PMID- 32618486
OWN - NLM
STAT- MEDLINE
DCOM- 20201102
LR  - 20221207
IS  - 1545-1550 (Electronic)
IS  - 1526-6028 (Print)
IS  - 1526-6028 (Linking)
VI  - 27
IP  - 5
DP  - 2020 Oct
TI  - Three-Year Outcomes of Orbital Atherectomy for the Endovascular Treatment of 
      Infrainguinal Claudication or Chronic Limb-Threatening Ischemia.
PG  - 714-725
LID - 10.1177/1526602820935611 [doi]
AB  - Purpose: To investigate the outcomes of orbital atherectomy (OA) for the 
      treatment of patients with peripheral artery disease (PAD) manifesting as 
      claudication or chronic limb-threatening ischemia (CLTI). Materials and Methods: 
      The database from the LIBERTY study (ClinicalTrials.gov identifier NCT01855412) 
      was interrogated to identify 503 PAD patients treated with any commercially 
      available endovascular devices and adjunctive OA for 617 femoropopliteal and/or 
      infrapopliteal lesions. Cox regression analyses were employed to examine the 
      association between baseline Rutherford category (RC) stratified as RC 2-3 
      (n=214), RC 4-5 (n=233), or RC 6 (n=56) and all-cause mortality, target vessel 
      revascularization (TVR), major amputation, major adverse event (MAE), and major 
      amputation/death at up to 3 years of follow-up. The mean lesion lengths were 
      78.7+/-73.7, 131.4+/-119.0, and 95.2+/-83.9 mm, respectively, for the 3 groups. 
      Results: After OA, balloon angioplasty was used in >98% of cases, with bailout 
      stenting necessary in 2.0%, 2.8%, and 0% of the RC groups, respectively. A small 
      proportion (10.8%) of patients developed angiographic complications, without 
      differences based on presentation. During the 3-year follow-up, claudicants were 
      at lower risk for MAE, death, and major amputation/death than patients with CLTI. 
      The 3-year Kaplan-Meier survival estimates were 84.6% for the RC 2-3 group, 76.2% 
      for the RC 4-5 group, and 63.7% for the RC 6 group. The 3-year freedom from major 
      amputation was estimated as 100%, 95.3%, and 88.6%, respectively. Among CLTI 
      patients only, the RC at baseline was correlated with the combined outcome of 
      major amputation/death, whereas RC classification did not affect TVR, MAE, major 
      amputation, or death rates. Conclusion: Peripheral artery angioplasty with 
      adjunctive OA in patients with CLTI or claudication is safe and associated with 
      low major amputation rates after 3 years of follow-up. These results demonstrate 
      the utility of OA for patients across the spectrum of PAD.
FAU - Giannopoulos, Stefanos
AU  - Giannopoulos S
AUID- ORCID: 0000-0002-1942-911X
AD  - Division of Cardiology, Rocky Mountain Regional VA Medical Center, University of 
      Colorado, Denver, CO, USA.
FAU - Secemsky, Eric A
AU  - Secemsky EA
AD  - Division of Cardiology, Department of Medicine, Beth Israel Deaconess Medical 
      Center, Boston, MA, USA.
FAU - Mustapha, Jihad A
AU  - Mustapha JA
AD  - Advanced Cardiac and Vascular Centers for Amputation Prevention, Grand Rapids, 
      MI, USA.
FAU - Adams, George
AU  - Adams G
AD  - Rex Hospital, UNC Health System, Raleigh, NC, USA.
FAU - Beasley, Robert E
AU  - Beasley RE
AD  - Mount Sinai Medical Center, Miami, FL, USA.
FAU - Pliagas, George
AU  - Pliagas G
AD  - Premier Surgical Associates, Vascular Division, Knoxville, TN, USA.
FAU - Armstrong, Ehrin J
AU  - Armstrong EJ
AUID- ORCID: 0000-0002-1381-4754
AD  - Division of Cardiology, Rocky Mountain Regional VA Medical Center, University of 
      Colorado, Denver, CO, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT01855412
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
DEP - 20200703
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
CIN - J Endovasc Ther. 2020 Oct;27(5):726-727. PMID: 32744120
MH  - Aged
MH  - Aged, 80 and over
MH  - Amputation, Surgical
MH  - *Angioplasty, Balloon/adverse effects/instrumentation/mortality
MH  - *Atherectomy/adverse effects/instrumentation/mortality
MH  - Chronic Disease
MH  - Female
MH  - *Femoral Artery/diagnostic imaging/physiopathology
MH  - Humans
MH  - Intermittent Claudication/diagnostic imaging/mortality/physiopathology/*therapy
MH  - Ischemia/diagnostic imaging/mortality/physiopathology/*therapy
MH  - Limb Salvage
MH  - Male
MH  - Middle Aged
MH  - Peripheral Arterial Disease/diagnostic imaging/mortality/physiopathology/*therapy
MH  - *Popliteal Artery/diagnostic imaging/physiopathology
MH  - Prospective Studies
MH  - Risk Factors
MH  - Stents
MH  - Time Factors
MH  - Treatment Outcome
MH  - United States
MH  - Vascular Patency
PMC - PMC7545657
OTO - NOTNLM
OT  - amputation
OT  - balloon angioplasty
OT  - critical limb ischemia
OT  - endovascular treatment/therapy
OT  - femoropopliteal segment
OT  - infrapopliteal arteries
OT  - mortality
OT  - orbital atherectomy
OT  - peripheral artery disease
OT  - stent
COIS- Declaration of Conflicting Interests: The author(s) declared the following 
      potential conflicts of interest with respect to the research, authorship, and/or 
      publication of this article: Eric A. Secemsky reports grants and modest 
      consulting fees given by Medtronic. Jihad A. Mustapha is a consultant to Bard 
      Peripheral Vascular, Boston Scientific, Cardiovascular Systems Inc (CSI), 
      Medtronic, Spectranetics, and Terumo. George Pliagas is a consultant to Cook, 
      Philips, CSI, and Medtronic. Ehrin J. Armstrong is a consultant to Abbott 
      Vascular, Boston Scientific, CSI, Medtronic, Philips, and PQ Bypass.
EDAT- 2020/07/04 06:00
MHDA- 2020/11/03 06:00
PMCR- 2020/10/09
CRDT- 2020/07/04 06:00
PHST- 2020/07/04 06:00 [pubmed]
PHST- 2020/11/03 06:00 [medline]
PHST- 2020/07/04 06:00 [entrez]
PHST- 2020/10/09 00:00 [pmc-release]
AID - 10.1177_1526602820935611 [pii]
AID - 10.1177/1526602820935611 [doi]
PST - ppublish
SO  - J Endovasc Ther. 2020 Oct;27(5):714-725. doi: 10.1177/1526602820935611. Epub 2020 
      Jul 3.