CSI's LIBERTY 360° Demographic Data Presented at ISET

February 10, 2016—Cardiovascular Systems, Inc. (CSI) announced that key baseline demographic data from its LIBERTY 360° postmarket study were presented by Jihad Mustapha, MD, and George L. Adams, MD, at ISET 2016, the 28th International Symposium on Endovascular Therapy in Hollywood, Florida.

The study, which completed enrollment on February 1, will evaluate the acute and long-term clinical and economic outcomes of endovascular device interventions, including CSI’s orbital atherectomy system, in treating peripheral arterial disease (PAD).

According to CSI, LIBERTY 360° is a prospective, observational, multicenter postmarket study that enrolled more than 1,200 patients at 53 sites in the United States. The enrolled patient population is composed of 500 patients in the claudicant Rutherford class 2–3 (R2–3) arm; 600 patients in the CLI (critical limb ischemia) Rutherford class 4–5 (R4–5) arm; and 100 patients in the CLI Rutherford class 6 (R6) arm. The patients will be followed for up to 5 years, and patient risk score(s) will be developed as a clinical predictor of outcomes to provide guidance for interventions.

LIBERTY 360° will evaluate numerous parameters including procedural success, rate of major adverse events, duplex ultrasound findings, quality of life, a 6-minute walk test, wound status, economic outcomes, and development of plaque burden assessment.

The interim LIBERTY demographic analysis indicates that the prevalence of diabetes and renal disease increases statistically as the PAD disease state progresses from R2–3 (claudicant) to R6 (CLI). The data indicate racial disparity in PAD/CLI treatment, which warrants further investigation.

In addition to Dr. Mustapha, of Metro Health Hospital in Wyoming, Michigan, and Dr. Adams, of Rex Healthcare in Raleigh, North Carolina, the LIBERTY 360º publication committee is composed of the Chair, Michael Jaff, DO, of Massachusetts General Hospital in Boston, Massachusetts; William Gray, MD, of Main Line Health in Wynnewood, Pennsylvania; and Gary Ansel, MD, of Riverside Methodist Hospital in Columbus, Ohio. 

In the company’s press release, Dr. Mustapha commented, “100 patients with severe CLI (R6), the most life-threatening form of PAD, were included in this study. This data may provide unprecedented evidence that these difficult-to-treat patients can be successfully treated. We look forward to sharing this information with the scientific, medical, and patient communities.”

Dr. Adams added, “LIBERTY 360°, the largest all-comers endovascular-PAD study, includes four core labs to help physicians adequately personalize treatment options.”

Dr. Jaff concluded, “LIBERTY 360° represents a real-world patient outcome experience with various endovascular strategies across quite severe patient types. Many of these patients would never be included in typical clinical trials. The data from this very large, multicenter, independently adjudicated experience will undoubtedly add to our knowledge base about how to manage patients with advanced, complex PAD.”