NYMC Faculty Publications

Baseline Modern Medical Management in the BEST-CLI Trial


Matthew T. Menard, Division of Vascular and Endovascular Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, MA. Electronic address: mmenard@bwh.harvard.edu.
Michael R. Jaff, Harvard Medical School (retired), Boston, MA.
Alik Farber, Division of Vascular and Endovascular Surgery, Boston Medical Center, Boston University School of Medicine, Boston, MA.
Kenneth Rosenfield, Section of Vascular Medicine and Intervention Massachusetts General Hospital, Harvard Medical School, Boston, MA.
Michael S. Conte, Division of Vascular and Endovascular Surgery, University of California, San Francisco, CA.
Christopher J. White, Department of Cardiovascular Diseases, The Ochsner Clinical School, University of Queensland, Queensland, Australia.
Joshua A. Beckman, Vascular Medicine, Department of Medicine, UT Southwestern, Dallas, TX.
Niteesh K. Choudhry, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.
Leonardo C. Clavijo, Coastal Cardiology, French Hospital Medical Center, San Luis Obispo, CA.
Thomas S. Huber, Vascular Surgery Department, University of Florida College of Medicine, Gainesville, FL.
Katherine R. Tuttle, Nephrology Division, University of Washington, Providence Health Care, Spokane, WA.
Taye H. Hamza, HealthCore, Inc, Watertown, MA.
Andres Schanzer, Division of Vascular Surgery, UMass Memorial Health, Worcester, MA.
Igor A. Laskowski, Westchester Medical Center, Valhalla, NY; Department of Surgery, Section of Vascular Surgery, New York Medical College, Valhalla, NY.
Mark J. Cziraky, HealthCore, Inc, Watertown, MA.
Alain Drooz, Division of Vascular and Interventional Radiology, Fairfax Radiological Consultants & INOVA Fairfax Hospital, Fairfax, VA.
Max van Over, HealthCore, Inc, Watertown, MA.
Michael B. Strong, Division of Vascular and Endovascular Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.
Ido Weinberg, Vascular Medicine Section, Cardiology Division, Massachusetts General Hospital, Boston, MA.

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Journal of Vascular Surgery

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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.