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”.