One-Year Outcomes of Peripheral Endovascular Device Intervention in Critical Limb Ischemia Patients: Sub-Analysis of the LIBERTY 360 Study

Jihad A Mustapha, Zsuzsanna Igyarto, David O'Connor, Ehrin J Armstrong, Anthony R Iorio, Vickie R Driver, Fadi Saab, Ann N Behrens, Brad J Martinsen, George L Adams, Jihad A Mustapha, Zsuzsanna Igyarto, David O'Connor, Ehrin J Armstrong, Anthony R Iorio, Vickie R Driver, Fadi Saab, Ann N Behrens, Brad J Martinsen, George L Adams

Abstract

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://ichgcp.net/clinical-trials-registry/NCT01855412, ClinicalTrials.gov Identifier: NCT01855412.

Keywords: CLI; amputation; critical limb ischemia; endovascular therapy.

Conflict of interest statement

JAM reports consulting agreements with Cardiovascular Systems, Inc., Medtronic, Bard Peripheral Vascular, Terumo, and Philips. Equity ownership CardioFlow. ZI is employed by and owns stock in CSI, during the conduct of the study. DO reports consulting agreement with CSI, a consulting agreement and grants from Boston Scientific, outside the submitted work. EJA reports consulting agreements with Cardiovascular Systems Inc., Abbott vascular, Boston scientific, Intact vascular, Gore, Medtronic, and Philips, outside the submitted work. FS reports speaker and consulting fees from CSI. ANB is employed by and owns stock in CSI. BJM is employed by and owns stock in CSI. GLA reports personal fees from Cardiovascular Systems, Philips, Abbott Vascular, Cook Medical and Gore, outside of the submitted work; and received consulting fees from Bard Peripheral Vascular, Terumo Interventional Systems, Medtronic, Boston Scientific, Spectranetics, and CSI. The authors report no other conflicts of interest in this work.

© 2020 Mustapha et al.

Figures

Figure 1
Figure 1
Device usage by lesion (N=558) assessed by angiographic core lab. *Hawk: Turbohawk, Silverhawk, Hawk One. Abbreviations: BMS, bare-metal stent; DCB, drug-coated balloon; DES, drug-eluting stent; OAS, orbital atherectomy system; PTA, percutaneous transluminal angioplasty.
Figure 2
Figure 2
Changes in quality of life from baseline to 12 months (VascuQoL). Vascular Quality of Life Questionnaire: (A) Total score; (B) Physical activity subdomain score; (C) Symptom subdomain score; (D) Pain subdomain score; (E) Emotional subdomain score; and (F) Social subdomain score. Higher subdomain scores indicate better rating of health. Value presented as mean as recorded at each follow-up visit. Abbreviations: BL, baseline; 30D, 30 days; 6M, 6 months; 12M, 12 months.
Figure 3
Figure 3
Kaplan–Meier curves for freedom from major adverse events (A) and amputation free survival (B) with number of subjects at risk. Abbreviation: MAE, major adverse events.
Figure 4
Figure 4
Critical limb ischemia (CLI) patients without revascularization (primary amputation treatment) vs LIBERTY 360 RC5-6 CLI patients (primary endovascular treatment). This summary graph shows the primary amputation rates presented in the literature and the major target limb amputation rates reported in LIBERTY, but it is not a head-to-head comparison since the analyses described vary in design.

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