“These will be important, salutary lessons. Should a controversy arise again involving a proven efficacious therapy, we now know that stopping access to that therapy may result in unwanted and unexpected negative effects on patient care.” These are the preluding thoughts of Andrew Holden (Auckland City Hospital; University of Auckland, Auckland, New Zealand)—one of the Charing Cross (CX) Symposium 2024 (23–25 April, London, UK) co-chairs—ahead of this year’s meeting, referencing the paclitaxel mortality controversy. Here, Holden sets sights on the unmissable peripheral arterial programme, which will tackle global controversies and host heated debates.
“The peripheral arterial programme is jam-packed with controversy this year— controversy being the theme for CX 2024,” says Holden, highlighting this fact by noting that the first session will address paclitaxel mortality. The paclitaxel mortality controversy in peripheral arterial disease (PAD) will be punctuated by a late-breaking presentation from Eric Secemsky (Beth Israel Deaconess Medical Center, Boston, USA), who plans to examine whether the meta-analysis and subsequent regulatory body restrictions on paclitaxel caused harm.
“Although the original paclitaxel mortality controversy did not make sense in terms of causation theories, it was appropriate to take this report very seriously. However, in many geographies this resulted in stopping a therapy that had been shown to be more effective and durable than our non-drug-coated strategies,” details Holden. “An important question that hasn’t been addressed to date is when depriving patients of a more effective treatment modality, were we causing patients harm? With the benefit of hindsight, can we learn important lessons regarding this?”
“Hopefully we will provide the final chapter of this controversy. We have key opinion leaders presenting new data, and some input from regulators such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA),” Holden says. “I’m very grateful to Eric and his group for providing additional data to allow us, for the first time, to dive into this issue.”
Holden notes that during this session, speakers and audience members will have the opportunity to ask the regulators what their thoughts are with regard to the removal of access to paclitaxel-coated devices and the duration of time it has taken to have these therapies reinstated.
“When depriving patients of a more effective treatment modality, were we causing patients harm?”
Paclitaxel-coated devices also feature in later sessions, Holden contributes, commenting that the ‘Paclitaxel and sirolimus-coated balloons in the femoropopliteal arteries’ session will end with a debate, which asks if “following the FDA announcement, do paclitaxel-coated devices now beat limus-coated devices”. He adds that drug-coated technologies will be of “great interest” at this year’s CX Symposium and will provide delegates with the opportunity to share their thoughts and experiences.
“Promising” future for bioresorbable scaffolds in the tibial arteries
Later in the peripheral programme, speakers will turn to bioresorbable scaffolds in the tibial arteries. Brian DeRubertis (Weill Cornell Medicine, New York, USA) will present late-breaking data in the LIFE-BTK clinical trial evaluating the safety and efficacy of the everolimus-eluting Esprit below-the-knee (BTK) system (Abbott) in chronic limb-threatening ischaemia (CLTI) patients with infrapopliteal artery disease.
“Bioresorbable scaffolds have been the holy grail for lower limb arterial interventions for many years,” Holden details. He draws attention to the high percentage of cases that require a scaffold due to issues such as dissection and recoil after angioplasty, but also the long-term negative effects of metal stents when placed in the tibial arteries.
“We’ve looked for a bioresorbable scaffold that works in the acute phase, but then dissolves with time and allows arterial structure and physiology to be restored. Many trials have failed both above and below the knee,” he says. However, following the LIFE-BTK trial results in 2023, which showed a statistically significant benefit for primary bioresorbable scaffolds, Holden believes this year’s CX is positioned well for a “timely deep dive” into the subject and “promising” emergent technologies.
Inaugural Roger M Greenhalgh late-breaking trials session
On both Tuesday 23 and Wednesday 24 April at CX 2024 the inaugural Roger M Greenhalgh late-breaking trials sessions will take place. “I believe Professor Greenhalgh would be very proud of the late-breaking trial sessions we are hosting in the peripheral arterial space at CX 2024,” says Holden.
At a glance, he highlights that deep venous arterialisation is a topic of “growing interest” that will feature in this session. He states the session will provide an opportunity for attendees to evaluate where this new technology may sit within physicians’ current armamentarium, particularly in patients with advanced CLTI. New data from the CLARITY trial will be presented by Anahita Dua (Massachusetts General Hospital, Boston, USA), evaluating transcatheter arterialisation of deep veins for no-option CLTI.
Holden also places focus on the six-month SHOCC study data, which will be presented by Athanasios Saratzis (University of Leicester, Leicester, UK). The trial analysed the Shockwave lithotripsy device (Shockwave Medical) for patients with PAD and will produce new data during Wednesday’s Roger M Greenhalgh late-breaking trials session. This data, Holden shares, will shed light on the device’s “effectiveness” at the trial’s UK centre.
CLTI and imaging modalities
Elsewhere in the peripheral programme, Holden highlights the comprehensive coverage of CLTI trials—including updates from BEST-CLI and the BASIL-3 podium first—and points toward the imaging modalities session.
“One of the big challenges with imaging and CLTI is trying to identify the patients who are going to respond to revascularisation. We know that CLTI patients often have a multifactorial cause for their disease in addition to their macrovascular arterial disease. In many cases, we can spend a lot of time revascularising patients who don’t benefit so we need to get a better idea of favourable responders,” says Holden.
Holden restates the importance of pre-procedural and intra-procedural imaging, which will be explored during this session, enabling physicians to get to grips with new technologies to assist in measuring when a therapeutic endpoint has been reached during a revascularisation procedure”.
“Imaging and CLTI is an expanding and very important topic that we’re going to certainly delve into on the Thursday [25 April] of CX 2024,” he adds.
Great debates in the peripheral arterial programme
The CX 2024 peripheral programme will also play host to a variety of controversial debates including paclitaxel versus limus-coated devices, and bypass versus endovascular surgery, affording CX delegates the opportunity to cast their votes. Aptly devised, the debates in the peripheral arterial programme are centred on controversial topics and are hoped to spark lively discussion. To this end, Holden believes that they will “drive consensus and effectively further the conversation” surrounding these complex treatment modalities.
