In a Charing Cross (CX) Live discussion, filmed at the 2024 CX Symposium, Andrew Holden (Auckland, New Zealand) and Eric Secemsky (Boston, USA) pinpoint several salutary lessons that can be taken from the now resolved paclitaxel controversy that was originally sparked by the 2018 Katsanos meta-analysis.
Secemsky points out that 2023 represented a turning point in the controversy when a patient-level meta-analysis “definitively said there’s no evidence that [paclitaxel-coated] devices are harming patients in terms of all-cause death”. The analysis prompted the US Food and Drug Administration (FDA) to remove its warning against use of paclitaxel devices in lower limb interventions that had been in place since 2019. As a result, Secemsky notes that “there was a slow return to prior practices” following a drop off in their use that he remarks caused harm to patients.
Holden states the Katsanos meta-analysis was not the first to have caused the loss of access to an efficacious device, and asks Secemsky what lessons can be learnt going forward.
Secemsky responds, warning against taking meta-analyses as read: “We kind of gave a green light to meta-analyses because we all look at that evidence pyramid and it sits at the top, but just because it’s a meta-analysis doesn’t mean it’s done correctly or was done with the right data. Let’s step back, let’s understand why this was done, let’s understand the data that went into it, let’s understand if this is the right approach [and] not be swift with our decision-making until we’ve done that process.”
