Efficacy of carotid endarterectomy for asymptomatic carotid stenosis. The Veterans Affairs Cooperative Study Group. Long-term outcome of endovascular treatment versus medical care for carotid artery stenosis in patients not suitable for surgery and randomised in the Carotid and Vertebral Artery Transluminal Angioplasty study (CAVATAS). A prospective randomized study on bilateral carotid endarterectomy: patching versus eversion. Endovascular versus surgical treatment in patients with carotid stenosis in the Carotid and Vertebral Artery Transluminal Angioplasty Study (CAVATAS): a randomised trial. Carotid angioplasty and stenting versus carotid endarterectomy for treatment of asymptomatic carotid stenosis: a randomized trial in a community hospital. [Carotid endarterectomy versus carotid stenting: a prospective randomized trial]. A prospective, randomized study of saphenous vein patching versus synthetic patching during carotid endarterectomy. Beneficial effect of carotid endarterectomy in symptomatic patients with high-grade carotid stenosis. Randomised trial of endarterectomy for recently symptomatic carotid stenosis: final results of the MRC European Carotid Surgery Trial (ECST) Stenting versus endarterectomy for treatment of carotid-artery stenosis. Prospective randomized study of carotid endarterectomy with Fluoropassiv thin wall carotid patch versus venous patch. Alert for increased long-term follow-up after carotid artery stenting: results of a prospective, randomized, single-center trial of carotid artery stenting vs carotid endarterectomy.
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. Optimal treatment of carotid stenosis in patients not suitable for surgery is unclear. The Carotid and Vertebral Artery Transluminal Angioplasty study contained a trial comparing medical and endovascular treatment in patients not suitable for surgery.
                Forty patients were randomised to medical or endovascular treatment in equal numbers, and patients were followed up for up to 10 years. The primary outcome measure was defined as stroke or death during follow-up, analysed by intention-to-treat. Secondary analyses included disabling stroke, death, any stroke, any stroke or transient ischemic attack (TIA), all during follow-up.
                Baseline characteristics were similar. The risk of stroke, retinal infarction or death within 30 days of endovascular treatment was 5% (95% CI: 0.1-24.9%). By the study end, >50% of patients had suffered a recurrent TIA, stroke or died. One third of events were non-stroke deaths. Overall, there was no significant difference between medical and endovascular treatment in the primary outcome rate of stroke or death after randomisation (hazard ratio: 0.98, 95% CI: 0.39-2.48) or the rate of any stroke or TIA (hazard ratio: 1.43, 95% CI: 0.54-3.75).
                We failed to show superiority of endovascular treatment above medical care alone for carotid stenosis in a very small group of patients not suitable for surgical treatment. However, the trial randomised only 40 patients, and was therefore severely underpowered to detect clinically relevant treatment differences. Ongoing trials of carotid stenting will need to demonstrate improved safety and efficacy before endovascular treatment should enter routine practice.
                (c) 2009 S. Karger AG, Basel. To compare the clinical outcome and restenosis incidence of patients who underwent carotid endarterectomy with patch closure (CEAP) on one side and carotid eversion endarterectomy (CEE) on the other.
                Although a few investigators have compared the results of CEAP versus CEE, no reports have compared the outcome of CEAP versus CEE in the same patient.
                Eighty-six patients were randomly selected for sequential surgical treatment involving either CEAP/CEE or CEE/CEAP. All patients underwent postoperative duplex ultrasound study and clinical follow-up at 1, 6, and 12 months and every year thereafter. Various factors were analyzed to ascertain any association with restenosis, and Kaplan-Meier analysis was used to estimate the risk of restenosis.
                Demographic and clinical data were similar in the CEAP and CEE groups. The selective shunting rate was statistically higher in the CEAP group. There were no perioperative deaths. Although the incidence of perioperative ipsilateral stroke was not significant, CEAP patients had a rate of combined transient ischemic attacks and strokes that approached statistical significance. The mean follow-up was 40 months. CEAP patients had a significantly higher incidence of restenosis and combined occlusive events and restenoses. Kaplan-Meier analysis showed that CEE had a significantly better cumulative patency rate than CEAP and that freedom from restenoses at 24 and 36 months was 87% and 83% for CEAP and 98% and 98% for CEE, respectively.
                CEE is less likely to cause perioperative neurologic complications and restenoses than CEAP. The significantly higher rate of unilateral recurrence suggests that local factors play a more important role than systemic factors in the occurrence of restenosis. Percutaneous transluminal angioplasty and stenting (endovascular treatment) can be used to treat carotid stenosis, but risks and benefits are uncertain. We therefore compared endovascular treatment with conventional carotid surgery.
                In a multicentre clinical trial, we randomly assigned 504 patients with carotid stenosis to endovascular treatment (n=251) or carotid endarterectomy (n=253). For endovascular patients treated successfully, we used stents in 55 (26%) and balloon angioplasty alone in 158 (74%). An independent neurologist followed up patients. Analysis was by intention to treat.
                The rates of major outcome events within 30 days of first treatment did not differ significantly between endovascular treatment and surgery (6.4% vs 5.9%, respectively, for disabling stroke or death; 10.0% vs 9.9% for any stroke lasting more than 7 days, or death). Cranial neuropathy was reported in 22 (8.7%) surgery patients, but not after endovascular treatment (p<0.0001). Major groin or neck haematoma occurred less often after endovascular treatment than after surgery (three [1.2%] vs 17 [6.7%], p<0.0015). At 1 year after treatment, severe (70-99%) ipsilateral carotid stenosis was more usual after endovascular treatment (25 [14%] vs seven [4%], p<0.001). However, no substantial difference in the rate of ipsilateral stroke was noted with survival analysis up to 3 years after randomisation (adjusted hazard ratio=1.04, 95% CI 0.63-1.70, p=0.9).
                Endovascular treatment had similar major risks and effectiveness at prevention of stroke during 3 years compared with carotid surgery, but with wide CIs. Endovascular treatment had the advantage of avoiding minor complications. Carotid endarterectomy (CEA) is effective in reducing the risk of stroke in individuals with more than 60% carotid stenosis. Carotid angioplasty and stenting (CAS) has been proffered as effective and used in treating individuals with asymptomatic carotid stenosis despite the absence of proven clinical equivalency. This randomized trial was designed to explore the hypothesis that CAS is equivalent to CEA for treating asymptomatic carotid stenosis.
                A total of 85 individuals presenting with asymptomatic carotid stenosis of more than 80% were selected randomly for CAS or CEA and followed up for 48 months.
                Stenosis decreased to an average of 5% after CAS. The patency of the reconstructed artery remained satisfactory regardless of the technique, as determined by carotid ultrasonography. No major complications such as cerebral ischemia or death occurred. Procedural complications associated with CAS (n = 5) were hypotension and/or bradycardia; those concomitant with CEA (n = 3) were cervical nerve injury or complications related to general anesthesia (n = 4). Both procedures were well tolerated in the context of pain and discomfort. Hospital stay was similar in the two groups (mean, 1.1 versus 1.2 d). The occurrence of complications associated with CAS or CEA prolonged hospitalization by 3 days (mean, 4.0 versus 4.5 d). Return to full activity was achieved within 1 week by more than 85% of patients; all returned to their usual lifestyle by 2 weeks. Although hospital charges were slightly higher for CAS, costs were similar.
                CAS and CEA may be equally effective and safe in treating individuals with asymptomatic carotid stenosis. 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. The objective of this study was the determination of whether the choice of either autogenous saphenous vein (ASV) or synthetic material for patch angioplasty significantly influences the results after carotid endarterectomy (CEA).
                With Institutional Review Board approval, 195 patients (145 men and 50 women; mean age, 69 years) who underwent 207 CEAs were prospectively randomized to arteriotomy closure with ASV or synthetic patches from July 1996 to January 2000. One hundred and one patients (52%) were randomized to the ASV cohort, and 94 (48%) were randomized to the synthetic cohort. Aside from a slight gender imbalance (70% versus 79% male in the ASV versus the synthetic group), there were no clinically important differences in baseline demographic variables, risk factors, or surgical indications between the ASV and synthetic groups.
                With all 207 randomized procedures on an intent-to-treat basis, there were two early (<30 days) postoperative deaths (1%). There were three perioperative strokes in the ASV cohort (3.0%) and two in the synthetic cohort (2.1%; P =.99). Two of these early strokes occurred in a subset of nine patients who received neither patch material, all after randomization but before CEA. Two patients in each group had late strokes. The cumulative freedom from stroke rate at 1 year (ASV, 94%; synthetic, 95%) was virtually identical for both cohorts. With the 125 patients who had at least one postoperative duplex scan, the incidence rate of recurrent (>or=60%) carotid stenosis was 4.8% (three of 62) for the ASV group and 6.3% (four of 63) for the synthetic group (P =.99).
                No significant differences in the stroke, mortality, or restenosis rates were shown between the ASV and the synthetic cohorts. While conceding the power limitations inherent in this study, we conclude that CEA may be safely performed with similar early results with ASV or synthetic patches. 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.
                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.
                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).
                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. Our objective was to assess the risks and benefits of carotid endarterectomy, primarily in terms of stroke prevention, in patients with recently symptomatic carotid stenosis.
                This multicentre, randomised controlled trial enrolled 3024 patients. We enrolled men and women of any age, with some degree of carotid stenosis, who within the previous 6 months had had at least one transient or mild symptomatic ischaemic vascular event in the distribution of one or both carotid arteries. Between 1981 and 1994, we allocated 1811 (60%) patients to surgery and 1213 (40%) to control (surgery to be avoided for as long as possible). Follow-up was until the end of 1995 (mean 6.1 years), and the main analyses were by intention to treat.
                The overall outcome (major stroke or death) occurred in 669 (37.0%) surgery-group patients and 442 (36.5%) control-group patients. The risk of major stroke or death complicating surgery (7.0%) did not vary substantially with severity of stenosis. On the other hand, the risk of major ischaemic stroke ipsilateral to the unoperated symptomatic carotid artery increased with severity of stenosis, particularly above about 70-80% of the original luminal diameter, but only for 2-3 years after randomisation. On average, the immediate risk of surgery was worth trading off against the long-term risk of stroke without surgery when the stenosis was greater than about 80% diameter; the Kaplan-Meier estimate of the frequency of a major stroke or death at 3 years was 26.5% for the control group and 14.9% for the surgery group, an absolute benefit from surgery of 11.6%. However, consideration of variations in risk with age and sex modified this simple rule based on stenosis severity. We present a graphical procedure that should improve the selection of patients for surgery.
                Carotid endarterectomy is indicated for most patients with a recent non-disabling carotid-territory ischaemic event when the symptomatic stenosis is greater than about 80%. Age and sex should also be taken into account in decisions on whether to operate. Carotid-artery stenting and carotid endarterectomy are both options for treating carotid-artery stenosis, an important cause of stroke.
                We randomly assigned patients with symptomatic or asymptomatic carotid stenosis to undergo carotid-artery stenting or carotid endarterectomy. The primary composite end point was stroke, myocardial infarction, or death from any cause during the periprocedural period or any ipsilateral stroke within 4 years after randomization.
                For 2502 patients over a median follow-up period of 2.5 years, there was no significant difference in the estimated 4-year rates of the primary end point between the stenting group and the endarterectomy group (7.2% and 6.8%, respectively; hazard ratio with stenting, 1.11; 95% confidence interval, 0.81 to 1.51; P=0.51). There was no differential treatment effect with regard to the primary end point according to symptomatic status (P=0.84) or sex (P=0.34). The 4-year rate of stroke or death was 6.4% with stenting and 4.7% with endarterectomy (hazard ratio, 1.50; P=0.03); the rates among symptomatic patients were 8.0% and 6.4% (hazard ratio, 1.37; P=0.14), and the rates among asymptomatic patients were 4.5% and 2.7% (hazard ratio, 1.86; P=0.07), respectively. Periprocedural rates of individual components of the end points differed between the stenting group and the endarterectomy group: for death (0.7% vs. 0.3%, P=0.18), for stroke (4.1% vs. 2.3%, P=0.01), and for myocardial infarction (1.1% vs. 2.3%, P=0.03). After this period, the incidences of ipsilateral stroke with stenting and with endarterectomy were similarly low (2.0% and 2.4%, respectively; P=0.85).
                Among patients with symptomatic or asymptomatic carotid stenosis, the risk of the composite primary outcome of stroke, myocardial infarction, or death did not differ significantly in the group undergoing carotid-artery stenting and the group undergoing carotid endarterectomy. During the periprocedural period, there was a higher risk of stroke with stenting and a higher risk of myocardial infarction with endarterectomy. (ClinicalTrials.gov number, NCT00004732.)
                2010 Massachusetts Medical Society The practice of carotid endarterectomy (CEA) with patch angioplasty is more effective compared to primary closure. However, the type of patch material remains a controversy. The Fluoropassiv thin wall carotid patch is a polyester patch with an interpenetrating, nanometer-scale, solvent-applied surface modification, based on a biocompatible fluoropolymer. The present pilot study is the first clinical trial evaluating results of CEA with Fluoropassiv versus venous patch.
                Eighty-seven patients were randomized to 42 Fluoropassiv patching and 45 venous patching. Patients were observed by a vascular surgeon and a neurologist and scanned using duplex ultrasound with a follow-up of 2 years. No patients were lost to follow-up. Restenosis was defined as a Peak Systolic Velocity ratio >2.6, lumen reduction >50%.
                Perioperative stroke rate was 2.4% in the Fluoropassiv group and 8.9% in the venous group (p=0.02; 1 regressive, 4 non-regressive strokes). Multivariate analysis showed that bilateral carotid stenosis and stroke as indication for CEA were related to perioperative stroke. There was no link between perioperative stroke and patch type after correction for these factors. Patch type had no influence on operation time, clamp time, cranial nerve damage, hypertension, hematoma, infections, time to discharge, or early thromboembolic events. There were no significant differences between the Fluoropassiv and the venous group for cumulative mortality (respectively 4.4 vs 4.8%), patch occlusion (4.8 vs 2.2%), or stroke rate during 2 year follow-up (2.2 vs 2.4%).
                This first clinical study with the Fluoropassiv thin wall carotid patch showed no enhanced thrombogenicity compared to a venous patch. The Fluoropassiv patch is not related to a higher rate of postoperative bleeding events either. Carotid endarterectomy (CEA) has been shown to be effective in stroke prevention for patients with symptomatic or asymptomatic carotid artery stenosis. Although several prospective randomized trials indicate that carotid artery stenting (CAS) is an alternative but not superior treatment modality, there is still a significant lack of long-term data comparing CAS with CEA. This study presents long-term results of a prospective, randomized, single-center trial.
                Between August 1999 and April 2002, 87 patients with a symptomatic high-grade internal carotid artery stenosis (>70%) were randomized to CAS or CEA. After a median observation time of 66 +/- 14.2 months (CAS) and 64 +/- 12.1 months (CEA), 42 patients in each group were re-evaluated retrospectively by clinical examination and documentation of neurologic events. Duplex ultrasound imaging was performed in 61 patients (32 CAS, 29 CEA), and patients with restenosis >70% were re-evaluated by angiography.
                During the observation period, 23 patients (25.2%) died (10 CAS, 13 CEA), and three were lost to follow up. The incidence of strokes was higher after CAS, with four strokes in 42 CAS patients vs none in 42 CEA patients. One transient ischemic attack occurred in each group. A significantly higher rate of restenosis >70% (6 of 32 vs 0 of 29) occurred after CAS compared with CEA. Five of 32 CAS patients (15.6%) presented with high-grade (>70%) restenosis as an indication for secondary intervention or surgical stent removal, and three presented with neurologic symptoms. No CEA patients required reintervention (P < .05 vs CAS). A medium-grade (<70%) restenosis was detected in eight of 32 CAS patients (25%) and in one of 29 CEA patients (3.4%). In five of 32 CAS (15.6%) and three of 29 CEA patients (10.3%), a high-grade stenosis of the contralateral carotid artery was observed and treated during the observation period.
                The long-term results of this prospective, randomized, single-center study revealed a high incidence of relevant restenosis and neurologic symptoms after CAS. CEA seems to be superior to CAS concerning the development of restenosis and significant prevention of stroke. However, the long-term results of the ongoing multicenter trials have to be awaited for a final conclusion.
Endovascular treatment is associated with an increased risk of peri-procedural stroke or death compared with endarterectomy. However, this excess risk appears to be limited to older patients. The longer term efficacy of endovascular treatment and the risk of restenosis are unclear and require further follow-up of existing trials. Further trials are needed to determine the optimal treatment for asymptomatic carotid stenosis.