Carotid endarterectomy: to shunt or not to shunt. Local versus general anaesthesia in carotid surgery. A prospective, randomised study. Carotid artery stenting compared with endarterectomy in patients with symptomatic carotid stenosis (International Carotid Stenting Study): an interim analysis of a randomised controlled trial. Subtle cerebral damage after shunting vs non shunting during carotid endarterectomy. Randomized study of carotid angioplasty and stenting versus carotid endarterectomy: a stopped trial. A randomized study on eversion versus standard carotid endarterectomy: study design and preliminary results: the Everest Trial. Efficacy of carotid endarterectomy for asymptomatic carotid stenosis. The Veterans Affairs Cooperative Study Group. [Carotid endarterectomy versus carotid stenting: a prospective randomized trial]. 30 day results from the SPACE trial of stent-protected angioplasty versus carotid endarterectomy in symptomatic patients: a randomised non-inferiority trial.
Because of controversies in the cerebrovascular literature regarding the use of an intraluminal shunt in carotid endarterectomy, we report a randomized prospective study of 118 consecutive symptomatic patients receiving surgery within a single neurosurgical practice. Over 4 years, 138 carotid endarterectomies were performed in the 118 patients, 63 operations with intraluminal shunting and 75 without. Standard rationale for surgery included ipsilateral cerebral infarction in 38% of the operations and ipsilateral transient ischemic attacks in 36%. Unilateral angiographic stenosis of greater than 90% was seen in 58% of the operations; there were no ipsilateral occlusions. Surgery was performed under general anesthesia with barbiturate induction and mild blood pressure elevation. The 30-day complication rate included a mortality rate of 0.7% with a 5.1% incidence of postoperative neurologic deficit and a 1.4% rate of myocardial infarction. In the 24 hours after surgery there were no cerebral infarctions in the shunted group and six in the unshunted group. This 8% rate in the unshunted group compared with 0% in the shunted group was significant at p = 0.023 with a power of 0.95 by Fisher's exact test and chi 2 analysis. This suggests that in our neurosurgical practice (resident training program) the use of an intraluminal shunt during carotid endarterectomy significantly reduces the risk of intraoperative neurologic deficit without increasing the incidence of other complications. A randomised, prospective study was performed to compare local (LA) and general anaesthesia (GA) in carotid surgery with special emphasis on complications and the need for intra-operative shunting. Fifty-six patients were randomised to LA and 55 to GA. Eight patients in the LA group required a GA for various reasons. During the same period 14 patients were not randomised. Seven perioperative neurological deficits occurred (5.6%), four in the LA group, two in the GA group, and one in the non-randomised group (NS). Selective shunting was used, in the Ga group according to stump pressure or in cases with a previous stroke and in the LA group according to the appearance of neurological symptoms. In the GA group 25 patients were shunted and in the LA group five patients (P less than 0.001) needed a shunt. If strict pressure criteria for shunting had been used in the LA patients, ten would have been shunted and three of the patients who developed symptoms during clamping would not have been shunted. During surgery the highest recorded systolic pressure was significantly higher in the LA group (210 mmHg versus 173 mmHg, P less than 0.001). LA for carotid endarterectomy is comparable with general anaesthesia regarding peroperative complications but produces significantly higher blood pressures than general anaesthesia. On the other hand it allows the possibility of neurologic monitoring of the patient and leads to significantly less use of an intra-operative shunt. Stents are an alternative treatment to carotid endarterectomy for symptomatic carotid stenosis, but previous trials have not established equivalent safety and efficacy. We compared the safety of carotid artery stenting with that of carotid endarterectomy.
                The International Carotid Stenting Study (ICSS) is a multicentre, international, randomised controlled trial with blinded adjudication of outcomes. Patients with recently symptomatic carotid artery stenosis were randomly assigned in a 1:1 ratio to receive carotid artery stenting or carotid endarterectomy. Randomisation was by telephone call or fax to a central computerised service and was stratified by centre with minimisation for sex, age, contralateral occlusion, and side of the randomised artery. Patients and investigators were not masked to treatment assignment. Patients were followed up by independent clinicians not directly involved in delivering the randomised treatment. The primary outcome measure of the trial is the 3-year rate of fatal or disabling stroke in any territory, which has not been analysed yet. The main outcome measure for the interim safety analysis was the 120-day rate of stroke, death, or procedural myocardial infarction. Analysis was by intention to treat (ITT). This study is registered, number ISRCTN25337470.
                The trial enrolled 1713 patients (stenting group, n=855; endarterectomy group, n=858). Two patients in the stenting group and one in the endarterectomy group withdrew immediately after randomisation, and were not included in the ITT analysis. Between randomisation and 120 days, there were 34 (Kaplan-Meier estimate 4.0%) events of disabling stroke or death in the stenting group compared with 27 (3.2%) events in the endarterectomy group (hazard ratio [HR] 1.28, 95% CI 0.77-2.11). The incidence of stroke, death, or procedural myocardial infarction was 8.5% in the stenting group compared with 5.2% in the endarterectomy group (72 vs 44 events; HR 1.69, 1.16-2.45, p=0.006). Risks of any stroke (65 vs 35 events; HR 1.92, 1.27-2.89) and all-cause death (19 vs seven events; HR 2.76, 1.16-6.56) were higher in the stenting group than in the endarterectomy group. Three procedural myocardial infarctions were recorded in the stenting group, all of which were fatal, compared with four, all non-fatal, in the endarterectomy group. There was one event of cranial nerve palsy in the stenting group compared with 45 in the endarterectomy group. There were also fewer haematomas of any severity in the stenting group than in the endarterectomy group (31 vs 50 events; p=0.0197).
                Completion of long-term follow-up is needed to establish the efficacy of carotid artery stenting compared with endarterectomy. In the meantime, carotid endarterectomy should remain the treatment of choice for patients suitable for surgery.
                Medical Research Council, the Stroke Association, Sanofi-Synthélabo, European Union.
                Copyright 2010 Elsevier Ltd. All rights reserved. To compare the extent of subtle cerebral damage (SCD) in patients undergoing carotid endarterectomy with or without shunt placement.
                Prospective, randomised study.
                We assessed a consecutive series of 96 patients undergoing endarterectomy for severe unilateral left carotid stenosis who had been randomly assigned to receive a shunt (48) or not (48). Eligibility criteria included age up to 80 years and Mini-Mental State Examination score >24 points. Patients underwent neuropsychological testing before surgery. Serum concentrations of S100 protein, neuron-specific enolase (NSE) and interleukin-6 (IL-6) were measured intraoperatively before and after carotid clamping. Finally, each patient underwent neuropsychological testing 3 weeks after surgery.
                Patients with and without shunt had similar serum concentrations of S100 protein, NSE and IL-6 as well as similar neuropsychological test scores, all p>0.05.
                There was no difference in subtle cerebral damage between patients randomized to receive a shunt or not. Carotid angioplasty (CA) has been suggested to be a safer and more cost-effective alternative to carotid endarterectomy (CEA) in the management of symptomatic severe internal carotid artery (ICA) disease.
                The study was conducted as a prospective consecutive randomized trial of CEA versus CA for symptomatic severe ICA disease in a university teaching hospital. All patients were assessed before and after surgery by a neurologist. The study consisted of 23 patients with focal carotid territory symptoms and severe ICA stenosis (> 70%) who were randomized to either CEA or CA. However, only 17 had received their allocated treatment before trial suspension. CEA with patching or CA with stenting were used as interventions. The main outcome measures were death or disabling or nondisabling stroke within 30 days.
                All 10 CEA operations proceeded without complication, but 5 of the 7 patients who underwent CA had a stroke (P=.0034), 3 of which were disabling at 30 days.
                After referral, the Data Monitoring Committee invoked the stopping rule and the trial was suspended. The investigators and the Ethics Committee subsequently concluded that the trial could not be restarted--even in an amended format-primarily because of problems with informed consent. We review many of the ethical dilemmas encountered in the performance of this study. If future trials do suggest a selected role for CA, it is essential that both the inclusion and the exclusion criteria are fully documented. The EVEREST Trial was designed to determine whether the surgical technique influences the durability and complications of carotid endarterectomy (CEA). The current report focuses on the study design and preliminary results.
                EVEREST is a randomized multicenter trial. A total of 1353 patients with carotid stenosis requiring surgical treatment were randomly assigned to received standard (n = 675) or eversion (n = 678) CEA. Primary end points included carotid occlusion, major stroke, death, and restenosis rate.
                The rate of perioperative major stroke and death (1.3 for each study group) and the incidence of early carotid occlusion (0.6% for eversion vs 0.4% for standard) were similar. No significant differences were found between eversion and standard CEA with respect to incidence of perioperative transient ischemic accident, minor stroke, cranial nerve injuries, neck hematoma, myocardial infarction, or surgical defects as detected with intraoperative quality controls. Clamping time was significantly shorter for eversion CEA compared with patch standard procedures (31.7 +/- 15.9 vs 34.5 +/- 14.4 minutes, p = 0.02). A shunt was inserted in 11% of patients undergoing eversion CEAs and in 16% of patients undergoing standard procedures. Overall 30-day events occurred in 13.3% of the eversion group and in 11.4% of the standard group (p = 0.3). At a mean follow-up of 14.9 months (range, 1 to 38 months), 16 (2.4%) restenoses occurred in the eversion group and 28 (4.1%) occurred in the standard group (odds ratio, 0.56; 95% confidence interval, 0.3 to 1.1; p = 0.08).
                The preliminary results of the EVEREST Trial suggest that eversion CEA is a safe and rapid procedure with low major complication rates. No significant differences in restenosis rates were observed between eversion and standard CEA at the available follow-up. Longer-term results are necessary to assess whether the eversion technique influences the durability of CEA. The efficacy of carotid endarterectomy in patients with asymptomatic carotid stenosis has not been confirmed in randomized clinical trials, despite the widespread use of operative intervention in such patients.
                We conducted a multicenter clinical trial at 11 Veterans Affairs medical centers to determine the effect of carotid endarterectomy on the combined incidence of transient ischemic attack, transient monocular blindness, and stroke. We studied 444 men with asymptomatic carotid stenosis shown arteriographically to reduce the diameter of the arterial lumen by 50 percent or more. The patients were randomly assigned to optimal medical treatment including antiplatelet medication (aspirin) plus carotid endarterectomy (the surgical group; 211 patients) or optimal medical treatment alone (the medical group; 233 patients). All the patients at each center were followed independently by a vascular surgeon and a neurologist for a mean of 47.9 months.
                The combined incidence of ipsilateral neurologic events was 8.0 percent in the surgical group and 20.6 percent in the medical group (P < 0.001), giving a relative risk (for the surgical group vs. the medical group) of 0.38 (95 percent confidence interval, 0.22 to 0.67). The incidence of ipsilateral stroke alone was 4.7 percent in the surgical group and 9.4 percent in the medical group. An analysis of stroke and death combined within the first 30 postoperative days showed no significant differences. Nor were there significant differences between groups in an analysis of all strokes and deaths (surgical, 41.2 percent; medical, 44.2 percent; relative risk, 0.92; 95 percent confidence interval, 0.69 to 1.22). Overall mortality, including postoperative deaths, was primarily due to coronary atherosclerosis.
                Carotid endarterectomy reduced the overall incidence of ipsilateral neurologic events in a selected group of male patients with asymptomatic carotid stenosis. We did not find a significant influence of carotid endarterectomy on the combined incidence of stroke and death, but because of the size of our sample, a modest effect could not be excluded. To evaluate the early and midterm outcomes of carotid endarterectomy (CEA) compared with carotid stenting (CAS) in patients with carotid artery stenosis.
                A prospective randomized single-center clinical trail to compare with endarterectomy and stenting in patients with symptomatic carotid stenosis of at least 50% and asymptomatic stenosis of at least 70%. From May 2004 to December 2006, there were 40 patients who agreed with the treatment were randomly assigned to undergo either CEA or CAS. The primary end point was any stroke or death within 30 d after treatment and the secondary end point was any stroke, myocardial infarction and any complications of the treatment, or death or ipsilateral stroke and carotid restenosis between 1 month and 18 months, and the cost-effectiveness of both groups were analyzed retrospectively as well.
                There were no significant differences of the characteristics in the two groups. Twenty cases in CEA group underwent 23 endarterectomies (3 cases had bilateral CEA, respectively), in which 9 carotid shunt (39.1%) and 12 patching (52.2%) were used. Twenty cases in CAS group underwent 23 stents (3 cases had bilateral CSA, respectively), in which 21 emboli-protection devices (91.3%) were used. There was no significant difference in 30 d neurological complications (4.3% vs. 8.7%), acute myocardial infarction (4.3% vs. 0), and wound hematoma (8.7% vs. 0) between CEA and CAS, respectively. There was no ipsilateral transient ischemic attack or carotid restenosis at 18 months in each group. The average cost of hospitalization was (16 450.95 +/- 6188.76) vs. (70 130.15 +/- 11 999.02) RMB in CEA and CAS, respectively, with significant difference (P < 0.01).
                The early and midterm outcomes are no significant difference between CEA and CAS, but in China, the cost of hospitalization in CAS is much higher than that of CEA. Carotid endarterectomy is effective in stroke prevention for patients with severe symptomatic carotid-artery stenosis, and carotid-artery stenting has been widely used as alternative treatment. Since equivalence or superiority has not been convincingly shown for either treatment, we aimed to compare the two.
                1200 patients with symptomatic carotid-artery stenosis were randomly assigned within 180 days of transient ischaemic attack or moderate stroke (modified Rankin scale score of < or =3) carotid-artery stenting (n=605) or carotid endarterectomy (n=595). The primary endpoint of this hospital-based study was ipsilateral ischaemic stroke or death from time of randomisation to 30 days after the procedure. The non-inferiority margin was defined as less than 2.5% on the basis of an expected event rate of 5%. Analyses were on an intention-to-treat basis. This trial is registered at Current Controlled Trials with the international standard randomised controlled trial number ISRCTN57874028.
                1183 patients were included in the analysis. The rate of death or ipsilateral ischaemic stroke from randomisation to 30 days after the procedure was 6.84% with carotid-artery stenting and 6.34% with carotid endarterectomy (absolute difference 0.51%, 90% CI -1.89% to 2.91%). The one-sided p value for non-inferiority is 0.09.
                SPACE failed to prove non-inferiority of carotid-artery stenting compared with carotid endarterectomy for the periprocedural complication rate. The results of this trial do not justify the widespread use in the short-term of carotid-artery stenting for treatment of carotid-artery stenoses. Results at 6-24 months are awaited.
This review concluded that the data available were too limited to either support or refute the use of routine or selective shunting in carotid endarterectomy. It was suggested that large scale randomised trials between routine shunting versus selective shunting were required. No one method of monitoring in selective shunting has been shown to produce better outcomes.