Randomized Controlled Trial

. 2023 Sep;78(3):711-718.e5.

doi: 10.1016/j.jvs.2023.05.006. Epub 2023 May 17.

Baseline modern medical management in the BEST-CLI trial

Matthew T Menard¹, Michael R Jaff², Alik Farber³, Kenneth Rosenfield⁴, Michael S Conte⁵, Christopher J White⁶, Joshua A Beckman⁷, Niteesh K Choudhry⁸, Leonardo C Clavijo⁹, Thomas S Huber¹⁰, Katherine R Tuttle¹¹, Taye H Hamza¹², Andres Schanzer¹³, Igor A Laskowski¹⁴, Mark J Cziraky¹², Alain Drooz¹⁵, Max van Over¹², Michael B Strong¹⁶, Ido Weinberg¹⁷

Affiliations

¹ Division of Vascular and Endovascular Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, MA. Electronic address: mmenard@bwh.harvard.edu.
² Harvard Medical School (retired), Boston, MA.
³ Division of Vascular and Endovascular Surgery, Boston Medical Center, Boston University School of Medicine, Boston, MA.
⁴ Section of Vascular Medicine and Intervention Massachusetts General Hospital, Harvard Medical School, Boston, MA.
⁵ Division of Vascular and Endovascular Surgery, University of California, San Francisco, CA.
⁶ Department of Cardiovascular Diseases, The Ochsner Clinical School, University of Queensland, Queensland, Australia.
⁷ Vascular Medicine, Department of Medicine, UT Southwestern, Dallas, TX.
⁸ Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.
⁹ Coastal Cardiology, French Hospital Medical Center, San Luis Obispo, CA.
¹⁰ Vascular Surgery Department, University of Florida College of Medicine, Gainesville, FL.
¹¹ Nephrology Division, University of Washington, Providence Health Care, Spokane, WA.
¹² HealthCore, Inc, Watertown, MA.
¹³ Division of Vascular Surgery, UMass Memorial Health, Worcester, MA.
¹⁴ Westchester Medical Center, Valhalla, NY; Department of Surgery, Section of Vascular Surgery, New York Medical College, Valhalla, NY.
¹⁵ Division of Vascular and Interventional Radiology, Fairfax Radiological Consultants & INOVA Fairfax Hospital, Fairfax, VA.
¹⁶ Division of Vascular and Endovascular Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.
¹⁷ Vascular Medicine Section, Cardiology Division, Massachusetts General Hospital, Boston, MA.

PMID: 37201761
PMCID: PMC10528824
DOI: 10.1016/j.jvs.2023.05.006

Randomized Controlled Trial

Baseline modern medical management in the BEST-CLI trial

Matthew T Menard et al. J Vasc Surg. 2023 Sep.

. 2023 Sep;78(3):711-718.e5.

doi: 10.1016/j.jvs.2023.05.006. Epub 2023 May 17.

Authors

Affiliations

¹ Division of Vascular and Endovascular Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, MA. Electronic address: mmenard@bwh.harvard.edu.
² Harvard Medical School (retired), Boston, MA.
³ Division of Vascular and Endovascular Surgery, Boston Medical Center, Boston University School of Medicine, Boston, MA.
⁴ Section of Vascular Medicine and Intervention Massachusetts General Hospital, Harvard Medical School, Boston, MA.
⁵ Division of Vascular and Endovascular Surgery, University of California, San Francisco, CA.
⁶ Department of Cardiovascular Diseases, The Ochsner Clinical School, University of Queensland, Queensland, Australia.
⁷ Vascular Medicine, Department of Medicine, UT Southwestern, Dallas, TX.
⁸ Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.
⁹ Coastal Cardiology, French Hospital Medical Center, San Luis Obispo, CA.
¹⁰ Vascular Surgery Department, University of Florida College of Medicine, Gainesville, FL.
¹¹ Nephrology Division, University of Washington, Providence Health Care, Spokane, WA.
¹² HealthCore, Inc, Watertown, MA.
¹³ Division of Vascular Surgery, UMass Memorial Health, Worcester, MA.
¹⁴ Westchester Medical Center, Valhalla, NY; Department of Surgery, Section of Vascular Surgery, New York Medical College, Valhalla, NY.
¹⁵ Division of Vascular and Interventional Radiology, Fairfax Radiological Consultants & INOVA Fairfax Hospital, Fairfax, VA.
¹⁶ Division of Vascular and Endovascular Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.
¹⁷ Vascular Medicine Section, Cardiology Division, Massachusetts General Hospital, Boston, MA.

PMID: 37201761
PMCID: PMC10528824
DOI: 10.1016/j.jvs.2023.05.006

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 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.

Keywords: Chronic limb-threatening ischemia; Critical limb ischemia; Guideline-based medical therapy; Medical therapy; Peripheral artery disease.

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Conflict of interest statement

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

References

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Baseline modern medical management in the BEST-CLI trial

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Baseline modern medical management in the BEST-CLI trial

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