LIBERTY 360°: Regardless of PAD severity, endovascular interventions helpful at 3 years
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At 3 years, patients with various stages of peripheral artery disease who underwent endovascular interventions had high rates of freedom from adverse limb events, according to new data from the LIBERTY 360° study presented at the International Symposium on Endovascular Therapy.
LIBERTY 360° is a prospective, observational, multicenter study evaluating procedural and long-term clinical and economic outcomes of endovascular interventions in 1,204 patients with symptomatic lower-extremity PAD. Operators could treat patients with any endovascular device that is FDA-approved for the treatment of PAD.
“LIBERTY represents the largest contemporary real-world experience with various endovascular strategies across the full range of Rutherford categories, including many patients for whom longitudinal data are sparse, particularly category 6 patients,” William A. Gray, MD, system chief of cardiovascular services at Main Line Health and president of Lankenau Heart Institute in Wynnewood, Pennsylvania, said during a presentation.
The 3-year rates of amputation-free survival were 84.6% in Rutherford category 2 or 3, 74.7% in Rutherford category 4 or 5 and 51.8% in Rutherford category 6, he said.
“Rutherford category 6 subjects that survive past the first year after treatment see similar benefits in amputation-free survival as Rutherford category 2 to 3 and Rutherford category 4 to 5 subjects,” he said.
The 3-year rates of freedom from major adverse limb events and perioperative death were 96.2% in Rutherford category 2 or 3, 92.1% in Rutherford category 4 or 5 and 79.9% in Rutherford category 6, Gray said, noting that these figures were similar to the 1-year results.
Gray also reported the following 3-year results:
- freedom from major adverse events: Rutherford category 2 or 3, 70%; Rutherford category 4 or 5, 61.9%; Rutherford category 6, 47.1%;
- freedom from target limb revascularization/target vessel revascularization: Rutherford category 2 or 3, 70.8%; Rutherford category 4 or 5, 64%; Rutherford category 6, 61.6%;
- freedom from major target limb amputation: Rutherford category 2 or 3, 96.5%; Rutherford category 4 or 5, 93.9%; Rutherford category 6, 79.9%; and
- freedom from all-cause mortality: Rutherford category 2 or 3, 85.8%; Rutherford category 4 or 5, 79.6%; Rutherford category 6, 61.8%.
Improvements in quality of life as assessed by the VascuQoL score were sustained out to 3 years (Rutherford category 2 or 3, improvement of 1; P < .001; Rutherford category 4 or 5, improvement of 1.1; P < .001; Rutherford category 6, improvement of 1.1; P = .003), Gray said.
Predictors of death or major amputation included number of wounds on target limb at baseline, Rutherford category, history of renal disease, previous major amputation on nontarget limb, history of MI, age, use of bailout stent and history of stroke or transient ischemic attack, he said.
Predictors of major adverse limb events or perioperative death included Rutherford category, previous major amputation on nontarget limb, age, chronic total occlusion and history of renal disease, according to Gray.
“The results of this novel all-comers PAD study continue to suggest that peripheral vascular intervention is a reasonable treatment option for Rutherford categories 2 through 5,” Gray said during the presentation. “Primary amputation may not be necessary in Rutherford category 6. Peripheral vascular intervention can be successful in this patient population, as evidenced at 3 years by high freedom from major amputation and improvement in quality of life.” – by Erik Swain
Reference:
Gray WA. CLI and Complex PAD. Presented at: the International Symposium on Endovascular Therapy (ISET); Jan. 22-25, 2020; Hollywood, Fla.
Disclosures: The study was funded by Cardiovascular Systems Inc. Gray reports he consults for Abbott Vascular, Boston Scientific, Cook Medical, Medtronic, Shockwave Medical and W.L. Gore and Associates, received research/grant support from Abbott Vascular, Boston Scientific, Intact Vascular, Shockwave Medical and W.L. Gore and Associates, and holds equity in Biocardia, Contego Medical and Silk Road Medical.