New meta-analysis: No connection between paclitaxel-coated devices, mortality
In a new meta-analysis covering more than 7,000 patients with peripheral artery disease, there was no association between paclitaxel-coated devices and all-cause mortality, researchers reported.
“Given the clear benefit of paclitaxel-coated devices in femoropopliteal disease, we recommend the continued use of these devices in this patient population,” Andrew Holden, MBChB, FRANZCR, EBIR, ONZM, director of interventional radiology at Auckland City Hospital in New Zealand, said during a presentation at the International Symposium on Endovascular Therapy.
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 and 5 years in patients with PAD.
However, Holden said, those pivotal trials “were only powered for 1-year patency, not long-term mortality; the control groups were small and often there was 2:1 randomization; there was ascertainment bias in mortality assessment; and there was treatment bias, in that both groups were not treated the same after the index procedure.”
Holden and colleagues conducted a meta-analysis of randomized trials of paclitaxel-coated devices to treat patients with femoropopliteal disease which had all-cause mortality and were published by Dec. 10, 2020. The cohort included 7,654 patients, 84% of whom had intermittent claudication, from 34 trials.
Holden said there was no difference in all-cause mortality between those assigned a paclitaxel-coated device and controls at 12 months (RR = 0.99; 95% CI, 0.81-1.22; P = .94), 24 months (RR = 1.16; 95% CI, 0.87-1.55; P = .31) and 60 months (RR = 1.19; 95% CI, 0.98-1.45; P = .08).
“The time has arrived for regulators to provide updated and clear guidance on these devices for the benefit of patients globally,” Holden said during the presentation.
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Holden A, et al. CLI and complex PAD. Presented at: the International Symposium on Endovascular Therapy (ISET); May 9-11, 2021; Miami Beach, Florida (hybrid meeting).