Trial aiming to find best way to reduce leg amputation concludes

A team from the University of Birmingham have conducted a five-year trial, with almost 500 participants, assessing different methods of restoring blood flow for patients suffering severe ischaemia (lack of blood flow) in the leg. These patients are at risk of amputation or death.

Chronic limb-threatening ischaemia is a growing global healthcare burden, mainly owing to tobacco smoking, diabetes mellitus, and ageing populations. Chronic limb-threatening ischaemia often occurs around the knee and lower parts of the limb are not able to receive enough blood supply, affecting the lower leg and feet particularly. The condition can lead to pain, longer- or non-healing wounds, and eventual loss of limb through amputation.

Researchers concluded that the drug coated balloons or drug eluting stents offered no benefit over plain balloons and bare metal stents, when measuring amputation free survival, overall survival and time to major amputation. Therefore, the study does not support the use of these methods in management of patients with chronic limb threatening ischemia.

Patients were randomly assigned to receive one of three methods of treatment:

• Balloon angioplasty
• Drug-coated balloon angioplasty
• Drug-coated stent

With the first two methods, a small balloon is gradually inflated to reopen the artery, while the third method involves placing a mesh-like tube into the artery to improve blood flow. Academics assessed the effectiveness of the drug-coated balloon and drug-coated stent for improving blood flow in relation to the plain balloon, which found neither were significantly more clinically beneficial over the plain balloon angioplasty for patients.

A separate health economics report will be published in due course to assess the cost effectiveness and cost utility analyses of these devices.

The BASIL-3 Trial is third in a series of trials exploring revascularisation, or restoring the blood flow to areas experiencing a severe lack of blood flow. The trial was funded by the National Institute of Health and Care Research (NIHR) Health Technology Assessment, following a call for a trial in this area from the National Institute of Health and Care Excellence (NICE). Results were published in the BMJ.

Read the full paper: https://www.bmj.com/content/388/bmj-2024-080881