The North American Symptomatic Carotid Endarterectomy Trial (NASCET) and the Asymptomatic Carotid Atherosclerosis Study (ACAS) demonstrated the efficacy of carotid endarterectomy (CEA) in reducing the risk of stroke and death in selected patients when surgery was performed in institutions whose participation depended on demonstrated excellence. Thirty-day mortality rates in the trials were very low: 0.6% in NASCET and 0.1% in ACAS.Objective
To assess perioperative mortality among Medicare patients undergoing CEA in all nonfederal institutional settings.Design
Retrospective national cohort study.Main Outcome Measures
Crude and adjusted perioperative (30 day) mortality rates.Results
The perioperative mortality rate was 1.4% (95% confidence interval [CI], 1.2%-1.7%) at trial hospitals; mortality in nontrial hospitals was higher: 1.7% (95% CI, 1.6%-1.8%) (high volume); 1.9% (95% CI, 1.7%-2.1%) (average volume); 2.5% (95% CI, 2.0%-2.9%) (low volume); (P for trend, <.001). In multivariate modeling, patients undergoing their procedures at trial hospitals had a mortality risk reduction of 15% (95% CI, 0%-31%) compared with high-volume nontrial hospitals, 25% (95% CI, 7%-40%) compared with average-volume hospitals, and 43% (95% CI, 25%-56%) compared with low-volume hospitals (P for trend, <.001).Conclusion
Medicare patients' perioperative mortality following CEA is substantially higher than that reported in the trials, even in those institutions that participated in the randomized studies. Caution is advised in translating the efficacy of carefully controlled studies of CEA to effectiveness in everyday practice.