Peter Schneider - The data negates a mortality spike with paclitaxel DCB.

The seminal talk for me from day one of Charing Cross 2022. Schneider spoke eloquently about 3 aspects.

1 - The bulk of Katsanos’ 2018 paper data (50% of it) was from the ZILVER PTX study. In that RCT, a substantial number of patients who were not randomised to DCB on the Intention To Treat analysis were in fact eventually treated with paclitaxel. Upon analysing the patient level ‘actual treatment’ data, there is no difference in mortality between the DCB and non DCB angioplasty groups.

2 - Subsequent registry data, including SWEDE PAD and a subgroup analysis of VOYAGER PAD studies, are not substantiating any mortality spike with paclitaxel

3 - All patient-level data meta-analysis, as opposed to summary-level data meta-analysis, is not reflecting a mortality spike with paclitaxel. Schneider on his penultimate slide was highly critical of and bemused by the fresh MHRA guidance that has come out in the UK in March 2022, stating that DCB shouldn't be used in claudicants, seeing as much of the data in the Katsanos trial was from IC pts.