörn and Hamoud, Maher and Hilbertson, Anna and Johansson, Patrik and Karlsson, Lars and Kragsterman, Björn and Lindgren, Hans and Ludwigs, Karin and Mellander, Stefan and Nyman, Niklas and Renlund, Henrik and Sigvant, Birgitta and Skoog, Per and Starck, Joachim and Tegler, Gustaf and Toivola, Asko and Truedson, Maria and Wahlgren, Carl Magnus and Wallinder, Jonas and Öjersjö, Andreas and Falkenberg, Mårten}},
  issn         = {{0028-4793}},
  language     = {{eng}},
  number       = {{26}},
  pages        = {{2538--2546}},
  publisher    = {{Massachusetts Medical Society}},
  series       = {{New England Journal of Medicine}},
  title        = {{Mortality with paclitaxel-coated devices in peripheral artery disease}},
  url          = {{http://dx.doi.org/10.1056/NEJMoa2005206}},
  doi          = {{10.1056/NEJMoa2005206}},
  volume       = {{383}},
  year         = {{2020}},
}