Outcomes of Orbital Atherectomy in Patients with Critical Limb Threatening Ischemia and Diabetes

Abstract

Purpose: Patients with diabetes and critical limb threatening ischemia (CLTI) are at significantly higher risk of limb loss and death. Here we evaluate the outcomes of orbital atherectomy (OA) for treatment of CLTI in patients with and without diabetes.

Methods: Retrospective analysis of the LIBERTY 360 study was performed to evaluate baseline demographics, and peri-procedural outcomes between patients with CLTI, and with and without diabetes. Hazard ratios (HRs) were determined with Cox regression to examine the impact of OA in patients with diabetes and CLTI over a 3-year follow-up.

Results: A total of 289 patients (201 with diabetes, 88 without diabetes) with Rutherford classification 4-6 were included. Patients with diabetes had higher proportion of renal disease (48.3% vs 28.4%, p=0.002), prior minor/major limb amputation (26% vs 8%, p<0.005), and presence of wounds (63.2% vs 48.9%, p=0.027). Operative times, radiation dosage, and contrast volume were similar between groups. The rate of distal embolization was higher in patients with diabetes (7.8% vs 1.9%, p=0.01; OR 4.33 [0.99, 18.88], p=0.05). However, at 3-years post-procedure, patients with diabetes had no differences in freedom from target vessel/lesion revascularization (HR 1.09, p=0.73), major adverse events (MAE; HR 1.25, p=0.36), major target limb amputation (HR 1.74, p=0.39), and death (HR 1.11, p=0.72).

Conclusion: The LIBERTY 360 observed high limb preservation and low MAEs in patients with diabetes and CLTI. Higher distal embolization was observed with OA in patients with diabetes, but OR did not indicate a significant difference in risk between groups.

Keywords: amputation; critical limb threatening ischemia; diabetes; endovascular revascularization; orbital atherectomy.

Conflict of interest statement

Disclosure: The authors report no financial relationships or conflicts of interest regarding the content of the manuscript.

Figures

Figure 1.

Incidence of severe angiographic complications in the diabetic vs non-diabetic group

Figure 2.

Kaplan-Meier estimates of rates of freedom from (A) target vessel/lesion revascularization, (B) major adverse events, (C) major target limb amputation, and (D) all-cause death over a 3-year period