Paclitaxel is an antiproliferative agent used for drug-coated balloons and drug-eluting stents for peripheral artery disease interventions. Drug-coated devices decrease the risk of restenosis and the likelihood of repeat interventions. A meta-analysis published almost 3 years ago showed a signal of an increased late risk of death associated with the use of paclitaxel-coated devices.1 Clinicians and patients were advised by the US Food and Drug Administration to consider both the benefits and the potential for increased mortality risk when making treatment decisions. No plausible mechanism for higher mortality was identified. Some authors have suggested that paclitaxel may exert negative long-term effects and that an unknown amount of the compound may embolize downstream of the target lesion. A recent study showed that longer drug-eluting stents may be associated with increased mortality.2 However, in the article reviewed here, an unplanned interim analysis did not show a significantly higher mortality rate with paclitaxel-coated devices. The total duration of follow-up in this trial (≤4 years) was longer than most trials and no patients were lost to follow-up.

By the time you read this review, more articles relating to paclitaxel-coated devices will likely have been published and likely with conflicting results.

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