Awaited first-release data and debates set to address critical challenges in CX 2025 peripheral arterial programme

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Andrew Holden

“These crucial results will help to shape next steps in research, including ongoing randomised controlled trials comparing bioresorbable scaffolds to angioplasty, and eventually, to drugeluting stents.” These are the words of Michel Bosiers (University Hospital Bern, Bern, Switzerland), sharing his initial predictions ahead of several new data releases during the peripheral arterial programme at the 2025 Charing Cross (CX) Symposium (23–25 April, London, UK). Set to address critical challenges in the treatment of intermittent claudication and chronic limb-threatening ischaemia (CLTI), the programme will host over 30 podium firsts, including breaking data from the BASIL-2 and BASIL-3 trials.

Bosiers, who will present on day one of the peripheral programme, will deliver three-year results from the MOTIV bioresorbable scaffold (Reva Medical) trial. The trial aims to evaluate safety and efficacy of the device for the treatment of patients with rest pain or minor tissue loss due to the presence of lesions of a maximum length of 100mm at the level of the below-the-knee (BTK) arteries.

“Research on bioresorbable scaffolds is crucial because these devices offer unique advantages over traditional treatments, addressing some of the most significant challenges associated with managing peripheral arterial disease in chronic limb-threatening ischaemia patients,” says Bosiers, speaking to Vascular News ahead of this year’s symposium.

To address the increasing incidence of peripheral arterial disease (PAD) worldwide due to aging populations and rising diabetes diagnoses, Bosiers hopes that “these results will provide crucial insights into the long-term efficacy and safety of bioresorbable scaffolds in treating CLTI patients, significantly contributing to the investigation of advanced treatment options”.

Following Bosiers, Andrew Holden (Auckland City Hospital; University of Auckland, Auckland, New Zealand)—CX co-chair and member of the peripheral arterial executive board—will begin his series of podium first presentations during the first day of the symposium.

Set to deliver a first data release on drug-eluting resorbable scaffolds in the femoropopliteal segment, Holden comments that there has been “renewed interest” in resorbable scaffolds in lower limb arterial intervention following the LIFE-BTK trial results which facilitated the approval of the ESPIRT BTK (Abbott) scaffold.

“Most companies that are investigating peripheral arterial indications for drug-eluting resorbable scaffolds are focusing on tibial artery applications. However, the advantages of drug-eluting resorbable scaffolds— which include providing an acute scaffold to optimise angioplasty results and resorbing without a permanent implant—are even more relevant in the femoropopliteal segment,” Holden describes.

In his talk, Holden will present an interim analysis from the first-in-human Efemoral-1 trial, including six-month follow-up of the Efemoral (Efemoral Medical) device, which was designed to manage the anatomic and restenotic challenges of the femoral artery. “These clinical outcomes will ultimately determine if this device translates from one of promise, to a standard tool for femoropopliteal arterial intervention. I believe these data have the potential to stimulate further interest and excitement around this important advancement in vascular care,” he adds.

Later in the peripheral programme, Holden will also deliver a podium-first talk on new intravascular lithotripsy (IVL) technologies and trial data for calcified tibial artery disease. He tells Vascular News that, in several vascular territories, IVL has achieved “excellent acute luminal gain” in calcified arteries with a “low incidence of dissection of provision stenting”. Yet, Holden notes that there has been limited evidence supporting IVL use in tibial arteries, calling for a successful technology which can address calcification in these vessels and achieve better results than when treating with angioplasty.

“These data will help support discussion on the optimum management algorithm for CLTI patients with calcified tibial artery disease,” says Holden, who adds that delegates can expect interesting debate on whether the two technologies presented are “complimentary or competitive”.

Elsewhere in the day one peripheral itinerary, Hany Zayed (Guy’s and St Thomas’ NHS Foundation Trust, London, UK) will present during a session dedicated to vessel preparation techniques, comparing plain balloon angioplasty, IVL and atherectomy prior to the application of a drug-coated balloon (DCB).

Zayed comments: “Vessel preparation is an evolving concept which is gaining popularity amongst interventionalists, with the aim to enhance the outcomes of definitive treatment of arterial lesions. It is therefore important that we appraise the available research in order to highlight areas in need of further research to help guide our routine daily practice.”

Zayed states that their first-release data to be presented at CX 2025 will highlight that the current evidence is still heterogeneous, particularly in regard to patient cohort e.g. CLTI or intermittent claudication, lesion characteristics and complexity, as well as duration of follow-up.

During a ‘Challenges in aortoiliac occlusive disease’ session, Maria Antonella Ruffino (IIMSI, Ente Ospedaliero Cantonale, Lugano, Switzerland) will present on new large balloon IVL in the treatment of aortic lesions. Importantly, she will question whether IVL is an effective therapy when used alone or in combination with stenting as a means of vessel preparation.

In conversation with Vascular News ahead of her presentation, she details that there is growing evidence in support of polytetrafluoroethylene (PTFE)-covered stents for the treatment of infrarenal occlusive disease of the abdominal aorta as an alternative to surgical reconstruction.

“Despite the type of stent we want to implant, suboptimal vessel expansion still represents a limit in the treatment of isolated aortic lesions, where neither high pressure balloon angioplasty nor atherectomy can significantly impact on wall calcifications,” says Antonella Ruffino.

Today, with the advent of ‘non-stent’ technology such as IVL that can be applied to large vessels and facilitate vessel expansion, Antonella Ruffino underlines the importance of confirming its safety and efficacy in aortic lesions. She hopes their research will highlight IVL technology as an “additional weapon” to treat very calcified isolated aortic lesions, and demonstrate that the combination of IVL and stenting could “help to overcome the risk of incomplete stent expansion with consequent restenosis”.

The CX 2025 peripheral programme will also showcase several challenging debates on technologies and techniques including vessel preparation devices versus high-quality plain balloon angioplasty, and whether endovascular techniques should only be offered to patients with common femoral artery disease who cannot undergo endarterectomy. Additionally, attendees will see the launch of the CX Hurting Leg campaign—an initiative to reduce amputations through increasing awareness in deprived communities and to promote systemic healthcare reform.


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