CX to spotlight audience view on new BASIL-2 findings in headline peripheral session

Profile: Jon Boyle page 16

Launch Pad

Surgical training: Change is needed page 25

Age is just a number: Individual patient data metaanalysis probes safety of CEA in the elderly

Data and discussion on revascularisation treatment strategies for patients with chronic limb-threatening ischaemia (CLTI) will take centre stage at the upcoming Charing Cross (CX) Symposium (25–27 April, London, UK), with first results from the BASIL-2 (Bypass versus angioplasty in severe ischaemia of the leg-2) randomised controlled trial set to be a highlight of this year’s programme.

In keeping with CX style, audience participation will be at the heart of the discussion in this headline session. Attendees in London and remote participants will have the opportunity to pose questions to the BASIL-2 investigators, who—along with an expert panel—will interrogate the evidence in a roundtable discussion to reach consensus on this hotly debated topic.

In the peripheral space, revascularisation treatment strategies for patients with CLTI have been firmly in the spotlight following the presentation of first results from BEST-CLI (Best endovascular versus best surgical therapy in patients with critical limb ischaemia) trial in November 2022. CX will provide a platform to move the conversation forward and reach consensus on the topic, with first-topodium results of the BASIL-2 randomised trial forming the centrepiece of a peripheral randomised controlled trial consensus update, taking place on the first day of the CX symposium.

During the session, BASIL-2 chief investigator Andrew Bradbury (University of Birmingham, Birmingham, UK) will deliver the first results from the trial, which Matthew A Popplewell (Heart of England Foundation Trust, Solihull, UK) et al note their 2016 study protocol paper, published in Trials, will “compare, at the point of clinical equipoise, the clinical and costeffectiveness of a ‘vein bypass first’ with a ‘best endovascular treatment first’ revascularisation strategy for severe limb ischaemia due to infrapopliteal (below-the-knee) disease”.

The trial, the authors continue, “is designed to be pragmatic and representative of the ‘real- world’ [UK] NHS management of severe limb ischaemia due to infrapopliteal disease”.

The original BASIL-1 trial, on which BASIL-2 is based, randomised 452 patients with severe limb ischaemia, mainly due to femoropopliteal disease, to either an angioplasty first or a bypass surgery first strategy, Popplewell and colleagues write. This study, published in The Lancet in 2005, found that, in patients presenting with severe limb ischaemia due to infrainguinal disease and who are suitable for surgery and angioplasty, a bypass-surgeryfirst and a balloon-angioplasty-first strategy are associated with “broadly similar outcomes in terms of amputation-free survival,” and in the short term, “surgery is more expensive than angioplasty”.

BASIL-2 officially began its recruitment phase in July 2014 with its first randomisation from the lead centre— Heart of England NHS Foundation Trust—and, according to the BASIL-2 trial webpage, a total of 41 clinical centres were open to the end of the trial; 31 in England, three in Scotland, two in Wales, three in Denmark, and two in Sweden. On the webpage it is noted that 39 of the 41 clinical centres have cumulatively recruited 345 participants out of a revised sample size of 389 patients.

The headline CX session on revascularisation strategies in CLTI also sees participation from the USA, with BEST-CLI investigators Matthew Menard (Brigham and Women’s Hospital, Boston, USA) and Alik Farber (Boston Medical Center, Boston, USA)

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A newly published meta-analysis of individual patient data has found that older patients with symptomatic carotid disease are likely to benefit as much from timely intervention as younger patients. Speaking to Vascular News in light of this key finding, senior author Dominic Howard (Oxford University Hospitals NHS Trust, Oxford, UK) stresses that “vascular surgeons must not turn down symptomatic patients just because of their age”.

WRITING IN STROKE, YA YUAN

Rachel Leung (University of Oxford, Oxford, UK), Howard and colleagues note that there is “uncertainty” around whether elderly patients with symptomatic carotid stenosis have higher rates of adverse events following carotid endarterectomy (CEA). “In trials, recurrent stroke risk on medical therapy alone increased with age, whereas operative stroke risk was not related,” they detail, adding, however, that few octogenarians were included in previous trials and that there has been no systematic analysis of all study types. For these reasons, the investigators aimed to evaluate the safety of CEA in symptomatic elderly patients, particularly in octogenarians.

Leung, Howard et al state that they performed a systematic review and metaanalysis of all studies published between 1 Jan 1980 and 1 March 2022 reporting post-CEA risk of stroke, myocardial infarction (MI), and death in patients with symptomatic carotid stenosis. The authors write that they included observational studies and interventional arms of randomised trials if the outcome rates— or the raw data to calculate these—were provided, and that individual patient data from four prospective cohorts enabled multivariate analysis.

The investigators included a total of 47 studies—representing 107,587 patients—in their meta-analysis. Within this cohort, the risk of perioperative stroke was 2.04%

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