Kenneth Ouriel (New York, USA) talks to BLearning Peripheral at LINC 2020 (Leipzig Interventional Course; 28–31 January 2020, Leipzig, Germany) about a recent independent analysis to assess safety outcomes of femoropopliteal drug-coated balloon (DCB) angioplasty using patient-level data from the Lutonix clinical programme–and further studies looking at data with the IN.PACT DCB and Stellarex DCB.
This particular independent analysis, explains Ouriel, included an oncologist on the review committee to re-examine the adverse events and deaths in order to determine if these were related to paclitaxel. The findings of this review committee found that the deaths “appeared not to be related to the paclitaxel” but rather other patient issues like heart disease or lung cancer caused by smoking for example.
Ouriel concludes that he believes it was the trial design and a “failure to follow patients through five years” rather than a problem with the drug which led to the mortality signal described by Katsanos et al in the 2018 meta-analysis. He adds that he is “95% sure that what we see is not related to a few milligrams of a drug that the oncologists have been using for a long time”.