Cost-effectiveness outcomes defy expectations in latest BEST-CLI data drop

72
Alik Farber (left) and Matthew Menard

The open surgical approach will prove to be “slightly superior” to endovascular intervention in terms of cost per life year gained, while the latter will be slightly superior to open surgery with regard to cost per quality-adjusted life year gained, pending results from a cost-effectiveness BEST-CLI analysis show.

The data, revealed during the 2025 Charing Cross (CX) International Symposium (April 23–25) in London, England, were part of a series of four podium-first presentations from the landmark BEST-CLI and BASIL-2 trials delivered at the meeting that aimed to add nuance to the ongoing conversation around the best treatment option for chronic limb-threatening ischemia (CLTI) patients.

Sharing the main conclusion from new BEST-CLI cost-effectiveness data, Matthew Menard, MD, from Brigham and Women’s Hospital in Boston, told CX 2025: “I can tell you that, based on the data that we have— with the caveat that the final results are pending—we would predict that open will prove to be slightly superior to endo[vascular] with regard to cost per life year gained and that endo[vascular] will be slightly superior to open with regard to cost per quality-adjusted life year gained.”

Topline results from this trial were shared at the American Heart Association (AHA) scientific sessions in 2022, with investigators revealing that surgical bypass with adequate single-segment great saphenous vein is a more effective revascularization strategy for patients with CLTI who are deemed suitable for either an open or endovascular approach. Both strategies were deemed safe and effective for CLTI treatment.

At CX, Menard added a further prediction that “given the small and statistically insignificant magnitude of the differences in the relevant inputs, it is very unlikely we will detect any meaningful cost-effectiveness difference,” noting that more granular data will be released later in the year. Andrew Holden, MD, from Auckland City Hospital, New Zealand, moderating, expressed surprise at the results. “Before you shared these data,” he said, “I intuitively thought that endovascular, while not being successful overall, was going to be more cost-effective and I thought it would be driven by lower hospital stay and certainly lower intensive care stay, but you actually found the opposite, so I find that counterintuitive.”

Holden asked Menard whether he could explain the findings, to which Menard responded that “our goal was to undertake a very comprehensive analysis, in which all costs associated with the initial index procedure and hospitalization were captured, along with all of the costs of follow-up reinterventions, hospitalizations and rehabilitation care. The challenge is figuring out what’s relevant to the disease,” he said, adding that “this is how the data are looking” when all of the costs that are associated with CLTI revascularization are assessed in aggregate over time. Hospital stay—almost always the key driver in cost-effectiveness analyses, he stressed—appears to be the “key metric” in their evaluation as well.

BASIL-2 trialist Matthew Popplewell, MD, from the University of Birmingham in Birmingham, England, noted that he was “quite relieved” on hearing the new findings. He explained that the length of stay in the BASIL-2 health economic analysis has been criticized for being “really long,” with the suggestion being that this could be due to a healthcare system issue. “Clearly it’s not, because it’s happening on both sides of the pond,” Popplewell commented.

Holden added that a “new lesson” to take from these cost-effectiveness data is that the driver of shorter hospital stay in these patients is perhaps not a less invasive procedure but, instead, making progress with wound healing to facilitate discharge.

Could primary endo ‘actually burn bridges’?

Subsequently, Alik Farber, MD, from Boston Medical Center in Boston, shared a new subset analysis from BEST-CLI. “We found that primary endo may actually burn bridges for secondary bypass,” the presenter concluded, noting that primary bypass was associated with “significantly better” outcomes. Farber went on to add that the BEST-CLI dataset is a “treasure trove for CLTI research” and will continue to add to a “badly needed evidence base.”

A question from the audience probed whether there are enough granular data available to know how a primary endovascular intervention “actually burns the bridge.” Farber responded: “There are many potential reasons as to how endovascular therapy may burn bridges for a future bypass. It may occur due to disruption of vulnerable plaque, wire injury, compromise to collateral vessels, damage to run-off vessels, compromise of a bypass target, progression of tissue loss and concomitant loss of optimal window for intervention, or it could simply be a marker for a higher-risk patient or disease pattern. Which of these reasons are at play is not clear; however, our findings do show that the amputation rates are higher after secondary bypass.”

Here, Farber pointed to future research that might bring answers. He shared that the Novo Nordisk Foundation has provided a grant to the BEST-CLI team to fully unpack the BEST-CLI dataset. Menard added that the National Institutes of Health (NIH) has granted the BEST-CLI team permission to look more closely at the first major adverse limb event (MALE) data in the trial: “We have been able to obtain the source data and so will be able to look at the etiology of treatment failures. We are hopeful this will help us understand the important questions related to the need for reinterventions following an initial open or endovascular revascularization.”

Summarizing this part of the discussion, Holden remarked: “I think it’s fair to say that we are learning that endo may burn bridges, and I never used to like to hear that, but I think it is potentially true.”

LEAVE A REPLY

Please enter your comment!
Please enter your name here