LIBERTY 360° 18-month study was presented at the Cardiovascular Research Technologies (CRT) 2018 interventional cardiology conference in Washington, D.C. The study evaluates the acute and long-term clinical and economic outcomes of endovascular device interventions, including CSI’s orbital atherectomy system, in treating peripheral artery disease (PAD).
Cardiovascular Systems states the 18-month study outcomes were presented at CRT by Dr. William Gray, interventional cardiologist at Lankenau Heart Institute in Wynnewood, Pa. Dr. Gray’s presentation highlighted the continued high freedom from (FF) 18-month Major Adverse Events (MAE) in Rutherford Classifications (RC) 2-3 (76.9%) and RC4-5 (68.2%). Even when considering advanced disease in RC6, MAEs are not driven by major amputation (FF 81.7%). In addition, quality of life improved significantly from baseline to 18 months in all RC arms of the LIBERTY study.
Dr. Gray reported, “LIBERTY 360° represents an unrestricted real-world experience with various endovascular strategies across different RCs, many of whom would never be included in clinical trials, especially, RC6 patients. The results we’ve seen in this novel, all-comers PAD study indicate that endovascular peripheral vascular intervention is a reasonable treatment option for RC2-3, RC4-5 and RC6.”
In his presentation, Dr. Gray also noted that an orbital atherectomy sub analysis of the LIBERTY data indicated high freedom from major amputation in all Rutherford Classes (RC2-3, 100%; RC4-5, 95.3%; and RC6, 91.3%). Primary amputation is not necessary in RC6 as peripheral vascular intervention (PVI) can be successful in this patient population.
“The 18-month LIBERTY 360° results continue to show that PVI, including the use of orbital atherectomy, can lead to amputation free survival for patients with claudication or critical limb ischemia,” concluded Said Scott Ward, CSI’s Chairman, President and Chief Executive Officer