Paclitaxel-coated devices not linked to death risk in PAD patients: NEJM
Sweden: The use of paclitaxel-coated devices versus uncoated endovascular devices is not associated with a significant increase in mortality risk, reveals results from an unplanned interim analysis of the SWEDEPAD trial. The findings were published in the New England Journal of Medicine.
The results from the analysis puts to rest concerns aroused from findings of a recent meta-analysis that showed an increased risk of death with the use of paclitaxel-coated angioplasty balloons and stents in lower-limb endovascular interventions for symptomatic peripheral artery disease.
Mårten Falkenberg, Gothenburg University, Gothenburg, Sweden, and colleagues conducted an unplanned interim analysis of data from SWEDEPAD -- a multicenter, randomized, open-label, registry-based clinical trial. At the time of analysis, 2289 patients were 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 the severity of the disease based on 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.
Key findings of the study include:
- 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).
- 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," wrote the authors.
The study titled, "Mortality with Paclitaxel-Coated Devices in Peripheral Artery Disease," is published in the New England Journal of Medicine.
DOI: https://www.nejm.org/doi/full/10.1056/NEJMoa2005206
