The president of the Society for Cardiovascular Angiography & Interventions (SCAI), George Dangas (Icahn School of Medicine at Mount Sinai, New York, USA), has welcomed the US Food and Drug Administration (FDA) decision to remove restrictions on the use of paclitaxel-coated devices to treat peripheral arterial disease (PAD).
The regulatory body issued a letter to healthcare providers last week, in which it communicated that the risk of mortality associated with paclitaxel-devices is no longer supported based upon the totality of the available data and analyses.
This update signalled a lowering of the red flag raised in a 2019 letter from the Administration—published in response to a meta-analysis that indicated a late mortality signal—warning that treatment of PAD with paclitaxel-coated balloons and paclitaxel-eluting stents was “potentially associated with increased mortality”.
In response to the release of the update, SCAI issued a statement from Dangas welcoming the decision.
“SCAI applauds the FDA for its decision to reverse restrictions on using paclitaxel-coated devices to treat peripheral artery disease, based on continued efforts to collect and analyse data related to the mortality risk for these devices,” Dangas was quoted as saying. “SCAI, with a broad coalition of physician stakeholders, worked to provide the FDA with additional data used by the agency to update its previous guidance. We encourage SCAI members to continue to follow guidance from the FDA when evaluating appropriate treatment for patients.”
The safety of paclitaxel—used in peripheral interventions to prevent restenosis—was called into question by data put forward in 2018 by Konstantinos Katsanos (University of Patras, Patras, Greece) et al that pointed to an increased risk of death at two and five years following the use of paclitaxel-coated balloons and paclitaxel-eluting stents in the femoropopliteal artery.
The FDA responded, notifying healthcare providers in early 2019 about a late mortality signal in patients treated for PAD in the femoropopliteal artery with paclitaxel-coated balloons and paclitaxel-eluting stents.
In its new update, the FDA notes that “additional data from the pivotal randomised controlled trials (RCTs) has become available,” and that the Administration has worked with device manufacturers and external stakeholders to develop the protocol and analysis plan for new data generation.