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VIVA 2019: New Paclitaxel Data Shows Consistent Mortality Signal, No Clear Cause

 
• By Elizabeth Orr

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. 

Krishna Singh first takes the podium at VIVA 2019
Krishna Rocha-Singh takes the podium at VIVA 2019. • Source: VIVA

Ongoing scrutiny has not explained an apparent link between paclitaxel-coated cardiac devices and an increased mortality rate, speakers said at the Vascular Interventional Advances (VIVA) 2019 conference in Las Vegas last week.

The issue has created major concerns in the sector since a December 2018 meta-analysis suggested patients who received balloons and stents coated in the drug had a five-year mortality rate almost twice that of patients who received bare metal devices. Subsequent research by trade groups and the US Food and Drug Administration has cut the apparent increase significantly, but has not disproved the link. Scientists have also been unable to establish a specific mechanism of death

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