To compare the risk of stroke, myocardial infarction and death as a result of carotid endarterectomy under either general or local anaesthesia.
- Endarterectomy, carotid (CEA)Procedure/Surgery
Intervention Desc: Surgical therapy to remove atherosclerotic plaque in narrowed carotid arteries.
Multi-center, randomised trial.
Eligible patients were randomized to receive carotid endarterectomy under either local or general anaesthesia. Hospital follow-up at discharge, 7 days post-surgery or death. Neurology follow-up at one month post-surgery. One year follow-up. Quality of life assessments performed at 30 days post-surgery (UK only).
|Type||Measure||Time Frame||Safety Issue|
|Primary||Relative and absolute differences in the proportion of patients alive and stroke-free (including retinal infarction) and without myocardial infarction at 30 days after surgery, or 30 days after randomisation for those few patients when surgery was scheduled but never carried out.|
|Secondary||Proportion of patients alive and stroke free at one year and in the longer term, a comparison of health related quality of life at 30 days and any surgical adverse events, re-operation and re-admission rates, the relative cost of the two methods of anaesthesia, length of stay and intensive and high dependency bed occupancy.|