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Asymptomatic Carotid Asymptomatic Carotid Disease: Guidelines for Disease: Guidelines for Assessment and Management Assessment and Management Peter A. Soukas, MD, FACC, FSVM, FSCAI, Peter A. Soukas, MD, FACC, FSVM, FSCAI, RPVI RPVI Director: Vascular Medicine, Interventional Vascular Lab, Brown Vascular & Endovascular Fellowship Program The Miriam and Rhode Island Hospitals Assistant Professor of Medicine The Warren Alpert School of Medicine of Brown University

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Page 1: Asymptomatic Carotid Disease: Guidelines for Assessment ... 2011-2.pdf · Asymptomatic Carotid Disease: Guidelines for Assessment and Management Peter A. Soukas, MD, FACC, FSVM, FSCAI,

Asymptomatic Carotid Asymptomatic Carotid Disease: Guidelines for Disease: Guidelines for Assessment and ManagementAssessment and Management

Peter A. Soukas, MD, FACC, FSVM, FSCAI, Peter A. Soukas, MD, FACC, FSVM, FSCAI, RPVIRPVIDirector: Vascular Medicine, Interventional Vascular Lab, Brown Vascular & Endovascular Fellowship ProgramThe Miriam and Rhode Island HospitalsAssistant Professor of MedicineThe Warren Alpert School of Medicine of Brown University

Page 2: Asymptomatic Carotid Disease: Guidelines for Assessment ... 2011-2.pdf · Asymptomatic Carotid Disease: Guidelines for Assessment and Management Peter A. Soukas, MD, FACC, FSVM, FSCAI,

DisclosuresDisclosuresConsultant/Research or Grant SupportConsultant/Research or Grant Support

Gore MedicalGore Medical

Abbott VascularAbbott Vascular

CordisCordis EndovascularEndovascular

IDEV TechnologiesIDEV Technologies

Atrium MedicalAtrium Medical

Bard MedicalBard Medical

Cook MedicalCook Medical

Medrad/PossisMedrad/Possis

Page 3: Asymptomatic Carotid Disease: Guidelines for Assessment ... 2011-2.pdf · Asymptomatic Carotid Disease: Guidelines for Assessment and Management Peter A. Soukas, MD, FACC, FSVM, FSCAI,

My Carotid Stent Trials as My Carotid Stent Trials as PIPI

CRESTCREST-- leading NE siteleading NE site

SAPPHIRESAPPHIRE

SAPPHIRESAPPHIRE--WWWW

CHOICECHOICE

EXACTEXACT

CARESCARES

CARESCARES--PMSPMS

PROTECTPROTECT

SONOMASONOMA

EMBOLDENEMBOLDEN

CREATECREATE

CREATECREATE--PASPAS

FREEDOMFREEDOM

EPICEPIC

Page 4: Asymptomatic Carotid Disease: Guidelines for Assessment ... 2011-2.pdf · Asymptomatic Carotid Disease: Guidelines for Assessment and Management Peter A. Soukas, MD, FACC, FSVM, FSCAI,

Management of Patients Management of Patients With Atherosclerotic With Atherosclerotic Disease of the Carotid Disease of the Carotid ArteriesArteries

2011 ASA/ACCF/AHA/AANN/AANS/ACR/ASNR/CNS/SAIP/SCAI/SIR/SNIS/SVM/SVS Guideline on the Management of Patients With Extracranial Carotid and Vertebral Artery DiseaseA Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines, and the American Stroke Association, American Association of Neuroscience Nurses, American Association of Neurological Surgeons, American College of Radiology, American Society of Neuroradiology, Congress of Neurological Surgeons, Society of Atherosclerosis Imaging and Prevention, Society for Cardiovascular Angiography and Interventions, Society of Interventional Radiology, Society of NeuroInterventional Surgery, Society for Vascular Medicine, and Society for Vascular Surgery

Circulation 2011;124:489Circulation 2011;124:489--523523

Page 5: Asymptomatic Carotid Disease: Guidelines for Assessment ... 2011-2.pdf · Asymptomatic Carotid Disease: Guidelines for Assessment and Management Peter A. Soukas, MD, FACC, FSVM, FSCAI,

StrokeStroke-- Scope of the Scope of the ProblemProblem

~700,000 strokes/yr=1/min~700,000 strokes/yr=1/min

3rd leading cause of death in the US 3rd leading cause of death in the US ~150,000/yr.; #1 cause of disability~150,000/yr.; #1 cause of disability

~20% strokes due to carotid disease~20% strokes due to carotid disease

Stroke cost= $58.8 billion/yr.Stroke cost= $58.8 billion/yr.

4.4 million stroke survivors4.4 million stroke survivors

20% require institutional care20% require institutional care

up to 1/3 have permanent disabilityup to 1/3 have permanent disability

Page 6: Asymptomatic Carotid Disease: Guidelines for Assessment ... 2011-2.pdf · Asymptomatic Carotid Disease: Guidelines for Assessment and Management Peter A. Soukas, MD, FACC, FSVM, FSCAI,

Stroke Risk of Stroke Risk of ExtracranialExtracranial Carotid Carotid DiseaseDisease-- WhoWho’’s at Risk?s at Risk?

Asymptomatic Asymptomatic ≥≥80%80%

annual risk of 1annual risk of 1--4.3%4.3%

TIATIA

15% risk of stroke at 1 month15% risk of stroke at 1 month

30% risk of TIA/CVA/death within 3 30% risk of TIA/CVA/death within 3 monthsmonths

Symptom Status

Stenosis Severity

Stroke 1991;22:1485Stroke 1991;22:1485

Page 7: Asymptomatic Carotid Disease: Guidelines for Assessment ... 2011-2.pdf · Asymptomatic Carotid Disease: Guidelines for Assessment and Management Peter A. Soukas, MD, FACC, FSVM, FSCAI,

Vascular Risk of Asymptomatic Vascular Risk of Asymptomatic Carotid Carotid StenosisStenosis-- mean F/U 43 mean F/U 43 monthsmonths

Norris et al, Stroke 1991;22:1485Norris et al, Stroke 1991;22:1485

StenosisStenosis TIATIA CVACVA CardiacCardiacEventEvent

VascularVascularDeathDeath

<50%<50% 1.01.0 1.31.3 2.72.7 1.81.8

5050--75%75% 3.03.0 1.31.3 6.66.6 3.33.3

>75%>75% 7.27.2 3.33.3 8.38.3 6.56.5

Page 8: Asymptomatic Carotid Disease: Guidelines for Assessment ... 2011-2.pdf · Asymptomatic Carotid Disease: Guidelines for Assessment and Management Peter A. Soukas, MD, FACC, FSVM, FSCAI,

Diagnosing Carotid Artery Diagnosing Carotid Artery DiseaseDisease

Complete neurologic & Complete neurologic & medical history and medical history and physical examphysical exam

Carotid Duplex Carotid Duplex UltrasonographyUltrasonography (CDUS)(CDUS)

MRAMRA

CTACTA

Digital Subtraction Digital Subtraction Angiography (DSA)Angiography (DSA)

Page 9: Asymptomatic Carotid Disease: Guidelines for Assessment ... 2011-2.pdf · Asymptomatic Carotid Disease: Guidelines for Assessment and Management Peter A. Soukas, MD, FACC, FSVM, FSCAI,

What Can the Physical Exam Tell What Can the Physical Exam Tell You About the Etiology of Stroke?You About the Etiology of Stroke?

AFibAFib/Flutter/Flutter CardiogenicCardiogenic EmbolusEmbolus

No distal pulsesNo distal pulses Systemic Systemic embolizationembolization

Carotid bruitCarotid bruit ExtracranialExtracranial carotid diseasecarotid disease

Fever and acute CVAFever and acute CVA EndocarditisEndocarditis with with cardiogeniccardiogenicembolusembolus

Page 10: Asymptomatic Carotid Disease: Guidelines for Assessment ... 2011-2.pdf · Asymptomatic Carotid Disease: Guidelines for Assessment and Management Peter A. Soukas, MD, FACC, FSVM, FSCAI,

Indications for Carotid Duplex Indications for Carotid Duplex (CDUS)(CDUS)

Cervical bruitCervical bruit

TIA/TMBTIA/TMB

CVACVA

F/U of known F/U of known stenosisstenosis

F/U after CEA or CASF/U after CEA or CAS

IntraIntra--op assessment of op assessment of CEACEA

CVD assessment in CVD assessment in patients with multiple patients with multiple CRFsCRFs

Radiology 2000;214:247Radiology 2000;214:247--252252

Relationship Between PSV and Carotid Stenosis

Page 11: Asymptomatic Carotid Disease: Guidelines for Assessment ... 2011-2.pdf · Asymptomatic Carotid Disease: Guidelines for Assessment and Management Peter A. Soukas, MD, FACC, FSVM, FSCAI,

CDUSCDUSAdvantagesAdvantages

recrec as initial testas initial test--Class IClass I

excellent sensitivity/specificityexcellent sensitivity/specificity

inexpensiveinexpensive

reproducible; can follow prereproducible; can follow pre--post CEA/CASpost CEA/CAS

no pain, radiationno pain, radiation

DisadvantagesDisadvantages

difficult to assess calcified lesions; low/high neck difficult to assess calcified lesions; low/high neck segmentssegments

may be difficult to tell subtotaled vs. occluded vesselmay be difficult to tell subtotaled vs. occluded vessel

Page 12: Asymptomatic Carotid Disease: Guidelines for Assessment ... 2011-2.pdf · Asymptomatic Carotid Disease: Guidelines for Assessment and Management Peter A. Soukas, MD, FACC, FSVM, FSCAI,

MRAMRAAdvantagesAdvantages

Assess arch, cervical and cerebral Assess arch, cervical and cerebral arteriesarteries

accurate, excellent sensitivity/specificityaccurate, excellent sensitivity/specificity

DisadvantagesDisadvantages

overestimates overestimates stenosisstenosis severityseverity

contraindicated in pts. with CRI, contraindicated in pts. with CRI, PPM/ICDPPM/ICD

claustrophiaclaustrophia

costcost

Page 13: Asymptomatic Carotid Disease: Guidelines for Assessment ... 2011-2.pdf · Asymptomatic Carotid Disease: Guidelines for Assessment and Management Peter A. Soukas, MD, FACC, FSVM, FSCAI,

CTACTAAdvantagesAdvantages

very good sensitivity/specificityvery good sensitivity/specificity

accurate, quickaccurate, quick

can use in pts. with PPM/ICDcan use in pts. with PPM/ICD

DisadvantagesDisadvantages

ionizing radiationionizing radiation

contrast in pts with CRIcontrast in pts with CRI

difficult to assess calcified difficult to assess calcified lesionslesions

may overestimate may overestimate stenosisstenosis

costcost

Page 14: Asymptomatic Carotid Disease: Guidelines for Assessment ... 2011-2.pdf · Asymptomatic Carotid Disease: Guidelines for Assessment and Management Peter A. Soukas, MD, FACC, FSVM, FSCAI,

Contrast AngiographyContrast Angiography-- DSADSAAdvantagesAdvantages

““gold standardgold standard”” imaging modality; used during imaging modality; used during CASCAS

used when nonused when non--invasive angiography yields invasive angiography yields conflicting results, or when obesity, CRI, conflicting results, or when obesity, CRI, implantable devices renders CTA /MRA implantable devices renders CTA /MRA inadequate or impossibleinadequate or impossible

able to distinguish true occlusion vs. string able to distinguish true occlusion vs. string signsign

DisadvantagesDisadvantages

risk or stroke, <1%risk or stroke, <1%

invasive; risks of contrast, radiation, access invasive; risks of contrast, radiation, access site complicationssite complications

Page 15: Asymptomatic Carotid Disease: Guidelines for Assessment ... 2011-2.pdf · Asymptomatic Carotid Disease: Guidelines for Assessment and Management Peter A. Soukas, MD, FACC, FSVM, FSCAI,

Stroke Risk FactorsStroke Risk Factors

DiabetesDiabetes

HLPHLP HBPHBP

Physical Physical InactivityInactivity

SmokingSmoking

Page 16: Asymptomatic Carotid Disease: Guidelines for Assessment ... 2011-2.pdf · Asymptomatic Carotid Disease: Guidelines for Assessment and Management Peter A. Soukas, MD, FACC, FSVM, FSCAI,

HypertensionHypertensionMost potent risk factor for strokeMost potent risk factor for stroke

ARIC, MESA, ARIC, MESA, CardiovascCardiovasc Health Study, Framingham Health Study, Framingham all found association between HBP and strokeall found association between HBP and stroke

For each 10mmHg drop in BP, risk for stroke For each 10mmHg drop in BP, risk for stroke decreases 33%decreases 33%

Antihypertensive therapy reduces risk of recurrent Antihypertensive therapy reduces risk of recurrent stroke by 24%stroke by 24%

Type of drug therapy less important than the Type of drug therapy less important than the responseresponse

Page 17: Asymptomatic Carotid Disease: Guidelines for Assessment ... 2011-2.pdf · Asymptomatic Carotid Disease: Guidelines for Assessment and Management Peter A. Soukas, MD, FACC, FSVM, FSCAI,

Effect of ACEEffect of ACE--I Therapy vs. I Therapy vs. Placebo on CV EndpointsPlacebo on CV Endpoints

Blood Pressure Lowering Treatment Blood Pressure Lowering Treatment TrialistsTrialists’’ Collaboration, Lancet 2000;355:1955Collaboration, Lancet 2000;355:1955--6464

Page 18: Asymptomatic Carotid Disease: Guidelines for Assessment ... 2011-2.pdf · Asymptomatic Carotid Disease: Guidelines for Assessment and Management Peter A. Soukas, MD, FACC, FSVM, FSCAI,

Recommendations for Recommendations for Treatment of HypertensionTreatment of Hypertension

1. Class I2.Antihypertensive treatment is recommended for patients with hypertension and

asymptomatic extracranial carotid or vertebral atherosclerosis to maintain blood pressure below 140/90 mm Hg.111,228–231 (Level of Evidence: A)

3.Class IIa• Except during the hyperacute period, antihypertensive treatment is probably

indicated in patients with hypertension and symptomatic extracranial carotid or vertebral atherosclerosis, but the benefit of treatment to a specific target blood pressure (eg, below 140/90 mm Hg) has not been established in relation to the risk of exacerbating cerebral ischemia. (Level of Evidence: C)

Circulation 2011;124:489Circulation 2011;124:489--523523

Page 19: Asymptomatic Carotid Disease: Guidelines for Assessment ... 2011-2.pdf · Asymptomatic Carotid Disease: Guidelines for Assessment and Management Peter A. Soukas, MD, FACC, FSVM, FSCAI,

Smoking and Smoking and StrokeStroke

Smoking increases Smoking increases relative risk of stroke relative risk of stroke 2525--50%50%

Stroke risk drops Stroke risk drops significantly in those significantly in those who quitwho quit

JAMA 1988;259:1025JAMA 1988;259:1025--10291029

2626-- y

r. A

ge A

djus

ted

yr. A

ge A

djus

ted

Inci

denc

e S

troke

/100

0In

cide

nce

Stro

ke/1

000

Framingham StudyFramingham Study

Page 20: Asymptomatic Carotid Disease: Guidelines for Assessment ... 2011-2.pdf · Asymptomatic Carotid Disease: Guidelines for Assessment and Management Peter A. Soukas, MD, FACC, FSVM, FSCAI,

Recommendations for Recommendations for Cessation of Tobacco SmokingCessation of Tobacco Smoking

1.Class I2.Patients with extracranial carotid or vertebral

atherosclerosis who smoke cigarettes should be advised to quit smoking and offered smoking cessation interventions to reduce the risks of atherosclerosis progression and stroke.246–250 (Level of Evidence: B)

Circulation 2011;124:489Circulation 2011;124:489--523523

Page 21: Asymptomatic Carotid Disease: Guidelines for Assessment ... 2011-2.pdf · Asymptomatic Carotid Disease: Guidelines for Assessment and Management Peter A. Soukas, MD, FACC, FSVM, FSCAI,

HyperlipidemiaHyperlipidemia and Strokeand Stroke

Randomized 4731 pts. S/P Randomized 4731 pts. S/P TIA/CVA with no CAD and TIA/CVA with no CAD and LDL 100LDL 100--190, to 80 mg 190, to 80 mg atorvastatinatorvastatin vs. placebovs. placebo

Primary endpoint: first Primary endpoint: first nonfatal or fatal strokenonfatal or fatal stroke

SPARCL Investigators, NEJM 2006;2006:355:549SPARCL Investigators, NEJM 2006;2006:355:549--559559

Page 22: Asymptomatic Carotid Disease: Guidelines for Assessment ... 2011-2.pdf · Asymptomatic Carotid Disease: Guidelines for Assessment and Management Peter A. Soukas, MD, FACC, FSVM, FSCAI,

HyperlipidemiaHyperlipidemia and and StrokeStroke

SPARCL Investigators, NEJM 2006;2006:355:549SPARCL Investigators, NEJM 2006;2006:355:549--559559

ARR of 2.2% @ 5-yrs.

RRR of ischemic stroke by 22%

Page 23: Asymptomatic Carotid Disease: Guidelines for Assessment ... 2011-2.pdf · Asymptomatic Carotid Disease: Guidelines for Assessment and Management Peter A. Soukas, MD, FACC, FSVM, FSCAI,

StatinsStatins Decrease the Risk Decrease the Risk of Stroke in Highof Stroke in High--Risk Risk Patients:Patients:Heart Protection StudyHeart Protection Study

Page 24: Asymptomatic Carotid Disease: Guidelines for Assessment ... 2011-2.pdf · Asymptomatic Carotid Disease: Guidelines for Assessment and Management Peter A. Soukas, MD, FACC, FSVM, FSCAI,

Recommendations for Control Recommendations for Control of of HyperlipidemiaHyperlipidemia

1. Class I2. Treatment with a statin medication is recommended for all patients with extracranial

carotid or vertebral atherosclerosis to reduce low-density lipoprotein (LDL) cholesterol below 100 mg/dL.111,259,260 (Level of Evidence: B)

3. Class IIa• Treatment with a statin medication is reasonable for all patients with extracranial carotid

or vertebral atherosclerosis who sustain ischemic stroke to reduce LDL cholesterol to a level near or below 70 mg/dL.259 (Level of Evidence: B)

• If treatment with a statin (including trials of higher-dose statins and higher-potency statins) does not achieve the goal selected for a patient, intensifying LDL-lowering drug therapy with an additional drug from among those with evidence of improving outcomes (ie, bile acid sequestrants or niacin) can be effective.261–264 (Level of Evidence: B)

• For patients who do not tolerate statins, LDL-lowering therapy with bile acid sequestrantsand/or niacin is reasonable.261,263,265 (Level of Evidence: B)

Circulation 2011;124:489Circulation 2011;124:489--523523

Page 25: Asymptomatic Carotid Disease: Guidelines for Assessment ... 2011-2.pdf · Asymptomatic Carotid Disease: Guidelines for Assessment and Management Peter A. Soukas, MD, FACC, FSVM, FSCAI,

Diabetes and StrokeDiabetes and Stroke

Risk of ischemic Risk of ischemic stroke in pts. with DM stroke in pts. with DM increased 2increased 2--5 fold5 fold

Progression of carotid Progression of carotid IMT in pts. with DMIMT in pts. with DM

UKPKD and ACCORD UKPKD and ACCORD trials showed intensive trials showed intensive Rx of DM did NOT Rx of DM did NOT reduce risk of stroke...reduce risk of stroke...

Page 26: Asymptomatic Carotid Disease: Guidelines for Assessment ... 2011-2.pdf · Asymptomatic Carotid Disease: Guidelines for Assessment and Management Peter A. Soukas, MD, FACC, FSVM, FSCAI,

Intensive Diabetes Treatment Intensive Diabetes Treatment and CV Disease in Patients and CV Disease in Patients with Type I Diabeteswith Type I Diabetes

The Diabetes Control and The Diabetes Control and Complications Complications

Trial/Epidemiology of Trial/Epidemiology of Diabetes Interventions and Diabetes Interventions and

Complications Complications (DCCT/EDIC) Study (DCCT/EDIC) Study

Research GroupResearch Group

NEJM 2005;353:2643NEJM 2005;353:2643--5353

Randomized to conventional vs. intensive glycemic control; mean F/U 6.5

years

CV Disease= nonCV Disease= non--fatal MI, CVA, death due to CVD, angina, need for fatal MI, CVA, death due to CVD, angina, need for CABG/PCICABG/PCI

Reduced risk of any CV event by 42%Reduced risk of non-fatal MI, CVA, CVD death by 57%

Page 27: Asymptomatic Carotid Disease: Guidelines for Assessment ... 2011-2.pdf · Asymptomatic Carotid Disease: Guidelines for Assessment and Management Peter A. Soukas, MD, FACC, FSVM, FSCAI,

Recommendations for Recommendations for Management of Diabetes in Management of Diabetes in Patients with Carotid DiseasePatients with Carotid Disease

Circulation 2011;124:489Circulation 2011;124:489--523523

1. Class IIa2.Diet, exercise, and glucose-lowering drugs can be useful for patients with

diabetes mellitus and extracranial carotid or vertebral artery atherosclerosis. The stroke prevention benefit, however, of intensive glucose-lowering therapy to a glycosylated hemoglobin A1c level less than 7.0% has not been established.286,287 (Level of Evidence: A)

3.Administration of statin-type lipid-lowering medication at a dosage sufficient to reduce LDL cholesterol to a level near or below 70 mg/dL is reasonable in patients with diabetes mellitus and extracranial carotid or vertebral artery atherosclerosis for prevention of ischemic stroke and other ischemic cardiovascular events.288 (Level of Evidence: B)

Page 28: Asymptomatic Carotid Disease: Guidelines for Assessment ... 2011-2.pdf · Asymptomatic Carotid Disease: Guidelines for Assessment and Management Peter A. Soukas, MD, FACC, FSVM, FSCAI,

AntiAnti--thrombotic Therapy thrombotic Therapy ASA recommended in pts. with ECVDASA recommended in pts. with ECVD

WARSSWARSS-- WarfarinWarfarin--Aspirin Recurrent Stroke StudyAspirin Recurrent Stroke Study--ASA vs. ASA vs. warfarinwarfarin-- no benefit of no benefit of warfarinwarfarin over aspirinover aspirin

ASA/ASA/DipyridamoleDipyridamole superior to ASA alone in pts. with superior to ASA alone in pts. with prior TIA/stroke in the 2nd European Stroke prior TIA/stroke in the 2nd European Stroke Prevention StudyPrevention Study

ClopidogrelClopidogrel: NO : NO reduction in stroke risk w/combo Rxreduction in stroke risk w/combo Rx

MATCHMATCH-- Management of Management of AtherothrombosisWithAtherothrombosisWithClopidogrelClopidogrel in Highin High--Risk PatientsRisk Patients

CHARISMACHARISMA-- ClopidogrelClopidogrel for High for High AtherothromboticAtherothrombotic Risk Risk and Ischemic Stabilization, Management, and Avoidanceand Ischemic Stabilization, Management, and Avoidance

Page 29: Asymptomatic Carotid Disease: Guidelines for Assessment ... 2011-2.pdf · Asymptomatic Carotid Disease: Guidelines for Assessment and Management Peter A. Soukas, MD, FACC, FSVM, FSCAI,

Recommendations for Antithrombotic Therapy in Recommendations for Antithrombotic Therapy in Patients With Carotid Disease Not Undergoing Patients With Carotid Disease Not Undergoing RevascularizationRevascularization

1. Class I2. Antiplatelet therapy with aspirin, 75 to 325 mg daily, is recommended for patients with obstructive

or nonobstructive atherosclerosis that involves the extracranial carotid and/or vertebral arteries for prevention of MI and other ischemic cardiovascular events, although the benefit has not been established for prevention of stroke in asymptomatic patients.33,260,305,338 (Level of Evidence: A)

3. In patients with obstructive or nonobstructive extracranial carotid or vertebral atherosclerosis who have sustained ischemic stroke or TIA, antiplatelet therapy with aspirin alone (75 to 325 mg daily), clopidogrel alone (75 mg daily), or the combination of aspirin plus extended-release dipyridamole(25 and 200 mg twice daily, respectively) is recommended (Level of Evidence: B) and preferred over the combination of aspirin with clopidogrel.260,305,339–342 (Level of Evidence: B) Selection of an antiplatelet regimen should be individualized on the basis of patient risk factor profiles, cost, tolerance, and other clinical characteristics, as well as guidance from regulatory agencies.

4. Antiplatelet agents are recommended rather than oral anticoagulation for patients with atherosclerosis of the extracranial carotid or vertebral arteries with343,344 (Level of Evidence: B) or without (Level of Evidence: C) ischemic symptoms. (For patients with allergy or other contraindications to aspirin, see Class IIa recommendation #2 below.)

Circulation 2011;124:489Circulation 2011;124:489--523523

Page 30: Asymptomatic Carotid Disease: Guidelines for Assessment ... 2011-2.pdf · Asymptomatic Carotid Disease: Guidelines for Assessment and Management Peter A. Soukas, MD, FACC, FSVM, FSCAI,

Carotid Carotid EndarterectomyEndarterectomy (CEA) (CEA) in in AsxAsx LowLow--RiskRisk PatientsPatients-- ACASACAS

MC, RCT of CEA vs. MC, RCT of CEA vs. Med Rx with >60% Med Rx with >60% stenosisstenosis

N=1662; median F/U N=1662; median F/U 2.7 years2.7 years

Primary outcome: Primary outcome: ipsilateralipsilateral stroke and stroke and periproceduralperiprocedural stroke stroke or deathor death

JAMA 1995;273:1421JAMA 1995;273:1421--88

Page 31: Asymptomatic Carotid Disease: Guidelines for Assessment ... 2011-2.pdf · Asymptomatic Carotid Disease: Guidelines for Assessment and Management Peter A. Soukas, MD, FACC, FSVM, FSCAI,

ACAS CEA CaveatsACAS CEA CaveatsElite surgeons, <3% stroke rate Elite surgeons, <3% stroke rate in prior yearin prior year

HighHigh--risk Patients Excluded:risk Patients Excluded:

age > 79age > 79

prior prior ipsilateralipsilateral CEACEA

ACS or MI in past 6 moACS or MI in past 6 mo

contralateralcontralateral occlusionocclusion

prior CVAprior CVA

cardiac valve or rhythm abnormality cardiac valve or rhythm abnormality likely to cause embolilikely to cause emboli

No No RCTsRCTs of Med Rx vs. of Med Rx vs. CEA in high surgical CEA in high surgical

risk patientsrisk patients

Page 32: Asymptomatic Carotid Disease: Guidelines for Assessment ... 2011-2.pdf · Asymptomatic Carotid Disease: Guidelines for Assessment and Management Peter A. Soukas, MD, FACC, FSVM, FSCAI,

Early vs. Deferred CEA in Early vs. Deferred CEA in Asymptomatic Patients with >70% ICA Asymptomatic Patients with >70% ICA StenosisStenosis-- ACSTACST

MC, RCT of 3120 pts, with MC, RCT of 3120 pts, with carotid carotid stenoisstenois >70% to >70% to immediate vs. deferred immediate vs. deferred CEACEA

55--yr. F/Uyr. F/U

Similar exclusions to Similar exclusions to ACAS, i.e., lowACAS, i.e., low--risk for risk for surgerysurgery

3.1% risk of Stroke/Death 3.1% risk of Stroke/Death w/in 30days of CEAw/in 30days of CEA

No benefit of CEA age >80No benefit of CEA age >80ACST Investigators, Lancet 2004;363:1491ACST Investigators, Lancet 2004;363:1491--15021502

Half of strokes were Half of strokes were disablingdisabling

Page 33: Asymptomatic Carotid Disease: Guidelines for Assessment ... 2011-2.pdf · Asymptomatic Carotid Disease: Guidelines for Assessment and Management Peter A. Soukas, MD, FACC, FSVM, FSCAI,

CEA: Risk of Stroke/DeathCEA: Risk of Stroke/DeathDepends who checking!Depends who checking!

selfself--reported, reported, 2.3%2.3%

neurologist oversight, neurologist oversight, 7.7%7.7%

High surgical riskHigh surgical risk

age > 75:age > 75: 77--10% 10% symptomatic;symptomatic; asymptomaticasymptomatic ~ 3%~ 3%

CHF: CHF: 88--9%9%

CAD requiring CABG: CAD requiring CABG: 66--10%10%

ContralateralContralateral carotid occlusion: carotid occlusion: 14.3%14.3% in NASCETin NASCET

Prior CEA Prior CEA w/restenosisw/restenosis: : 88--10%10%

CKDCKD-- Cr>1.5 Cr>1.5 (8.2%)(8.2%); Cr>2.9 ; Cr>2.9 (43%)

Page 34: Asymptomatic Carotid Disease: Guidelines for Assessment ... 2011-2.pdf · Asymptomatic Carotid Disease: Guidelines for Assessment and Management Peter A. Soukas, MD, FACC, FSVM, FSCAI,

NonNon--Stroke Risks of CEAStroke Risks of CEAWound ComplicationsWound Complications-- higher if XRT, prior surgery, higher if XRT, prior surgery, high/low locationhigh/low location

hematoma 1hematoma 1--5%5%

cranial nerve dysfunction 5cranial nerve dysfunction 5--8%, permanent 18%, permanent 1--2%2%

Higher risk if CKD, Higher risk if CKD, espesp HD; pulmonary diseaseHD; pulmonary disease

HyperperfusionHyperperfusion syndrome <1%syndrome <1%

MI 1MI 1--3%3%

RestenosisRestenosis 22--6%6%

Page 35: Asymptomatic Carotid Disease: Guidelines for Assessment ... 2011-2.pdf · Asymptomatic Carotid Disease: Guidelines for Assessment and Management Peter A. Soukas, MD, FACC, FSVM, FSCAI,

What Constitutes HighWhat Constitutes High--Risk for Risk for CEA?CEA?Medical CoMedical Co--morbiditiesmorbidities

EF <30%, NYHA class EF <30%, NYHA class ≥≥III III

FEV1 < 30%FEV1 < 30%

ESRD on dialysisESRD on dialysis

Need for heart surgery w/in Need for heart surgery w/in 30 days30 days

ACS, prior MI past 30 daysACS, prior MI past 30 days

2 or more 2 or more corcor vessels with vessels with ≥≥70% stenosis70% stenosis

Age > 80 Age > 80

Unfavorable AnatomyUnfavorable Anatomy

S/P radical neck surgeryS/P radical neck surgery

Inaccessible lesionsInaccessible lesions

Spinal immobilitySpinal immobility

TracheostomyTracheostomy

Contralateral occlusionContralateral occlusion

Contralateral laryngeal nerve Contralateral laryngeal nerve palsypalsy

Restenosis after prior CEARestenosis after prior CEA

Page 36: Asymptomatic Carotid Disease: Guidelines for Assessment ... 2011-2.pdf · Asymptomatic Carotid Disease: Guidelines for Assessment and Management Peter A. Soukas, MD, FACC, FSVM, FSCAI,

Carotid Artery Carotid Artery StentingStenting(CAS)(CAS)

PrePre PostPost

Page 37: Asymptomatic Carotid Disease: Guidelines for Assessment ... 2011-2.pdf · Asymptomatic Carotid Disease: Guidelines for Assessment and Management Peter A. Soukas, MD, FACC, FSVM, FSCAI,

Early CAS High Risk RegistriesEarly CAS High Risk Registries

Courtesy of W GrayCourtesy of W Gray

Page 38: Asymptomatic Carotid Disease: Guidelines for Assessment ... 2011-2.pdf · Asymptomatic Carotid Disease: Guidelines for Assessment and Management Peter A. Soukas, MD, FACC, FSVM, FSCAI,

EXACT/CAPTURE Combined EXACT/CAPTURE Combined 3030--day MAE: asymptomatic,< day MAE: asymptomatic,< 8080

Page 39: Asymptomatic Carotid Disease: Guidelines for Assessment ... 2011-2.pdf · Asymptomatic Carotid Disease: Guidelines for Assessment and Management Peter A. Soukas, MD, FACC, FSVM, FSCAI,

Remarkable Results for Recent Remarkable Results for Recent High Surgical Risk PatientsHigh Surgical Risk Patients

3% AHA/ASA Guideline3% AHA/ASA Guideline

Page 40: Asymptomatic Carotid Disease: Guidelines for Assessment ... 2011-2.pdf · Asymptomatic Carotid Disease: Guidelines for Assessment and Management Peter A. Soukas, MD, FACC, FSVM, FSCAI,

HighHigh--Risk RCT of CAS vs. Risk RCT of CAS vs. CEA: CEA: SapphireSapphire

NEJM 2004;351:1493NEJM 2004;351:1493--501501

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Sapphire: Sapphire: Death/Stroke/MI within 30 Death/Stroke/MI within 30 d, d, ipsilateralipsilateral CVA CVA between 31between 31--365 days365 days

NEJM 2004;351:1493NEJM 2004;351:1493--501501

CAS Superior

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Sapphire: Cumulative % of Sapphire: Cumulative % of StrokeStroke

NEJM 2005;112:416NEJM 2005;112:416

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Standard Risk US RCT Standard Risk US RCT of CAS vs. CEA: of CAS vs. CEA: CRESTCREST

NEJM 2010;363:11NEJM 2010;363:11--2323

Landmark NINDS/NIH sponsored, prospective, MC, RCT Landmark NINDS/NIH sponsored, prospective, MC, RCT

Independent Independent angioangio, EKG, MI, US core labs; , EKG, MI, US core labs; indind. . neuroneuro evaleval

53% symptomatic, 47% asymptomatic53% symptomatic, 47% asymptomatic

Only 52% CAS operators were accepted into trialOnly 52% CAS operators were accepted into trial

Required surgeons to achieve stroke/death rate of <3% for Required surgeons to achieve stroke/death rate of <3% for asymptomatic, <6% symptomatic patientsasymptomatic, <6% symptomatic patients

Began in 2000, completed enrollment in 2008Began in 2000, completed enrollment in 2008

1st generation stent/EPD; early CAS experience1st generation stent/EPD; early CAS experience

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CREST: Composite PrimaryCREST: Composite Primary Endpoint of Endpoint of Death/Stroke/MI Within 30 DaysDeath/Stroke/MI Within 30 Days

Per ProtocolPer Protocol CASCASN=1,131N=1,131

CEACEAN=1,176N=1,176 DifferenceDifference p=valuep=value

All Death, All Death, Stroke, or MIStroke, or MI 5.8%5.8% 5.1%5.1% 0.7%0.7% 0.520.52

DeathDeath 0.53%0.53% 0.26%0.26% 0.27%0.27% 0.330.33

Any StrokeAny Stroke 4.1%4.1% 1.9%1.9% 2.2%2.2% 0.00190.0019

Major StrokeMajor Stroke 0.9%0.9% 0.4%0.4% 0.5%0.5% 0.200.20

Minor StrokeMinor Stroke 3.2%3.2% 1.5%1.5% 1.7%1.7% 0.00880.0088

MIMI 2.0%2.0% 3.4%3.4% --1.5%1.5% 0.03870.0387

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Primary Composite Primary Composite Endpoint for Asymptomatic Endpoint for Asymptomatic StatusStatus

Primary Endpoint= Death/Stroke/MIPrimary Endpoint= Death/Stroke/MI

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Neurological Residual Deficits by Neurological Residual Deficits by mRSmRSAssociated With Minor Strokes:Associated With Minor Strokes:Similar at 6 MonthsSimilar at 6 Months

ΔΔ = 0.70%= 0.70% ΔΔ = 0.30%= 0.30%

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Lack of Association of Minor Lack of Association of Minor Stroke With Long Term MortalityStroke With Long Term Mortality

NEJM 2010;363:11NEJM 2010;363:11--2323

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Association of Cardiac Association of Cardiac TroponinTroponin, CK, CK--MB, MB, and Postoperative Myocardial Ischemia and Postoperative Myocardial Ischemia With LongWith Long--Term Survival After Major Term Survival After Major SurgerySurgery

J Am J Am CollCollCardiolCardiol

2003;42:2003;42:15471547--5454

Peri-op MI carries significant mortality risk!

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Similar Association of Any Similar Association of Any Stroke or MI on Long Term Stroke or MI on Long Term MortalityMortality

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CRESTCREST-- Primary OutcomePrimary Outcome--4 Years4 Years

NEJM 2010;363:11NEJM 2010;363:11--2323

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CREST 1CREST 1°° Endpoint at 4 Endpoint at 4 YearsYears

NEJM 2010;363:11NEJM 2010;363:11--2323

p=ns

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CREST ConclusionsCREST ConclusionsCAS nonCAS non--inferior to inferior to CEA for the primary CEA for the primary endpoint of endpoint of death/stroke/MIdeath/stroke/MI

CAS shows similar CAS shows similar durability to CEA by durability to CEA by freedom from primary freedom from primary endpoint, mortality, endpoint, mortality, ipsilateralipsilateral stroke and stroke and TLR to 4 yearsTLR to 4 years

CAS less invasive, CAS less invasive, avoids CN injuryavoids CN injury

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ACTACT--1: RCT of CEA vs. CAS in Standard 1: RCT of CEA vs. CAS in Standard Surgical Risk Patients: Surgical Risk Patients: CASCAS LeadLead--in in OutcomesOutcomes

EventEvent 30 days, N=11830 days, N=118Death, Stroke, MIDeath, Stroke, MI 1.7%1.7%All Stroke and DeathAll Stroke and Death 1.7%1.7%Major Stroke and DeathMajor Stroke and Death 0.0%0.0%

DeathDeath 0.0%0.0%All Stroke All Stroke 1.7%1.7%

Major StrokeMajor Stroke 0.0%0.0%

Minor StrokeMinor Stroke 1.7%1.7%MIMI 0.0%0.0%

3131--365 days, N=77365 days, N=77IpsilateralIpsilateral StrokeStroke 0.0%0.0%

Contemporary, on going trial with modern devices, experienced opContemporary, on going trial with modern devices, experienced operators erators

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Recommendations for Selection of Recommendations for Selection of Asymptomatic Patients for Carotid Asymptomatic Patients for Carotid RevascularizationRevascularization-- Now Class I Now Class I IndicationIndication

Circulation 2011;124:489Circulation 2011;124:489--523523

1.Selection of asymptomatic patients for carotid revascularization should be guided by an assessment of comorbid conditions, life expectancy, and other individual factors and should include a thorough discussion of the risks and benefits of the procedure with an understanding of patient preferences. (Level of Evidence: C)

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Recommendations for Selection of Asymptomatic Recommendations for Selection of Asymptomatic Patients for Carotid RevascularizationPatients for Carotid Revascularization

Circulation 2011;124:489Circulation 2011;124:489--523523

1. Class IIa2.It is reasonable to perform CEA in asymptomatic patients who have more

than 70% stenosis of the internal carotid artery if the risk of perioperativestroke, MI, and death is low.74,76,359,361–363 (Level of Evidence: A)

3.It is reasonable to choose CEA over CAS when revascularization is indicated in older patients, particularly when arterial pathoanatomy is unfavorable for endovascular intervention.360,364–368 (Level of Evidence: B)

4.It is reasonable to choose CAS over CEA when revascularization is indicated in patients with neck anatomy unfavorable for arterialsurgery.369–373§ (Level of Evidence: B)

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ConclusionsConclusions

You should screen for CVDYou should screen for CVD-- CDUS best initial testCDUS best initial test

Aggressively treat risk factors with ASA, statins, Aggressively treat risk factors with ASA, statins, ACE/ARB, diet, exercise, intensive glucose control, ACE/ARB, diet, exercise, intensive glucose control, smoking cessation aidssmoking cessation aids

Asymptomatic patients with Asymptomatic patients with ≥≥80% ICA stenosis 80% ICA stenosis should be referred for revascularization; there is should be referred for revascularization; there is NONOlevel 1 evidence that medical therapy is better level 1 evidence that medical therapy is better than/equal to revascularizationthan/equal to revascularization

CAS ~ CEA for standard risk patients, preferred for CAS ~ CEA for standard risk patients, preferred for high surgical risk patients, younger patientshigh surgical risk patients, younger patients

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Thanks for your Thanks for your attention!attention!

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Recommendations for Selection of Recommendations for Selection of Asymptomatic Patients for Carotid Asymptomatic Patients for Carotid RevascularizationRevascularization

1. Class IIb2.Prophylactic CAS might be considered in highly selected patients with

asymptomatic carotid stenosis (minimum 60% by angiography, 70% by validated Doppler ultrasound), but its effectiveness compared with medical therapy alone in this situation is not well established.360 (Level of Evidence: B)

3.In symptomatic or asymptomatic patients at high risk of complications for carotid revascularization by either CEA or CAS because of comorbidities,‖ the effectiveness of revascularization versus medical therapy alone is not well established.35,361,362,366,369–372,375,376 (Level of Evidence: B)

Circulation 2011;124:489Circulation 2011;124:489--523523