PMID- 35503774
OWN - NLM
STAT- MEDLINE
DCOM- 20230918
LR  - 20230919
IS  - 1545-1550 (Electronic)
IS  - 1526-6028 (Linking)
VI  - 30
IP  - 5
DP  - 2023 Oct
TI  - Clinical Outcomes of Additional Below-The-Ankle Intervention Compared to 
      Below-The-Knee Intervention Alone: A Post-Hoc Analysis of a Prospective 
      Multicenter Study.
PG  - 711-720
LID - 10.1177/15266028221092981 [doi]
AB  - PURPOSE: To investigate the clinical implication of additional below-the-ankle 
      (BTA) intervention in patients with chronic limb-threatening ischemia (CLTI) 
      undergoing below-the-knee (BTK) intervention. MATERIALS AND METHODS: A 
      sub-analysis was performed using data from the LIBERTY trial (ClinicalTrials.gov 
      identifier NCT01855412), a prospective, observational, core-laboratory 
      adjudicated, multicenter study of endovascular intervention in 1204 patients. 
      Patients with CLTI (Rutherford Classification 4-6) who underwent BTK intervention 
      were included in this sub-analysis. Participants were then stratified into 2 
      treatment groups according to whether at least one lesion intervened on was BTA 
      (n=66) or not (n=273). The decision on whether and where to intervene was made 
      during the procedure. The main outcome measures included major amputation, target 
      vessel revascularization (TVR), major adverse events (MAE), survival, 
      amputation-free survival, major adverse limb events or peri-operative death 
      (MALE-POD), and all-cause death. Other outcome measures included procedural 
      success, procedural complications, and wound healing rate. RESULTS: There were no 
      differences in procedural success or severe angiographic complications between 
      the 2 groups. At 1-year post-procedure, patients in the BTK group had a higher 
      rate of freedom from major amputation (95.0% vs. 86.9%, respectively; HR: 2.87, 
      95% CI: 1.17-7.03), a higher rate of freedom from TVR (80.1% vs. 66.9%, 
      respectively; HR: 1.94, 95% CI: 1.14-3.32), a higher rate of freedom from 
      MALE-POD (94.6% vs. 86.9%, respectively; HR: 2.65, 95% CI: 1.10-6.41), and a 
      higher rate of freedom from MAE at both 1 (76.0% vs. 60.1%, respectively; HR: 
      2.00, 95% CI: 1.24-3.22) and 3 years post procedure (67.5% vs. 55.8%, 
      respectively; HR: 1.69, 95% CI: 1.08-2.65). There was a significantly lower rate 
      of survival in the BTK group at 3 years (74.3% vs. 91.1%, respectively; HR: 0.35, 
      95% CI: 0.14-0.87). After risk adjustment, there was a higher rate of all-cause 
      death in the BTK group at 3 years (19.4% vs. 9.1%, respectively; p=0.023) 
      post-intervention. CONCLUSION: Patients with disease requiring intervention to 
      BTA lesions have a potential increased amputation rate in the short term, but BTA 
      intervention carries a potential survival benefit in the long term when compared 
      to BTK intervention alone.
FAU - Metser, Gil
AU  - Metser G
AUID- ORCID: 0000-0001-7816-7722
AD  - Division of General Internal Medicine, Department of Medicine, Columbia 
      University Medical Center and New York-Presbyterian Hospital, New York, NY, USA.
FAU - Puma, Joseph
AU  - Puma J
AD  - Division of Cardiology, Department of Medicine, Icahn School of Medicine at Mount 
      Sinai, New York, NY, USA.
FAU - Mustapha, Jihad
AU  - Mustapha J
AD  - Advanced Cardiac and Vascular Centers, Grand Rapids, MI, USA.
FAU - Adams, George L
AU  - Adams GL
AUID- ORCID: 0000-0002-9820-943X
AD  - UNC Rex Healthcare, Raleigh, NC, USA.
FAU - Ratcliffe, Justin
AU  - Ratcliffe J
AD  - Division of Cardiology, Department of Medicine, Icahn School of Medicine at Mount 
      Sinai, New York, NY, USA.
FAU - Khullar, Pankaj
AU  - Khullar P
AD  - Division of Cardiology, Department of Medicine, Icahn School of Medicine at Mount 
      Sinai, New York, NY, USA.
FAU - Rosero, Joshua H C
AU  - Rosero JHC
AD  - Division of Cardiology, Department of Medicine, Icahn School of Medicine at Mount 
      Sinai, New York, NY, USA.
AD  - Philadelphia College of Osteopathic Medicine, Philadelphia, PA, USA.
FAU - Armstrong, Ehrin J
AU  - Armstrong EJ
AD  - Adventist Heart and Vascular Institute, Adventist Health St. Helena, St. Helena, 
      CA, USA.
FAU - Zayed, Mohamed
AU  - Zayed M
AD  - Department of Surgery, Section of Vascular Surgery, Washington University School 
      of Medicine, St. Louis, MO, USA.
FAU - Green, Philip
AU  - Green P
AD  - Division of Cardiology, Department of Medicine, Icahn School of Medicine at Mount 
      Sinai, New York, NY, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT01855412
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20220503
PL  - United States
TA  - J Endovasc Ther
JT  - Journal of endovascular therapy : an official journal of the International 
      Society of Endovascular Specialists
JID - 100896915
SB  - IM
MH  - Humans
MH  - *Ankle
MH  - Prospective Studies
MH  - Treatment Outcome
MH  - *Lower Extremity/blood supply
MH  - Wound Healing
OTO - NOTNLM
OT  - below-the-ankle intervention
OT  - critical limb threatening ischemia
OT  - endovascular therapy
OT  - major amputation
OT  - pedal artery disease
OT  - peripheral artery disease
EDAT- 2022/05/04 06:00
MHDA- 2023/09/18 12:43
CRDT- 2022/05/03 13:33
PHST- 2023/09/18 12:43 [medline]
PHST- 2022/05/04 06:00 [pubmed]
PHST- 2022/05/03 13:33 [entrez]
AID - 10.1177/15266028221092981 [doi]
PST - ppublish
SO  - J Endovasc Ther. 2023 Oct;30(5):711-720. doi: 10.1177/15266028221092981. Epub 
      2022 May 3.