Paclitaxel Safety

In this extract, Prof. Nasr discusses the controversy stemming from a 2018 meta-analysis that suggested an increased risk of all-cause mortality with paclitaxel-coated balloons and drug-eluting stents. This led to regulatory warnings and a decline in the use of these devices. However, subsequent studies and analyses have provided more nuanced insights. For instance, a pooled analysis of 1,980 patients from the In.Pact DCB program demonstrated no significant difference in all-cause mortality between the paclitaxel-coated balloon and the control arm at five years. Similarly, data from the ZILVER PTX randomized trial showed no statistically significant difference in all-cause mortality between the paclitaxel-eluting peripheral stent and the control group at five years.

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