Two-Year Outcomes Presented From CSI's LIBERTY 360° Postmarket Study
August 8, 2018—Cardiovascular Systems, Inc. (CSI) announced that Jihad A. Mustapha, MD, presented 1-year outcomes from the company's LIBERTY 360° study in a late-breaking presentation at AMP, the 2018 Amputation Prevention Symposium, held August 8–11 in Chicago, Illinois.
According to CSI, LIBERTY 360° is an all-comers, prospective, observational, multicenter postmarket study. It is designed to evaluate the acute and long-term clinical and economic outcomes of peripheral vascular interventions (PVI) in patients with peripheral artery disease (PAD) using any endovascular device that has been FDA-cleared for the treatment of PAD.
More than 1,204 patients were enrolled at 51 sites across the United States to investigate patients across the spectrum of symptomatic PAD, including 501 patients with Rutherford class (RC) 2–3 disease, 603 patients with RC 4–5 disease, and 100 patients with RC 6 disease.
Enrollment in LIBERTY 360° was completed in February 2016 and patients will be followed for up to 5 years. Investigators will assess numerous parameters, including procedural success, rate of major adverse events, duplex ultrasound findings, quality of life, 6-minute walk test, wound status, and economic outcomes.
As presented at AMP, the 2-year study outcomes highlighted the continued high freedom from major amputation at 2 years: RC 2–3 = 99.1%; RC 4–5 = 94.5%; and RC 6 = 79.8%.
Additionally, Dr. Mustapha advised that an orbital atherectomy subanalysis of the LIBERTY data indicated high freedom from major amputation in all classes: RC 2–3 = 100%; RC 4–5 = 95.3%; and RC 6 = 88.5%.
In CSI's announcement, Dr. Mustapha commented, “LIBERTY 360° represents as close to a real-world experience as possible with various endovascular strategies across Rutherford classes. Following endovascular intervention, we saw a marked improvement across all Rutherford classes at 2 years, as well as high freedom from major amputation. In particular, LIBERTY 360° provides compelling evidence that PVI can lead to amputation-free survival even in RC 6 patients, which showed a 79.8% freedom from major amputation following PVI.”