LIBERTY Real-World Evidence on CLTI and Diabetic Patients

In a session from Tuesday, George Adams, MD, MHS, MBA, FACC, FSCAI, from UNC REX Hospital in Raleigh, North Carolina, presented results from the LIBERTY 360 analysis on patients with chronic limb-threatening ischemia (CLTI) and diabetes. Diabetes is a major risk factor for advancing peripheral arterial disease. Patients with diabetes and CLTI have a 30% to 45% risk of lower-extremity amputation, a 20% 1-year mortality rate following amputation, and are more susceptible to major adverse limb events following endovascular intervention. Recent studies suggest that earlier revascularization with catheter-based interventions may improve limb salvage rates.

LIBERTY 360 is a subanalysis of outcomes following orbital atherectomy in patients with CLTI, diabetes, and Rutherford class 4-6. There were 201 subjects with diabetes (260 lesions) and 88 subjects without diabetes (106 lesions). Patients with diabetes in this analysis were younger than those without diabetes, were more likely to have renal disease, hypertension, prior limb amputation, and wounds on the target limb. Obesity and renal disease rates were higher in patients with diabetes, whereas smoking was more common in patients without diabetes.

The lesions in each group were comparable with no significant difference in rates of infrapopliteal disease, lesion length, or prevalence of calcified lesions. Severe stenosis was more common in patients with diabetes (40.7% vs 27.2%). Chronic total occlusions were more common in patients without diabetes (30.8% vs 46.6%).

Procedural details, such as procedure time, fluoroscopy time, and contrast were similar between groups, but primary stenting was less frequent in patients with diabetes. Treatment success rates were similar between patients with and without diabetes. Both had similarly low rates of severe dissection of perforation. The distal embolization rate was higher in treated lesions in patients with diabetes (7.8% vs. 1.9%; p=.01; odds ratio 4.33 [95% CI: 0.99-18.88]; p=.05).

There was no significant difference in 30-day rates of freedom from all-cause death, major target-limb amputation, major amputation, or death. At 3 years, patients with and without diabetes had similar rates of freedom from major adverse events, all-cause death, major target-limb amputation, and target vessel revascularization and target lesion revascularization.

Patients with and without diabetes benefited from orbital atherectomy in this subanalysis, with limb salvage rates >93%, and low rates of major adverse events over 3 years The 3-year mortality rates were 26.9% in patients with diabetes and 24.3% in patients without diabetes. This is below the previously reported 3-year mortality rates of 40% to 60% in patients with CLTI.

Patients with CLTI and diabetes would benefit from additional studies on the effectiveness of orbital atherectomy when treating their complex lesions, CTOs, and variable peripheral arterial calcification.