Surgery or Endovascular Therapy for Chronic Limb Ischemia

To the Editor: In the BEST-CLI trial, in which Farber et al. (Dec. 22 issue) 1 compare surgery and endovascular therapy for chronic limb-threatening ischemia, the definition of the composite primary outcome — a major adverse limb event or death from any cause — is problematic. The number of deaths was substantial, and the vast majority occurred more than 30 days after the trial intervention. Presumably, these deaths were related to the patients’ coexisting conditions, which were abundant, and not to the randomized intervention. Thus, the primary outcome definition exaggerates the frequency of intervention failures and underestimates the relative difference in . . .