PMID- 32981918
OWN - NLM
STAT- MEDLINE
DCOM- 20211213
LR  - 20211214
IS  - 1880-3873 (Electronic)
IS  - 1340-3478 (Print)
IS  - 1340-3478 (Linking)
VI  - 28
IP  - 7
DP  - 2021 Jul 1
TI  - Effects of PCSK9 Inhibitor on Favorable Limb Outcomes in Patients with Chronic 
      Limb-Threatening Ischemia.
PG  - 754-765
LID - 10.5551/jat.57653 [doi]
AB  - AIM: The aim of this study was to examine the effects of evolocumab on favorable 
      limb events in patients with chronic limb-threatening ischemia (CLTI). METHODS: A 
      single-center, prospective observational study was performed on 30 patients with 
      CLTI. The subjects were divided into 2 groups based on evolocumab administration: 
      evolocumab-treated (E) group ( n=14) and evolocumab non-treated (non-E) group 
      (n=16). The primary outcome was 12-month freedom from major amputation. The 
      secondary outcomes were 12-month amputation-free survival (AFS), overall survival 
      (OS), and wound-free limb salvage. The mean follow-up period was 18+/-11 months. 
      RESULTS: No significant difference was detected between the two groups for the 
      12-month freedom from major amputation (log-rank p=0.15), while the 12-month AFS 
      rate was significantly higher in the E group than that in the non-E group 
      (log-rank p=0.02). The 12-month OS rate in the E group was shown a tendency for 
      improvement, as compared with that in the non-E group (log-rank p=0.056). 
      Evolocumab administration was not associated with a significant change in freedom 
      from major amputation (HR, 0.23, 95% CI, 0.03-2.07, p=0.19). However, evolocumab 
      administration was related to a tendency for improvement of AFS and OS (HR, 0.13, 
      95% CI, 0.02-1.06, p=0.056; HR, 0.16, 95% CI, 0.02-1.37, p=0.09, respectively). 
      Moreover, The E group had a higher proportion of wound-free limb salvage at 12 
      months (92% vs. 42%, p=0.03). CONCLUSION: Evolocumab administration was 
      associated with a better AFS outcome in patients with CLTI. Long-term 
      administration of evolocumab over 12 months contributed to improving proportion 
      of wound-free limb salvage.
FAU - Sato, Yusuke
AU  - Sato Y
AD  - Department of Cardiovascular Medicine, Faculty of Medical Sciences, University of 
      Fukui.
FAU - Uzui, Hiroyasu
AU  - Uzui H
AD  - Department of Cardiovascular Medicine, Faculty of Medical Sciences, University of 
      Fukui.
FAU - Morishita, Tetsuji
AU  - Morishita T
AD  - Department of Cardiovascular Medicine, Faculty of Medical Sciences, University of 
      Fukui.
FAU - Fukuoka, Yoshitomo
AU  - Fukuoka Y
AD  - Department of Cardiovascular Medicine, Faculty of Medical Sciences, University of 
      Fukui.
FAU - Hasegawa, Kanae
AU  - Hasegawa K
AD  - Department of Cardiovascular Medicine, Faculty of Medical Sciences, University of 
      Fukui.
FAU - Ikeda, Hiroyuki
AU  - Ikeda H
AD  - Department of Cardiovascular Medicine, Faculty of Medical Sciences, University of 
      Fukui.
FAU - Tama, Naoto
AU  - Tama N
AD  - Department of Cardiovascular Medicine, Faculty of Medical Sciences, University of 
      Fukui.
FAU - Ishida, Kentaro
AU  - Ishida K
AD  - Department of Cardiovascular Medicine, Faculty of Medical Sciences, University of 
      Fukui.
FAU - Miyazaki, Shinsuke
AU  - Miyazaki S
AD  - Department of Cardiovascular Medicine, Faculty of Medical Sciences, University of 
      Fukui.
FAU - Tada, Hiroshi
AU  - Tada H
AD  - Department of Cardiovascular Medicine, Faculty of Medical Sciences, University of 
      Fukui.
LA  - eng
PT  - Journal Article
PT  - Observational Study
DEP - 20200925
PL  - Japan
TA  - J Atheroscler Thromb
JT  - Journal of atherosclerosis and thrombosis
JID - 9506298
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (PCSK9 Inhibitors)
RN  - LKC0U3A8NJ (evolocumab)
SB  - IM
MH  - Aged
MH  - Antibodies, Monoclonal, Humanized/*administration & dosage
MH  - *Chronic Limb-Threatening Ischemia/diagnosis/drug therapy/epidemiology
MH  - Conservative Treatment/*methods
MH  - Female
MH  - Humans
MH  - Japan/epidemiology
MH  - Limb Salvage/methods
MH  - Male
MH  - Outcome and Process Assessment, Health Care
MH  - PCSK9 Inhibitors/administration & dosage
MH  - Peripheral Arterial Disease/complications/epidemiology/therapy
MH  - Prospective Studies
MH  - Risk Adjustment/methods
MH  - Survival Analysis
PMC - PMC8265925
OTO - NOTNLM
OT  - Amputation
OT  - Chronic limb-threatening ischemia
OT  - Evolocumab
OT  - Peripheral artery disease
OT  - Proprotein convertase subtilisin/kexin type 9 inhibitor
EDAT- 2020/09/29 06:00
MHDA- 2021/12/15 06:00
PMCR- 2021/07/01
CRDT- 2020/09/28 05:35
PHST- 2020/09/29 06:00 [pubmed]
PHST- 2021/12/15 06:00 [medline]
PHST- 2020/09/28 05:35 [entrez]
PHST- 2021/07/01 00:00 [pmc-release]
AID - DN/JST.JSTAGE/jat/57653 [pii]
AID - 10.5551/jat.57653 [doi]
PST - ppublish
SO  - J Atheroscler Thromb. 2021 Jul 1;28(7):754-765. doi: 10.5551/jat.57653. Epub 2020 
      Sep 25.