Analysis of outcome in carotid endarterectomy trials

The trials for carotid endarterectomy have had a major impact on the practice of medicine. Beyond demonstrating the efficacy of this procedure for stroke prevention in certain patient cohorts, these studies have set a standard for the evaluation of surgical procedures by carefully planned, scientifically rigorous, prospective randomized controlled trials. In addition, data from these trials have been used to develop clinical guidelines (2, 12, 24), determine reimbursement policies, and establish criteria for perioperative morbidity. Concordance of methodology (especially primary outcome measures) among the various trials has enabled important valid comparisons between different patient cohorts. The benefit provided by carotid endarterectomy in most trials was so profound that the relative imprecision of stroke-related outcome measures did not significantly affect the findings. New outcome measures for stroke that evolved during these studies are being applied to ongoing trials for a variety of stroke therapies.