Cost Surprises and Delayed Care in Women: BASIL-2 and BEST-CLI

LONDON, England—Updated data from the BASIL-2 and BEST-CLI trials, presented this week at Charing Cross International Symposium 2025, add more context around cost-effectiveness and gender patterns in the management of chronic limb-threatening ischemia (CLTI).

In the analysis of BASIL-2, a study that supported an endovascular-first strategy as being less likely than bypass surgery to result in death or major amputation, investigators showed that women were less likely to be offered revascularization than men. A closer look BEST-CLI, the largest head-to-head comparison thus far of endovascular therapy and surgery in people with CLTI, pointed to some nuances in the economic data.

Session anchor Naseer Ahmad, MBChB, MD (Manchester University Hospitals, England), said it’s important to remember when looking for takeaways about CLTI management that the two trials speak to the subset of patients for whom there is genuine equipoise between the endovascular and surgical strategies.

“They're the patients where we sit  . . . and argue for half an hour [about] what the best strategy is,” he said. “So, these trials are designed to try and help those people make decisions.”

Both of these trials plus BASIL-3, which was reported at the CX Symposium last year, are an effort to fill evidence gaps regarding best treatment strategies for CLTI. As to whether or how the results have begun to impact practice, experts here said they believe the studies have given clinicians more to think about and that alterations in practice patterns might eventually emerge in the National Cardiovascular Data Registry.

 

BEST-CLI

BEST-CLI co-principal investigator Matthew Menard, MD (Brigham and Women's Hospital, Boston, MA), presenting the economic analysis, said that its results do at least somewhat point to a winner.

“I can tell you that based on data that we have and with the caveat that final results are pending, we would predict that open is slightly superior to endo with regard to cost per life-year gained and that endo is slightly superior to open with regard to cost per quality-adjusted life-year gained,” he commented. The trial’s main findings, reported in 2022, showed fewer major adverse limb events (MALE), major limb interventions, and amputations with surgery than endovascular therapy in patients eligible for both procedures.

While the cost analysis is not complete, the BEST-CLI investigators included the full healthcare resource burden of both treatments based on what economists say is important for these types of comparison calculations, said Menard.

Ancillary treatments relevant to disease management such as wound care have not been adequately captured in other studies but are included in this analysis, as are emergency department visits, inpatient and outpatient rehabilitation, physician visits, long-term care, and procedures and diagnostic tests performed on an outpatient basis. The investigators are also seeking to capture hours of work missed by patients who require outpatient care and other quality-of-life factors.

Hospitalization stays were slightly longer in the endovascular group (n = 690), at a mean of 23.6 days versus 21.0 for the surgery group (n = 676) over a medium follow-up time of 2.7 years, once all the inpatient and outpatient resources were factored in.

While the number of inpatient rehab days were similar, the surgery group required about 6 more outpatient rehab days than the endovascular group and a few more outpatient visits.

Given the small and statistically insignificant magnitude of the differences in the relevant resource categories, Menard said for now the take-home message is that it’s “very unlikely” that the final cost-effectiveness analysis will detect any further meaningful differences between the two treatments.

Session moderator Andrew Holden, MBChB (Auckland Hospital, New Zealand), for his part, found the cost-effectiveness data counterintuitive.

“I must say before you shared this data that 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, certainly lower intensive-care stay,” he said. “Actually you found the opposite.”

“The point was to capture everything and it's . . . hard to know whether we got it right,” Menard acknowledged.

Holden also drew attention to what he called a “new lesson,” specifically “that the driver of hospital stay in these patients is not potentially a less invasive procedure—it's actually time to making progress with wound healing.”

We find that primary endo may actually burn bridges for secondary bypass, because primary bypass was associated with significantly better outcomes. Alik Farber

In a second presentation, BEST-CLI’s other co-primary investigator Alik Farber, MD (Boston Medical Center, MA), said the data are pointing toward a higher risk of major amputation at 1 year for patients who undergo an endovascular-first approach that fails and requires a secondary bypass.

Compared with an amputation rate of 8.1% with primary surgical bypass, those who had secondary bypass for a failed procedure within 30 days or after 30 days had major amputation rates of 17.7% and 10.1%, respectively.

“We find that primary endo may actually burn bridges for secondary bypass, because primary bypass was associated with significantly better outcomes,” Farber added.

Less Aggressive Treatment in Women

Updating the CX Symposium audience on BASIL-2, Matthew A. Popplewell, MBChB (University of Birmingham, England), focused on the 60 patients (13%) recruited for the endo-first versus surgery study who could not undergo revascularization so instead were managed conservatively with medication and wound care.

These patients were an average of 6 to 7 years older than those who underwent revascularization, were more likely to be women, and had higher rates of kidney disease and prior stroke. This group also was less likely than those who were revascularized to be on best medical therapy.

At 1 year, the mortality rate was 67%, and by 5 years it was 90%. Conversely, mortality rates in the revascularization group were 21.6% and 66.2%, respectively. In Kaplan-Meier survival estimation analysis, the revascularization group was 70% less likely to die (P < 0.001).

“I think it reinforces the fact that we need to be aggressive with revascularization,” Popplewell said. In addition to being referred for treatment earlier, there may have been adjunctive therapies that some patients may have been eligible for, making it important to look at all available options in this population, he added.

Holden added that BASIL-2 also draws attention to the “disgraceful” scenario of women with CLTI not being offered treatment at the same rate as men.

One explanation suggested by their analysis, Popplewell said, is that women presented at a later age and stage of CLTI, with more calcific vascular disease unrelated to smoking than typically seen among male smokers with diabetes.

“I think it's a slightly different pattern of disease that may explain some of it, but there also might be another facet to it,” he said.