Three-Year Outcomes Presented From CSI's LIBERTY 360° Postmarket Study
August 16, 2019—Cardiovascular Systems, Inc. (CSI) announced that 3-year outcomes from its LIBERTY 360° study were presented at the 2019 Amputation Prevention Symposium (AMP) held August 14–17 in Chicago, Illinois. The data were presented by Jihad A. Mustapha, MD, from Advanced Cardiac & Vascular Amputation Prevention Centers in Grand Rapids, Michigan.
According to CSI, LIBERTY 360° is a prospective, observational, multicenter postmarket study that enrolled more than 1,200 patients at 51 sites across the United States, including 501 patients with claudication (Rutherford classification [RC] 2–3), 603 patients with critical limb ischemia (CLI; RC 4–5), and 100 patients with the most severe form of CLI (RC 6).
The study included any endovascular device FDA-cleared for the treatment of peripheral artery disease (PAD) with CSI’s orbital atherectomy system (OAS) being the most frequently used atherectomy device. Enrollment was completed in February 2016 and patients will be followed for up to 5 years.
Dr. Mustapha’s presentation highlighted continued high freedom from major amputation at 3 years (RC 2-3, 98.5%; RC 4-5, 93.9%; and RC 6, 79.9%). Additionally, the OAS subanalysis of the LIBERTY data indicated high freedom from major amputation (RC 2-3, 100%; RC 4-5, 95.3%; and RC 6, 88.6%) with no additional amputations reported after the 2-year visit.
In the CSI announcement, Dr. Mustapha commented, “LIBERTY 360° represents as close to a real-world experience as possible with various endovascular strategies across Rutherford classifications. In addition to demonstrating durable clinical outcomes, LIBERTY 360° also demonstrated a positive quality-of-life impact on the PAD patients in the study. Quality-of-life scores improved significantly by 30 days postprocedure and were maintained out to 3 years."
Dr. Mustapha continued:
"The durable outcomes from the endovascular-first approach demonstrated in LIBERTY 360° are indicative of key findings from other recent studies published in the Journal of the American Heart Association and Circulation: Cardiovascular Quality and Outcomes.
"Compared to primary amputation, revascularization approaches have shown to be associated with longer survival time, lower risk of subsequent amputation, and lower health care costs. Furthermore, within revascularization strategies, an endovascular approach has been associated with a lower risk of amputation than surgical bypass.
"Additionally, the importance of atherectomy as a treatment option for CLI is being reinforced based on a new analysis of Medicare data that I first presented at AMP where atherectomy showed statistically lower rates of mortality and major amputation relative to percutaneous transluminal angioplasty, stent placement, or surgical bypass among patients with CLI."