The Operating Theatre Journal - Journal - Page 21
Endovascular treatment more likely to avoid amputation or
death for limb-threatening artery disease
In the only randomised controlled trial of its kind, BASIL-2 enrolled 345 patients in 41 vascular surgery centres in UK, Sweden and Denmark
Patients from the UK, Sweden and Denmark were randomly assigned to
either a vein bypass (VB) first or a best endovascular treatment (BET)
first revascularisation strategy.
Patients who were randomised to VB first were one third more likely to
require a major amputation or die during follow-up than patients who
were randomised to BET, which in most cases comprised plain balloon
angioplasty with selective use of stents.
Professor Andrew Bradbury, Sampson Gamgee Professor of Vascular
Surgery at the University of Birmingham and Chief Investigator of the
BASIL-2 trial said:
“Patients with chronic limb-threatening ischaemia generally have very
poor prognosis and optimal strategies for restoring limb perfusion
remain incompletely defined. BASIL-2 is only the third published RCT
in patients with CLTI, and the only one to have specifically recruited
patients who required intervention to arteries below the knee to
restore blood flow to the lower leg and foot.
In patients with chronic limb threatening ischaemia (CLTI) due to
atherosclerosis affecting the arteries below the knee, data from the
first clinical trial of its kind shows that a best endovascular treatment
first revascularisation strategy was more likely to prevent major
amputation and death than a vein bypass first strategy.
Published in the Lancet, the Bypass versus Angioplasty in Severe
Ischaemia of the Leg (BASIL-2) randomised controlled trial (RCT),
which was run through the University of Birmingham Clinical Trials
Unit (BCTU), and which was funded by the National Institute for Health
and Care Research (NIHR), compared two revascularisation strategies
for restoring limb perfusion in patients with chronic limb-threatening
ischaemia (CLTI) due to atherosclerosis affecting the arteries below the
knee.
“There were many challenges to recruitment and follow-up, most
recently due to the COVID-19 pandemic. However, BASIL-2 has now
produced a statistically robust and clinically meaningful result that is
likely to have an influence on the management of CLTI worldwide”
Professor Andrew Farmer, Director of NIHR’s Health Technology
Assessment (HTA) Programme, which funded the trial, said:
“The findings of this important study are likely to greatly improve
treatments for patients with this life-threatening and debilitating
condition. Once again NIHR-funded research is providing vital evidence
to drive forward outcomes for patients and better ways of delivering
care for the NHS for those who plan and deliver services.”
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Issue 392
May
2023
21