Actionable Insights Newsletter

Translating research to power whole health

Issue 6    |    August 2023

Study provides compelling evidence of best treatment option for patients with chronic limb-threatening ischemia

Results from an international, randomized controlled trial provide some of the first published evidence comparing two common options.

Enterprise Analytics Core domain(s): Cardiometabolic, quality of care, policy guidance

Summary

Background
Peripheral artery disease is a condition that affects 200 million people worldwide (Fowkes, 2013). Eleven percent of people with peripheral artery disease have the most severe type, called chronic limb-threatening ischemia (CLTI), a medical condition where the foot is not receiving enough blood flow. CLTI causes foot pain, ulcers, and gangrene, and can result in the need for foot amputation.

A procedure called “revascularization” is used to try to improve blood flow to the leg and foot and avoid the need for amputation. There are two types of revascularizations:

• Surgical uses a patient’s own leg vein to connect to an artery above and below blockages in the leg to create a new pathway for blood to flow to the leg and foot.
• Endovascular involves the insertion of a catheter through the skin of the leg and into the artery to open the narrowed artery in the leg with a balloon. A stent is then inserted through the catheter to keep the artery in the leg open.

The use of these two different treatments for CTLI varies greatly among providers and is based on several patient and physician factors. There exists little to no published evidence comparing the two treatment options.

Objective
This study aimed to compare outcomes between both treatments for CTLI.

Methods
The BEST-CLI trial was an international randomized trial that enrolled eligible participants from 2014-2019 at 150 study sites in the United States, Canada, Finland, Italy, and New Zealand. Participants were split into two groups based on whether the saphenous vein in their leg could be used for revascularization. Within the two groups, participants were randomized to the surgical treatment arm or the endovascular treatment arm. Participants were followed for up to 7 years after the trial and information about any major limb event, such as amputation or the need for another treatment for CTLI, was collected.

Results

• Above-ankle amputation occurred in 10.4% of surgical group participants and 14.9% of endovascular group patients. This suggests that surgical treatment may be superior to endovascular treatment overall.
  
• A deeper analysis of study data showed that in patients that had a good quality saphenous vein available for surgery, surgical treatment was associated with a 32% lower risk of major limb events or death when compared to endovascular treatment (Figure 1).
• For participants who did not have a good quality saphenous vein for revascularization, the overall efficacy and safety between the two treatment groups were similar.

Key takeaways