Contemporary outcomes of initial treatment strategy of endovascular intervention or bypass in patients with critical limb ischemia

Abstract

Objective The optimal management for revascularization after critical limb ischemia (CLI) is controversial due to limited studies comparing long-term results of endovascular and open techniques. This study compares long-term outcomes after initial management of CLI via lower extremity bypass (LEB) and percutaneous vascular intervention (PVI). Methods This retrospective cohort study investigates outcomes of patients who underwent endovascular or open surgical management for CLI at a single institution from 2013–2018. All patients with diagnosis of CLI were included and separated based on initial therapy of PVI or LEB. Demographic, procedural, and follow-up data were assessed. Primary endpoints included major adverse limb events (MALE), specifically the need for major amputation and reintervention. Secondary endpoints included mortality at 30 days and one year. A multivariable Cox Proportional Hazard regression model was used to assess the relationship between Surgery group and time to MALE/death while controlling for confounding variables. Results This study identified 338 patients with an initial diagnosis of CLI who underwent either LEB ( n = 108, 32%) or PVI ( n = 230, 68%). The average age was 71.4, 54.4% were male, 30% were African American, 53.6% were diabetic, and 93.2% had hypertension. Patients who underwent LEB were more predominantly smokers ( p = .003) and less predominantly on dialysis at time of surgery ( p = .01). Re-intervention rates in the bypass group (11%) were not significantly different than the PVI group (9%; p = .95). In the bypass group, 20 (19%) patients had a major amputation with a median time of 189.5 days compared to 23 (10%) patients at a median time of 113 days in the PVI group; however, this difference was not significant ( p = .16). There was no significant difference in 1-year mortality between the LEB (2%) and PVI group (4%; p = .2). The cumulative incidence of MALE/death at 30 days was 4.0% in the bypass group and 3.7% in the PVI group ( p = .2). Incidences of MALE/death were 21.1% and 48.5% in the bypass group and 19.7 and 45.9% in the PVI group at one and 2 years, respectively. Intervention type was not found to be significantly associated with MALE/death after controlling for possible confounders (HR = 0.82, p = .43). Conclusions In the initial management of CLI, there is no significant difference in long-term outcomes in terms of major amputation, need for reintervention, limb-salvage, and 1-year mortality.