Two-year outcomes from the LIBERTY 360° study have shown a marked improvement across all Rutherford classes, as well as high freedom from major amputation. The results were presented as a late-breaking presentation at the Amputation Prevention Symposium (AMP; 8–11 August, Chicago, USA).
The LIBERTY 360° study is designed to evaluate the acute and long-term clinical and economic outcomes of peripheral vascular interventions in patients with peripheral arterial disease. With over 1,204 patients enrolled at 51 sites across the USA, it is among the first peripheral arterial disease studies to investigate patients across the spectrum of symptomatic peripheral arterial disease (Rutherford classes 2–6). As an “all comers” study, LIBERTY 360°’s trial design included any endovascular device FDA-cleared for treatment of peripheral arterial disease.
Key endpoints include procedural and lesion success, major adverse events (MAEs), duplex ultrasound, quality of life (QoL), six-minute walk test (6MWT) and economic analysis.
The two-year study outcomes were presented by Jihad A Mustapha, Advanced Cardiac & Vascular Amputation Prevention Centers, Grand Rapids, USA. Mustapha’s presentation highlighted the continued high freedom from major amputation in all Rutherford Classifications (RC) at two years (RC2–3, 99.1%; RC4–5, 94.5%; and RC6, 79.8%).
“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 two years, as well as high freedom from major amputation. In particular, LIBERTY 360° provides compelling evidence that peripheral vascular interventions can lead to amputation free survival even in RC6 patients, which showed a 79.8% freedom from major amputation following peripheral vascular intervention,” Mustapha said.
Mustapha also noted that an orbital atherectomy (using Diamondback 360, Cardiovascular Systems Inc) 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, 88.5%).