Drug coated balloons are widely used to reduce restenosis after peripheral endovascular interventions and are therefore recommended in current guidelines . Recently long-term safety of drug coated balloons and stents was under discussion. Katsanos et al. reported increased mortality beyond one year from a meta-analysis including pervious published randomized trials . This publication triggered a large scientific discussion and several statements from the U.S. Food and Drug Administration (FDA).
Now a recent publication including real word data showed no evidence for increased mortality associated with paclitaxel-based balloons or stents . In this paper by Freisinger at al. data from the German BARMER Health insurance on the application of paclitaxel-based drug-eluting devices were analysed. In total 64.771 patients with 107.112 procedures have been included over a time period of 11 years. During this time period 42% of the patients died. In a Cox regression analysis no association between mortality and the previous use of drug coated balloons or stents was found. In contrast to the meta-analysis from Katsanos et al. the use of all drug coated devices during the assessed time period could be considered. In addition, a time dependent Cox analysis was used to address the cumulative use of paclitaxel coated devices during the time intervals. This increases the strength of these data in comparison to the meta-analysis which includes data from different randomized trials with shorter follow-up.
In conclusion the recent publication by Freisinger et al. showed no association between paclitaxel coated devices and mortality. The publication is based on a large real word database, included the cumulative use of paclitaxel during a long time period and is of higher statistic power compared to the meta-analysis from Katsanos et al. Based on this data the discussion about safety of drug coated devices should be terminated.