Cost-Effectiveness of Endovascular vs Open Surgery for Chronic Limb-Threatening Ischemia.

Importance: Choosing between endovascular and open (bypass) surgical revascularization for chronic limb-threatening ischemia has major implications for clinical practice. Objective: To evaluate the cost-effectiveness of endovascular vs bypass surgical revascularization. Design, Setting, and Participants: This economic evaluation used individual-level data from the Best Endovascular vs Best Surgical Therapy for Patients With Chronic Limb Ischemia (BEST-CLI) trial, with the first patient enrolled August 28, 2014, and the final October 18, 2019, for a median follow-up of 2.7 years. An individual-level, continuous-time Markov model with health states based on adjudicated clinical events from BEST-CLI was developed. Rates of clinical outcomes, health utilities, and health care resource use were derived from trial data. Unit costs came from Medicare insurance claims data and the physician fee schedule. The data were analyzed between June 27, 2025, and May 28, 2026. Main Outcomes and Measures: The main outcomes were incremental cost per life-years gained, incremental quality-adjusted life-years (QALYs) gained, incremental net monetary benefit, and cost per major events of revascularization and amputation avoided over a 5- and 10-year time horizon. One-way and probabilistic sensitivity analyses were performed to quantify uncertainty. Results: The cohort included 1434 patients from BEST-CLI (mean [SD] age, 67 [10] years; 1026 male [71.5%]). In the base case analysis, over a 5-year time horizon, the mean per-person direct medical costs were $118 559 (95% credible interval [CrI], $86 978-$157 152) for bypass surgery and $125 535 (95% CrI, $96 205-$160 357) for endovascular surgery. The mean survival per person was 3.84 years (95% CrI, 3.74-3.93 years) and 3.78 years (95% CrI, 3.61-3.94 years) for bypass and endovascular surgery, respectively. The mean QALYs per person were 2.53 (95% CrI, 2.34-2.70) for bypass surgery and 2.48 (95% CrI, 2.28-2.67) for endovascular surgery. Bypass surgery dominated endovascular surgery with respect to both costs per life-year and per QALY gained. The results over 10 years were consistent with those of the 5-year BEST-CLI follow-up. In the Monte Carlo simulation, there was a 93% chance that bypass surgery was more cost-effective than endovascular surgery. Conclusions and Relevance: This cost-effectiveness study found that bypass surgery was more cost-effective in most probabilistic simulations; however, uncertainty remained, highlighting the need for future research to identify subgroups in whom each approach may be cost-effective.