This article is more than 5 years old. Information may no longer be current.
LIBERTY 360°: Endovascular interventions improve outcomes across all Rutherford classes
Click Here to Manage Email Alerts
HOLLYWOOD, Fla. — Treatment with FDA-approved endovascular device interventions was associated with improved clinical outcomes at 2.5-year follow-up, regardless of severity of peripheral artery disease or critical limb ischemia at baseline, according to new data from the LIBERTY 360° study.
LIBERTY 360° is a prospective, observational, multicenter study designed to evaluate procedural and long-term clinical and economic outcomes of endovascular interventions in patients with symptomatic lower-extremity PAD. The trial’s novel design includes any endovascular device that is FDA approved for the treatment of PAD.
As Cardiology Today’s Intervention previously reported, LIBERTY 360° enrolled 1,204 patients with PAD or CLI, ranging from Rutherford classes 2 to 6. Operators were free to use whatever endovascular therapy they saw fit.
At 18 months, most participants were free from major adverse events and experienced improvements in quality of life. Jihad A. Mustapha, MD, FACC, FSCAI, CEO of Advanced Cardiac and Vascular Amputation Prevention Centers in Grand Rapids, Michigan, presented new 2.5-year data at the International Symposium on Endovascular Therapy.
Patients enrolled in LIBERTY 360° were stratified by Rutherford class 2-3, Rutherford class 4-5 or Rutherford class 6.
At 2.5 years, more than 94% of patients in Rutherford classes 2-5 at baseline were free from major target limb amputation and more than 93% were free from major adverse limb events/perioperative death. Rates of freedom from target vessel revascularization/target limb revascularization at 2.5 years were more than 64%, and more than 83% of patients were still alive, Mustapha said.
“This has never been reported before, and is a great deal to show,” he said.
Among patients with Rutherford class 6 — the most severe class of CLI — 63.6% of patients were alive at 2.5 years and 79.9% were free from target limb major amputation.
Rates of all adverse events were lower among patients who underwent orbital atherectomy compared with the entire cohort, according to the researchers.
From baseline to 2 years, all groups showed significant improvements in Rutherford class and quality of life metrics, Mustapha said.
Mean number of wounds on the target limb were reduced in all groups from baseline to 2 years, and the percentage improvement in mean number of wounds compared with baseline was significant at 2 years in the Rutherford 4-5 and Rutherford 6 groups (P < .001 for both), he said.
“This study shows that if you treat patients at any level, they will do better, and if you treat them with orbital atherectomy, they will do even better,” Mustapha said. – by Erik Swain
Reference:
Mustapha JA, et al. Hot topics and late-breaking trials. Presented at: the International Symposium on Endovascular Therapy (ISET); Jan. 27-30, 2019; Hollywood, Fla.
Disclosures: The study was funded by Cardiovascular Systems Inc. Mustapha reports he has financial ties with 480 Biomedical, BD/Bard, Bioendothelium, Boston Scientific, Cagent Vascular, Cardio Flow, Cardiovascular Systems Inc., Medtronic, Micromedical Solutions, Philips, PQ Bypass, Reflow Medical and Terumo.