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Background and Purpose: This study reports the surgical results in those patients who underwent carotid endarterectomy in the North American Symptomatic Carotid Endarterectomy Trial (NASCET)., Methods: The rates of perioperative stroke and death at 30 days and the final assessment of stroke severity at 90 days were calculated. Regression modeling was used to identify variables that increased or decreased perioperative risk. Nonoutcome surgical complications were summarized. The durability of carotid endarterectomy was examined., Results: In 1415 patients there were 92 perioperative outcome events, for an overall rate of 6.5%. At 30 days the results were as follows: death, 1.1%; disabling stroke, 1.8%; and nondisabling stroke, 3.7%. At 90 days, because of improvement in the neurological status of patients judged to have been disabled at 30 days, the results were as follows: death, 1.1%; disabling stroke, 0.9%; and nondisabling stroke, 4.5%. Thirty events occurred intraoperatively; 62 were delayed. Most strokes resulted from thromboembolism. Five baseline variables were predictive of increased surgical risk: hemispheric versus retinal transient ischemic attack as the qualifying event, left-sided procedure, contralateral carotid occlusion, ipsilateral ischemic lesion on CT scan, and irregular or ulcerated ipsilateral plaque. History of coronary artery disease with prior cardiac procedure was associated with reduced risk. The risk of perioperative wound complications was 9.3%, and that of cranial nerve injuries was 8.6%; most were of mild severity. At 8 years, the risk of disabling ipsilateral stroke was 5.7%, and that of any ipsilateral stroke was 17.1%., Conclusions: The overall rate of perioperative stroke and death was 6.5%, but the rate of permanently disabling stroke and death was only 2.0%. Other surgical complications were rarely clinically important. Carotid endarterectomy is a durable procedure.

Background: Endarterectomy benefits certain patients with carotid stenosis, but benefits are lessened by perioperative surgical risk. Acetylsalicylic acid lowers the risk of stroke in patients who have experienced transient ischaemic attack and stroke. We investigated appropriate doses and the role of acetylsalicylic acid in patients undergoing carotid endarterectomy., Methods: In a randomised, double-blind, controlled trial, 2849 patients scheduled for endarterectomy were randomly assigned 81 mg (n=709), 325 mg (n=708), 650 mg (n=715), or 1300 mg (n=717) acetylsalicylic acid daily, started before surgery and continued for 3 months. We recorded occurrences of stroke, myocardial infarction, and death. We compared patients on the two higher doses of acetylsalicylic acid with patients on the two lower doses., Findings: Surgery was cancelled in 45 patients, none were lost to follow-up by 30 days, and two were lost by 3 months. The combined rate of stroke, myocardial infarction, and death was lower in the low-dose groups than in the high-dose groups at 30 days (5.4 vs 7.0%, p=0.07) and at 3 months (6.2 vs 8.4%, p=0.03). In an efficacy analysis, which excluded patients taking 650 mg or more acetylsalicylic acid before randomisation, and patients randomised within 1 day of surgery, combined rates were 3.7% and 8.2%, respectively, at 30 days (p=0.002) and 4.2% and 10.0% at 3 months (p=0.0002)., Interpretation: The risk of stroke, myocardial infarction, and death within 30 days and 3 months of endarterectomy is lower for patients taking 81 mg or 325 mg acetylsalicylic acid daily than for those taking 650 mg or 1300 mg.

Background: Previous studies have shown that carotid endarterectomy in patients with symptomatic severe carotid stenosis (defined as stenosis of 70 to 99 percent of the luminal diameter) is beneficial up to two years after the procedure. In this clinical trial, we assessed the benefit of carotid endarterectomy in patients with symptomatic moderate stenosis, defined as stenosis of less than 70 percent. We also studied the durability of the benefit of endarterectomy in patients with severe stenosis over eight years of follow-up., Methods: Patients who had moderate carotid stenosis and transient ischemic attacks or nondisabling strokes on the same side as the stenosis (ipsilateral) within 180 days before study entry were stratified according to the degree of stenosis (50 to 69 percent or <50 percent) and randomly assigned either to undergo carotid endarterectomy (1108 patients) or to receive medical care alone (1118 patients). The average follow-up was five years, and complete data on outcome events were available for 99.7 percent of the patients. The primary outcome event was any fatal or nonfatal stroke ipsilateral to the stenosis for which the patient underwent randomization., Results: Among patients with stenosis of 50 to 69 percent, the five-year rate of any ipsilateral stroke (failure rate) was 15.7 percent among patients treated surgically and 22.2 percent among those treated medically (P=0.045); to prevent one ipsilateral stroke during the five-year period, 15 patients would have to be treated with carotid endarterectomy. Among patients with less than 50 percent stenosis, the failure rate was not significantly lower in the group treated with endarterectomy (14.9 percent) than in the medically treated group (18.7 percent, P=0.16). Among the patients with severe stenosis who underwent endarterectomy, the 30-day rate of death or disabling ipsilateral stroke persisting at 90 days was 2.1 percent; this rate increased to only 6.7 percent at 8 years. Benefit was greatest among men, patients with recent stroke as the qualifying event, and patients with hemispheric symptoms., Conclusions: Endarterectomy in patients with symptomatic moderate carotid stenosis of 50 to 69 percent yielded only a moderate reduction in the risk of stroke. Decisions about treatment for patients in this category must take into account recognized risk factors, and exceptional surgical skill is obligatory if carotid endarterectomy is to be performed. Patients with stenosis of less than 50 percent did not benefit from surgery. Patients with severe stenosis (> or =70 percent) had a durable benefit from endarterectomy at eight years of follow-up.

Purpose: The timing of carotid endarterectomy (CE) after a recent nondisabling stroke remains controversial. Delaying surgery in such cases may needlessly place patients at risk for a recurrent stroke that may be major and disabling. This study examines the prognostic implications of performing early endarterectomy compared with delayed endarterectomy in patients from the North American Symptomatic Carotid Endarterectomy Trial., Method: This retrospective, subgroup analysis involved 100 surgical patients with severe (70% to 99%) angiographically defined carotid artery stenosis, who were diagnosed with a nondisabling hemispheric stroke at entry into the trial. Forty-two CEs were performed within 30 days (early group, ranging 3 to 30 days), and 58 were performed beyond 30 days (delayed group, range 33 to 117 days) after stroke. The risk of subsequent stroke after CE was compared between the two groups., Results: Baseline clinical characteristics were comparable in both the early and delayed groups. In the delayed group more lesions were identified ipsilateral to the symptomatic side on the preoperative computed tomography scans. The postoperative (30 days after endarterectomy) stroke rate was 4.8% in the early group and 5.2% in the delayed group, yielding a relative rate of 0.92 (95% confidence interval, 0.16 to 5.27; p = 1.00). No deaths occurred after operation in either group. At the end of 18 months, the rates of any stroke or death were 11.9% and 10.3% for the early and delayed groups, respectively, resulting in a relative rate of 1.15 (95% confidence interval, 0.38 to 3.52; p = 1.00). No association was found between an abnormal preoperative computed tomography scan result and the subsequent risk of stroke when early operation was used., Conclusion: Early CE for severe carotid artery stenosis after a nondisabling ischemic stroke can be performed with rates of morbidity and mortality comparable to those who receive delayed endarterectomy. Delaying the procedure by 30 days for patients with symptomatic high-grade stenosis exposes them to a risk of a recurrent stroke, which may be avoidable by earlier surgery.

Objective: To determine whether carotid endarterectomy prevents deterioration of functional status among patients with transient ischemic attacks or nondisabling strokes and ipsilateral carotid stenosis of 70% to 99%., Design: Multicentered randomized controlled trial with an average 18-month follow-up., Setting: Fifty clinical centers in North America., Patients: A total of 659 patients presenting with recent transient attacks of nondisabling stroke and ipsilateral atherosclerotic carotid stenosis of 70% to 99% were included. Patients were stable neurologically at the time of entry. No patient was lost to follow-up., Intervention: Vascular surgeons and neurosurgeons were prescreened for low perioperative complication rates. Patients were randomly allocated to carotid endarterectomy plus continuing medical care (n = 328) or medical care alone (n = 331), including antiplatelet therapy., Main Outcome Measures: All patients were assessed by neurologists for the occurrence of stroke and functional status at scheduled intervals after entry., Results: In addition to a previously reported risk reduction for ipsilateral stroke for patients assigned to carotid endarterectomy, there was an absolute risk reduction (and relative risk reduction [RRR]) for functional status impairment of 5.6% (RRR, 69%) for vision, 4.6% (RRR, 87%) for comprehension of language, 8.3% (RRR, 88%) for fluency of speech, 4.3% (RRR, 84%) for swallowing, 6.0% (RRR, 53%) for lower-limb function, 9.3% (RRR, 75%) for upper-limb function, 7.4% (RRR, 60%) for shopping, and 10.5% (RRR, 50%) for visiting outside usual residence (P < .05, two-tailed, for all items)., Conclusions: Carotid endarterectomy reduced the risk for impairment of function among patients with recent symptomatic cerebral ischemia and ipsilateral high-grade carotid stenosis.

Background and Purpose: The importance of carotid plaque ulceration as a cause of cerebral ischemic symptoms remains uncertain. Moreover, its prominence in symptomatic patients with severe carotid stenosis is unknown., Methods: The association between angiographically defined plaque ulceration and risk of subsequent stroke was assessed using Cox proportional hazards regression in 659 patients with severe (70% to 99%) carotid stenosis from the North American Symptomatic Carotid Endarterectomy Trial., Results: Treatment assignment (medical versus surgical) and degree of ipsilateral stenosis were identified as having a significant influence on the results. The risk of ipsilateral stroke at 24 months for medically treated patients with ulcerated plaques increased incrementally from 26.3% to 73.2% as the degree of stenosis increased from 75% to 95%. For patients with no ulcer, the risk of stroke remained constant at 21.3% for all degrees of stenosis. The net result yielded relative risks of stroke (ulcer versus no ulcer) ranging from 1.24 (95% confidence interval, 0.61 to 2.52) to 3.43 (95% confidence interval, 1.49 to 7.88). Conversely, for surgically treated patients with antecedent presence of an ulcerated plaque, the risk of stroke increased slightly at the highest degrees of stenosis. Overall, carotid endarterectomy reduced the risk of ipsilateral stroke at 24 months by at least 50%. Similar results were obtained for risk of major ipsilateral stroke and risk of all strokes and death., Conclusions: The presence of angiographically defined ulceration for medically treated symptomatic patients is associated with an increased risk of stroke. The risk of stroke more than doubles at higher degrees of stenosis. Carotid endarterectomy is beneficial in substantially reducing the risk of stroke, regardless of plaque ulceration and degree of severe carotid stenosis.

Background: Without strong evidence of benefit, the use of carotid endarterectomy for prophylaxis against stroke rose dramatically until the mid-1980s, then declined. Our investigation sought to determine whether carotid endarterectomy reduces the risk of stroke among patients with a recent adverse cerebrovascular event and ipsilateral carotid stenosis., Methods: We conducted a randomized trial at 50 clinical centers throughout the United States and Canada, in patients in two predetermined strata based on the severity of carotid stenosis--30 to 69 percent and 70 to 99 percent. We report here the results in the 659 patients in the latter stratum, who had had a hemispheric or retinal transient ischemic attack or a nondisabling stroke within the 120 days before entry and had stenosis of 70 to 99 percent in the symptomatic carotid artery. All patients received optimal medical care, including antiplatelet therapy. Those assigned to surgical treatment underwent carotid endarterectomy performed by neurosurgeons or vascular surgeons. All patients were examined by neurologists 1, 3, 6, 9, and 12 months after entry and then every 4 months. End points were assessed by blinded, independent case review. No patient was lost to follow-up., Results: Life-table estimates of the cumulative risk of any ipsilateral stroke at two years were 26 percent in the 331 medical patients and 9 percent in the 328 surgical patients--an absolute risk reduction (+/- SE) 17 +/- 3.5 percent (P less than 0.001). For a major or fatal ipsilateral stroke, the corresponding estimates were 13.1 percent and 2.5 percent--an absolute risk reduction of 10.6 +/- 2.6 percent (P less than 0.001). Carotid endarterectomy was still found to be beneficial when all strokes and deaths were included in the analysis (P less than 0.001)., Conclusions: Carotid endarterectomy is highly beneficial to patients with recent hemispheric and retinal transient ischemic attacks or nondisabling strokes and ipsilateral high-grade stenosis (70 to 99 percent) of the internal carotid artery.