One-year data from Cardiovascular System’s all-comers LIBERTY 360 clinical study have demonstrated sustained benefits following endovascular intervention in critical limb ischaemia patients.
The data were presented during a late-breaking presentation at the 2017 Amputation Prevention Symposium (AMP) in Chicago, USA.
The LIBERTY 360 study 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). With over 1,200 patients enrolled at 51 sites across the USA, it is among the first PAD studies to investigate patients across the spectrum of symptomatic PAD (RC 2-6). As an all-comers study, LIBERTY 360°’s novel trial design included any endovascular device US Food and Drug Administration (FDA)-approved for treatment of PAD.
One-year study outcomes were presented at AMP by Jihad Mustapha, director of Cardiac Research at Metro Health Hospital, University of Michigan Health, Wyoming, Michigan. Mustapha’s presentation highlighted results in critical limb ischemia (CLI) spanning RC 4-6, and where amputation prevention should be the primary goal in treating these patients.
Twelve-month data from LIBERTY 360 showed 96% freedom from amputation in RC 4-5 (N=589) and 81.7% in RC 6 (N=100). In addition, CLI patients in the study showed notable improvements in Rutherford Classification, Wound Healing, and Quality of Life out to 12 months.
Says Mustapha, “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 one year, as well as high freedom from major adverse events. In particular, LIBERTY 360 provides new, compelling evidence that PVI can lead to amputation free survival in CLI patients and serves as a patient-centric alternative to primary amputation.”
In his presentation, Mustapha also noted that the LIBERTY 360 clinical outcomes for CLI patients appear to support a new Class I guideline in the recently revised 2016 AHA/ACC Guidelines on the Management of Patients with PAD which states that “an evaluation for revascularization options should be performed by an interdisciplinary care team before amputation in the patient with CLI.”