Efficacy of Carotid Endarterectomy for Asymptomatic Carotid Stenosis
Robert W. Hobson, David G. Weiss, William S. Fields, Jerry Goldstone, Wesley S. Moore, Jonathan B. Towne, Creighton B. Wright, for Veterans Affairs Cooperative Study Group
Background The efficacy of carotid endarterectomy in patientswith asymptomatic carotid stenosis has not been confirmed inrandomized clinical trials, despite the widespread use of operativeintervention in such patients.
Methods We conducted a multicenter clinical trial at 11 VeteransAffairs medical centers to determine the effect of carotid endarterectomyon the combined incidence of transient ischemic attack, transientmonocular blindness, and stroke. We studied 444 men with asymptomaticcarotid stenosis shown arteriographically to reduce the diameterof the arterial lumen by 50 percent or more. The patients wererandomly assigned to optimal medical treatment including antiplateletmedication (aspirin) plus carotid endarterectomy (the surgicalgroup; 211 patients) or optimal medical treatment alone (themedical group; 233 patients). All the patients at each centerwere followed independently by a vascular surgeon and a neurologistfor a mean of 47.9 months.
Results The combined incidence of ipsilateral neurologic eventswas 8.0 percent in the surgical group and 20.6 percent in themedical group (P<0.001), giving a relative risk (for thesurgical group vs. the medical group) of 0.38 (95 percent confidenceinterval, 0.22 to 0.67). The incidence of ipsilateral strokealone was 4.7 percent in the surgical group and 9.4 percentin the medical group. An analysis of stroke and death combinedwithin the first 30 postoperative days showed no significantdifferences. Nor were there significant differences betweengroups in an analysis of all strokes and deaths (surgical, 41.2percent; medical, 44.2 percent; relative risk, 0.92; 95 percentconfidence interval, 0.69 to 1.22). Overall mortality, includingpostoperative deaths, was primarily due to coronary atherosclerosis.
Conclusions Carotid endarterectomy reduced the overall incidenceof ipsilateral neurologic events in a selected group of malepatients with asymptomatic carotid stenosis. We did not finda significant influence of carotid endarterectomy on the combinedincidence of stroke and death, but because of the size of oursample, a modest effect could not be excluded.
The role of carotid endarterectomy in both symptomatic and asymptomaticcarotid occlusive disease is an important topic for prospectiveclinical research. The recent publication of data from threeclinical trials has confirmed the benefits of carotid endarterectomyin symptomatic patients with high-grade carotid stenosis1,2,3.However, the role of operative intervention in patients withasymptomatic carotid stenosis remains controversial and ill-defined.
We report the results of a multicenter randomized clinical trialto determine the efficacy of carotid endarterectomy in patientswith asymptomatic carotid stenosis, defined as a reduction of50 percent or more in the diameter of the arterial lumen asdetermined arteriographically. This clinical trial4 was conductedin 11 Veterans Affairs medical centers throughout the UnitedStates from 1983 to 1991.
Methods
Study Objective
A description of the methods used (Cooperative Studies Protocol167 of the Department of Veterans Affairs) has been publishedelsewhere4. In brief, the primary objective of this randomizedclinical trial was to compare the incidence of transient ischemicattack, transient monocular blindness, and stroke, in patientswith asymptomatic carotid stenosis ( 50 percent) randomly assignedto carotid endarterectomy with optimal medical management, includingantiplatelet therapy (the surgical group), as compared withoptimal medical management and antiplatelet therapy alone (themedical group). After noninvasive screening with ocular pneumoplethysmography5or duplex ultrasonography,6 the percentage of stenosis was confirmedarteriographically in all the patients.
Study Design
Eleven Veterans Affairs medical centers throughout the UnitedStates were selected by the Planning Committee to participatein this study (see Appendix). At each medical center, the clinicalteam consisted of a vascular surgeon (the principal investigator),a collaborating neurologist (the co-principal investigator),and a nurse vascular specialist.
Criteria for Enrollment in the Study
Adult male patients were included in this study when the resultsof noninvasive testing (ocular pneumoplethysmography and optionalduplex ultrasonography) were positive and a suspected carotidstenosis was confirmed arteriographically. Medical criteriafor exclusion included previous cerebral infarction, previousendarterectomy with restenosis, previous extracranial-to-intracranialbypass, high surgical risk due to associated medical illness,long-term anticoagulant therapy, intolerance of aspirin or long-termaspirin therapy at a high dose, life expectancy under five years,surgically inaccessible lesion, noncompliance, and refusal toparticipate in the protocol. In the absence of criteria forexclusion, informed consent was obtained from asymptomatic patientsbefore arteriography, whereas it was obtained before randomizationfrom a subgroup of patients in whom previous arteriograms hadalso shown contralateral symptomatic lesions. Random assignmentto surgical or medical treatment occurred if the biplanar arteriogramconfirmed the presence of a substantial asymptomatic carotidstenosis. A substantial stenosis was defined as one that reducedthe diameter of the arterial lumen by 50 percent or more asmeasured arteriographically (by comparing the least transversediameter at the point of maximal stenosis with the measureddiameter of the postbulbar internal carotid artery, once itsdiameter had become uniform). Representative arteriograms foreach patient were sent to the study chairman's office for reviewby a consulting neuroradiologist who was not involved in thestudy. Patients randomly assigned to carotid endarterectomyunderwent the operation within 10 days of randomization. Allthe patients received an initial dose of aspirin (650 mg twicedaily), which was reduced to 325 mg daily for patients who couldnot tolerate the larger dose during the subsequent clinicalfollow-up. All the study patients were scheduled for clinicvisits every 13 weeks during the first year of follow-up andevery 26 weeks thereafter.
Patients who had clinically defined neurologic outcome eventswere evaluated independently by the vascular surgeon and theneurologist at each center, and their conclusions were submittedfor blinded review and adjudication by the Endpoints Committee(see Appendix). The study group adopted the definitions of transientischemic attack and stroke presented by an ad hoc committeeestablished by the Advisory Council of the National Institutesof Neurological and Communicative Disorders and Stroke7. Oncesuch an event was recorded, a crossover from medical to surgicaltreatment was permitted at the recommendation of the co-principalinvestigators. All deaths were reviewed by the Endpoints Committee.
Statistical Analysis
A detailed statistical review has been provided elsewhere4.The target sample for this study was 500 patients. The PlanningCommittee anticipated that the rate of combined neurologic outcomeevents in the medical group would be 20 percent over the courseof the study and that a reduction by 50 percent -- i.e., froman absolute rate of 20 percent in the medical group to a rateof 10 percent in the surgical group -- would represent a clinicaldifference of importance.
All the statistical analyses were performed with the StatisticalAnalysis System or BMDP statistical software. For the resultsreported, the two treatment groups were compared at the startof the study with chi-square tests for categorical data andt-tests for continuous data. The treatment groups were comparedby the chi-square test with respect to combined neurologic outcomeevents. Cumulative rates for the time to an event (Figure 1and Figure 2) were estimated separately for the surgical andmedical groups by Kaplan-Meier methods. Treatment groups werecompared by the log-rank statistic with regard to cumulativerates for the time to an event. All statistical comparisonswere two-tailed. Relative risks and 95 percent confidence intervalswere based on the Cox proportional-hazards model, which incorporatesthe duration of follow-up8.
Figure 1. Kaplan-Meier Curves for Event-free Rates of First Ipsilateral Stroke and Transient Ischemic Attack Including Transient Monocular Blindness.
The analysis shows the time to the first event in the surgical and medical groups. The number of patients remaining event-free and in the study at the beginning of each 12-month period is shown below the graph. Comparisons between treatment groups by the log-rank test demonstrated significant differences in favor of the surgical group (P<0.001). The relative risk in the surgical group as compared with the medical group was 0.38 (95 percent confidence interval, 0.22 to 0.67).
Figure 2. Kaplan-Meier Curves for Event-free Rates of Stroke and Death in the Surgical and Medical Groups.
The number of patients remaining event-free and in the study at the beginning of each 12-month period is shown below the graph. Comparison by the log-rank test demonstrated that there was no significant difference between the treatment groups. The relative risk in the surgical group as compared with the medical group was 0.92 (95 percent confidence interval, 0.69 to 1.22).
Results
Screening
Eleven Veterans Affairs medical centers screened 1935 adultmale patients from April 1, 1983, through September 30, 1987.Patients with clinically apparent or suspected cardiovascularor cerebrovascular disease, accompanied in some instances bycervical bruit, were referred to the Vascular Laboratory fornoninvasive testing. Of these, 444 patients met all the criteriafor inclusion and were enrolled and followed in the study. Twohundred eleven patients were randomly assigned to the surgicalgroup, and 233 patients to the medical group. The reasons forexclusion and the numbers of patients excluded for each reasonare summarized in Table 1.
Table 1. Reasons for Excluding Patients from the Study during the Initial Screening of 1935 Patients.
Characteristics of Study Patients at Entry
The clinical characteristics of the 444 patients (mean age,64.5 years) at entry are shown in Table 2. Thirty-two percentof the study patients had a history of ischemic events due tocontralateral stenoses, 80 percent of which were reported astransient ischemic attacks. The remainder were described asstrokes with minimal residual neurologic deficits. The patientswith contralateral symptomatic lesions were studied with allthe other patients. Separate analyses of their outcomes yieldedresults similar to those in the patients who were free of symptoms.Analysis of the data in Table 2 demonstrated no significantdifferences between the surgical and medical groups.
Table 2. Characteristics of the Patients at Entry.
Follow-up of Patients
The enrollment of patients began on April 1, 1983, and follow-upended on March 31, 1991. The mean (±SD) duration of follow-up,as measured from the time of entry to that of the first neurologicevent, death, loss to follow-up, or most recent examination,was 47.9 ±27.9 months. Thirty-five patients (20 in thesurgical group and 15 in the medical group) withdrew or didnot return for follow-up during the study period. Substantialfollow-up data were available for these patients, however, witha mean follow-up of 40.9 ±25.3 months.
A survey of operating-room logs at all the participating medicalcenters during the enrollment period showed that 51 patientswith the diagnosis of asymptomatic carotid stenosis underwentsurgery without being screened for the study. These patientscould not be considered to be ineligible on the basis of theirmedical charts. Unfortunately, data on their outcomes are unavailable.
Arteriography
After giving informed consent, patients who met all the medicalcriteria of the study were required to undergo selective carotidarteriography before randomization. Patients who had undergonearteriography for a contralateral symptomatic lesion not morethan six months before they gave informed consent and who wererandomized were not required to undergo a repeat arteriographicstudy. Data on 714 arteriography procedures were submitted foranalysis. Of these, 67 percent were conventional selective catheterizationprocedures and 33 percent were arterial digital subtractionprocedures. Arteriograms for 439 of the 444 randomized patientswere subsequently submitted for central review to assess possiblelocal variation in clinical evaluation. All cases were examinedby the study neuroradiologist, and caliper readings to the nearestmillimeter were used to calculate the percentage of stenosis.Consistency was high (95 percent) between the local and thecentral readings with respect to the minimally acceptable stenosisof 50 percent. In the remaining 5 percent of cases, the meanpercentage of stenosis was only 41 percent, which was withinpreviously reported variations between observers in arteriographicreadings9. All the patients were included in the analyses andconclusions reported here. Separate analyses of outcome thatexcluded patients with marginal degrees of stenosis yieldedessentially the same results and support the same conclusions.
Aspirin Therapy
The patients in both treatment groups received 650 mg of aspirintwice daily after randomization. A standard protocol for adjustmentof medication was adopted in anticipation of possible reactionsin the study patients. A cross-sectional evaluation of eachpatient at the time of one of the combined neurologic outcomes,death, or withdrawal from the study demonstrated that 16 percenthad discontinued aspirin therapy because of intolerance, 57percent were taking full-dose aspirin, and 27 percent were takingless than the full dose (i.e., 325 mg daily). There were nosignificant differences between the treatment groups.
Surgical Morbidity and Mortality
The surgical group consisted of 195 patients who underwent unilateralcarotid endarterectomy and 8 patients who underwent staged bilateralprocedures, for a total of 211 procedures. Eight patients declinedsurgery after randomization, but they are included in the outcomeanalyses according to the intention-to-treat principle. The30-day operative mortality was 1.9 percent (4 of 211), with3 deaths from myocardial infarction and 1 from myocardial infarctionfollowed by stroke. There were 5 postoperative strokes (nonfatal),for an incidence of 2.4 percent (5 of 211). Transient ischemicattack was observed in 0.9 percent of patients (2 of 211). Threenonfatal strokes (0.4 percent, or 3 of 714) occurred as a resultof arteriography; 1 was accompanied by hemiparesis (0.2 percent),and 2 by minimal neurologic deficits. Other complications includedcranial-nerve injuries in 3.8 percent (8 of 211): recurrentlaryngeal-nerve injury in 3 patients, hypoglossal-nerve injuriesin 2, injury to the mandibular branch of the facial nerve in2, and injury to the lower division of the trigeminal nervein 1 patient with a postoperative wound hematoma. Functionalrecovery was observed in all these neural injuries, and therewas no permanent disability. Postoperative hypotension occurredin 5.2 percent of patients, and hypertension in 25.1 percent,all of which was treated pharmacologically. Four nonfatal myocardialinfarctions (in 1.9 percent of patients) occurred during thepostoperative period. These operative complications have beenreported previously10.
The rate of permanent stroke and death within 30 days afterrandomization was 4.7 percent in the surgical group, when thecomplications of arteriography were assigned to the surgicalgroup. In contrast, during the first 30 days after the assignmentof patients to the medical group, there was one death due tosuicide (0.4 percent) and two neurologic events (0.9 percent):one permanent stroke and one transient ischemic event. The deathby suicide was included in the analysis of deaths in the medicalgroup.
Neurologic Events
The results are shown in Table 3 for all neurologic events,contralateral and ipsilateral. Eighty-four events were observed-- 27 (12.8 percent) in the surgical group and 57 (24.5 percent)in the medical group. This represented an absolute risk reductionof 11.6 percent (P<0.002) and a relative risk (for the surgicalgroup vs. the medical group) of 0.51 (95 percent confidenceinterval, 0.32 to 0.81). The results for ipsilateral eventsonly are shown in Table 4. There were 65 such events -- 17 (8.0percent) in the surgical group and 48 (20.6 percent) in themedical group. The absolute reduction in risk was 12.6 percent(P<0.001), and the relative risk 0.38 (95 percent confidenceinterval, 0.22 to 0.67). Analysis of the ipsilateral neurologicevents in the medical group showed 24 events for stenoses of50 to 75 percent (12 strokes, 7 transient ischemic attacks,and 5 episodes of transient monocular blindness, in 19.2 percentof patients) and 24 events for stenoses of 76 to 99 percent(10 strokes, 8 transient ischemic attacks, and 6 episodes oftransient monocular blindness, in 22.4 percent of patients)(P not significant).
Table 4. Incidence of Neurologic End Points for Ipsilateral Events Only.
Among the 45 ipsilateral or contralateral strokes (Table 3),32 were ipsilateral (Table 4) -- 10 (4.7 percent) in the surgicalgroup and 22 (9.4 percent) in the medical group. These strokesoccurred as first neurologic events without antecedent transientischemic attacks. The differences in the incidence of strokealone suggested a preference for surgical management (P<0.06).However, when four perioperative deaths (1.9 percent) and threestrokes associated with arteriography (0.4 percent) were assignedto the surgical group, there was no significant difference betweensurgical and medical treatment for stroke alone. Each of the45 strokes was assigned a severity score by the Endpoints Committee,using a stroke-severity scale adopted in a previous clinicaltrial11. The mean scores were 3.6 for the surgical group and4.1 for the medical group (P not significant).
The incidence of ipsilateral neurologic events among patientswith a history of contralateral symptomatic events at entry(32 percent of the patients in the trial) was 9.0 percent inthe surgical group and 23.4 percent in the medical group (P<0.04),for a relative risk of 0.38 (95 percent confidence interval,0.16 to 1.01). In patients with no history of any symptomaticevent at entry (68 percent of the patients in the trial), theincidence was 7.6 percent and 19.2 percent, respectively (P<0.004),for a relative risk of 0.38 (95 percent confidence interval,0.19 to 0.75).
In addition to calculating the rates of combined neurologicoutcome events, we determined the temporal distribution of theseevents over the duration of follow-up by constructing Kaplan-Meiersurvival curves, with survival defined as the time to the firstevent. The data from Table 4 on ipsilateral events are presentedin Figure 1.
Analysis of Stroke and Death
The study patients were elderly veterans, many of whom had substantialcoronary or cerebral vascular disease (Table 2). The incidenceof stroke and death in these patients is shown in Table 5. Althoughthe total number of stroke end points was 45 (Table 3), therewere 2 additional deaths due to stroke (1 in each treatmentgroup) after the initial neurologic end points had been recorded.This resulted in a total of 47 nonfatal and fatal strokes (Table 5).Kaplan-Meier curves for the two treatment groups are shownin Figure 2. There were no significant differences between groups.Similarly, comparisons of event rates between the group witha history of contralateral symptomatic events (surgical, 41.8percent; medical, 41.6 percent; relative risk, 1.17; 95 percentconfidence interval, 0.67 to 1.84) and the group with no historyof any symptomatic event at entry (surgical, 41.0 percent; medical,45.5 percent; relative risk, 0.84; 95 percent confidence interval,0.59 to 1.18) revealed no significant differences between treatmentgroups.
Table 5. Incidence of Stroke, Deaths from Stroke, and All Other Deaths.
Discussion
The primary objective of this randomized clinical trial wasto determine the efficacy of carotid endarterectomy, when addedto optimal medical management that included aspirin therapy,in reducing the incidence of neurologic outcome events, includingtransient ischemic attack, transient monocular blindness, andstroke. The incidence of ipsilateral neurologic outcome eventswas reduced from 20.6 percent in the medical group to 8.0 percentin the surgical group (P<0.001). However, although the incidenceof ipsilateral stroke alone was lower in the surgical group(Table 4), the combined incidence of stroke and death withinthe first 30 postoperative days and the incidence of death fromall causes showed no benefit from operative intervention (Figure 2).In the presence of high mortality from other causes (Table 5),it may be difficult to identify the contribution of lessfrequent events, such as stroke. For example, to detect a reductionof 50 percent in the stroke rate in the surgical group as comparedwith the medical group (annual ipsilateral-stroke rate, 2.5percent) would require more than 3000 patients8 -- beyond thescope of any contemporary clinical trial in patients with asymptomaticcarotid stenosis12.
Including transient ischemic attacks in the analysis of neurologicoutcomes is justified by their importance as indicators or predictorsof stroke. Differentiating a transient ischemic attack froma stroke causing minimal disability may require making an unnecessarilyrigid distinction in view of the similarity of their clinicaldefinitions,13 the subsequent risk of stroke after transientevents,1,2 and the acknowledged incidence (30 to 40 percent)of abnormal computed tomography and magnetic resonance scansin patients with clinical evidence of a transient ischemic attackalone14,15. The results of the North American Symptomatic CarotidEndarterectomy Trial1 and the European Carotid Surgery Trial2confirm that transient ischemic attack in the presence of high-gradestenosis is an important risk factor for stroke. These considerationssupport the original design of this study,4 in which transientischemic events were combined with stroke in the analysis ofneurologic outcome. Patients with transient ischemic attackor nondisabling stroke ipsilateral to a carotid stenosis of70 percent or more have been found to have an incidence of strokeof 26 percent, according to life-table analysis during the firsttwo years of follow-up1. An analysis of the relevant data fromour trial (Figure 1) showed that 26 of the 32 ipsilateral strokesoccurred during the first two years of clinical follow-up. Furthermore,as observed in the medical group in our study, half the neurologicoutcome events were strokes and were not preceded by transientischemic attack.
Surgical complications included an operative mortality of 1.9percent, a permanent-stroke rate of 2.4 percent, and a rateof associated strokes due to arteriography of 0.4 percent. Therate of perioperative permanent stroke and death combined (4.7percent) was higher than the 2.9 percent cited by Barnett andcolleagues16 and the 3.0 percent limit promulgated by Callowet al.17. Although many reports18,19,20,21,22,23 during thepast two decades have documented combined rates of stroke andmortality of less than 5 percent in patients undergoing carotidendarterectomy for asymptomatic stenosis, not all institutions24,25,26have achieved these results. The referral of patients to centerscapable of low rates of surgical complications is essentialin a plan that includes carotid endarterectomy with optimalmedical management. Coexisting surgical conditions includedcranial-nerve deficits in 3.8 percent of cases and nonfatalmyocardial infarction in 1.9 percent. The neural deficits weretransient, however, resulting in no permanent disability, andnone of the patients with nonfatal postoperative myocardialinfarctions died of myocardial infarction within the first yearof follow-up. Although such surgical complications are sometimesregarded as comparable in gravity to transient ischemic attacks,we emphasized the occurrence of transient ischemic events inthis analysis because of their reported association with subsequentstroke1,2. Since virtually all patients who had transient ischemicevents were referred for carotid endarterectomy, we could notdetermine the subsequent rate of stroke in this group.
The identification of a subgroup of patients at higher riskwho might best benefit from operative intervention has beenconsidered a key factor in selecting patients for carotid endarterectomy.The degree of stenosis has emerged as an important risk factor26,27,28,29,30.Chambers and Norris27 prospectively followed 500 asymptomaticpatients with carotid stenoses reducing the cross-sectionalarea by 75 percent or more and observed ischemic cerebrovascularevents in 18 percent of patients (5.5 percent of strokes) inthe first year, and in 22 percent of patients in the first twoyears. In patients with stenoses of less than 75 percent, therates were less than 3 percent and 6 percent for the first yearand the first two years, respectively. The threshold of 50 percentfor the reduction in diameter as a result of stenosis in ourtrial plus the added requirement of positive noninvasive studies5,6results in a calculated reduction in the area of the arteriallumen that is equivalent to that studied by Chambers and Norris26,27.This may account for the comparability of rates of ipsilateralneurologic events between the Toronto data27 and ours. In ourstudy, ipsilateral neurologic events had occurred in approximately10 percent and 18 percent of patients with high-grade asymptomaticstenosis at one and two years of follow-up, respectively. Theexclusion from a recently reported clinical trial of patientswith high-grade stenosis or stenosis of rapidly progressingseverity and their assignment to surgical treatment may haveneutralized potentially important differences between the surgicaland medical groups31.
Chambers and Norris27 also identified as risk factors male sex,heart disease, and increased severity of carotid stenosis. Wecould not detect progression of carotid stenosis in our trialbecause the use of duplex ultrasonography at participating clinicalcenters was not uniform, but the men we studied, with theirhigh incidence of cardiovascular disease, constitute a high-riskgroup. Our results may be less directly relevant to patientswho do not share this high-risk profile.
We conclude that carotid endarterectomy, combined with optimalmedical management, can reduce the incidence of ipsilateralneurologic events in high-risk male patients with arteriographicallyconfirmed asymptomatic carotid stenosis. Not all such patients,however, should be considered candidates for carotid endarterectomy.Despite their higher risk of transient ischemic attack and stroke,most of these patients will die as a result of coronary atherosclerosis.Care must be exercised in selecting those who will undergo surgery.In addition, a low rate of perioperative complications shouldbe confirmed by clinical audit at each institution before aprogram of operative intervention is begun. Although carotidendarterectomy did not appear to have a significant effect onthe combined incidence of stroke and death in this study, afirm conclusion on this important question must await the publicationof data from clinical trials involving larger numbers of patients.
Supported by the Cooperative Studies Program, Medical ResearchService, Department of Veterans Affairs.
We are indebted to Drs. James C. Grotta and Allan D. Callowfor their assistance and critique of this manuscript, and toSterling-Winthrop Research, New York, and Smith Kline BeechamConsumer Brands, Parsippany, N.J., for providing the aspirinused in the study.
Source Information
From the Veterans Affairs Cooperative Studies Program Coordinating Center, Perry Point, Md., and 11 Veterans Affairs medical centers. Participants and participating centers are listed in the Appendix.
Address reprint requests to Dr. Hobson at the Section of Vascular Surgery, Medical Science Building G-532, 185 S. Orange Ave., University of Medicine and Dentistry of New Jersey, New Jersey Medical School, Newark, NJ 07103.
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Appendix
The following persons participated in the Veterans Affairs CooperativeStudy Group. Planning Committee: R.W. Hobson II, W.S. Fields,A. Gage, J. Goldstone, C. Haakenson, W.S. Moore, J.B. Towne,D.G. Weiss, and C.B. Wright; Executive Committee: R.W. HobsonII, C. Colling, W.S. Fields, J. Goldstone, W.S. Moore, J.B.Towne, D.G. Weiss, and C.B. Wright; Study administrative coordinators:S. Rossos and A. George; Data Monitoring Board: A.D. Callow,R.E. Flora, J.C. Grotta, and A. Imparato; Human Rights Committee:C. Crigler, W. Beard, S.L. Caesar, L. Covi, S.K. Gauvey, R.S.Lipman, R. Kurz, K. Block, S.P. Leviton, A. Raskin, M. Moore,D. Safer, M.W. Feldbush, E. Perez, R. Weiss, M.M. Arthur, andT.E. Hobbins; Central neuroradiologist: I.S. Song; EndpointCommittee: L.R. Caplan, W.S. Fields, J. Goldstone, W.S. Moore,and C. Wright; Veterans Affairs Cooperative Studies ProgramCoordinating Center, Perry Point, Md.: C.J. Klett, J.F. Collins,D.G. Weiss, P. Jackson, D. Morson, B.D. Carter, B. McMullen,R. Kuhn, B. Miller, M. Lee, D. Preston, D. Davis, L. Linzy,and C. Lucas; Veterans Affairs Cooperative Studies Program:D. Deykin, J. Gold, and P. Huang.
The following Veterans Affairs medical centers and personnelparticipated in the study group. Atlanta: R.B. Smith, J. Ammons,and R. Giannetti; Boston: R.W. Vollman, W. Johnson, R. Butler,C. Kase, J. Hamilton, and N. Walker; Buffalo, N.Y.: A. Gage,C.S. Powell, E. Soria, W.A. Olszewski, I. Gutierrez, D.E. Young,and K. Burch; East Orange, N.J.: T.G. Lynch, F. Padberg, S.Shanawani, D.A. Johnson, and C. Rogers; Iowa City: L.F. Hiratzka,J. Corson, W.T. Talman, C. Martin, V.B. Griffith, J. Yutzy,and B. Lutes; Little Rock, Ark.: B.W. Thompson, D. Morgan, andC. McDonald; Los Angeles (Sepulveda): J.D. Baker, E.J. Metter,N. Rabey, and D. Dix; Milwaukee (Wood): J.B. Towne, D. Bandyk,V.K. Saxena, J. Navine, K. Catarozoli, D. Lanza, and P. Parson;San Francisco: W.C. Krupski, J. Rapp, F. Sharp, and S. Perez;Tucson, Ariz.: J. Goldstone, V. Bernhard, E. Labadie, M. Nash,B. Phelps, J. Vance, and G. Anderson; West Los Angeles (Wadsworth):R.E. Zierler, B. Stabile, S.E. Wilson, S. Cohen, L. Emma, andC. Hubbert; Clinical Research Pharmacy Coordinating Center:C. Haakenson, D. Toussaint, L. Young, and C. Colling.
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(2007). ACC/AHA 2007 Guidelines on Perioperative Cardiovascular Evaluation and Care for Noncardiac Surgery: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines on Perioperative Cardiovascular Evaluation for Noncardiac Surgery) Developed in Collaboration With the American Society of Echocardiography, American Society of Nuclear Cardiology, Heart Rhythm Society, Society of Cardiovascular Anesthesiologists, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine and Biology, and Society for Vascular Surgery. J Am Coll Cardiol
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(2007). Carotid Artery Stenting Will Replace Carotid Endarterectomy. PERSPECT VASC SURG ENDOVASC THER
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(2007). Incidence of New Brain Lesions After Carotid Stenting With and Without Cerebral Protection. Stroke
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Bates, E. R., Babb, C. J. D., Casey, D. E., Cates, C. U., Duckwiler, G. R., Feldman, T. E., Gray, W. A., Ouriel, K., Peterson, E. D., Rosenfield, K., Rundback, J. H., Safian, R. D., Sloan, M. A., White, C. J.
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(2007). Endarterectomy and Stenting for Asymptomatic Carotid Stenosis: A Race at Breakneck Speed. Stroke
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(2006). Inflammation and Atherosclerosis: Novel Insights Into Plaque Formation and Destabilization. Stroke
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Goldstein, L. B., Adams, R., Alberts, M. J., Appel, L. J., Brass, L. M., Bushnell, C. D., Culebras, A., DeGraba, T. J., Gorelick, P. B., Guyton, J. R., Hart, R. G., Howard, G., Kelly-Hayes, M., Nixon, J.V., Sacco, R. L.
(2006). Primary Prevention of Ischemic Stroke: A Guideline From the American Heart Association/American Stroke Association Stroke Council: Cosponsored by the Atherosclerotic Peripheral Vascular Disease Interdisciplinary Working Group; Cardiovascular Nursing Council; Clinical Cardiology Council; Nutrition, Physical Activity, and Metabolism Council; and the Quality of Care and Outcomes Research Interdisciplinary Working Group: The American Academy of Neurology affirms the value of this guideline.. Circulation
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(2006). Pregnancy-Associated Plasma Protein-A Is Markedly Expressed by Monocyte-Macrophage Cells in Vulnerable and Ruptured Carotid Atherosclerotic Plaques: A Link Between Inflammation and Cerebrovascular Events. J Am Coll Cardiol
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Goldstein, L. B., Adams, R., Alberts, M. J., Appel, L. J., Brass, L. M., Bushnell, C. D., Culebras, A., DeGraba, T. J., Gorelick, P. B., Guyton, J. R., Hart, R. G., Howard, G., Kelly-Hayes, M., Nixon, J.V., Sacco, R. L.
(2006). Primary Prevention of Ischemic Stroke: A Guideline From the American Heart Association/American Stroke Association Stroke Council: Cosponsored by the Atherosclerotic Peripheral Vascular Disease Interdisciplinary Working Group; Cardiovascular Nursing Council; Clinical Cardiology Council; Nutrition, Physical Activity, and Metabolism Council; and the Quality of Care and Outcomes Research Interdisciplinary Working Group: The American Academy of Neurology affirms the value of this guideline.. Stroke
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Heyer, E. J., Sharma, R., Rampersad, A., Winfree, C. J., Mack, W. J., Solomon, R. A., Todd, G. J., McCormick, P. C., McMurtry, J. G., Quest, D. O., Stern, Y., Lazar, R. M., Connolly, E. S.
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Dietz, A., Berkefeld, J., Theron, J. G., Schmitz-Rixen, T., Zanella, F. E., Turowski, B., Steinmetz, H., Sitzer, M.
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(2001). Should severe monolateral asymptomatic carotid artery stenosis be treated at the time of coronary artery bypass operation?. Eur. J. Cardiothorac. Surg.
19: 619-626
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(2001). Results of Carotid Endarterectomy Performed with Preoperative Duplex Ultrasound Assessment Alone. VASC ENDOVASCULAR SURG
35: 95-101
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50 percent) randomly assigned to carotid endarterectomy with optimal medical management, including antiplatelet therapy (the surgical group), as compared with optimal medical management and antiplatelet therapy alone (the medical group). After noninvasive screening with ocular pneumoplethysmography5 or duplex ultrasonography,6 the percentage of stenosis was confirmed arteriographically in all the patients. 
