Research finds no association between paclitaxel-coated devices and mortality risk in patients with PAD

USA: An updated patient-level meta-analysis revealed no significant increase in mortality in patients exposed to paclitaxel-coated devices. The findings published in The Lancet provided reassurance to physicians, patients, and regulators on the safety of paclitaxel-coated devices.
The study found no significant increase in mortality between the paclitaxel-coated and control devices in both the intention-to-treat and as-treated analyses groups.
Several randomized controlled trials (RCTs) and real-world studies have supported the safety of paclitaxel-coated devices for treating femoropopliteal occlusive disease. However, a 2018 summary-level meta-analysis raised concerns about increased mortality risk for paclitaxel-coated devices compared with uncoated control devices.
Numerous randomised clinical trials and real-world studies have supported the safety of paclitaxel-coated devices for the treatment of femoropopliteal occlusive disease. However, a 2018 summary-level meta-analysis suggested an increased mortality risk for paclitaxel-coated devices compared with uncoated control devices. Despite methodological limitations of these meta-analyses, notices were issued by regulatory bodies worldwide that the use of paclitaxel-coated devices should be restricted for femoropopliteal occlusive disease.
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