BLearning

Webinar: Safety of paclitaxel devices – what does the evidence say?

Jos van den Berg (Lugano, Switzerland), Antonio Micari (Bergamo, Italy) and Marianne Brodmann (Graz, Austria) sit down after a specially convened US FDA panel reviewed paclitaxel device data, with recommendations still to come. The physicians discuss the safety of paclitaxel devices and examine what the evidence says.

Micari presented a patient-level analysis from the IN.PACT randomised controlled trials to state that they have collectively shown there is no drug-related mortality signal and suggests that study design and conduct might be responsible for the “transient” mortality signal. He also looks at the long-term effectiveness of paclitaxel devices to state that the IN.PACT DCB (Medtronic) provides a vast improvement over plain balloon angioplasty, and shows “durable treatment benefit”.

Brodmann, meanwhile, outlines evidence from real world data sources – such as Medicare, OPTUM and VQI – which has indicated that there is “no difference in mid-term or long-term survival between patients treated with drug-coated or non drug-coated devices”.

Summing up, van den Berg states that “several methods of investigation have demonstrated the absence of a dose relationship to mortality”. What we need to do now, he says, is to “perform well-conducted real world comparative studies that are followed up for a sufficient duration”.

This webinar was filmed by SparkBio. Medtronic sponsored its distribution in association with Vascular News and Interventional News.

van den Berg, Jos, Micari, Antonio and Brodmann, Marianne, Micari, Antonio and Brodmann, Marianne

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