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Baseline modern medical management in the BEST-CLI trial

Matthew T Menard1, Michael R Jaff2, Alik Farber3

  • 1Division of Vascular and Endovascular Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.

Journal of Vascular Surgery
|May 18, 2023
PubMed

Insights

Optimal medical therapy (OMT) adherence is low in patients with chronic limb-threatening ischemia (CLTI). Only 25% of patients met all four OMT criteria at trial entry, highlighting a gap in care for advanced peripheral atherosclerosis.

Area of Science:

  • Vascular Surgery
  • Cardiology
  • Internal Medicine
  • Clinical Trials

Background:

  • Optimal medical therapy (OMT) is crucial for managing patients with chronic limb-threatening ischemia (CLTI).
  • The adherence to guideline-based OMT in CLTI patients has not been extensively studied.
  • The Best Endovascular vs Best Surgical Therapy in Patients with CLTI (BEST-CLI) trial provides a unique opportunity to evaluate OMT use.

Purpose of the Study:

  • To assess the utilization of guideline-based optimal medical therapy (OMT) in patients with chronic limb-threatening ischemia (CLTI) at the time of enrollment in the BEST-CLI trial.
  • To identify factors associated with OMT adherence in this patient population.

Main Methods:

  • A multidisciplinary committee defined OMT criteria including blood pressure, diabetes management, lipid-lowering, antiplatelet use, and smoking status.
  • Data on baseline demographics, comorbidities, and OMT adherence were collected for 1830 randomized patients in the BEST-CLI trial.
  • A linear regression model was employed to determine predictors of OMT use.

Main Results:

  • At randomization, a high prevalence of comorbidities was observed: 87% hypertension, 69% diabetes, 73% hyperlipidemia, and 35% current smokers.
  • Adherence to OMT was modest, with only 25% of patients meeting all four defined criteria (controlled blood pressure, non-smoking, lipid-lowering medication, antiplatelet agent).
  • Older age (≥80 years), coronary artery disease, diabetes, and Hispanic ethnicity were positively associated with OMT use, while Black race showed a negative association.

Conclusions:

  • A significant proportion of patients with CLTI in the BEST-CLI trial did not meet guideline-based OMT recommendations upon enrollment.
  • These findings indicate a substantial gap in the medical management of patients with advanced peripheral atherosclerosis and CLTI.
  • Future analyses will examine changes in OMT adherence and its impact on clinical outcomes and quality of life throughout the trial.
Abstract

Keywords:
Chronic limb-threatening ischemiaCritical limb ischemiaGuideline-based medical therapyMedical therapyPeripheral artery disease

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