No mortality signal in trial paused due to paclitaxel-coated device concerns
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An interim analysis of the SWEDEPAD trial, which was paused after a meta-analysis detected a mortality hazard associated with paclitaxel-coated devices, found no death risk from the devices in patients with peripheral artery disease.
As Healio previously reported, a summary-level meta-analysis of pivotal trials of paclitaxel-coated devices published in December 2018 found elevated mortality risk associated with the devices compared with controls at 2 years and 5 years in patients with PAD. One of the immediate effects of the news was the pausing of recruitment of the randomized, open-label, registry-based SWEDEPAD trial on Dec. 10, 2018.
The SWEDEPAD investigators conducted an unplanned interim analysis of the 2,289 patients (809 with claudication, 1,480 with chronic limb-threatening ischemia) who had been randomly assigned to treatment for PAD with a paclitaxel-coated device or an uncoated device. They published their findings in The New England Journal of Medicine.
During a mean follow-up of 2.49 years, there was no difference between the groups in all-cause mortality (paclitaxel group, 25.5%; uncoated group, 24.6%; HR = 1.06; 95% CI, 0.92-1.22), Joakim Nordanstig, MD, PhD, from the department of molecular and clinical medicine, Institute of Medicine, Sahlgrenska Academy, Gothenburg University, Sweden, and colleagues wrote.
There was also no difference between the groups in death at 1 year (paclitaxel group, 10.2%; uncoated group, 9.9%; HR = 1.03; 95% CI, 0.77-1.37).
Among patients with chronic limb-threatening ischemia, there was no difference between the device groups in death at 2.49 years (HR = 1.04; 95% CI, 0.9-1.21) or at 1 year (HR = 1; 95% CI, 0.75-1.35), according to the researchers. The same was true in patients with intermittent claudication (HR for death at 2.49 years = 1.18; 95% CI, 0.72-1.93; HR for death at 1 year = 1.26; 95% CI, 0.49-3.24).
“Because this interim analysis does not show a significantly higher incidence of death resulting from use of paclitaxel-coated devices than from the use of uncoated devices, we believe that equipoise remains, and recruitment has recently resumed, with enrollment of patients in both the chronic limb-threatening ischemia cohort and the intermittent claudication cohort,” Nordanstig and colleagues wrote.
The goal of the trial is to determine whether paclitaxel-coated devices improve quality of life and reduce amputations compared with uncoated devices in patients with PAD, they wrote.
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