Failed endovascular intervention before open bypass does not worsen outcomes for chronic limb-threatening ischemia

The Best Endovascular vs Best Surgical Therapy in Patients with Chronic Limb-Threatening Ischemia trial showed inferior outcomes of open bypass after failed endovascular procedure (OAFEs). However, we have reported excellent long-term limb preservation in patients treated with an endovascular-first approach. The purpose of this study was to compare outcomes following initial index open lower-extremity bypass (iOPEN) vs OAFE in diabetic patients treated in a multidisciplinary setting using this protocol.

All patients enrolled in our multidisciplinary diabetic limb preservation service from June 2012 to December 2024 were entered into a prospective database. Patients who underwent either iOPEN or OAFE were included in the analysis. All endovascular interventions adhered to a strict protocol to avoid any intervention to what would be the distal bypass target. Kaplan-Meier analyses were used to evaluate outcomes between the groups.

Of the 503 patients enrolled in our multidisciplinary service, 81 patients met the study inclusion criteria and underwent 94 open bypasses. The study cohort was more often male (63%) and Black (64%). Review of the preoperative angiograms confirmed that the distal bypass target had not changed in 100% of the OAFE group. There were no significant differences in the 4-year limb salvage rate [iOPEN, 89%; 95% confidence interval (CI), 81%-98% vs OAFE, 91%; 95% CI, 79%-100%; P = .92], freedom from major adverse limb events (iOPEN, 69%; 95% CI, 57%-83% vs OAFE, 86%; 95% CI, 72%-100%; P = .20), freedom from major adverse limb events or mortality (iOPEN, 49%; 95% CI, 37%-65% vs OAFE, 51%; 95% CI, 32%-82%; P = .54), and amputation-free survival (iOPEN, 55%; 95% CI, 43%-71% vs OAFE, 55%; 95% CI, 37%-82%; P = .92) between the two groups.

Our results did not show any statistically significant difference in outcomes between bypasses after failed endovascular interventions and index bypasses. An endovascular-first approach to the management of infrainguinal diabetic vascular disease may be considered provided that distal bypass targets are maintained.