OBJECTIVES:

To compare the real-world outcomes of open and endovascular revascularization approaches in chronic limb-threatening ischemia (CLTI) patients with diabetic foot ulcers (DFUs).

METHODS:

We conducted a retrospective cohort study using the OPTUM’s de-identified Clinformatics® Data Mart (2010-2021), focusing on patients who underwent revascularization after the initial diagnosis of DFUs. Outcomes of the open-first and endovascular-first revascularization strategies included major amputation-free survival, major adverse limb events (MALE, defined as major amputation or reintervention), and reintervention. Unadjusted and adjusted multivariate regression models were used to assess the association between the revascularization strategy and outcomes. Propensity score weighting was applied to balance the cohorts.

RESULTS:

Among the 19,802 patients included, 85.3% underwent endovascular revascularization and 14.7% underwent open bypass. Patient characteristics were comparable after propensity score weighting. The 12-months major amputation rate was higher with open revascularization (10.9% vs. 8.1%). In the unadjusted KM survival analysis, although the overall mortality and major amputation-free survival were similar, the open-first group had a higher amputation rate (p<0.0001) but a lower MALE rate (p<0.0001), primarily driven by fewer reinterventions. In the Cox model, the open-first approach was associated with a higher likelihood of major amputation (Hazard Ratio [HR] 1.18, 95% Confidence Interval [CI] 1.07-1.30; propensity score weighted cohort: HR 1.28, 95% CI 1.16-1.44) than endovascular-first revascularization. In logistic regressions, open-first revascularization was associated with a lower probability of MALE (34.2% vs. 41%; Odds Ratio (OR) 0.80, 95% CI 0.75-0.85) and reintervention (28.5% vs. 37.3%; OR 0.65, 95% CI 0.6-0.71) at 12 months.

CONCLUSIONS:

We found that an open revascularization approach in patients with DFUs was associated with an increased risk of major amputation, despite similar amputation-free survival rates compared to endovascular revascularization. The lower MALE rate associated with open revascularization was primarily driven by the reduced need for reintervention.