OBJECTIVES: The objectives of this study were to determine the results of a specific technique in the performance of carotid endarterectomy (CEA) and to compare results using this technique between standard-risk and high-risk patients eligible for Stenting and Angioplasty with Protectionin Patients at High Risk for Endarterectomy (SAPPHIRE) and between asymptomatic and symptomatic patients. METHODS: A total of 391 patients underwent 442 consecutive CEA procedures under general anesthesia with the intent to shunt, patch, and perform intraoperative completion duplex ultrasound imaging. Indications included 272 asymptomatic patients (61.5%) with carotid stenoses > or =60% and 170 symptomatic patients (38.5%) with carotid stenosis > or =50%. Data were analyzed to determine the early (< or =30 days) and long-term morbidity and mortality overall in standard-risk and high-risk procedures and in asymptomatic and symptomatic patients. The primary end points were the occurrence of all strokes or death or myocardial infarction (MI) in the first 30 postoperative days (100% follow-up) and the occurrence by life-table analysis of ipsilateral stroke or death or MI (SDMI) out to 93 months (mean, 31.4 months). RESULTS:A total of 441 (99.7%) procedures included shunting, 440 (99.5%) included patching, and 442 (100%) had completion duplex ultrasound imaging. Of these, 235 procedures were standard risk and 207 procedures were high risk. At the 30-day follow-up, there were two ipsilateral central neurologic deficits (1 major stroke, 1 minor stroke), no death, and one MI (0.45% for all strokes or death; 0.68% for all strokes or death or MI). After 30 days of follow-up, an additional 16 strokes (9 ipsilateral, 7 contralateral), eight MIs, and 38 deaths had occurred. No statistically significant difference was found between standard-risk and high-risk groups or between asymptomatic and symptomatic groups for stroke, death, MI, stroke or death, or stroke or death or MI at 30 days or during long-term follow-up at any interval up to 93 months. CONCLUSION: CEA performed with intent to treat using general anesthesia, shunting, patching, and completion duplex scanning results in extremely low 30-day and long-term morbidity and mortality in asymptomatic, symptomatic, standard-risk and high-risk patients. These results are substantially superior to those reported in carotid stenting trials for both carotid stenting and CEA and do not support the contention that there is a high-risk group for CEA.
RCT Entities:
OBJECTIVES: The objectives of this study were to determine the results of a specific technique in the performance of carotid endarterectomy (CEA) and to compare results using this technique between standard-risk and high-risk patients eligible for Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy (SAPPHIRE) and between asymptomatic and symptomatic patients. METHODS: A total of 391 patients underwent 442 consecutive CEA procedures under general anesthesia with the intent to shunt, patch, and perform intraoperative completion duplex ultrasound imaging. Indications included 272 asymptomatic patients (61.5%) with carotid stenoses > or =60% and 170 symptomatic patients (38.5%) with carotid stenosis > or =50%. Data were analyzed to determine the early (< or =30 days) and long-term morbidity and mortality overall in standard-risk and high-risk procedures and in asymptomatic and symptomatic patients. The primary end points were the occurrence of all strokes or death or myocardial infarction (MI) in the first 30 postoperative days (100% follow-up) and the occurrence by life-table analysis of ipsilateral stroke or death or MI (SDMI) out to 93 months (mean, 31.4 months). RESULTS: A total of 441 (99.7%) procedures included shunting, 440 (99.5%) included patching, and 442 (100%) had completion duplex ultrasound imaging. Of these, 235 procedures were standard risk and 207 procedures were high risk. At the 30-day follow-up, there were two ipsilateral central neurologic deficits (1 major stroke, 1 minor stroke), no death, and one MI (0.45% for all strokes or death; 0.68% for all strokes or death or MI). After 30 days of follow-up, an additional 16 strokes (9 ipsilateral, 7 contralateral), eight MIs, and 38 deaths had occurred. No statistically significant difference was found between standard-risk and high-risk groups or between asymptomatic and symptomatic groups for stroke, death, MI, stroke or death, or stroke or death or MI at 30 days or during long-term follow-up at any interval up to 93 months. CONCLUSION: CEA performed with intent to treat using general anesthesia, shunting, patching, and completion duplex scanning results in extremely low 30-day and long-term morbidity and mortality in asymptomatic, symptomatic, standard-risk and high-risk patients. These results are substantially superior to those reported in carotid stenting trials for both carotid stenting and CEA and do not support the contention that there is a high-risk group for CEA.