LIBERTY is a prospective, observational, multi-center study to evaluate procedural and long-term clinical and economic outcomes of endovascular device interventions in patients with symptomatic lower extremity peripheral artery disease (PAD).
- For intermittent claudication (IC) patients, over a 5-year period, significant deterioration appears in 20% of cases, of whom 2/3 with worsening claudication and 1/3 with Critical Limb Ischemia (CLI). For CLI patients, after 1-year, mortality is 20%, amputations are needed in 30%, while 45% are alive with both legs intact.1
- The LIBERTY study includes any FDA-approved technology to treat claudication and CLI.
- Lesions studied were within or extending into 10 cm above the medial epicondyle to the digital arteries (distal 1/3 of the SFA and below).
- 4 core laboratories were utilized for independent analysis.
- 1204 subjects were enrolled at 51 sites spanning a broad spectrum of sites of care including community hospitals, large teaching hospitals, VA centers, and office-based labs (OBLs).
- 131 operators treated patients in LIBERTY; 37 individual operators treated RC6 patients.
- Endpoints include: Procedural and lesion success, Major Adverse Events (MAEs), Duplex ultrasound, Quality of Life (QoL), Six-minute walk test (6MWT), Economic analysis.
- The findings in this novel, all-comers, 1,200-patient PAD study demonstrated high freedom from major amputation at 2 years and in an OAS sub-analysis despite complex demographics.
- Freedom from 2-year target vessel revascularization (TVR)/target lesion revascularization (TLR) rates are similar in RC4-5 and RC6.
- Significant improvement through 2 years in: Rutherford Class (RC) in all groups; Patient reported quality of life in all groups; Number of wounds in RC4-5 and RC6.
- 2-year MAE predictor model indicates that many traditional predictors are significant in an unadjusted model yet when accounting for potential covariates, those associated with disease progression and previous treatments were most strongly correlated with 2-year MAE.
- Peripheral vascular intervention (PVI) is a reasonable treatment option for RC2-3 and RC4-5.
- Primary amputation may not be necessary in RC6—PVI can be successful in this patient population, as evidenced at 2 years by high freedom from major amputation (79.8%) and improvement in QoL and RC.