Baseline modern medical management in the BEST-CLI trial

Matthew T Menard; Michael R Jaff; Alik Farber; Kenneth Rosenfield; Michael S Conte; Christopher J White; Joshua A Beckman; Niteesh K Choudhry; Leonardo C Clavijo; Thomas S Huber; Katherine R Tuttle; Taye H Hamza; Andres Schanzer; Igor A Laskowski; Mark J Cziraky; Alain Drooz; Max van Over; Michael B Strong; Ido Weinberg

doi:10.1016/j.jvs.2023.05.006

Baseline modern medical management in the BEST-CLI trial

Matthew T Menard
, Michael R Jaff
, Alik Farber
, Kenneth Rosenfield
, Michael S Conte
, Christopher J White
, Joshua A Beckman
, Niteesh K Choudhry
, Leonardo C Clavijo
, Thomas S Huber
, Katherine R Tuttle
, Taye H Hamza
, Andres Schanzer
, Igor A Laskowski
, Mark J Cziraky
, Alain Drooz
, Max van Over
, Michael B Strong
, Ido Weinberg

Research output: Contribution to journal › Article › peer-review

35 Scopus citations

Abstract

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 (BEST-CLI) is sponsored 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.

Original language	English
Pages (from-to)	711-718.e5
Journal	Journal of Vascular Surgery
Volume	78
Issue number	3
Early online date	Apr 17 2023
DOIs	https://doi.org/10.1016/j.jvs.2023.05.006
State	Published - Sep 2023

Keywords

Chronic limb-threatening ischemia
Critical limb ischemia
Guideline-based medical therapy
Medical therapy
Peripheral artery disease

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10.1016/j.jvs.2023.05.006

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Menard, M. T., Jaff, M. R., Farber, A., Rosenfield, K., Conte, M. S., White, C. J., Beckman, J. A., Choudhry, N. K., Clavijo, L. C., Huber, T. S., Tuttle, K. R., Hamza, T. H., Schanzer, A., Laskowski, I. A., Cziraky, M. J., Drooz, A., van Over, M., Strong, M. B., & Weinberg, I. (2023). Baseline modern medical management in the BEST-CLI trial. Journal of Vascular Surgery, 78(3), 711-718.e5. https://doi.org/10.1016/j.jvs.2023.05.006

@article{7f1f986345bc463a833645a339ac3c7b,

title = "Baseline modern medical management in the BEST-CLI trial",

abstract = "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 (BEST-CLI) is sponsored 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.",

keywords = "Chronic limb-threatening ischemia, Critical limb ischemia, Guideline-based medical therapy, Medical therapy, Peripheral artery disease",

author = "Menard, \{Matthew T\} and Jaff, \{Michael R\} and Alik Farber and Kenneth Rosenfield and Conte, \{Michael S\} and White, \{Christopher J\} and Beckman, \{Joshua A\} and Choudhry, \{Niteesh K\} and Clavijo, \{Leonardo C\} and Huber, \{Thomas S\} and Tuttle, \{Katherine R\} and Hamza, \{Taye H\} and Andres Schanzer and Laskowski, \{Igor A\} and Cziraky, \{Mark J\} and Alain Drooz and \{van Over\}, Max and Strong, \{Michael B\} and Ido Weinberg",

note = "Copyright {\textcopyright} 2023. Published by Elsevier Inc.",

year = "2023",

month = sep,

doi = "10.1016/j.jvs.2023.05.006",

language = "English",

volume = "78",

pages = "711--718.e5",

journal = "Journal of Vascular Surgery",

issn = "0741-5214",

publisher = "Elsevier Inc.",

number = "3",

}

Menard, MT, Jaff, MR, Farber, A, Rosenfield, K, Conte, MS, White, CJ, Beckman, JA, Choudhry, NK, Clavijo, LC, Huber, TS, Tuttle, KR, Hamza, TH, Schanzer, A, Laskowski, IA, Cziraky, MJ, Drooz, A, van Over, M, Strong, MB & Weinberg, I 2023, 'Baseline modern medical management in the BEST-CLI trial', Journal of Vascular Surgery, vol. 78, no. 3, pp. 711-718.e5. https://doi.org/10.1016/j.jvs.2023.05.006

TY - JOUR

T1 - Baseline modern medical management in the BEST-CLI trial

AU - Menard, Matthew T

AU - Jaff, Michael R

AU - Farber, Alik

AU - Rosenfield, Kenneth

AU - Conte, Michael S

AU - White, Christopher J

AU - Beckman, Joshua A

AU - Choudhry, Niteesh K

AU - Clavijo, Leonardo C

AU - Huber, Thomas S

AU - Tuttle, Katherine R

AU - Hamza, Taye H

AU - Schanzer, Andres

AU - Laskowski, Igor A

AU - Cziraky, Mark J

AU - Drooz, Alain

AU - van Over, Max

AU - Strong, Michael B

AU - Weinberg, Ido

PY - 2023/9

Y1 - 2023/9

N2 - 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 (BEST-CLI) is sponsored 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.

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 (BEST-CLI) is sponsored 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.

KW - Chronic limb-threatening ischemia

KW - Critical limb ischemia

KW - Guideline-based medical therapy

KW - Medical therapy

KW - Peripheral artery disease

UR - https://www.scopus.com/pages/publications/85162977508

U2 - 10.1016/j.jvs.2023.05.006

DO - 10.1016/j.jvs.2023.05.006

M3 - Article

C2 - 37201761

SN - 0741-5214

VL - 78

SP - 711-718.e5

JO - Journal of Vascular Surgery

JF - Journal of Vascular Surgery

IS - 3

ER -

Baseline modern medical management in the BEST-CLI trial

Abstract

Keywords

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