Cardiovascular Systems has presented baseline demographic data from its LIBERTY 360° post-marked study in a late-breaking presentation at the 28th International Symposium on Endovascular Therapy (ISET) in Hollywood, USA.
The study completed its enrolment on 1 February 2016, and 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).
LIBERTY 360° is a prospective, observational, multi-centre post-market study that enrolled over 1,200 patients at 53 sites across the USA, including 500 patients in the Claudicant Rutherford class two–three (R2–3) Arm, 600 in the CLI (critical limb ischaemia) Rutherford class four–five (R4–5) arm and 100 in the CLI Rutherford class six (R6) Arm. The patients will be followed for up to five years, and patient risk score(s) will be developed as a clinical predictor of outcomes to provide guidance for interventions.
LIBERTY 360°, the first PAD study to specifically include these disease states, will evaluate numerous parameters including procedural success, rate of major adverse events, duplex ultrasound findings, quality of life, six-minute walk test, wound status, economic outcomes and development of plaque burden assessment.
With enrollment now complete, key baseline demographic data was presented at ISET on Tuesday, February 9 by Jihad Mustapha of Metro Health Hospital in Wyoming, USA, and George L Adams, Rex Healthcare, Raleigh, USA. Additional authors on the abstract are William Gray, Main Line Health, Pennsylvania, USA; Gary Ansel, Riverside Methodist Hospital, Columbus, USA; and Michael Jaff, Massachusetts General Hospital, Boston, USA, who also served as chair of the LIBERTY 360° publication committee.
Mustapha says, “One hundred patients with severe CLI (Rutherford class six), 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.”
Adams adds, “LIBERTY 360°, the largest all-comers endovascular-PAD study, includes four core labs to help physicians adequately personalise treatment options.”
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 indicates racial disparity in PAD/CLI treatment, which warrants further investigation, according to a company release.
Jaff concludes, “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.”