BEST-CLI Cost Analysis Favors Surgery Over Endovascular Therapy

In patients with chronic limb-threatening ischemia (CLTI), surgical revascularization may be more cost-effective over time than minimally invasive procedures, according to an economic analysis of BEST-CLI.

The findings are in line with the main results of the 1,830-patient BEST-CLI trial, published in 2022, which found that surgery was associated with fewer major adverse limb events (MALE), major limb interventions, and amputations than endovascular procedures. The study is the largest head-to-head comparison to date of the two options among CLTI patients eligible for either treatment.

Researchers led by Zafar Zafari, PhD (University of Maryland Institute for Health Computing, Bethesda), conducted the health economic simulation using an individual-level continuous-time model that included 1,434 patients (mean age 67 years; 28.5% women) who comprised Cohort 1 of BEST-CLI. These were all patients with adequate single-segment great saphenous vein that could be used for bypass surgery. 

With their estimates for incremental costs per each year of added survival or quality-adjusted life-year (QALY) gained, “bypass surgery was associated with lower costs and better survival and QALYs over both a 5- and 10-year time horizon in our base case analysis, meaning that bypass surgery was dominant compared with endovascular surgery,” Zafari and colleagues write in the paper published August 4, 2026, in JAMA Network Open.

Over 5 years, the mean per-person direct medical costs were $118,559 for bypass surgery and $125,535 for endovascular surgery, with mean survival times of 3.84 years and 3.78 years, respectively. Analyses for sensitivity indicated a 93% probability that surgery would be cost-effective at conventional willingness-to-pay thresholds of $100,000 per QALY gained.

David Cohen, MD (St. Francis Hospital & Heart Center, Roslyn, NY, and Cardiovascular Research Foundation, New York, NY), said for a trial that came down heavily in favor of surgery, the cost-effectiveness data are not surprising. But, he added, they may not tell the whole story.

“The issue that I think is important and that [the BEST-CLI investigators] do raise, is that there are other studies that have shown different things for the main endpoints, and if you had started with those studies, you probably would have gotten a very different answer than what you see in this study,” he told TCTMD. “It’s quite involved . . . and methodologically solid, but this is a hard area to study.”

Parsing the Model

The economic model consisted of five health states representing prespecified and adjudicated clinical events from the BEST-CLI trial that occurred after the index procedure: no event, minor reintervention, major reintervention (ie, a major index limb reintervention such as a new bypass graft or jump or interposition graft revision), amputation, and death. It also included covariates such as treatment arm, age, sex, body mass index, comorbid conditions, use of a direct oral anticoagulant, and use of warfarin, but did not include race or ethnicity. 

For each of the health states, Zafari and colleagues estimated costs for a slew of factors: the number of annualized hospitalization days, intensive care unit days, emergency department visits, dialysis days, tracheostomy, gastrointestinal endoscopy, cardiac catheterization procedures, imaging scans, ultrasonography, echocardiography, cardiac stress tests, physical therapy sessions, outpatient visits, and both outpatient and inpatient rehabilitation hours. They then used publicly available data sources to estimate the average direct medical costs associated with each health state in each treatment arm, with procedural costs based on Centers for Medicare & Medicaid Services claims for the intervention itself and the 30 days that followed. 

For the base case estimate, the mean QALY over 5 years was 2.53 per person for bypass surgery and 2.48 for endovascular therapy. That resulted in a dominated incremental cost per QALY gained and a mean incremental net monetary benefit (INMB) of -$11,841 for endovascular therapy compared with bypass surgery.

Vein bypass is a good option for patients who are eligible, and when they’re not eligible, we need to do what’s best for the patient. Sahil Parikh

Over 10 years, the mean per-person direct medical costs were $179,074 for bypass surgery and $186,598 for endovascular surgery. As in the 5-year time horizon, this resulted in a dominated incremental cost per QALY gained and a mean INMB of -$20,321 for endovascular compared with bypass surgery.

For every major reintervention avoided over 5 years, bypass surgery was predicted to reduce spending by $52,724 compared with endovascular therapy. For every amputation avoided, the spending reduction was $197,066.

Among subgroups, surgery was more cost-effective for patients undergoing femoropopliteal, infrapopliteal, or tibial revascularization when considering the point estimates of the incremental costs per QALY gained.

Questions Remain

Bypass dominated for cost-effectiveness in most instances, Zafari and colleague conclude. “Nevertheless, the remaining uncertainty suggests that future research is needed to identify subgroups for whom each of these interventions is more definitively cost-effective,” they write. “Furthermore, additional value of information may be gained from better characterizing the relative effects and costs of these two revascularization approaches for CLTI.”

The BEST-CLI investigators also note that only two prior analyses from RCTs have evaluated cost-effectiveness in this setting. One came from the BASIL trial, which showed surgery and plain balloon angioplasty to be comparable, but favored surgery for those with a life expectancy of more than 2 years. In terms of cost, surgery was associated with slightly higher spending, with a resulting incremental cost per QALY gained of $184,492.

Conversely, a cost-utility analysis of the more recent BASIL-2 trial found surgery to be substantially more expensive and associated with slightly higher QALYs than endovascular treatment. The incremental cost per QALY gained for surgery versus endovascular therapy was $730,000, with substantial cost savings per amputation avoided. These findings are in agreement with the main BASIL-2 findings showing that CLTI patients with infrapopliteal disease had a greater likelihood of dying or needing major amputation with surgical vein bypass rather than endovascular therapy as the primary intervention.

The BEST-CLI investigators acknowledge several limitations of their analysis, including that the rate of technical failure in the endovascular group was higher than expected based on contemporary endovascular studies. The downstream consequences of those failures, they suggest, may have disproportionally inflated expenses in that group.

“The  take home is vein bypass is a good option for patients who are eligible, and when they’re not eligible, we need to do what’s best for the patient,” said Sahil Parikh, MD (NewYork-Presbyterian/Columbia University Irving Medical Center, New York, NY), who also commented on the results for TCTMD.

He added that every decision for CLTI patients should continue to be made based on a patient-by-patient basis, considering all factors. 

“With the advent of other techniques like [deep venous arterialization], which has shown really impressive limb salvage in otherwise no-option patients,  I don’t know how you put a number on those kinds of outcomes,” Parikh said. “There are always going to be technological iterations that will potentially change the balance. I think these analyses are important for reimbursement and from a health economic analyses standpoint, but we’re still not really sure where to go with it.”