The rollercoaster of paclitaxel in the lower limbs and skeletons in the closet: An opinion review.

Abstract There have been concerns about the long-term risk of all-cause death with the use of paclitaxel-coated devices in the lower limbs. The 2018 meta-analysis was corroborated by FDA analyses and later confirmed by an individual patient data meta-analysis. However, population-based observational studies have produced contradictory results and often claimed a survival benefit with use of paclitaxel. The recently published Swedepad trial did not confirm a significant mortality risk. The authors discuss key elements of the identified mortality signal, and stress important facts and figures that remain under-recognized and elusive. They also highlight important types of epidemiological bias pertaining to the ongoing paclitaxel debate.