Outcomes of Infra-Inguinal Bypass Using the Omniflow II Graft in Diabetic and Nondiabetic Patients

Background Diabetes mellitus is a major risk factor for peripheral arterial disease and is often associated with inferior outcomes after infra-inguinal bypass surgery. The Omniflow II biosynthetic graft has shown favorable results in various settings, but evidence comparing outcomes between diabetic and nondiabetic patients is lacking. Methods We performed a multicenter retrospective cohort study of 190 infra-inguinal Omniflow II bypasses (2014–2024) across 7 Dutch hospitals. Primary endpoint was primary patency; secondary endpoints included assisted and secondary patency, major amputation, vascular graft or endograft infection (VGEI), and mortality. Differences between diabetics and nondiabetics were assessed using Kaplan–Meier and Cox regression. Results Of the 190 patients, 62 (32.6%) had diabetes mellitus. The median follow-up was 30 months (interquartile range [IQR] 13–51). Diabetes was not associated with differences in primary patency (adjusted hazard ratio [HR] 0.95, 95% confidence interval [CI] 0.58–1.49, P = 0.78), primary assisted patency (adjusted HR 1.14, 95% CI 0.72–1.81, P = 0.58), or secondary patency (adjusted HR 1.25, 95% CI 0.77–2.02, P = 0.36). Major amputation (adjusted HR 0.85, 95% CI 0.38–1.96, P = 0.72) and VGEI (adjusted HR 2.20, 95% CI 0.38–12.66, P = 0.29) rates were comparable between groups. Mortality was higher in unadjusted analysis (HR 1.76, P = 0.02), but this association disappeared after adjustment (HR 1.50, 95% CI 0.81–2.78, P = 0.20). Conclusion Despite an unfavorable baseline risk profile, diabetic patients had similar graft-related outcomes compared with nondiabetics. The Omniflow II biosynthetic graft appears to be a safe and effective conduit in this high-risk population.