PMID- 37201761
OWN - NLM
STAT- MEDLINE
DCOM- 20230822
LR  - 20240210
IS  - 1097-6809 (Electronic)
IS  - 0741-5214 (Print)
IS  - 0741-5214 (Linking)
VI  - 78
IP  - 3
DP  - 2023 Sep
TI  - Baseline modern medical management in the BEST-CLI trial.
PG  - 711-718.e5
LID - S0741-5214(23)01177-1 [pii]
LID - 10.1016/j.jvs.2023.05.006 [doi]
AB  - OBJECTIVES: The use of optimal medical therapy (OMT) in patients with chronic 
      limb-threatening ischemia (CLTI) has not been well-studied. The Best Endovascular 
      vs Best Surgical Therapy in Patients with CLTI study (BEST-CLI) is a multicenter, 
      randomized, controlled trial sponsored by the National Institutes of Health 
      comparing revascularization strategies in patients with CLTI. We evaluated the 
      use of guideline-based OMT among patients with CLTI at the time of their 
      enrollment into the trial. METHODS: A multidisciplinary committee defined OMT 
      criteria related to blood pressure and diabetic management, lipid-lowering and 
      antiplatelet medication use, and smoking status for patients enrolled in 
      BEST-CLI. Status reports indicating adherence to OMT were provided to 
      participating sites at regular intervals. Baseline demographic characteristics, 
      comorbid medical conditions, and use of OMT at trial entry were evaluated for all 
      randomized patients. A linear regression model was used to identify the 
      relationship of predictors to the use of OMT. RESULTS: At the time of 
      randomization (n = 1830 total enrolled), 87% of patients in BEST-CLI had 
      hypertension, 69% had diabetes, 73% had hyperlipidemia, and 35% were currently 
      smoking. Adherence to four OMT components (controlled blood pressure, not 
      currently smoking, use of one lipid-lowering medication, and use of an 
      antiplatelet agent) was modest. Only 25% of patients met all four OMT criteria; 
      38% met three, 24% met two, 11% met only one, and 2% met none. Age >/=80 years, 
      coronary artery disease, diabetes, and Hispanic ethnicity were positively 
      associated, whereas Black race was negatively associated, with the use of OMT. 
      CONCLUSIONS: A significant proportion of patients in BEST-CLI did not meet OMT 
      guideline-based recommendations at time of entry. These data suggest a persistent 
      major gap in the medical management of patients with advanced peripheral 
      atherosclerosis and CLTI. Changes in OMT adherence over the course of the trial 
      and their impact on clinical outcomes and quality of life will be assessed in 
      future analyses.
CI  - Copyright (c) 2023 Society for Vascular Surgery. Published by Elsevier Inc. All 
      rights reserved.
FAU - Menard, Matthew T
AU  - Menard MT
AD  - Division of Vascular and Endovascular Surgery, Brigham and Women's Hospital, 
      Harvard Medical School, Boston, MA. Electronic address: mmenard@bwh.harvard.edu.
FAU - Jaff, Michael R
AU  - Jaff MR
AD  - Harvard Medical School (retired), Boston, MA.
FAU - Farber, Alik
AU  - Farber A
AD  - Division of Vascular and Endovascular Surgery, Boston Medical Center, Boston 
      University School of Medicine, Boston, MA.
FAU - Rosenfield, Kenneth
AU  - Rosenfield K
AD  - Section of Vascular Medicine and Intervention Massachusetts General Hospital, 
      Harvard Medical School, Boston, MA.
FAU - Conte, Michael S
AU  - Conte MS
AD  - Division of Vascular and Endovascular Surgery, University of California, San 
      Francisco, CA.
FAU - White, Christopher J
AU  - White CJ
AD  - Department of Cardiovascular Diseases, The Ochsner Clinical School, University of 
      Queensland, Queensland, Australia.
FAU - Beckman, Joshua A
AU  - Beckman JA
AD  - Vascular Medicine, Department of Medicine, UT Southwestern, Dallas, TX.
FAU - Choudhry, Niteesh K
AU  - Choudhry NK
AD  - Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, 
      Boston, MA.
FAU - Clavijo, Leonardo C
AU  - Clavijo LC
AD  - Coastal Cardiology, French Hospital Medical Center, San Luis Obispo, CA.
FAU - Huber, Thomas S
AU  - Huber TS
AD  - Vascular Surgery Department, University of Florida College of Medicine, 
      Gainesville, FL.
FAU - Tuttle, Katherine R
AU  - Tuttle KR
AD  - Nephrology Division, University of Washington, Providence Health Care, Spokane, 
      WA.
FAU - Hamza, Taye H
AU  - Hamza TH
AD  - HealthCore, Inc, Watertown, MA.
FAU - Schanzer, Andres
AU  - Schanzer A
AD  - Division of Vascular Surgery, UMass Memorial Health, Worcester, MA.
FAU - Laskowski, Igor A
AU  - Laskowski IA
AD  - Westchester Medical Center, Valhalla, NY; Department of Surgery, Section of 
      Vascular Surgery, New York Medical College, Valhalla, NY.
FAU - Cziraky, Mark J
AU  - Cziraky MJ
AD  - HealthCore, Inc, Watertown, MA.
FAU - Drooz, Alain
AU  - Drooz A
AD  - Division of Vascular and Interventional Radiology, Fairfax Radiological 
      Consultants & INOVA Fairfax Hospital, Fairfax, VA.
FAU - van Over, Max
AU  - van Over M
AD  - HealthCore, Inc, Watertown, MA.
FAU - Strong, Michael B
AU  - Strong MB
AD  - Division of Vascular and Endovascular Surgery, Brigham and Women's Hospital, 
      Harvard Medical School, Boston, MA.
FAU - Weinberg, Ido
AU  - Weinberg I
AD  - Vascular Medicine Section, Cardiology Division, Massachusetts General Hospital, 
      Boston, MA.
LA  - eng
GR  - U01 HL107407/HL/NHLBI NIH HHS/United States
GR  - U01 HL107352/HL/NHLBI NIH HHS/United States
GR  - U01 DK100846/DK/NIDDK NIH HHS/United States
GR  - R01 MD014712/MD/NIMHD NIH HHS/United States
GR  - U2C DK114886/DK/NIDDK NIH HHS/United States
GR  - OT2 HL161847/HL/NHLBI NIH HHS/United States
GR  - U54 DK083912/DK/NIDDK NIH HHS/United States
GR  - U01 HL115662/HL/NHLBI NIH HHS/United States
GR  - UM1 AI108568/AI/NIAID NIH HHS/United States
GR  - UL1 TR002319/TR/NCATS NIH HHS/United States
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, N.I.H., Extramural
PT  - Research Support, Non-U.S. Gov't
PT  - Research Support, U.S. Gov't, P.H.S.
DEP - 20230517
PL  - United States
TA  - J Vasc Surg
JT  - Journal of vascular surgery
JID - 8407742
RN  - 0 (Lipids)
SB  - IM
MH  - Humans
MH  - Aged, 80 and over
MH  - *Peripheral Arterial Disease/diagnosis/therapy
MH  - Quality of Life
MH  - Treatment Outcome
MH  - Ischemia
MH  - Lipids
MH  - Risk Factors
MH  - Limb Salvage
MH  - *Endovascular Procedures/adverse effects
PMC - PMC10528824
MID - NIHMS1922972
OTO - NOTNLM
OT  - Chronic limb-threatening ischemia
OT  - Critical limb ischemia
OT  - Guideline-based medical therapy
OT  - Medical therapy
OT  - Peripheral artery disease
COIS- Beckman, Joshua: Consulting: Janssen, JanOne, Novartis. Grants: Bristol Myers 
      Squibb Clavijo, Leonard: Cook Medical, Consulting Speaker Conte, Michael: Abbott 
      Vascular DSMB Farber, Alik: Advisor: Sanifit Menard, Matthew: Advisor: Janssen 
      Rosenfield, Kenneth: KR receives income as a consultant or member of a scientific 
      advisory board for the following entities: Abbott Vascular; Althea Medical; 
      Angiodynamics; Auxetics; Becton-Dickinson; Boston Scientific; Contego; 
      Crossliner; Innova Vascular; Inspire MD; Janssen/Johnson and Johnson; Magneto; 
      Mayo Clinic; MedAlliance; Medtronic; Neptune Medical; Penumbra; Philips; 
      Surmodics; Terumo; Thrombolex; Truvic; Vasorum; Vumedi. KR owns equity or stock 
      options in the following entities: Access Vascular; Aerami; Althea Medical; 
      Auxetics; Contego; Crossliner; Cruzar Systems; Endospan; Imperative Care/Truvic; 
      Innova Vascular; InspireMD; JanaCare; Magneto; MedAlliance; Neptune Medical; 
      Orchestra; Prosomnus; Shockwave; Skydance; Summa Therapeutics; Thrombolex; 
      Vasorum; Vumedi. KR or his institution (on my behalf) receive research grants 
      from the following entities: NIH; Abiomed; Boston Scientific; Novo Nordisk 
      Foundation; Penumbra; Gettinge-Atrium. KR serves as a member of the Board of 
      Directors of the following organization: The National PERT ConsortiumTM Jaff, 
      Michael: Part time employee Boston Scientific Tuttle, Katherine: KRT is supported 
      by NIH research grants R01MD014712, U2CDK114886, UL1TR002319, U54DK083912, 
      U01DK100846, OT2HL161847, UM1AI109568, CDC project number 75D301-21-P-12254; and 
      reports other support from Eli Lilly; personal fees and other support from 
      Boehringer Ingelheim; personal fees and other support from AstraZeneca; grants, 
      personal fees and other support from Bayer AG; grants, personal fees and other 
      support from Novo Nordisk; grants and other support from Goldfinch Bio; other 
      support from Gilead; and grants from Travere outside the submitted work. 
      Weinberg, Ido: Consultant - Penumbra, Magneto Thrombectomy Solutions
EDAT- 2023/05/19 01:04
MHDA- 2023/08/22 06:42
PMCR- 2024/09/01
CRDT- 2023/05/18 19:28
PHST- 2023/01/12 00:00 [received]
PHST- 2023/05/05 00:00 [revised]
PHST- 2023/05/09 00:00 [accepted]
PHST- 2024/09/01 00:00 [pmc-release]
PHST- 2023/08/22 06:42 [medline]
PHST- 2023/05/19 01:04 [pubmed]
PHST- 2023/05/18 19:28 [entrez]
AID - S0741-5214(23)01177-1 [pii]
AID - 10.1016/j.jvs.2023.05.006 [doi]
PST - ppublish
SO  - J Vasc Surg. 2023 Sep;78(3):711-718.e5. doi: 10.1016/j.jvs.2023.05.006. Epub 2023 
      May 17.