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• W4247997672 abstract "CEREBROVASCULAR disease is the third leading cause of death in the United States (1The National Advisory Neurological Disorders and Stroke CouncilStroke and cerebrovascular disease. National Institutes of Health Report, Bethesda, Md1992: 26-27Google Scholar, 2Bonita R Beaglehole R Stroke: populations, cohorts, and clinical trials.in: Whisnant JP Stroke Mortality. Butterworth-Heinemann, Ltd, Oxford, England1993: 59-79Google Scholar). Approximately 750 000 people have a stroke annually, costing an estimated $45 billion in treatment and lost productivity (31999 Heart and Stroke Statistical Update. American Heart Association, Dallas, Tex1998: 13-15Google Scholar, 4Matchar D Duncan P Cost of Stroke Stroke Clinical Updates. 1994; : 9-12Google Scholar). Carotid occlusive disease is responsible for 25% of these strokes (5Dyken M Stroke Risk Factors in Prevention of Stroke.in: Norris JW Hachinski VC Springer-Verlag, New York1991: 83-102Google Scholar). Large population-based studies indicate that the prevalence of carotid stenosis is approximately 0.5% after age 60 and increases to 10% in persons older than age 80 years. The majority of cases are asymptomatic (6Ricci S Flamini FO Marini M Antonini D Bartolini S Celani MG Ballatori E De Angelis V The prevalence of stenosis of the internal carotid in subjects over 49: a population study.Epidemiol Prev. 1991; 13: 173-176PubMed Google Scholar, 7Prati P Vanuzzo D Casaroli M Di Chiara A De Biasi F Feruglio GA Touboul PJ Prevalence and determinants of carotid atherosclerosis in a general population.Stroke. 1992; 23: 1705-1711Crossref PubMed Google Scholar, 8O'Leary DH Polak JF Kronmal RA Kittner SJ Bond MG Wolfson Jr, SK Bommer W Price TR Gardin JM Savage PJ Distribution and correlates of sonographically detected carotid artery disease in the Cardiovascular Health Study. The CHS Collaborative Research Group.Stroke. 1992; 23: 1752-1760Crossref PubMed Google Scholar). Surgical carotid endarterectomy is currently the accepted standard of treatment for revascularization of extracranial carotid occlusive disease (9Zarins CK Carotid endarterectomy: the gold standard.J Endovasc Surg. 1996; 3: 10-15Crossref PubMed Scopus (56) Google Scholar). This has been validated by multiple, randomized, controlled trials that have demonstrated its efficacy over best medical therapy. However, in the past several years, carotid artery stenting has emerged as a potential therapeutic alternative to carotid endarterectomy for the treatment of atherosclerotic carotid artery disease. The future status of this endovascular approach will be determined by randomized trials directly comparing carotid artery stenting to endarterectomy, as well as by the potential for further innovation and improvement in endovascular devices, techniques, and safety. Comparisons of carotid stenting and endarterectomy are difficult because of differences in patient selection, the use of case series rather than randomized controlled trials for stenting, differences in definitions of outcomes and complications, and observer bias. The suggested reporting standards for carotid endarterectomy have not been uniformly followed up for surgical trials and not used in trials of carotid stenting (10Baker JD Rutherford RB Bernstein EF Courbier R Ernst CB Kempczinski RF Riles TS Zarins CK Suggested standards for reports dealing with cerebrovascular disease. Subcommittee on Reporting Standards for Cerebrovascular Disease, Ad Hoc Committee on Reporting Standards, Society for Vascular Surgery/North Am Chapter, International Society for Cardiovascular Surgery.J Vasc Surg. 1988; 8: 721-729PubMed Google Scholar). It is the purpose of this document to standardize reporting of carotid stent trials and recommend trial designs so that carotid stenting and endarterectomy may be fairly compared. This document is a consensus statement of the Technology Assessment Committees of the American Society of Interventional and Therapeutic Neuroradiology and the Society of Interventional Radiology.CAROTID ENDARTERECTOMYIn 1953, DeBakey performed the first successful carotid endarterectomy for the treatment of an occluded cervical carotid artery (11DeBakey ME Carotid endarterectomy revisited.J Endovasc Surg. 1996; 3: 4Crossref PubMed Scopus (65) Google Scholar). In 1954, Eastcott performed the first successful carotid endarterectomy in which the circulation to the brain was intentionally interrupted to remove a stenotic plaque (12Eastcott HH Pickering GW Rob CG Reconstruction of internal carotid artery in a patient with intermittent attacks of hemiplegia.Lancet. 1954; 267: 994-996Abstract PubMed Google Scholar, 13Eastcott HH Late thoughts and reflections on carotid reconstruction for the prevention of ischemic stroke.J Endovasc Surg. 1996; 3: 5-6Crossref PubMed Scopus (3) Google Scholar). Despite only anecdotal evidence of efficacy, ≈1 million carotid endarterectomies were performed worldwide between 1974 and 1985 (14Barnett H Symptomatic carotid endarterectomy trials.Stroke. 1991; 21: III/2-III/5Google Scholar, 15Barnett H Evaluating methods for prevention in stroke.Ann R Coll Physicians Surg Can. 1991; 24: 33-42Google Scholar). There was a temporary decline in the mid 1980s, when a number of critical reports suggested unacceptable rates of perioperative stroke or death (16Shaw DA Venables GS Cartlidge NE Bates D Dickinson PH Carotid end-arterectomy in patients with transient cerebral ischaemia.J Neurol Sci. 1984; 64: 45-53Abstract Full Text PDF PubMed Google Scholar, 17Muuronen A Outcome of surgical treatment of 110 patients with transient ischemic attack.Stroke. 1984; 15: 959-964Crossref PubMed Google Scholar, 18Slavish LG Nicholas GG Gee W Review of a community hospital experience with carotid endarterectomy.Stroke. 1984; 15: 956-959Crossref PubMed Google Scholar, 19Brott T Thalinger K The practice of carotid endarterectomy in a large metropolitan area.Stroke. 1984; 15: 950-955Crossref PubMed Google Scholar, 20Warlow C Carotid endarterectomy: does it work?.Stroke. 1984; 15: 1068-1076Crossref PubMed Google Scholar, 21Barnett HJ Plum F Walton JN Carotid endarterectomy—an expression of concern.Stroke. 1984; 15: 941-943Crossref PubMed Google Scholar), and a high rate of endarterectomy performed for inappropriate indications (22Winslow CM Solomon DH Chassin MR Kosecoff J Merrick NJ Brook RH The appropriateness of carotid endarterectomy.N Engl J Med. 1988; 318: 721-727Crossref PubMed Google Scholar). Rates of carotid endarterectomy in the United States and Canada have again increased since the publication of favorable, well constructed clinical studies, beginning in 1991 with the North American Symptomatic Carotid Endarterectomy Trial (NASCET) (23The North American Symptomatic Carotid Endarterectomy Trial CollaboratorsBeneficial effect of carotid endarterectomy in symptomatic patients with high-grade carotid stenosis.N Engl J Med. 1991; 325: 445-453Crossref PubMed Google Scholar, 24Tu JV Hannan EL Anderson GM Iron K Wu K Vranizan K Popp AJ Grumbach K The fall and rise of carotid endarterectomy in the United States and Canada.N Engl J Med. 1998; 339: 1441-1447Crossref PubMed Scopus (160) Google Scholar). In 1996, ≈130 000 carotid endarterectomies were performed in the United States; twice that of 1991; in 2000, it was estimated that 174 000 carotid surgeries were performed (25Barnett HJ Taylor DW Eliasziw M Fox AJ Ferguson GG Haynes RB Rankin RN Clagett GP Hachinski VC Sackett DL Thorpe KC Meldrum HE Benefit of carotid endarterectomy in patients with symptomatic moderate or severe stenosis. North Am Symptomatic Carotid Endarterectomy Trial Collaborators.N Engl J Med. 1998; 339: 1415-1425Crossref PubMed Scopus (1932) Google Scholar). Because endarterectomy is considered the gold standard of carotid revascularization, the major trials that document its safety and efficacy are summarized by the following text.Randomized Trials of Symptomatic PatientsNorth American Symptomatic Carotid Endarterectomy TrialThe North American Symptomatic Carotid Endarterectomy Trial (NASCET) was conducted at 106 centers in the US and Canada and analyzed 2885 patients with symptomatic carotid stenosis that were stratified into 2 groups: 30% to 69% stenosis (2226 patients) (25Barnett HJ Taylor DW Eliasziw M Fox AJ Ferguson GG Haynes RB Rankin RN Clagett GP Hachinski VC Sackett DL Thorpe KC Meldrum HE Benefit of carotid endarterectomy in patients with symptomatic moderate or severe stenosis. North Am Symptomatic Carotid Endarterectomy Trial Collaborators.N Engl J Med. 1998; 339: 1415-1425Crossref PubMed Scopus (1932) Google Scholar) and 70% to 99% stenosis (659 patients) (23The North American Symptomatic Carotid Endarterectomy Trial CollaboratorsBeneficial effect of carotid endarterectomy in symptomatic patients with high-grade carotid stenosis.N Engl J Med. 1991; 325: 445-453Crossref PubMed Google Scholar). The degree of carotid stenosis was determined by the ratio between the luminal diameter at the point of greatest stenosis and the normal artery beyond the carotid bulb. The eligibility requirements for the NASCET were strictly defined. Patients with symptoms within 120 days of randomization were considered symptomatic. Patient exclusion criteria included a previous ipsilateral endarterectomy; an intracranial lesion that was more severe than the surgically accessible lesion; no angiographic visualization of both carotid arteries and their intracranial branches; or lung, liver, or renal failure. Temporary exclusion criteria included uncontrolled diabetes mellitus, hypertension or unstable angina pectoris; myocardial infarction within the previous 6 months; contralateral carotid endarterectomy within the previous 4 months; signs of progressive neurological dysfunction; or a major surgical procedure within the previous 30 days. These patients could be included if the disorder responsible for their ineligibility resolved within 120 days of their qualifying cerebrovascular event. Neurological classification was performed 30 and 90 days after the procedure with strokes (any new focal neurological deficit lasting >24 hours) categorized as disabling (modified Rankin score ≥3) or nondisabling. If sufficient functional recovery occurred within 90 days, then the stroke could be reclassified from disabling to nondisabling (26North Am Symptomatic Carotid Endarterectomy TrialMethods, patient characteristics, and progress.Stroke. 1991; 22: 711-720Crossref PubMed Google Scholar).The authors reported a 5.8% incidence of perioperative stroke and death (0.6%) in the endarterectomy group. The inclusion of perioperative myocardial infarction (0.9%) increased the complication rate to 6.7% (23The North American Symptomatic Carotid Endarterectomy Trial CollaboratorsBeneficial effect of carotid endarterectomy in symptomatic patients with high-grade carotid stenosis.N Engl J Med. 1991; 325: 445-453Crossref PubMed Google Scholar). There was an unequivocal benefit of surgery over best medical management in symptomatic patients with a severe carotid stenosis of ≥70%. Surgical intervention reduced the 2-year risk of any ipsilateral stroke in the medical group from 26% (annual event rate of 13%) to 9% in the surgical group, thus yielding an absolute risk reduction of 17%. Therefore, for every 100 patients undergoing surgery, 17 nonfatal strokes or deaths were prevented over a 2-year period. However, this risk reduction was not equal for all patients. The benefit was twice as great in patients with a stenosis of 90% to 99% as it was in those with a stenosis of 70% to 79%. At 8-year followup, the risk of an ipsilateral disabling stroke was 6.7%; of any ipsilateral stroke was 15.2%; of any stroke was 29.4%; and of any stroke or death was 46.6%. Therefore, despite the durability of endarterectomy in preventing an ipsilateral disabling stroke, the risk of any stroke or death over the ensuing 8 years was nearly 50% (25Barnett HJ Taylor DW Eliasziw M Fox AJ Ferguson GG Haynes RB Rankin RN Clagett GP Hachinski VC Sackett DL Thorpe KC Meldrum HE Benefit of carotid endarterectomy in patients with symptomatic moderate or severe stenosis. North Am Symptomatic Carotid Endarterectomy Trial Collaborators.N Engl J Med. 1998; 339: 1415-1425Crossref PubMed Scopus (1932) Google Scholar).The benefits of carotid endarterectomy in patients with symptomatic moderate stenoses of 30% to 69%, over a mean follow-up of 5 years, have also been reported. For patients with a stenosis of 50% to 69%, the 5-year rate of any ipsilateral stroke was 15.7% in the surgical group versus 22.2% in the medical group; an absolute risk reduction from any ipsilateral nonfatal or fatal stroke of 6.5% (1.3% per annum). However, among patients with 30% to 49% stenosis, the 5-year rate of any ipsilateral stroke was 14.9% for surgical patients versus 18.7% for medically treated patients, an insignificant risk reduction. The perioperative rate of disabling stroke and death was 2% (25Barnett HJ Taylor DW Eliasziw M Fox AJ Ferguson GG Haynes RB Rankin RN Clagett GP Hachinski VC Sackett DL Thorpe KC Meldrum HE Benefit of carotid endarterectomy in patients with symptomatic moderate or severe stenosis. North Am Symptomatic Carotid Endarterectomy Trial Collaborators.N Engl J Med. 1998; 339: 1415-1425Crossref PubMed Scopus (1932) Google Scholar).The surgical and medical complication rates for all patients (n=1415) undergoing carotid endarterectomy as part of the NASCET (30% to 99% symptomatic stenosis) have been reported (27Ferguson GG Eliasziw M Barr HW Clagett GP Barnes RW Wallace RW Taylor DW Haynes RB Finan JW Hachinski VC Barnett HJ The North Am Symptomatic Carotid Endarterectomy Trial: surgical results in 1415 patients.Stroke. 1999; 30: 1751-1758Crossref PubMed Google Scholar, 28Paciaroni M Eliasziw M Kappelle LJ Finan JW Ferguson GG Barnett HJ Medical complications associated with carotid endarterectomy. North Am Symptomatic Carotid Endarterectomy Trial (NASCET).Stroke. 1999; 30: 1759-1763Crossref PubMed Google Scholar). The overall rate of perioperative stroke and death (1.1%) was 6.5%. Five baseline variables were predictive of statistically significant 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. The incidence of perioperative wound complications was 9.3% and cranial nerve damage was 8.6% (27Ferguson GG Eliasziw M Barr HW Clagett GP Barnes RW Wallace RW Taylor DW Haynes RB Finan JW Hachinski VC Barnett HJ The North Am Symptomatic Carotid Endarterectomy Trial: surgical results in 1415 patients.Stroke. 1999; 30: 1751-1758Crossref PubMed Google Scholar). Cardiovascular complications occurred in 8.1% of patients undergoing endarterectomy. Cardiovascular complications included myocardial infarction (1.2%), congestive heart failure (1.2%), and hypotension (2.1%). Patients with a history of myocardial infarction, angina pectoris, or hypertension were at significantly higher risk. Medical complications resulted in a prolonged hospitalization in ≥30% of cases (28Paciaroni M Eliasziw M Kappelle LJ Finan JW Ferguson GG Barnett HJ Medical complications associated with carotid endarterectomy. North Am Symptomatic Carotid Endarterectomy Trial (NASCET).Stroke. 1999; 30: 1759-1763Crossref PubMed Google Scholar).European Carotid Surgery TrialThe results of The European Carotid Surgery Trial (ECST), another large, multicenter, randomized controlled trial, were in accordance with the NASCET after adjustment for the different methods used to calculate the angiographic degree of carotid stenosis (29The European Carotid Surgery Trialists' Collaborative GroupMRC European Carotid Surgery Trial: interim results for symptomatic patients with severe (70–99%) or with mild (0–29%) carotid stenosis.Lancet. 1991; 337: 1235-1243Abstract PubMed Google Scholar, 30The European Carotid Surgery Trialists' Collaborative GroupEndarterectomy for moderate symptomatic carotid stenosis: interim results from the MRC European Carotid Surgery Trial.Lancet. 1996; 347: 1591-1593Crossref PubMed Google Scholar, 31The European Carotid Surgery Trialists' Collaborative GroupRandomised trial of endarterectomy for recently symptomatic carotid stenosis: final results of the MRC European Carotid Surgery Trial (ECST).Lancet. 1998; 351: 1379-1387Abstract Full Text Full Text PDF PubMed Scopus (1870) Google Scholar). The ECST method of calculating angiographic stenosis used an approximation of the normal carotid bulb diameter as the denominator rather than the distal cervical internal carotid artery, which was used in the NASCET, and resulted in overestimation of narrowing compared with the NASCET.The ECST enrolled 3024 patients with symptomatic carotid stenosis stratified into 3 groups: 0% to 29%, 30% to 69%, and 70% to 99% stenosis, with a mean follow-up of 6.1- years. The ECST demonstrated that endarterectomy reduced the Kaplan-Meier 3-year risk of major stroke or death in patients with a symptomatic stenosis of ≥80% (≈60% as measured by the NASCET method) from 26.5% in the control group, with an annual event rate of 8.8%, to 14.9% in the surgical group, thus giving an absolute risk reduction of 11.6% at 3 years. The rate of nonfatal stroke, defined as symptoms lasting >7 days or death (1.3%) from surgery was 7%. The ECST did not specify rates of nonstroke surgical complications such as cranial nerve injury or cardiac events (31The European Carotid Surgery Trialists' Collaborative GroupRandomised trial of endarterectomy for recently symptomatic carotid stenosis: final results of the MRC European Carotid Surgery Trial (ECST).Lancet. 1998; 351: 1379-1387Abstract Full Text Full Text PDF PubMed Scopus (1870) Google Scholar, 32Donnan GA Davis SM Chambers BR Gates PC Surgery for prevention of stroke.Lancet. 1998; 351: 1372-1373Abstract Full Text Full Text PDF PubMed Scopus (38) Google Scholar).Veterans Affairs Cooperative Carotid TrialThe Veterans Affairs Cooperative Symptomatic Carotid Stenosis Trial (VA-CSP-309) was a third randomized trial evaluating endarterectomy in symptomatic carotid stenosis, but it was prematurely terminated when the NASCET and ECST data were released (33Mayberg MR Wilson SE Yatsu F Weiss DG Messina L Hershey LA Colling C Eskridge J Deykin D Winn HR Carotid endarterectomy and prevention of cerebral ischemia in symptomatic carotid stenosis. Veterans Affairs Cooperative Studies Program 309 Trialist Group.JAMA. 1991; 266: 3289-3294Crossref PubMed Google Scholar). The VA-CSP-309 study enrolled 189 male patients, with a mean follow-up of 11.9- months, and demonstrated an absolute risk reduction for stroke or crescendo transient ischemic attacks of 11.7% in men with a carotid stenosis >50% who underwent endarterectomy (17.7% for stenosis >70%). They reported a perioperative surgical stroke and death rate of 5.5%. Among the 3 perioperative deaths, none was caused by ischemic stroke.Randomized Trials of Asymptomatic PatientsAsymptomatic Carotid Atherosclerosis StudyThe only large, well-constructed, randomized, controlled trial published to date comparing surgical endarterectomy with medical therapy in asymptomatic carotid stenosis is the Asymptomatic Carotid Atherosclerosis Study (ACAS), which enrolled 1662 patients at 39 centers with a median follow-up of 2.7 years (34Executive Committee for the Asymptomatic Carotid Atherosclerosis StudyEndarterectomy for Asymptomatic Carotid Artery Stenosis.JAMA. 1995; 273: 1421-1461Crossref PubMed Google Scholar). As in the NASCET, the inclusion criteria for the ACAS were stringent. Patients were excluded from the ACAS because of previous cerebral infarction; previous endarterectomy with restenosis; previous extracranial-to-intracranial bypass; any disorder that could seriously complicate surgery or prevent continuing participation over 5 years; long-term anticoagulation therapy; or a surgically inaccessible lesion.Patients in the medical control group received 325 mg aspirin per day. Some authors have suggested this does not represent optimum medical therapy (the recommended dose in the NASCET was 1300 mg per day), because high-dose aspirin, ticlopidine, and aspirin combined with warfarin may be more effective (35Connors JJ Wojak JC General considerations for endovascular therapy of the extracranial internal carotid artery at the bifurcation. Interventional Neuroradiology.in: Strategies and Practical Techniques. WB Saunders, Philadelphia1999: 442-456Google Scholar). The ACAS reported an actuarial estimated 5-year risk, with a mean follow-up of only 2.7 years, for ipsilateral stroke and any perioperative stroke or death in patients with a carotid stenosis of ≥60%, of 5.1% for surgical patients versus 11%, with an annual event rate of 2.2% for medically treated patients, and yielded an absolute risk reduction of 5.9%. Therefore, over a 5-year period, ≈1 stroke per year was prevented for every 85 patients undergoing endarterectomy. However, the absolute risk reduction for disabling ipsilateral stroke was only 2.6%, which doubles the number of endarterectomies needed to prevent 1 ipsilateral disabling stroke compared with any ipsilateral stroke. This result was obtained with a very low 30-day perioperative stroke and death (0.1%) rate of 2.3%; 52% of these complications attributable to strokes were caused by diagnostic cerebral angiography (arteriography stroke rate of 1.2%). Stratification of data revealed no significant reduction in risk of stroke or death for females undergoing endarterectomy. Furthermore, no correlation between benefit and degree of stenosis was demonstrated.Veterans Affairs Cooperative StudyThe Veterans Affairs Cooperative Study (VA-CSP-167), a smaller multicenter trial that enrolled 444 males with asymptomatic carotid stenosis ≥50%, failed to demonstrate a statistically significant difference in the combined rate of stroke or death between the endarterectomy and medical groups at a mean follow-up of 47.9 months. The authors concluded that a modest effect could not be excluded because of the relatively small sample size. The 30-day perioperative rate of permanent stroke or death was 4.7%, which included a 0.4% stroke rate from diagnostic cerebral angiography (36Hobson RW Weiss DG Fields WS Goldstone J Moore WS Towne JB Wright CB Efficacy of carotid endarterectomy for asymptomatic carotid stenosis. The Veterans Affairs Cooperative Study Group.N Engl J Med. 1993; 328: 221-227Crossref PubMed Scopus (768) Google Scholar). As in NASCET and ACAS patients undergoing endarterectomy for symptomatic carotid stenosis of ≥70%, cardiac-related deaths were the most frequent cause of mortality in the endarterectomy patients (23The North American Symptomatic Carotid Endarterectomy Trial CollaboratorsBeneficial effect of carotid endarterectomy in symptomatic patients with high-grade carotid stenosis.N Engl J Med. 1991; 325: 445-453Crossref PubMed Google Scholar, 34Executive Committee for the Asymptomatic Carotid Atherosclerosis StudyEndarterectomy for Asymptomatic Carotid Artery Stenosis.JAMA. 1995; 273: 1421-1461Crossref PubMed Google Scholar).European Carotid Surgery Trialhe European Carotid Surgery Trial (ECST) also reported on the risk of stroke in the distribution of the asymptomatic carotid artery in 2295 patients stratified into 4 categories of carotid stenosis: 0% to 29% (n=1270); 30% to 69% (n=843); 70% to 99% (n=127); and occluded (n=55). During a mean follow-up of 4.5 years, the 3-year Kaplan-Meier risks for ipsilateral stroke and fatal stroke were 2.1% and 0.3%, respectively. The 3-year risk of ipsilateral stroke for patients with an asymptomatic, severe (70% to 99%) carotid stenosis was 5.7%. This was significantly less than the 17.1%, 3-year ipsilateral stroke risk for ECST patients with a symptomatic, severe, carotid stenosis treated medically, and not significantly greater than the 3.1%, 3-year ipsilateral stroke risk for a severe, symptomatic, carotid stenosis after successful endarterectomy.Given the modest benefit results of the asymptomatic endarterectomy trials and the low annual event rates associated with asymptomatic carotid stenosis, the cost-effectiveness of performing surgical endarterectomy for asymptomatic carotid stenosis has been questioned (37Warlow C Endarterectomy for asymptomatic carotid stenosis?.Lancet. 1995; 345: 1254-1255Abstract PubMed Scopus (64) Google Scholar). The results of a second, large, multicenter, randomized trial examining endarterectomy in asymptomatic carotid stenosis, The Asymptomatic Carotid Surgery Trial (ACST), currently in progress, are awaited (38Halliday AW Thomas D Mansfield A The Asymptomatic Carotid Surgery Trial (ACST). Rationale and design. Steering Committee.Eur J Vasc Surg. 1994; : 8703-8710Google Scholar).Mayo Asymptomatic Carotid Endarterectomy StudyThe Mayo Clinic undertook a randomized controlled trial to compare the effects of carotid endarterectomy with medical treatment. Over 30 months of recruitment, 71 patients were randomized and 87 patients who were eligible but unrandomized were included in the follow-up protocol. The total ipsilateral perioperative stroke and death rate was 0% in the randomized group and 3% in the nonrandomized group. The major stroke and death rate was 0% for both groups. Too few cerebral ischemic events occurred to compare the efficacy of endarterectomy with low-dose aspirin for asymptomatic carotid stenosis. However, the trial was prematurely terminated because there was a significantly high number of myocardial infarctions and transient ischemic events in the surgical group compared with the medical group (39Mayo Asymptomatic Carotid Endarterectomy Study GroupResults of a randomized controlled trial of carotid endarterectomy for asymptomatic carotid stenosis.Mayo Clin Proc. 1992; 67: 513-518Abstract Full Text Full Text PDF PubMed Google Scholar).Nonrandomized StudiesInnumerable case series of carotid endarterectomy have been published. A systematic review of the risk of stroke and death caused by endarterectomy for symptomatic carotid stenosis was performed by Rothwell et al (40Rothwell PM Slattery J Warlow CP A systematic review of the risks of stroke and death due to endarterectomy for symptomatic carotid stenosis.Stroke. 1996; 27: 260-265Crossref PubMed Google Scholar). The authors analyzed 51 studies since 1980, including the NASCET, and reported an overall perioperative risk of stroke and/or death of 5.64%. The overall death rate was 1.62%, with the risk of a fatal stroke (0.86%) slightly exceeding the risk of a nonstroke death (0.7%). The authors noted there was significant heterogeneity in the reported stroke and mortality rates between studies. Surgical series in which neurological outcome assessment was independently adjudicated by neurologists reported significantly higher risks of stroke and death (41Rothwell P Warlow C Is self-audit reliable?.Lancet. 1995; 346: 1623PubMed Scopus (84) Google Scholar).Rothwell et al performed a similar systematic review comparing the risk of stroke and death caused by carotid endarterectomy, performed by the same surgeons in the same institutions, for symptomatic versus asymptomatic stenosis (42Rothwell PM Slattery J Warlow CP A systematic comparison of the risks of stroke and death due to carotid endarterectomy for symptomatic and asymptomatic stenosis.Stroke. 1996; 27: 266-269Crossref PubMed Google Scholar). The authors analyzed 25 studies since 1980 and reported an overall perioperative risk of stroke and/or death for asymptomatic lesions of 3.35%. This risk estimate was significantly lower than for symptomatic lesions (5.18%) and consistent across virtually all studies.Results from randomized trials may not be generalizable to the results of treatment in clinical practice. Wennberg et al assessed the perioperative mortality among 113 300 Medicare patients undergoing carotid endarterectomy during 1992 to 1993 in “trial hospitals” (those participating in NASCET and ACAS, n=86), and “nontrial hospitals” (nonfederal institutions performing endarterectomy n=2613), looking at all patients treated rather than those selected for a trial (43Wennberg DE Lucas FL Birkmeyer JD Bredenberg CE Fisher ES Variation in carotid endarterectomy mortality in the Medicare population: trial hospitals, volume, and patient characteristics.JAMA. 1998; 279: 1278-1281Crossref PubMed Scopus (372) Google Scholar). The perioperative mortality rate was 1.4% at trial hospitals compared with 2.5% at low-volume (>6 procedures/year) nontrial hospitals.High-Risk PatientsNASCET, ACAS, and the VA Cooperative studies excluded patients with significant comorbid illnesses such as lung, liver, or renal failure, unstable angina, and recent myocardial infarction. Therefore, the complication rates reported in these studies may be lower than the rates achievable when all patients are included. Wennberg et al (43Wennberg DE Lucas FL Birkmeyer JD Bredenberg CE Fisher ES Variation in carotid endarterectomy mortality in the Medicare population: trial hospitals, volume, and patient characteristics.JAMA. 1998; 279: 1278-1281Crossref PubMed Scopus (372) Google Scholar), as noted, found that the perioperative mortality rate at NASCET trial hospitals was 1.4% when all patients were included, compared with 0.6% in NASCET patients. Similar findings were reported by Lepore et al (44Lepore Jr, MR Sternbergh III, WC Salartash K Tonnessen B Money SR Influence of NASCET/ACAS trial eligibility on outcome after carotid endarterectomy.J Vasc Surg. 2001; 34: 581-586Abstract Full Text Full Text PDF PubMed Scopus (51) Google Scholar), who found that NASCET/ACAS trial-eligible patients had a perioperative stroke and death rate of 1.5% compared with 3.6% for trial-ineligible patients (45Estes J Guadagnoli E Wolf R LoGerfo F Whittemore A The impact of cardiac comor" @default.
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• W4247997672 title "Reporting Standards for Carotid Artery Angioplasty and Stent Placement" @default.
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