February 10, 2020
One-Year Outcomes Published From CLI Substudy of LIBERTY 360º
February 10, 2020—One-year findings from a critical limb ischemia (CLI) subanalysis of the LIBERTY 360º study were published by Jihad A. Mustapha, MD, et al in Vascular Health and Risk Management, the official journal of the International Society of Vascular Health (2020;16:57–66). The study evaluated peripheral endovascular device intervention with any FDA-cleared device in CLI patients.
The study included any endovascular device FDA-cleared for the treatment of peripheral artery disease (PAD). The study is sponsored by Cardiovascular Systems Inc., and the company’s orbital atherectomy system was the most frequently used atherectomy device.
According to the investigators, the study was conducted because high-risk patients with advanced PAD (including CLI) are often excluded from peripheral endovascular device intervention clinical trials, leading to difficulty in translating trial results into real-world practice. Therefore, there is a need for prospectively assessed studies to evaluate peripheral endovascular device intervention outcomes in patients with CLI.
As summarized in Vascular Health and Risk Management, LIBERTY 360º is a prospective, observational, multicenter study designed to evaluate the procedural and long-term clinical outcomes of peripheral endovascular device intervention in real-world patients with symptomatic lower extremity PAD. There were 1,204 patients enrolled and stratified based on Rutherford classification (RC): RC 2 to 3 (n = 501), RC 4 to 5 (n = 603), and RC 6 (n = 100). For this subanalysis, patients with RC 5 to 6 (n = 404) were pooled, and 1-year outcomes were assessed.
The investigators reported that procedural complications rarely resulted in postprocedural hospitalization (1.7%), and 89.1% of patients with RC 5 to 6 were discharged to home. Considering the advanced disease state in patients with RC 5 to 6, the investigators noted a 65.5% freedom from 1-year major adverse event rate (defined as target vessel revascularization, death to 30 days, and major target limb amputation).
At 1 year, freedom from major amputation was 89.6%. Wounds identified at baseline on the target limb had completely healed in 172 out of 243 (70.8%) patients with RC 5 to 6 by 1 year. Additionally, the overall quality of life (as measured by VascuQoL) improved from baseline to 1 year.
This analysis of patients with RC 5 to 6 in LIBERTY 360º demonstrated that peripheral endovascular device intervention can be successful in CLI patients, with low rates of major amputation and improvement in wound healing and quality of life through 1-year follow-up, concluded the investigators in Vascular Health and Risk Management.