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The Carotid Surgery for Ischemic Stroke trial: a prospective observational study on carotid endarterectomy in the early period after ischemic stroke.

OBJECTIVE
The purpose of this study was to examine the safety of carotid endarterectomy (CEA) within 6 weeks after a nondisabling carotid-related ischemic stroke. Endpoints were the perioperative stroke or mortality rate and the incidence rate of cerebral bleedings.


METHODS
This prospective observational multicenter trial was performed in community and university centers. One hundred sixty-four hospitalized patients with nondisabling carotid-related ischemic stroke were included. The patients were identified clinically with the modified Rankin scale (initial neurologic deficit grade >/= 2, n = 160). Four patients with evidence of ischemic territorial infarction on cerebral computed tomographic (CT) scan but no persisting functional deficit were also included. CEA was performed within 6 weeks after stroke. Neurologic examinations were performed initially, before surgery, 3 days after surgery, and 6 weeks after CEA. Worsening of more than 1 grade on the Rankin scale was considered as a new stroke or stroke extension. Unenhanced CT scans of the brain were performed before and after surgery. CT scans were evaluated blind to clinical patient data. Statistical analysis included univariate and multivariate analysis.


RESULTS
The combined stroke or mortality rate within 30 days after CEA was 6.7%. Ten patients had a new ipsilateral stroke or stroke extension, and one patient died after surgery of a myocardial infarction. One patient (0.6%) had parenchymatous cerebral bleeding, and in 10 patients, hemorrhagic transformation within the preexisting ischemic infarction was detected but no infarct extension was observed. In the multivariate analysis, American Society of Anesthesiology (ASA) grades III and IV and decreasing age were significant predictors for an increased perioperative risk. Patients with a higher risk profile (ASA classification grades III and IV) had a high perioperative risk when CEA was performed within the first 3 weeks (14.6% versus 4.8% beyond 3 weeks). Patients without severe concomitant diseases (ASA grades I/II) had a low perioperative risk of 3.4% if CEA was performed within the first 3 weeks.


CONCLUSION
Early CEA within 6 weeks after a carotid-related ischemic stroke can be performed with a perioperative stroke or mortality rate comparable with the results reported in the European Carotid Surgery Trial and the North American Symptomatic Carotid Endarterectomy Trial. The risk of parenchymatous bleeding is low. ASA grades III and IV and decreasing age were predictive of an increased perioperative risk, especially if CEA was performed within the first 3 weeks. Patients at low risk can undergo operation safely within the first 3 weeks. Individual patient selection in an interdisciplinary approach between neurologists, anesthesiologists, and vascular surgeons remains mandatory in these patients.