German Patient Data Shows No Paclitaxel Mortality Risk
A review of German insurance data found no additional risk of death in patients treated with drug-coated balloons and stents, even in patients who had the devices for more than a decade. The data appears to further challenge a bombshell meta-analysis that claimed paclitaxel could increase death rates by up to 90%.
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Research investigating outcomes in patients treated with paclitaxel-coated devices demonstrated a consistent if modest mortality signal when compared to bare-metal stents. However, the signal was not seen in real-world data, and some researchers question whether the signal might stem from problems in the original trials.
BD said an independent Lutonix review found no significant link to deaths, while further meta-analysis from trade group VIVA showed a decline in the risk. Both studies were unveiled at the Transcatheter Cardiovascular Therapeutics (TCT) conference in San Francisco.
Updated data from a postmarket study of Abiomed’s Impella RP right-heart pump further supports the device’s safety for a specific patient population.