Stenting of the SFA for intermittent claudication yields quality-of-life benefits out to 36 months

In a recent study of patients with intermittent claudication (IC) caused by isolated superficial femoral artery (SFA) lesions, researchers found that primary stenting conferred benefits in health-related quality of life (HRQoL) at 36 months from treatment compared with best medical therapy (BMT) alone, which were lost at the 60-month mark, where a high crossover rate affected the power of the final analysis.

RESULTS OF THE STUDY were recently published online in the European Journal of Vascular and Endovascular Surgery (EJVES). The investigators—led by Thordur Gunnarsson (Lund University, Lund, Sweden)— highlight their previous finding that primary stenting of the SFA in IC increased HRQoL after 12 and 24 months in this trial. The current paper, they note, presents an extended followup of HRQoL 36 and 60 months after randomisation.

This was a multicentre randomised controlled trial conducted at seven vascular clinics in Sweden between 2010 and 2020, which included 100 patients randomised to either primary stenting and BMT (n=48) or BMT alone

(n=52) followed for 60 months.

Gunnarsson et al detail that HRQoL—which they assessed using the Short-Form Health Survey (SF-36) and EuroQoL 5 dimensions (EQ5D) 36 and 60 months after randomisation— was the primary outcome. Walking Impairment Questionnaire (WIQ) score, reinterventions, progression to chronic limb-threatening ischaemia (CLTI), amputation, and death were secondary outcomes.

The authors report that, at 36-month follow-up, the stent group (n=32) had “significantly better” scores in the SF36 domain Role Physical (RP, p=0.023) and the Physical Component Summary (PCS, p=0.032) compared to the control group (n=30), however, there was no significant difference in EQ5D scores (p=0.523).

In addition, they reveal that WIQ was also “significantly better” compared to the control group (p=0.029) at 36 months.

At 60-month follow-up, Gunnarsson and colleagues found no significant difference in HRQoL between the stent (n=31) and the control group (n=32), months and the 25% crossover from the control group to stent at 60 months “negatively affected the power of the analysis”. In future trials of invasive treatment of IC, they write, crossover and loss to follow-up “need to be taken into account”.

MID-TERM RESULTS FROM A PHASE II STUDY OF SURGICAL bypass using the Human Acellular Vessel (HAV; Humacyte) demonstrated an overall secondary patency rate at 72 months of 60% measured by Kaplan Meier. There was no evidence of graft rejection or infection, the authors reported.

Humacyte said the publication describes the long-term analysis of the clinical trial as it evaluates the bioengineered HAV as a conduit in patients with symptomatic peripheral arterial disease (PAD). The research team, led by firstnamed author Piotr Gutowski (Pomeranian Medical University of Szczecin, Szczecin, Poland) concluded that “the infection-resistant, off-the-shelf human acellular vessel could provide a durable alternative conduit in the arterial circuit setting, to restore lower extremity blood supply in patients with peripheral artery disease.” The results were recently published in the Journal of Vascular Surgery-Vascular Science (JVS-VS).

No patients underwent amputation of the affected limb out to six years, they found, and none reported pain at rest or ischaemic ulcers on the affected legs. Gutowski et al reported that “these data have demonstrated the durability of the HAV and suggest the occurrence of cellular remodelling by the host.”

Gutowski commented: “Synthetic grafts can be limited due to poorly matched mechanical compliance, risk of infection, and variable patency rates. Furthermore, cryopreserved allogenic grafts are limited due to poor durability, thrombosis, and mechanical degradation. The HAV is designed to be consistent in size, durable in high-pressure circulation, show no clinical immunological response, and remodel with the patient’s own cells.” and that there was no difference in progression to CLTI, amputation (2.1% vs. 1.9%) or mortality (14.6% vs. 15.4%) between groups. The authors point out that crossover from control to stent group was 25% at this later follow-up point.

The HAV has been evaluated in eight clinical studies in the USA, Europe and Israel, including an ongoing phase II/III clinical trial in vascular trauma and an ongoing phase III trial as a haemodialysis access in end-stage kidney disease. The HAV is an investigational product and has not been approved for sale by the US Food and Drug Administration or any international regulatory agency.

The authors recognise that their study has some limitations. They note, for example, that as the study was originally designed to detect differences in the primary outcome at 24 months with an expected 10% loss to followup, both the prolonged follow-up and additional loss of patients at 36 and 60

CX 2023: Competition hopes to raise public awareness of the significance of “the hurting leg”

The Rouleaux Club—the UK’s national vascular trainee society—in association with the Charing Cross (CX) Symposium 2023 and BIBA Medical, has announced a new competition designed to encourage early detection and treatment of “hurting legs”.

THE COMPETITION, ENTITLED

‘The Hurting Leg’, involves creating an infographic and/or infomercial intended to educate members of the public about chronic limbthreatening ischaemia (CLTI) and encourage patients to present to their general practitioner.

“We interpret the trial results in favour of stent treatment for at least 36 months for physical HRQoL measures for the [IC] patient,” Gunnarsson et al write in the discussion of their findings. While they acknowledge that the trial does not give robust evidence for a lasting effect of stenting until 60 months, it suggests instead that a “transient period” of improved HRQoL “might be valuable” for an elderly vascular patient.

The trial was conducted at seven vascular clinics in Sweden between 2010 and 2020

They summarise the wider impact their results might have: “This trial provides information relevant when presenting treatment options for patients as well as for health authorities.”

Infographics and short infomercial videos are invited from all students and trainees involved in caring for vascular patients from all over the world. Submission should be made online at www.cxsymposium. com/the-hurting-leg-competitionsubmission-guidelines. The deadline for submission is midnight (GMT) on Tuesday 28 March.

Speaking to Vascular News at the 2022 Vascular Society of Great Britain and Ireland (VSGBI) annual scientific meeting (23–25 November, Brighton, UK), president of the Rouleaux Club Leanna Erete, who is a vascular trainee in the UK’s London deanery, described the competition as “innovative and exciting”.

Attendees at the CX Symposium 2023 (25–27 April, London, UK) will be able to view the top five infomercials and infographics and vote for their preferred one. The monetary prizes of £1,000 for the infomercial and £500 for the infographic will be announced at the symposium.

This year, CX is offering free registration to all fellows who are members of European Vascular Surgeons in Training (EVST), the Rouleaux Club or other equivalent societies worldwide, and 75% off for early career surgeons and physicians (terms apply).