‘18 AMPUTATION PREVENTION SYMPOSIUM: CARDIOVASCULAR SYSTEMS PRESENTS LIBERTY 360° TWO-YEAR OUTCOMES
Cardiovascular Systems Inc. , medical device company developing and commercializing innovative interventional treatment systems for patients with peripheral and coronary artery disease, presented two-year outcomes from its LIBERTY 360° study in a late-breaking presentation at the 2018 Amputation Prevention Symposium (AMP) in Chicago Aug. 8.
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. With more than 1,204 patients enrolled at 51 sites across the United States, 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 FDA-cleared for treatment of PAD.
The two-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 the continued high freedom from major amputation in all Rutherford Classifications (RC) at two years (RC2-3, 99.1 percent; RC4-5, 94.5 percent; and RC6, 79.8 percent).
“LIBERTY 360° represents as close to a real-world experience as possible with various endovascular strategies across Rutherford Classes,” Dr. Mustapha said. “Following endovascular intervention, we saw a marked improvement across all Rutherford Classes at two years, as well as high freedom from major amputation. In particular, LIBERTY 360° provides compelling evidence that PVI can lead to amputation free survival even in RC6 patients, which showed a 79.8 percent freedom from major amputation following PVI.”
In his presentation, Dr. Mustapha 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 percent; RC4-5, 95.3 percent; and RC6, 88.5 percent).
Scott Ward, CSI’s chairman, president and CEO said the two-year LIBERTY 360° results continue to show that PVI, including the use of orbital atherectomy, can lead to amputation free survival for patients with mild to severe PAD, even critical limb ischemia.
LIBERTY 360° is a prospective, observational, multi-center post-market study that enrolled more than 1,200 patients at 51 sites across the United States, including 501 patients with claudication (RC2-3), 603 patients with critical limb ischemia (CLI; RC4-5) and 100 patients with the most severe form of CLI (Rutherford 6). 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.
LIBERTY 360° is among the first PAD studies to investigate patients across the spectrum of symptomatic PAD and will assess numerous parameters including procedural success, rate of major adverse events, duplex ultrasound findings, quality of life, six-minute walk test, wound status, and economic outcomes. VTN
READ MORE: www.ClinicalTrials.gov; identifier: NCT01855412