Characteristics and Outcomes of Patients With Diabetes Mellitus Undergoing Peripheral Vascular Intervention for Infrainguinal Symptomatic Peripheral Artery Disease

Abstract

Purpose: Patients with diabetes mellitus (DM) are known to be at higher risk for peripheral artery disease (PAD), amputations, and major adverse cardiovascular events, though it is unclear whether they are at any higher risk for repeat intervention. LIBERTY 360 offered an opportunity to study a real-world cohort of patients who underwent distal superficial femoral artery endovascular revascularizations. We aimed to describe patients with DM, their outcomes following peripheral vascular intervention, and the effect of DM on outcomes in the LIBERTY 360 cohort.

Methods: LIBERTY 360 is a prospective, multi-center, non-randomized, mono-industry funded observational study of patients undergoing endovascular revascularization. Outcomes included 30-day and 1-year all-cause mortality, major amputation, target vessel/lesion revascularization, and a composite of those events. A multivariable regression model including DM was constructed to examine the effect of DM on outcomes. Multivariable survival estimates were made using Cox proportional hazards models.

Results: A total of 1,204 patients were enrolled, of whom 727 had DM (60.4%). Patients with DM had significantly more comorbidities and a third required insulin for DM management. Patients with DM had more severe disease based on Rutherford classification at baseline. After adjusting for comorbidities and disease severity, DM patients had more frequent major amputations at 1 year (5.2% versus 1.2%; HR 2.71, 95%CI 1.05-6.98, p = 0.040). The 1-year rates of all-cause mortality and target vessel/lesion revascularization were not significantly higher for patients with DM.

Conclusions: Diabetes mellitus was associated with increased major amputations at 1 year following endovascular revascularization after accounting for demographics, comorbidities, and PAD-related characteristics. Further research is needed to determine which aspects of PAD and DM are most strongly associated with poor outcomes following lower extremity revascularization.

Keywords: chronic limb threatening ischemia; diabetes mellitus; endovascular intervention; lower extremity intervention; peripheral artery disease.

Figures

Figure 1:

Participant accountability flow chart There were 727 patients with DM and 462 patients without DM for analysis. Over the course of a year, 62 patients with DM died and 108 were lost to follow-up or withdrawn. 27 patients without DM died and 79 were lost to follow-up or withdrawn. LTF: Lost to follow-up

Figure 2:

Kaplan Meier survival curves comparing major adverse dvents, death, major amputation, and target vessel revascularization in patients with diabetes versus no diabetes Kaplan Meier Curves are shown for rates of freedom from events in DM vs non-DM for (A) the primary outcome, major adverse events, along with the individual components of (B) all-cause death, (C) major amputation, and (D) target vessel revascularization. Unadjusted between-group differences for the composite major adverse events and major target-limb amputation were significant at one year.