One-Year Outcomes of Peripheral Endovascular Device Intervention in Critical Limb Ischemia Patients: Sub-Analysis of the LIBERTY 360 Study
Received 13 September 2019
Accepted for publication 30 November 2019
Published 10 February 2020 Volume 2020:16 Pages 57—66
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 2
Editor who approved publication: Dr Pietro Scicchitano
Jihad A Mustapha,1,2 Zsuzsanna Igyarto,3 David O’Connor,4 Ehrin J Armstrong,5,6 Anthony R Iorio,7 Vickie R Driver,8 Fadi Saab,2 Ann N Behrens,3 Brad J Martinsen,3 George L Adams9
1College of Osteopathic Medicine, Michigan State University, E. Lansing, MI, USA; 2Advanced Cardiac & Vascular Amputation Prevention Centers, Grand Rapids, MI, USA; 3Cardiovascular Systems, Inc., St. Paul, MN, USA; 4Hackensack University Medical Center, Hackensack, NJ, USA; 5Denver VA Medical Center, Denver, CO, USA; 6Anschutz Medical Campus, University of Colorado, Denver, CO, USA; 7Foot Center of New York, New York College of Podiatric Medicine, New York, NY, USA; 8Department of Orthopedics, Brown University School of Medicine, Providence, RI, USA; 9North Carolina Heart and Vascular, Rex Hospital, UNC School of Medicine, Raleigh, NC, USA
Correspondence: Jihad A Mustapha
Advanced Cardiac & Vascular Amputation Prevention Centers, 1525 East Beltline NE, Suite 101, Grand Rapids, MI 49525, USA
Tel +1 616-447-8220
Background: High-risk patients with advanced peripheral artery disease (PAD), including critical limb ischemia (CLI), are often excluded from peripheral endovascular device intervention clinical trials, leading to difficulty in translating trial results into real-world practice. There is a need for prospectively assessed studies to evaluate peripheral endovascular device intervention outcomes in CLI patients.
Methods: LIBERTY 360 is a prospective, observational, multi-center study designed to evaluate the procedural and long-term clinical outcomes of peripheral endovascular device intervention in real-world patients with symptomatic lower-extremity PAD. One thousand two hundred and four patients were enrolled and stratified based on Rutherford Classification (RC): RC2-3 (N=501), RC4-5 (N=603), and RC6 (N=100). For this sub-analysis, RC5 and RC6 patients (RC5-6; N=404) were pooled and 1-year outcomes were assessed.
Results: Procedural complications rarely (1.7%) resulted in post-procedural hospitalization and 89.1% of RC5-6 patients were discharged to home. Considering the advanced disease state in RC5-6 patients, there was a high freedom from 1-year major adverse event rate of 65.5% (defined as target vessel revascularization, death to 30 days, and major target limb amputation). At 1 year, freedom from major amputation was 89.6%. Wounds identified at baseline on the target limb had completely healed in 172/243 (70.8%) of the RC5-6 subjects by 1 year. Additionally, the overall quality of life, as measured by VascuQoL, improved from baseline to 1 year.
Conclusion: LIBERTY investigated real-world PAD patients with independent oversight of outcomes. This analysis of LIBERTY RC5-6 patients demonstrates that peripheral endovascular device intervention can be successful in CLI patients, with low rates of major amputation and improvement in wound healing and quality of life through 1-year follow-up.
LIBERTY 360, https://clinicaltrials.gov/ct2/show/NCT01855412, ClinicalTrials.gov Identifier: NCT01855412.
Keywords: amputation, critical limb ischemia, CLI, endovascular therapy
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