Dierk Scheinert (Leipzig, Germany) moderates a panel with Eva Freisinger (Münster, Germany) and Thomas Zeller (Bad Krozingen, Germany) to discuss the developments over the past 12 months surrounding the safety of paclitaxel.
Zeller notes that further analyses of the randomised controlled data of drug-coated device use in claudicants has indicated a lower risk of mortality. Importantly, he states that the addition of patient-specific data information, as requested by the US FDA, has highlighted a “significant reduction” in the overall risk. Zeller adds that with the inclusion of large real-world data analysis with appropriate sample size, the mortality risk totally disappears. He goes on to highlight his own centre’s findings of more than 1,500 patients suffering claudication or rest pain, split between a control group and those treated with a drug-coated balloon (DCB). The “major finding” of this comparison was a mortality benefit favouring the DCB approach, which Zeller notes contradicts the Katsanos et al findings in a real-world setting.
Freisinger discusses her team’s analysis of a real-world dataset which included insurants from German company BARMER Health Insurance. The findings showed “no evidence of a long-term mortality signal” at 7.6 years and a “slight beneficial signal” favouring DCB use. She outlines some of the study’s strengths, but cautions that there is “no study without limitations”.
Zeller maintains that it is important to complete the long-term follow-up of current trials, which he believes “will tell us that there is no real mortality issue”. He finally addresses Katsanos et al’s most recent meta-analysis (January 2020, Journal of Vascular and Interventional Radiology) – which he claims has “many limitations” – of DCB versus plain balloon angioplasty in below-the-knee lesions, which suggests a higher mortality in the short-term. This, according to Zeller, goes against the grain of the original findings which only showed a signal in the long-term.
Both Zeller and Freisinger conclude by agreeing that they will continue to use paclitaxel-coated devices, and Scheinert, for his part, says this new real-world safety data is “reassuring”.
This video is sponsored by Medtronic.