PMID- 35315918
OWN - NLM
STAT- MEDLINE
DCOM- 20220414
LR  - 20221207
IS  - 2574-3805 (Electronic)
IS  - 2574-3805 (Linking)
VI  - 5
IP  - 3
DP  - 2022 Mar 1
TI  - Analysis of a Machine Learning-Based Risk Stratification Scheme for Chronic 
      Limb-Threatening Ischemia.
PG  - e223424
LID - 10.1001/jamanetworkopen.2022.3424 [doi]
LID - e223424
AB  - IMPORTANCE: Valid risk stratification schemes are key to performing comparative 
      effectiveness research; however, for chronic limb-threatening ischemia (CLTI), 
      risk stratification schemes have limited efficacy. Improved, accurate, 
      comprehensive, and reproducible risk stratification models for CLTI are needed. 
      OBJECTIVE: To evaluate the use of topic model cluster analysis to generate an 
      accurate risk prediction model for CLTI. DESIGN, SETTING, AND PARTICIPANTS: This 
      multicenter, nested cohort study of existing Project of Ex Vivo Vein Graft 
      Engineering via Transfection (PREVENT) III clinical trial data assessed data from 
      patients undergoing infrainguinal vein bypass for the treatment of ischemic rest 
      pain or ischemic tissue loss. Original data were collected from January 1, 2001, 
      to December 31, 2003, and were analyzed in September 2021. All patients had 1 
      year of follow-up. EXPOSURES: Supervised topic model cluster analysis was applied 
      to nested cohort data from the PREVENT III randomized clinical trial. Given a 
      fixed number of clusters, the data were used to examine the probability that a 
      patient belonged to each of the clusters and the distribution of the features 
      within each cluster. MAIN OUTCOMES AND MEASURES: The primary outcome was 1-year 
      CLTI-free survival, a composite of survival with remission of ischemic rest pain, 
      wound healing, and freedom from major lower-extremity amputation without 
      recurrent CLTI. RESULTS: Of the original 1404 patients, 166 were excluded because 
      of a lack of sufficient feature and/or outcome data, leaving 1238 patients for 
      analysis (mean [SD] age, 68.4 [11.2] years; 800 [64.6%] male; 894 [72.2%] White). 
      The Society for Vascular Surgery Wound, Ischemia, and Foot Infection grade 2 
      wounds were present in 543 patients (43.8%), with rest pain present in 645 
      (52.1%). Three distinct clusters were identified within the cohort (130 patients 
      in stage 1, 578 in stage 2, and 530 in stage 3), with 1-year CLTI-free survival 
      rates of 82.3% (107 of 130 patients) for stage 1, 61.1% (353 of 578 patients) for 
      stage 2, and 53.4% (283 of 530 patients) for stage 3. Stratified by stage, 1-year 
      mortality was 10.0% (13 of 130 observed deaths in stage 1) for stage 1, 13.5% (78 
      of 578 patients) for stage 2, and 20.2% (105 of 521 patients) for stage 3. 
      Similarly, stratifying by stage revealed major limb amputation rates of 4.2% (5 
      of 119 observed major limb amputations in stage 1) for stage 1, 10.8% (55 of 509 
      patients) for stage 2, and 18.4% (81 of 440 patients) for stage 3. Among 
      survivors without a major amputation, the rates of CLTI recurrence were 9.2% (11 
      of 119 observed recurrences in stage 1) for stage 1, 24.9% (130 of 523 patients) 
      for stage 2, and 29.6% (132 of 446 patients) for stage 3. CONCLUSIONS AND 
      RELEVANCE: The topic model cluster analysis in this cohort study identified 3 
      distinct stages within CLTI. Findings suggest that CLTI-free survival is an end 
      point that can be accurately and reproducibly quantified and may be used as a 
      patient-centric outcome.
FAU - Chung, Jayer
AU  - Chung J
AD  - Division of Vascular Surgery and Endovascular Therapy, Michael E. DeBakey 
      Department of Surgery, Baylor College of Medicine, Houston, Texas.
FAU - Freeman, Nikki L B
AU  - Freeman NLB
AD  - Department of Biostatistics, University of North Carolina at Chapel Hill, Chapel 
      Hill.
FAU - Kosorok, Michael R
AU  - Kosorok MR
AD  - Department of Biostatistics, University of North Carolina at Chapel Hill, Chapel 
      Hill.
FAU - Marston, William A
AU  - Marston WA
AD  - Division of Vascular Surgery, Department of Surgery, University of North Carolina 
      at Chapel Hill, Chapel Hill.
FAU - Conte, Michael S
AU  - Conte MS
AD  - Department of Surgery, University of California at San Francisco, San Francisco.
FAU - McGinigle, Katharine L
AU  - McGinigle KL
AD  - Division of Vascular Surgery, Department of Surgery, University of North Carolina 
      at Chapel Hill, Chapel Hill.
LA  - eng
GR  - UL1 TR002489/TR/NCATS NIH HHS/United States
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, N.I.H., Extramural
DEP - 20220301
PL  - United States
TA  - JAMA Netw Open
JT  - JAMA network open
JID - 101729235
SB  - IM
MH  - Aged
MH  - Amputation, Surgical
MH  - *Chronic Limb-Threatening Ischemia
MH  - Cohort Studies
MH  - Humans
MH  - Ischemia/surgery
MH  - Limb Salvage/adverse effects
MH  - Machine Learning
MH  - Male
MH  - Pain/etiology
MH  - *Peripheral Arterial Disease
MH  - Retrospective Studies
MH  - Risk Assessment
MH  - Risk Factors
MH  - Time Factors
MH  - Treatment Outcome
PMC - PMC8941356
COIS- Conflict of Interest Disclosures: Dr Marston reported grants from Society for 
      Vascular Surgery Foundation Award during the conduct of the study; personal fees 
      from Boston Scientific and personal fees from Cook Medical outside the submitted 
      work. No other disclosures were reported.
EDAT- 2022/03/23 06:00
MHDA- 2022/04/15 06:00
PMCR- 2022/03/22
CRDT- 2022/03/22 12:11
PHST- 2022/03/22 12:11 [entrez]
PHST- 2022/03/23 06:00 [pubmed]
PHST- 2022/04/15 06:00 [medline]
PHST- 2022/03/22 00:00 [pmc-release]
AID - 2790184 [pii]
AID - zoi220129 [pii]
AID - 10.1001/jamanetworkopen.2022.3424 [doi]
PST - epublish
SO  - JAMA Netw Open. 2022 Mar 1;5(3):e223424. doi: 10.1001/jamanetworkopen.2022.3424.