Stroke is the third leading cause of death and the most common cause of long-term disability. Severe narrowing (stenosis) of the carotid artery is an important cause of stroke. Surgical treatment ...(carotid endarterectomy) may reduce the risk of stroke, but carries a risk of operative complications. This is an update of a Cochrane Review, originally published in 1999, and most recently updated in 2017.
To determine the balance of benefit versus risk of endarterectomy plus best medical management compared with best medical management alone, in people with a recent symptomatic carotid stenosis (i.e. transient ischaemic attack (TIA) or non-disabling stroke).
We searched the Cochrane Stroke Group Trials Register, CENTRAL, MEDLINE Ovid, Embase Ovid, Web of Science Core Collection, ClinicalTrials.gov, and the WHO International Clinical Trials Registry Platform (ICTRP) portal to October 2019. We also reviewed the reference lists of all relevant studies and abstract books from research proceedings.
We included randomised controlled trials (RCTs) comparing carotid artery surgery plus best medical treatment with best medical treatment alone. DATA COLLECTION AND ANALYSIS: Two review authors independently selected studies, assessed risk of bias, and extracted the data. We assessed the results and the quality of the evidence of the primary and secondary outcomes by the GRADE method, which classifies the quality of evidence as high, moderate, low, or very low.
We included three trials involving 6343 participants. The trials differed in the methods of measuring carotid stenosis and in the definition of stroke. Using the primary electronic data files, we pooled and analysed individual patient data on 6092 participants (35,000 patient-years of follow-up), after reassessing the carotid angiograms and outcomes from all three trials, and redefining outcome events where necessary, to achieve comparability. Surgery increased the five-year risk of any stroke or operative death in participants with less than 30% stenosis (risk ratio (RR) 1.25, 95% confidence interval (CI) 0.99 to 1.56; 2 studies, 1746 participants; high-quality evidence). Surgery decreased the five-year risk of any stroke or operative death in participants with 30% to 49% stenosis (RR 0.97, 95% CI 0.79 to 1.19; 2 studies, 1429 participants; high-quality evidence), was of benefit in participants with 50% to 69% stenosis (RR 0.77, 95% CI 0.63 to 0.94; 3 studies, 1549 participants; moderate-quality evidence), and was highly beneficial in participants with 70% to 99% stenosis without near-occlusion (RR 0.53, 95% CI 0.42 to 0.67; 3 studies, 1095 participants; moderate-quality evidence). However, surgery decreased the five-year risk of any stroke or operative death in participants with near-occlusions (RR 0.95, 95% CI 0.59 to 1.53; 2 studies, 271 participants; moderate-quality evidence).
Carotid endarterectomy reduced the risk of recurrent stroke for people with significant stenosis. Endarterectomy might be of some benefit for participants with 50% to 69% symptomatic stenosis (moderate-quality evidence) and highly beneficial for those with 70% to 99% stenosis (moderate-quality evidence).
Background and Purpose- This analysis was performed to assess the association between perioperative and clinical variables and the 30-day risk of stroke or death after carotid endarterectomy for ...symptomatic carotid stenosis. Methods- Individual patient-level data from the 5 largest randomized controlled carotid trials were pooled in the Carotid Stenosis Trialists' Collaboration database. A total of 4181 patients who received carotid endarterectomy for symptomatic stenosis per protocol were included. Determinants of outcome included carotid endarterectomy technique, type of anesthesia, intraoperative neurophysiological monitoring, shunting, antiplatelet medication, and clinical variables. Stroke or death within 30 days after carotid endarterectomy was the primary outcome. Adjusted risk ratios (aRRs) were estimated in multilevel multivariable analyses using a Poisson regression model. Results- Mean age was 69.5±9.2 years (70.7% men). The 30-day stroke or death rate was 4.3%. In the multivariable regression analysis, local anesthesia was associated with a lower primary outcome rate (versus general anesthesia; aRR, 0.70 95% CI, 0.50-0.99). Shunting (aRR, 1.43 95% CI, 1.05-1.95), a contralateral high-grade carotid stenosis or occlusion (aRR, 1.58 95% CI, 1.02-2.47), and a more severe neurological deficit (mRS, 3-5 versus 0-2: aRR, 2.51 95% CI, 1.30-4.83) were associated with higher primary outcome rates. None of the other characteristics were significantly associated with the perioperative stroke or death risk. Conclusions- The current results indicate lower perioperative stroke or death rates in patients operated upon under local anesthesia, whereas a more severe neurological deficit and a contralateral high-grade carotid stenosis or occlusion were identified as potential risk factors. Despite a possible selection bias and patients not having been randomized, these findings might be useful to guide surgeons and anesthetists when treating patients with symptomatic carotid disease.
Management of carotid bifurcation stenosis in stroke prevention has been the subject of extensive investigations, including multiple randomized controlled trials. The proper treatment of patients ...with carotid bifurcation disease is of major interest to vascular surgeons and other vascular specialists. In 2011, the Society for Vascular Surgery published guidelines for the treatment of carotid artery disease. At the time, several randomized trials, comparing carotid endarterectomy (CEA) and carotid artery stenting (CAS), were reported. Since the 2011 guidelines, several studies and a few systematic reviews comparing CEA and CAS have been reported, and the role of medical management has been reemphasized. In the present publication, we have updated and expanded on the 2011 guidelines with specific emphasis on five areas: (1) is CEA recommended over maximal medical therapy for low-risk patients; (2) is CEA recommended over transfemoral CAS for low surgical risk patients with symptomatic carotid artery stenosis of >50%; (3) the timing of carotid intervention for patients presenting with acute stroke; (4) screening for carotid artery stenosis in asymptomatic patients; and (5) the optimal sequence of intervention for patients with combined carotid and coronary artery disease.
A separate implementation document will address other important clinical issues in extracranial cerebrovascular disease. Recommendations are made using the GRADE (grades of recommendation assessment, development, and evaluation) approach, as was used for other Society for Vascular Surgery guidelines. The committee recommends CEA as the first-line treatment for symptomatic low-risk surgical patients with stenosis of 50% to 99% and asymptomatic patients with stenosis of 70% to 99%. The perioperative risk of stroke and death in asymptomatic patients must be <3% to ensure benefit for the patient. In patients with recent stable stroke (modified Rankin scale score, 0-2), carotid revascularization is considered appropriate for symptomatic patients with >50% stenosis and should be performed as soon as the patient is neurologically stable after 48 hours but definitely <14 days after symptom onset. In the general population, screening for clinically asymptomatic carotid artery stenosis in patients without cerebrovascular symptoms or significant risk factors for carotid artery disease is not recommended. In selected asymptomatic patients with an increased risk of carotid stenosis, we suggest screening for clinically asymptomatic carotid artery stenosis as long as the patients would potentially be fit for and willing to consider carotid intervention if significant stenosis is discovered. For patients with symptomatic carotid stenosis of 50% to 99%, who require both CEA and coronary artery bypass grafting, we suggest CEA before, or concomitant with, coronary artery bypass grafting to potentially reduce the risk of stroke and stroke/death. The sequencing of the intervention depends on the clinical presentation and institutional experience.
Management of carotid bifurcation stenosis is a cornerstone of stroke prevention and has been the subject of extensive clinical investigation, including multiple controlled randomized trials. The ...appropriate treatment of patients with carotid bifurcation disease is of major interest to the community of vascular surgeons. In 2008, the Society for Vascular Surgery published guidelines for treatment of carotid artery disease. At the time, only one randomized trial, comparing carotid endarterectomy (CEA) and carotid stenting (CAS), had been published. Since that publication, four major randomized trials comparing CEA and CAS have been published, and the role of medical management has been re-emphasized. The current publication updates and expands the 2008 guidelines with specific emphasis on six areas: imaging in identification and characterization of carotid stenosis, medical therapy (as stand-alone management and also in conjunction with intervention in patients with carotid bifurcation stenosis), risk stratification to select patients for appropriate interventional management (CEA or CAS), technical standards for performing CEA and CAS, the relative roles of CEA and CAS, and management of unusual conditions associated with extracranial carotid pathology. Recommendations are made using the GRADE (Grades of Recommendation Assessment, Development and Evaluation) system, as has been done with other Society for Vascular Surgery guideline documents. The committee recommends CEA as the first-line treatment for most symptomatic patients with stenosis of 50% to 99% and asymptomatic patients with stenosis of 60% to 99%. The perioperative risk of stroke and death in asymptomatic patients must be <3% to ensure benefit for the patient. CAS should be reserved for symptomatic patients with stenosis of 50% to 99% at high risk for CEA for anatomic or medical reasons. CAS is not recommended for asymptomatic patients at this time. Asymptomatic patients at high risk for intervention or with <3 years life expectancy should be considered for medical management as the first-line therapy.
In 2008, the Society for Vascular Surgery published guidelines for the treatment of carotid bifurcation stenosis. Since that time, a number of prospective randomized trials have been completed and ...have shed additional light on the best treastment of extracranial carotid disease. This has prompted the Society for Vascular Surgery to form a committee to update and expand guidelines in this area. The review was done using the GRADE methodology. The committee recommends carotid endarterectomy (CEA) as first line treatment for most symptomatic patients with stenosis 50% to 99% and asymptomatic patients with stenosis 60% to 99%. The perioperative risk of stroke and death in asymptomatic patients must be below 3% to ensure benefit for the patient. Carotid artery stenting (CAS) should be reserved for symptomatic patients with stenosis 50% to 99% at high risk for CEA for anatomic or medical reasons. CAS is not recommended for asymptomatic patients at this time. Asymptomatic patients at high risk for intervention or with <3 years life expectancy should be considered for medical management as first line therapy. In this Executive Summary, we only outline the specifics of the recommendations made in the six areas evaluated. The full text of these guidelines can be found on the on-line version of the Journal of Vascular Surgery at http://journals.elsevierhealth.com/periodicals/ymva.
Extracranial carotid artery stenosis is the major cause of stroke, which can lead to disability and mortality. Carotid endarterectomy (CEA) with carotid patch angioplasty is the most popular ...technique for reducing the risk of stroke. Patch material may be made from an autologous vein, bovine pericardium, or synthetic material including polytetrafluoroethylene (PTFE), Dacron, polyurethane, and polyester. This is an update of a review that was first published in 1996 and was last updated in 2010.
To assess the safety and efficacy of different types of patch materials used in carotid patch angioplasty. The primary hypothesis was that a synthetic material was associated with lower risk of patch rupture versus venous patches, but that venous patches were associated with lower risk of perioperative stroke and early or late infection, or both.
We searched the Cochrane Stroke Group trials register (last searched 25 May 2020); the Cochrane Central Register of Controlled Trials (CENTRAL; 2020, Issue 4), in the Cochrane Library; MEDLINE (1966 to 25 May 2020); Embase (1980 to 25 May 2020); the Index to Scientific and Technical Proceedings (1980 to 2019); the Web of Science Core Collection; ClinicalTrials.gov; and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) portal. We handsearched relevant journals and conference proceedings, checked reference lists, and contacted experts in the field.
Randomised and quasi-randomised trials (RCTs) comparing one type of carotid patch with another for CEA.
Two review authors independently assessed eligibility, risk of bias, and trial quality; extracted data; and determined the quality of evidence using the GRADE approach. Outcomes, for example, perioperative ipsilateral stroke and long-term ipsilateral stroke (at least one year), were collected and analysed.
We included 14 trials involving a total of 2278 CEAs with patch closure operations: seven trials compared vein closure with PTFE closure, five compared Dacron grafts with other synthetic materials, and two compared bovine pericardium with other synthetic materials. In most trials, a patient could be randomised twice and could have each carotid artery randomised to different treatment groups. Synthetic patch compared with vein patch angioplasty Vein patch may have little to no difference in effect on perioperative ipsilateral stroke between synthetic versus vein materials, but the evidence is very uncertain (odds ratio (OR) 2.05, 95% confidence interval (CI) 0.66 to 6.38; 5 studies, 797 participants; very low-quality evidence). Vein patch may have little to no difference in effect on long-term ipsilateral stroke between synthetic versus vein materials, but the evidence is very uncertain (OR 1.45, 95% CI 0.69 to 3.07; P = 0.33; 4 studies, 776 participants; very low-quality evidence). Vein patch may increase pseudoaneurysm formation when compared with synthetic patch, but the evidence is very uncertain (OR 0.09, 95% CI 0.02 to 0.49; 4 studies, 776 participants; very low-quality evidence). However, the numbers involved were small. Dacron patch compared with other synthetic patch angioplasty Dacron versus PTFE patch materials PTFE patch may reduce the risk of perioperative ipsilateral stroke (OR 3.35, 95% CI 0.19 to 59.06; 2 studies, 400 participants; very low-quality evidence). PTFE patch may reduce the risk of long-term ipsilateral stroke (OR 1.52, 95% CI 0.25 to 9.27; 1 study, 200 participants; very low-quality evidence). Dacron may result in an increase in perioperative combined stroke and transient ischaemic attack (TIA) (OR 4.41 95% CI 1.20 to 16.14; 1 study, 200 participants; low-quality evidence) when compared with PTFE. Early arterial re-stenosis or occlusion (within 30 days) was also higher for Dacron patches. During follow-up for longer than one year, more 'any strokes' (OR 10.58, 95% CI 1.34 to 83.43; 2 studies, 304 participants; low-quality evidence) and stroke/death (OR 6.06, 95% CI 1.31 to 28.07; 1 study, 200 participants; low-quality evidence) were reported with Dacron patch closure, although numbers of outcome events were small. Dacron patch may increase the risk of re-stenosis when compared with other synthetic materials (especially with PTFE), but the evidence is very uncertain (OR 3.73, 95% CI 0.71 to 19.65; 3 studies, 490 participants; low-quality evidence). Bovine pericardium patch compared with other synthetic patch angioplasty Bovine pericardium versus PTFE patch materials Evidence suggests that bovine pericardium patch results in a reduction in long-term ipsilateral stroke (OR 4.17, 95% CI 0.46 to 38.02; 1 study, 195 participants; low-quality evidence). Bovine pericardial patch may reduce the risk of perioperative fatal stroke, death, and infection compared to synthetic material (OR 5.16, 95% CI 0.24 to 108.83; 2 studies, 290 participants; low-quality evidence for PTFE, and low-quality evidence for Dacron; OR 4.39, 95% CI 0.48 to 39.95; 2 studies, 290 participants; low-quality evidence for PTFE, and low-quality evidence for Dacron; OR 7.30, 95% CI 0.37 to 143.16; 1 study, 195 participants; low-quality evidence, respectively), but the numbers of outcomes were small. The evidence is very uncertain about effects of the patch on infection outcomes.
The number of outcome events is too small to allow conclusions, and more trial data are required to establish whether any differences do exist. Nevertheless, there is little to no difference in effect on perioperative and long-term ipsilateral stroke between vein and any synthetic patch material. Some evidence indicates that other synthetic patches (e.g. PTFE) may be superior to Dacron grafts in terms of perioperative stroke and TIA rates, and both early and late arterial re-stenosis and occlusion. Pseudoaneurysm formation may be more common after use of a vein patch than after use of a synthetic patch. Bovine pericardial patch, which is an acellular xenograft material, may reduce the risk of perioperative fatal stroke, death, and infection compared to other synthetic patches. Further large RCTs are required before definitive conclusions can be reached.
Significant advances in vascular disease medical intervention since large randomized trials for asymptomatic severe carotid stenosis were conducted (1983-2003) have prompted doubt over current ...expectations of a surgical benefit. In this systematic review and analysis of published data it was found that rates of ipsilateral and any-territory stroke (+/-TIA), with medical intervention alone, have fallen significantly since the mid-1980s, with recent estimates overlapping those of operated patients in randomized trials. However, current medical intervention alone was estimated at least 3 to 8 times more cost-effective. In conclusion, current vascular disease medical intervention alone is now best for stroke prevention associated with asymptomatic severe carotid stenosis given this new evidence, other cardiovascular benefits, and because high-risk patients who benefit from additional carotid surgery or angioplasty/stenting cannot be identified.
Stroke is the third leading cause of death and the most common cause of long-term disability. Severe narrowing (stenosis) of the carotid artery is an important cause of stroke. Surgical treatment ...(carotid endarterectomy) may reduce the risk of stroke, but carries a risk of operative complications. This is an update of the Cochrane Review, originally published in 1999, and most recently updated in 2011.
To determine the balance of benefit versus risk of endarterectomy plus best medical management compared with best medical management alone, in people with a recent symptomatic carotid stenosis (i.e. transient ischaemic attack (TIA) or non-disabling stroke).
We searched the Cochrane Stroke Group Trials Register (last searched in July 2016), CENTRAL (2016, Issue 7), MEDLINE (1966 to July 2016), Embase (1990 to July 2016), Web of Science Core Collection, ClinicalTrials.gov, WHO International Clinical Trials Registry Platform (ICTRP) portal, and handsearched relevant journals and reference lists.
We included randomised controlled trials. DATA COLLECTION AND ANALYSIS: Two review authors independently selected studies, assessed risk of bias, and extracted the data.
We included three trials involving 6343 participants. As the trials differed in the methods of measurement of carotid stenosis and in the definition of stroke, we did a pooled analysis of individual patient data on 6092 participants (35,000 patient years of follow-up), after reassessing the carotid angiograms and outcomes from all three trials using the primary electronic data files, and redefined outcome events where necessary, to achieve comparability.On re-analysis, there were no significant differences between the trials in the risks of any of the main outcomes in either of the treatment groups, or in the effects of surgery. Surgery increased the five-year risk of ipsilateral ischaemic stroke in participants with less than 30% stenosis (N = 1746, risk ratio (RR) 1.27, 95% confidence interval (CI) 0.80 to 2.01), had no significant effect in participants with 30% to 49% stenosis (N = 1429, RR 0.93, 95%CI 0.62 to 1.38), was of benefit in participants with 50% to 69% stenosis (N = 1549, RR 0.84, 95%CI 0.60 to 1.18), and was highly beneficial in participants with 70% to 99% stenosis without near-occlusion (N = 1095, RR 0.47, 95%CI 0.25 to 0.88). However, there was no evidence of benefit (N = 271, RR 1.03, 95%CI 0.57 to 1.84) in participants with near-occlusions. Ipsilateral ischaemic stroke describes insufficient blood flow to the cerebral hemisphere, secondary to same side severe stenosis of the internal carotid artery.
Endarterectomy was of some benefit for participants with 50% to 69% symptomatic stenosis (moderate-quality evidence), and highly beneficial for those with 70% to 99% stenosis without near-occlusion (moderate-quality evidence). We found no benefit in people with carotid near-occlusion (high-quality evidence).
Among asymptomatic patients with severe carotid artery stenosis but no recent stroke or transient cerebral ischaemia, either carotid artery stenting (CAS) or carotid endarterectomy (CEA) can restore ...patency and reduce long-term stroke risks. However, from recent national registry data, each option causes about 1% procedural risk of disabling stroke or death. Comparison of their long-term protective effects requires large-scale randomised evidence.
ACST-2 is an international multicentre randomised trial of CAS versus CEA among asymptomatic patients with severe stenosis thought to require intervention, interpreted with all other relevant trials. Patients were eligible if they had severe unilateral or bilateral carotid artery stenosis and both doctor and patient agreed that a carotid procedure should be undertaken, but they were substantially uncertain which one to choose. Patients were randomly allocated to CAS or CEA and followed up at 1 month and then annually, for a mean 5 years. Procedural events were those within 30 days of the intervention. Intention-to-treat analyses are provided. Analyses including procedural hazards use tabular methods. Analyses and meta-analyses of non-procedural strokes use Kaplan-Meier and log-rank methods. The trial is registered with the ISRCTN registry, ISRCTN21144362.
Between Jan 15, 2008, and Dec 31, 2020, 3625 patients in 130 centres were randomly allocated, 1811 to CAS and 1814 to CEA, with good compliance, good medical therapy and a mean 5 years of follow-up. Overall, 1% had disabling stroke or death procedurally (15 allocated to CAS and 18 to CEA) and 2% had non-disabling procedural stroke (48 allocated to CAS and 29 to CEA). Kaplan-Meier estimates of 5-year non-procedural stroke were 2·5% in each group for fatal or disabling stroke, and 5·3% with CAS versus 4·5% with CEA for any stroke (rate ratio RR 1·16, 95% CI 0·86–1·57; p=0·33). Combining RRs for any non-procedural stroke in all CAS versus CEA trials, the RR was similar in symptomatic and asymptomatic patients (overall RR 1·11, 95% CI 0·91–1·32; p=0·21).
Serious complications are similarly uncommon after competent CAS and CEA, and the long-term effects of these two carotid artery procedures on fatal or disabling stroke are comparable.
UK Medical Research Council and Health Technology Assessment Programme.
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