LIBERTY 360° Study's 18-Month Outcomes Presented for CSI's Orbital Atherectomy System

March 6, 2018—Cardiovascular Systems, Inc. (CSI) announced that 18-month outcomes from its LIBERTY 360° study were presented by William Gray, MD, at CRT 2018, the Cardiovascular Research Technologies conference held March 3–6 in Washington, DC. The study is evaluating the acute and long-term clinical and economic outcomes of endovascular device interventions, including CSI's orbital atherectomy system, in treating peripheral artery disease (PAD).

According to the company, Dr. Gray's presentation highlighted the continued high freedom from (FF) 18-month major adverse events (MAEs) in Rutherford classification (RC) 2–3 (76.9%) and RC 4–5 (68.2%). The study found that even in advanced disease of RC 6, MAEs are not driven by major amputation (FF, 81.7%). Additionally, quality of life improved significantly from baseline to 18 months in all RC arms of the LIBERTY study.

In the CSI announcement, Dr. Gray commented, "LIBERTY 360° represents an unrestricted real-world experience with various endovascular strategies across different RCs, many of whom would never be included in clinical trials, especially, RC 6 patients. The results we've seen in this novel, all-comers PAD study indicate that endovascular peripheral vascular intervention is a reasonable treatment option for RC 2–3, RC 4–5, and RC 6."

Also in his presentation, Dr. Gray noted that an orbital atherectomy subanalysis of the LIBERTY data indicated high FF major amputation in all classes: RC 2–3, 100%; RC 4–5, 95.3%; and RC 6, 91.3%. Primary amputation is not necessary in RC 6 patients, as peripheral vascular intervention can be successful in this patient population, advised Dr. Gray.