LINC 2020: Geographical “inconsistencies” cast doubt on paclitaxel mortality signal

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Peter Schneider (San Francisco, USA) talks to BLearning Peripheral at LINC 2020 (Leipzig Interventional Course; 28–31 January 2020, Leipzig, Germany) about the relevance of dose relationship and geographical data when discussing the controversy surrounding the use of paclitaxel devices in peripheral arterial disease patients.

Schneider says that the key thing is to understand whether the relationship between paclitaxel and mortality is just an association” or “an actual causal relationship”. He notes that “if we have a dangerous agent on our hands”, it should be consistent in terms of being equally dangerous no matter where it is employed. However, Schneider highlights that looking at the data of paclitaxel-coated balloons in various countries has shown that there is “no signal” in Japan, “little or no signal” identified in the EU” and that the only signal seems to be related to the US, which Schneider describes as a “geographical inconsistency”.

Schneider believes that the importance of understanding these issues is of paramount importance and that as a physician he takes any signal on mortality “extremely seriously” but also does not want to leave “our most efficacious tool on the shelf gathering dust” if the risk is not significant.

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