Mortality with paclitaxel-coated devices in peripheral artery disease

Joakim Nordanstig, Stefan James, Manne Andersson, Mattias Andersson, Peter Danielsson, Peter Gillgren, Martin Delle, Jan Engström, Torbjörn Fransson, Maher Hamoud, Anna Hilbertson, Patrik Johansson, Lars Karlsson, Björn Kragsterman, Hans Lindgren, Karin Ludwigs, Stefan Mellander, Niklas Nyman, Henrik Renlund, Birgitta SigvantPer Skoog, Joachim Starck, Gustaf Tegler, Asko Toivola, Maria Truedson, Carl Magnus Wahlgren, Jonas Wallinder, Andreas Öjersjö, Mårten Falkenberg

Forskningsoutput: TidskriftsbidragArtikel i vetenskaplig tidskriftPeer review


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.

Sidor (från-till)2538-2546
Antal sidor9
TidskriftNew England Journal of Medicine
StatusPublished - 2020

Ämnesklassifikation (UKÄ)

  • Kardiologi


Utforska forskningsämnen för ”Mortality with paclitaxel-coated devices in peripheral artery disease”. Tillsammans bildar de ett unikt fingeravtryck.

Citera det här