LIBERTY 360° is a prospective, observational, multi-center post-market study that enrolled over 1,200 patients at 51 sites across the US
Image: The study included any endovascular device FDA-cleared for treatment of PAD. Photo: Courtesy of Reaper DZ from Pixabay.
Cardiovascular Systems, a medical device company developing and commercializing innovative interventional treatment systems for patients with peripheral and coronary artery disease (PAD and CAD), presented three-year outcomes from its LIBERTY 360° study in a late-breaking presentation at the 2019 Amputation Prevention Symposium (AMP) in Chicago.
LIBERTY 360° is a prospective, observational, multi-center post-market study that enrolled over 1,200 patients at 51 sites across the United States, including 501 patients with claudication (Rutherford Classifications, or RC, 2-3), 603 patients with critical limb ischemia (CLI; RC4-5) and 100 patients with the most severe form of CLI (RC6). The study included any endovascular device FDA-cleared for treatment of PAD. Enrollment was completed in February 2016 and patients will be followed for up to five years.
The three-year study outcomes were presented at AMP by Dr. Jihad A. Mustapha, MD, FACC, FSCAI, Advanced Cardiac & Vascular Amputation Prevention Centers, Grand Rapids, Michigan. Dr. Mustapha’s presentation highlighted continued high freedom from major amputation at three years (RC2-3, 98.5%; RC4-5, 93.9%; and RC6, 79.9%).
In his presentation, Dr. Mustapha also noted that CSI’s orbital atherectomy system (OAS) was the most frequently used atherectomy device in the study and that the OAS sub analysis of the LIBERTY data indicated high freedom from major amputation (RC2-3, 100%; RC4-5, 95.3%; and RC6, 88.6%) with no additional amputations reported after the two-year visit.
Said Dr. Mustapha, “LIBERTY 360° represents as close to a real-world experience as possible with various endovascular strategies across Rutherford Classifications. In addition to demonstrating durable clinical outcomes, LIBERTY 360° also demonstrated a positive quality of life impact to the PAD patients in the study. Quality of life scores improved significantly by 30 days post-procedure and were maintained out to three years.
“The durable outcomes from the endovascular-first approach demonstrated in LIBERTY 360° are indicative of key findings from other recent studies published in the Journal of the American Heart Association and Circulation: Cardiovascular Quality and Outcomes. Compared to primary amputation, revascularization approaches have shown to be associated with longer survival time, lower risk of subsequent amputation, and lower healthcare costs. Furthermore, within revascularization strategies, an endovascular approach has been associated with a lower risk of amputation than surgical bypass. Additionally, the importance of atherectomy as a treatment option for CLI is being reinforced based on a new analysis of Medicare data that I first presented at AMP where atherectomy showed statistically lower rates of mortality and major amputation relative to percutaneous transluminal angioplasty, stent placement, or surgical bypass among patients with CLI.”
Said Scott Ward, CSI’s Chairman, President and Chief Executive Officer, “The body of evidence in the field of peripheral arterial disease is building and yielding new insights for the optimal care of patients. CSI is committed to serving as a leader in the study of PAD and CLI patients and to continually advancing the technology used to treat this underserved patient population.”
Source: Company Press Release.
Source: Company Press Release