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www.vascularnews.com
September 2023 / Issue 99
20 Deep venous valve technologies
Addressing a “large unmet need worldwide”
Featured in this issue:
9A rtificial intelligence
13 Rohini J Patel
Emerging technology
Smoking cessation
Paclitaxel-coated devices: US FDA removes red flag after review finds data do not support mortality risk In a letter to healthcare providers dated 11 July 2023, the US Food and Drug Administration (FDA) communicates that the risk of mortality associated with paclitaxel-coated devices to treat peripheral arterial disease (PAD) is no longer supported based on the totality of the available data and analyses.
T
his update signals 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 paclitaxelcoated balloons and paclitaxel-eluting stents was “potentially associated with increased mortality”. Alongside the letter, the US FDA has updated its recommendations for healthcare providers regarding the use of paclitaxel-coated balloons and stents for PAD. As well as removing reference to the possibility of increased mortality with these devices, the amended guidance softens the language around the monitoring of patients who have been treated with paclitaxelcoated stents and balloons, stating that healthcare providers should continue ‘routine’ rather than ‘close’ monitoring of these patients, as had previously been stated. 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 paclitaxeleluting stents. Their most recent update on the topic, prior to that shared on 11 July 2023, was posted in August 2019. 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. The FDA references the fact that device manufacturers collaborated in an updated meta-analysis, which included “additional studies, more complete vital status information, and longer-term follow-up compared to prior studies”. Patient
follow-up in these studies ranged from two to five years, the Administration notes, and led it to conclude that the updated RCT meta-analysis “does not indicate that the use of paclitaxelcoated devices is associated with a late mortality signal”. Furthermore, the FDA states that it also reviewed additional analyses of the risk for late mortality, including the SWEDEPAD trial interim analysis, the VOYAGER PAD study, the German BARMER Health Insurance study, the US Veterans Health Administration study and the Medicare SAFE-PAD study. “None of these studies, with mean or median follow-up ranging from 1.7 to 3.5 years, found a risk for late mortality associated with paclitaxel-coated devices,” the FDA communicates, adding that longer-term follow-up in several of these studies is ongoing.
Societies and industry express support for use of paclitaxel-coated devices
The day following the release of the FDA update, the Cardiovascular Interventional Radiological Society of Europe (CIRSE) published an editorial in CardioVascular Interventional Radiology (CVIR) expressing its support for the use of paclitaxel-coated devices in femoropopliteal disease treatment. The editorial, written and accepted for publication in CVIR before the publication of the FDA letter, refutes a mortality signal for paclitaxel. Written on behalf of CIRSE’s Endovascular Subcommittee, the authors—including corresponding author Robert Morgan (St George’s University Hospitals NHS Foundation Trust, London, UK)—“advocate that the benefits of paclitaxelcoated devices used in the femoropopliteal segment in terms of increased primary patency and reduced TLR [target lesion revascularisation] warrant their use in the routine treatment of patients with femoropopliteal disease”. The following day, the Society for Cardiovascular Angiography & Interventions (SCAI) issued a statement from
Additional data from the pivotal randomised controlled trials has become available.”
16 P rofile
Jürgen Falkensammer
Computer model indicates optimal shielding can reduce operator radiation doses close to “background” levels “With effective use of apron and ceiling and table shields, operator [radiation] doses can be reduced to the equivalent of one to two days of natural background radiation,” investigators write in the conclusion of a recently published study. RICHARD W HARBRON (Royal Victoria Infirmary, Newcastle upon Tyne, UK) and colleagues— including senior author Bijan Modarai (King’s College London and Guy’s and St Thomas’ NHS Foundation Trust, London, UK)— recently shared this finding in a European Journal of Vascular and Endovascular Surgery (EJVES) Editor’s Choice paper. “The radiation doses received by staff members performing fluoroscopically guided interventional procedures are potentially high, raising concerns of increased risk of cancer and noncancer effects such as cataracts,” Harbron et al outline in their introduction. They continue by noting that endovascular aneurysm repair (EVAR) procedures “are associated with especially high doses to both staff and patients, due to the procedural complexity and the thickness and density of the abdominal region”. It was the investigators’ objective in the present study to estimate operator organ radiation doses from fluoroscopically guided infrarenal EVAR procedures, using Continued on page 3
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