Carotid Revascularization: Who, When, and How

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Carotid Revascularization:
Who, When, and How
JAMES T DEVRIES, MD, FACC, FSCAI
ASSISTANT PROFESSOR OF MEDICINE
GEISEL SCHOOL OF MEDICINE AT DARTMOUTH
DIRECTOR, CARDIAC CATHETERIZATION LAB
DARTMOUTH-HITCHCOCK MEDICAL CENTER
DISCLOSURES
None of the planners or presenters of
this session have disclosed any
conflict or commercial interest
Carotid Revascularization:
Who, When, and How
 OBJECTIVES:
1.
Describe symptomatic and asymptomatic carotid artery
disease.
2.
Review the research related to revascularization.
3.
Explain which procedure is indicate depending on the
specific patient evaluation.
Outline
 Background
 Part 1: Asymptomatic carotid disease
 Part 2: Symptomatic carotid disease
 Part 3: Stenting versus surgery
 Overall conclusions
PART 1: Asymptomatic Carotid
Stenosis
Clinical Question #1
 A 67 yo male is seen in clinic follow up. He has an




asymptomatic left carotid bruit and a duplex
demonstrates a 50-79% stenosis of the left internal
carotid artery. He has known CAD and
hyperlipidemia and is on aspirin and atorvastatin.
He has a normal creatinine. The one year risk for an
ipsilateral stroke is:
A. 1%
B. 3%
C. 5-7%
D. >10%
Clinical Question #2
The patient in question #2 wants the best therapy possible
for his carotid stenosis, telling you “I don’t want a stroke.”
You recommend:
 A. . Add clopodigrel (Plavix) to his medications and
monitor with serial duplex
 B. Referral for immediate carotid artery stent (CAS) with
embolic protection device
 C. Referral for immediate carotid endarterectomy (CEA)
 D. Continue current medical therapy with serial duplex
exams
Stroke: By the Numbers
 800,000 strokes/year in the United States
 Approximately 80% are ischemic, 20% hemorrhagic
 8-10% of ischemic strokes are attributed to carotid
stenosis; mechanism is plaque rupture and embolism
 In the year 2012, in the United States we performed:
~8,000 carotid artery stent (CAS) procedures
140,000
carotid endarterectomy (CEA) procedures
 CEA is one of the most common procedures
performed in vascular surgeons’ daily practice
Asymptomatic Carotid Stenosis
 By age 75, about 7% of the population will have some
degree of asymptomatic stenosis
 In the Medicare population over age 65, 1-2% will
have high grade asymptomatic carotid stenosis
 Management of these patients is controversial, based
in part on variable or small benefits for
revascularization in randomized trials and
improvements in medical therapy since pivotal trials
have been published
What would NEJM readers do?
Common problem; common
procedure, so…..
WHY THE
CONTROVERSY?
ACAS and ACST: Pivotal Trials
ACAS and ACST Results: 5 year Outcomes
ACAS and ACST: Issues
 Medical therapy arm had essentially no therapy:
statins, BP control, antiplatelet therapy
 Surgical sites were highly selected: best outcomes
(3% stroke risk during surgery)
 Population studied: Men!!
 Sooooo- the best surgeons compared to the worst
medical therapy had a very small benefit, maybe
none in women?
Are we sure about this??
Annual Stroke Risk for Asymptomatic Disease
Medical Therapy: A Moving Target
Changes in Stroke Risk over Time
Statin Use in ACST
Lancet 2010;376:1074
Effect of Statin Use on Outcomes
The writing is on the board: Statins work!
Guidelines: 2011 Update for Asymptomatic
 Class I
 Class IIA
Guidelines: 2011 Update for Asymptomatic
 Class IIb
How to Pick?
Management of Asymptomatic Stenosis
Clinical Question #1
 A 67 yo male is seen in clinic follow up. He has an




asymptomatic left carotid bruit and a duplex
demonstrates a 50-79% stenosis of the left internal
carotid artery. He has known CAD and
hyperlipidemia and is on aspirin and atorvastatin.
He has a normal creatinine. The one year risk for an
ipsilateral stroke is:
A. 1%
B. 3%
C. 5-7%
D. >10%
Clinical Question #2
The patient in question #2 wants the best therapy possible
for his carotid stenosis, telling you “I don’t want a stroke.”
You recommend:
 A. . Add clopidogrel (Plavix) to his medications and
monitor with serial duplex
 B. Referral for immediate carotid artery stent (CAS) with
embolic protection device
 C. Referral for immediate carotid endarterectomy (CEA)
 D. Continue current medical therapy with serial duplex
exams
Part 2: Symptomatic Carotid
Stenosis
Clinical Question
A 67 y.o. male presents with right eye amaurosis fugax
lasting for 5 minutes three days ago. His symptoms
resolved spontaneously and he underwent duplex scanning
of the carotid arteries, revealing an 80% RICA stenosis
with some “plaque ulceration.” He has known paroxsymal
atrial fibrillation, hypertension, and lower extremity PAD.
His medications include aspirin, lisinopril, atorvastatin,
and coumadin. INR is 1.9. Best next therapy is:
A. Add clopidogrel (Plavix) to medications and monitor
B. Refer for immediate CEA
C. Refer for immediate CAS
D. TEE
E. Double statin dose and repeat duplex in 3 months
Symptomatic Carotid disease
 Clinical symptoms are related to hemispheric
stroke/TIA from an unstable carotid plaque
 Symptoms occurred within the previous 6 months
 Pivotal Trials which have shaped guidelines are:


NASCET (North American Symptomatic Carotid
Endarterectomy Trial) published 1991 in NEJM
ECST (European Carotid Surgery Trial) published in Lancet in
1998
Outcomes: ECST and NASCET
Determining Stenosis Severity in Trials
 ECST and NASCET had different
stenosis determination
 ECST 80%= NASCET 60%
Relationship Between % Stenosis and Stroke
95-99%
70-95% stenosis
Relationship between % Stenosis, Age, Stroke
Relationship between Plaque Ulceration and Stroke
Timing of Surgery
CEA in Symptomatic Disease
 In trials, surgical stroke risk with CEA is ~6% in
experienced hands
 Most data supports early revascularization (within 24 weeks of index event) owing to high risk of
recurrent TIA/stroke with waiting, particularly in
those with higher grade lesions
 Women (again) underrepresented but did have
benefit, although not as great as men
 Elderly benefit
Guidelines
Clinical Question
A 67 y.o. male presents with right eye amaurosis fugax
lasting for 5 minutes three days ago. His symptoms
resolved spontaneously and he underwent duplex scanning
of the carotid arteries, revealing an 80% RICA stenosis
with some “plaque ulceration.” He has known paroxsymal
atrial fibrillation, hypertension, and lower extremity PAD.
His medications include aspirin, lisinopril, atorvastatin,
and coumadin. INR is 1.9. Best next therapy is:
A. Add clopidogrel (Plavix) to medications and monitor
B. Refer for immediate CEA
C. Refer for immediate CAS
D. TEE
E. Double statin dose and repeat duplex in 3 months
Part 3
STENTING (CAS) OR SURGERY
(CEA)FOR CAROTID
REVASCULARIZATION
The Data: CAS and CEA
CREST Trial
Methods
 Randomized, controlled trial with blinded end-
point
 117 centers in US and Canada (108 US)
 Proceduralists in study were certified to enroll
patients if:
>12 procedures/year
 Rates of complications and death < 3% among
asymptomatic pts and <6% among symptomatic pts.

Methods - Patient Selection
 Symptomatic = TIA, amaurosis fugax, or minor
disabling stroke involving study carotid w/in 180
days before randomization.
 Eligibility:
50%+ on angiography
 70%+ on u/s, CTA, MRA
 In 2005, included asymptomatic pts with:

60+% on angiography
 70+% on u/s
 80+% on CTA or MRI if u/s showed 50-69%.

Methods - Patient Selection
 Exclusion criteria:
 Previous CVA
 Atrial fibrillation w/in preceding 6 months
 MI within previous 30 days
 UA
 Anatomical reasons
CAS & CEA
 CAS
 Involved RX Acculink stent, when feasible RX Accunet
embolic protection device
 Pretreatment with ASA 325mg BID, Clopidogrel 75mg
QD, at least 48 hrs prior to CAS
 If CAS scheduled within 48hrs of randomization, ASA
650mg and Clopidogrel 450mg given 4 or more hours
before procedure
 Post-CAS: ASA 325mg or 650mg dail + Clopidogrel 75 or
Ticlopidine 250mg BID x 4 weeks.+
CAS & CEA
 CEA
 48+ hrs prior, ASA 325mg daily for 1 year or more (or
ticlopidine 250mg BID or Clopidogrel 75mg daily, ASA 81mg
daily, Dipyridamole BID)
F/U Assessment of End-Points
 Neuro evaluation at baseline, 18-54 hrs post



procedure, 1 month, q6 months thereafter.
Cardiac biomarkers measured pre-procedure, 6-8
hrs after, 1 month.
ECG before CAS/CEA, 6-48hrs after, 1 month
after.
Carotid u/s before CAS/CEA, 1, 6, and 12 months,
and annually thereafter
Phone f/u at 3 months and 6 months thereafter
Endpoints
 Primary end-point: CVA, MI, or death during
periprocedural period or ipsilateral CVA within 4
years after randomization.
N=2502
Results - Primary End Point
Results
 Stroke more common after CAS
 MI more common after CEA
 Overall composite endpoint showed no statistical
difference
Primary End Point (4yr)
Primary End Point by Age
Results
 Primary end point did NOT differ among
symptomatic or asymptomatic pts.
 Peri-procedural cranial-nerve palsies less frequent
among CAS patients.
 4-yr CVA or death 6.4% (CAS) vs 4.7% in CEA
(p=0.03).
Symptomatic pts: 8% vs 6.4% (p=0.14)
 Asymptomatic pts: 4.5% vs 2.7% (p=0.07)

Post-hoc Analyses
 Major/minor CVA found to have effect on physical
health at 1 year; periprocedural MI less clear.
 Minor CVA had significant effect on mental health
at 1 year
 Likelihood of primary end point not significantly
affected by the specialty of the interventionist
performing CAS (p=0.51).
CREST 10 Year Data (published 2016)
Brott et al. Long term results of stenting versus endarterectomy for
carotid stenosis. NEJM, 374(11), 2016
.
ACT 1
Limitations
 Overall, a very well conducted study!
 Highly trained proceduralists - may be more than
the average in practice.
 One stent platform used.
 Medical Rx not specifically tested.
Summary - CREST
 CAS and CEA associated with similar combined
rates of periprocedural CVA, MI, or death and
subsequent ipsilateral CVA (symptomatic and
asymptomatic men and women).
 Incidence of periprocedural stroke lower in CEA
cohort; incidence of MI lower in CAS cohort.
 Younger pts had slightly fewer events after CAS;
older pts had fewer events after CEA.
 Medical therapy similar in both groups
Overall Conclusions
(TIME TO WAKE UP)
Conclusions and Summary
 Asymptomatic carotid stenosis is common, and for
many patients medical therapy is all that is needed
 Selected patients with good life expectancy and
moderately high grade stenosis (in the hands of good
surgeons) may be appropriate for CEA
 Controversy exists over how to select the best
asymptomatic patients for carotid revascularization.
Conclusions and Summary
 Symptomatic patients with high grade stenosis
should be considered for CEA or CAS
 CAS and CEA should be considered as similar
procedures, with the choice of procedure dependent
on patient factors and local expertise
 Medical therapy is crucial in the management of any
carotid stenosis, regardless of symptoms
 Unknown how modern medical therapy fares against
revascularization for symptomatic patients- stayed
tuned!
Hopefully not too vague!!
THANK YOU
JAMES.DEVRIES@HITCHCOCK.ORG
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