Twelve-Month LIBERTY 360° Data Demonstrate Benefits of Endovascular Intervention in Patients With CLI
August 10, 2017—Cardiovascular Systems, Inc. (CSI) announced that 1-year data from its LIBERTY 360° clinical study were revealed by Jihad Mustapha, MD, in a late-breaking presentation at the AMP 2017, the Amputation Prevention Symposium held August 9–12 in Chicago, Illinois.
According to CSI, 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). The study 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.
LIBERTY 360° is an all-comers study designed to include any endovascular device approved by the US Food and Drug Administration for the treatment of PAD. The prospective, observational, multicenter postmarket study enrolled more than 1,200 patients at 51 sites across the United States. Enrollment was completed in February 2016 and patients will be followed for up to 5 years.
Patients in the study were across the spectrum of symptomatic PAD (Rutherford classification 2–6). Specifically, 501 patients had claudication (Rutherford classification 2–3), 603 patients with critical limb ischemia (CLI; Rutherford classification 4–5), and 100 patients with the most severe form of CLI (Rutherford classification 6).
Dr. Mustapha’s presentation highlighted results in CLI, spanning Rutherford classification 4–6, and where amputation prevention should be the primary goal in treating these patients. The 12-month data from LIBERTY 360° showed 96% freedom from amputation in Rutherford classification 4–5 (n = 589) and 81.7% in Rutherford classification 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.
In the company'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 1 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, Dr. 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 American Heart Association/American College of Cardiology 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.”