Abstract 6: Relationship between Center-Volume and Complication Rates in the Carotid Revascularization Endarterectomy versus Stenting Trial
Background There is evidence that center-volume of cases affects outcomes for both carotid endarterectomy (CEA) and stenting (CAS). We sought to evaluate the effect of center-volume by site on complication rates in the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST).
Methods In CREST, the primary composite endpoint was any stroke, myocardial infarction, or death within 30 days or ipsilateral stroke in follow-up. Certification was achieved by 477 surgeons performing more than 12 procedures per year with complication rates less than 3% for asymptomatic patients and less than 5% for symptomatic patients; 224 interventionists were certified after a rigorous training and credentialing process that included a lead-in registry. CREST centers were divided into tertiles based on the number of patients enrolled into the study, with Group 1 composed of 82 sites each enrolling <25 patients, Group 2 with 24 sites enrolling 25-51 patients and Group 3 with 10 sites enrolling >51 patients. Differences in periprocedural event rates for the primary composite endpoint and its components were compared using logistic regression adjusting for age, sex, and symptomatic status within site-volume level.
Results The safety of CAS and CEA did not vary by site-volume during the periprocedural period as indicated by occurrence of the primary endpoint (p=0.54) or by stroke and death (p=0.87).
Conclusion Complication rates (as indicated by the primary endpoint and its components) were low in CREST and were not associated with center-volume. The data are consistent with the value of rigorous training and credentialing in trials evaluating endovascular devices and surgical procedures; because of ongoing entry of new interventionalists and surgeons into CREST, operator experience independent of center-volume cannot be addressed.
- © 2012 by American Heart Association, Inc.