One Year Outcomes of Endovascular Device Intervention in Patients with Symptomatic Lower Extremity Peripheral Artery Disease (LIBERTY 360)
Ryan S. Turley, MD, David Nation, MD, Mazin Foteh, MD
Cardiothoracic and Vascular Surgeons, Austin, TX, USA.
OBJECTIVE: There is a need for objective peripheral vascular intervention (PVI) studies to evaluate clinical, functional and economic outcomes in patients with advanced peripheral artery disease (PAD). LIBERTY 360, a prospective, observational, multi-center study with liberal inclusion and few exclusion criteria, was designed to evaluate outcomes of endovascular device interventions in real-world patients with symptomatic lower extremity PAD.
METHODS: The LIBERTY study included any FDA-approved technologies to treat lower extremity PAD. 1,204 subjects were enrolled at 51 sites in the U.S. (501 Rutherford 2-3; 603 Rutherford 4-5; 100 Rutherford 6). One year outcomes were assessed by Rutherford group and include Major Adverse Events (MAE) defined as target vessel revascularization (TVR), death within 30 days of procedure, and unplanned major amputation of the target limb.
RESULTS: As shown in the Table below, there was high freedom from 1-year MAE in RC2-3 and RC4-5. Considering the advanced disease in RC6, the 81.7% freedom from major amputation rate suggests that even RC6 subjects can benefit from PVI. From baseline to 1 year, RC4-5 and RC6 showed improvement in the mean number of wounds on the target limb. Quality of life as measured by VascuQoL and overall Rutherford Classification improved in all Rutherford groups from baseline to 1 year.
Table. 1-Year Freedom from MAE in LIBERTY 360 Study
|Rutherford 2-3||Rutherford 4-5||Rutherford 6|
|Freedom from MAE||83.0%||73.9%||59.3%|
|Freedom from Major Amputation||99.3%||96.0%||81.7%|
|Freedom from TVR||83.5%||75.8%||72.3%|
|Freedom from All Death*||95.8%||92.1%||75.9%|
|*All Death rate shown here is at 1 year, but the Freedom from MAE only includes death within 30 days of the procedure.|
CONCLUSIONS: LIBERTY 360 represents a real-world experience with various endovascular strategies across Rutherford groups. There was high freedom from 1-year MAE in RC2-3 and RC4-5. Considering the advanced disease state in RC6, there was still an acceptable freedom from MAE and high freedom from major amputation in this population. One-year results showed improvement in Rutherford classification and overall quality of life from baseline in all Rutherford groups. The results of this novel all-comers PAD study suggest that PVI is a reasonable treatment option for RC2-3 and RC4-5. Additionally, primary amputation may not be necessary in RC6—PVI can be successful in this patient population.
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