Mortality with Paclitaxel-Coated Devices in Peripheral Artery Disease

Authors:
  • SJStefan James
    Stefan James
  • MAManne Andersson
    Manne Andersson
  • MAMattias Andersson
    Mattias Andersson
  • PDPeter Danielsson
    Peter Danielsson
  • PGPeter Gillgren
    Peter Gillgren
  • MDMartin Delle
    Martin Delle
  • JEJan Engström
    Jan Engström
  • TFTorbjörn Fransson
    Torbjörn Fransson
  • MHMaher Hamoud
    Maher Hamoud
  • AHAnna Hilbertson
    Anna Hilbertson
  • PJPatrik Johansson
    Patrik Johansson
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Abstract
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. 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. 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). 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. (Funded by the Swedish Research Council and others; ClinicalTrials.gov number, NCT02051088.)
Funding Information
  • Hjärt-Lungfonden (20130446)
  • Västra Götalandsregionen (ALFGBG 77190 and Regional 205531; ALFGBG 822921 an)
  • Swedish Research Council (521-2013-3436 and 921-2014-7231)

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