1. Medstar Washington Hospital Center
Carotid Artery Disease Past, Present & Future Who should have an intervention in 2017?
Rajesh Malik M.D., FACS
Vascular Surgery
Medstar Washington Hospital Center

2. Disclosure Statement of Financial Interest
I, Rajesh Malik, DO NOT have a financial interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation.

3. Overview Stroke 2nd leading cause of death U.S. 500,000 strokes/year
3 million stroke survivors
35% of carotid origin

4. Carotid Stenosis History
Fisher 1951
Ischemic stroke &
“occlusion of the
internal carotid artery”

5. Earliest Reported Case Resection, anastomosis
Eastcott and Rob
St. Mary’s Hospital, May 19th, 1954

6. Carotid Artery Pathology
Atherosclerosis
Fibromuscular Dysplasia
Coils/Kinks
Aneurysms
Takayasu's Arteritis
Radiation

7. Carotid Stenosis Clinical syndromes
Asymptomatic
Symptomatic
TIA - brief episode of focal loss of brain function < 24 hrs, 2-15 minutes
RIND - >24hrs, <1 week.
Stroke

8. Imaging Duplex sonography
Accurate
Non-invasive
Plaque characteristics
Screening
Intraop, postop

9. Imaging MRA Non-invasive Non-nephrotoxic Assess cerebral circulation
May overestimate degree of occlusion

10. Imaging Angiography Gold standard Plaque characteristics Invasive
Risk of stroke
Iodinated contrast

11. Copyright © 2015 American Medical Association. All rights reserved.
From: Management of Asymptomatic Internal Carotid Artery Stenosis
JAMA. 2013;310(15): doi: /jama
Table Title:
Level 1 Studies in Revascularization of Asymptomatic Carotid Artery Stenosis Disease
Date of download: 5/4/2015
Copyright © 2015 American Medical Association. All rights reserved.

12. Randomized Trials Asymptomatic
Surgical
+ Medical Medical
ACAS 5 year
> 60% stenosis death/stroke/TIA 5.1 % 11 %
* Highly sig 30 day actual
study halted death /stroke %
angio death/stroke 1.2 %

13. The benefit of surgery was greater for men than women (reduction in risk, 66% vs. 17%)
The rate of perioperative complications was higher among women than men (3.6% vs. 1.7%).

14. Randomized Trials Symptomatic
surgical
+ medical medical
NASCET 2 year % %
70-99% death/stroke
(p=0.001) 30 day % 3.3 %
death/stroke
NASCET 5 year 16 % 22 %
50-69% death/stroke
(p=0.045)
ECST 3 year
70-99% death/stroke/ 12% 22%
(p=0.001) 30 day
death /stroke %

15. NASCET

16. Carotid Endarterectomy Surgical complications
7.6 % cranial nerve injury
5.5 % wound hematoma
3.4 % wound infection
3.9 % cardiovascular (MI, CHF, PVCs)
81% considered to be minor
NASCET New Engl J Med 1991

17. Carotid Endarterectomy Indications - Asymptomatic
Proven
stenosis > 60%
Uncertain
high risk patient
surgeon morbidity-mortality >3%
combined carotid coronary operation
non-stenotic ulcerative lesions
Inappropriate
Morbidity-mortality rate >5%
Ad hoc committee, Stroke council, AHA, 1995

18. Carotid Endarterectomy Indications - Symptomatic
Proven
stenosis > 70%
Acceptable
stenosis 50-69%
Uncertain
symptomatic acute thrombosis
Inappropriate
stenosis <50%, not on aspirin
Ad hoc committee, Stroke council, AHA, 1995

19. Carotid Endarterectomy Technical controversies
Anesthesia
Shunting
Patch angioplasty

20. Carotid Endarterectomy Anesthesia
Local
patient monitoring
avoid general anesthesia
General
compliance
decrease cerebral metabolism
increase cerebral blood flow

21. Shunting Pitfalls
Dissection
Embolization
Flap

24. Carotid Endarterectomy Patch angioplasty
Recurrent stenosis more likely in:
women
smokers
small ICA
Prospective
randomized trials -
patch  recurrent stenosis

25. CAS vs. CEA
CAS
CEA

26. Carotid Stenting The goal

27. Carotid Stenting The problem

28. Quantification of emboli Transcranial Doppler
202±119
52±64
Number of hits
CAS
CEA
Procedure
Crawley F, Clifton A, Buckenham T, et al. Comparison of hemodynamic cerebral ischemia and microembolic signals detected during CEA and CAS. Stroke 1997

29. Cerebral Protection Devices The Solution?
Distal balloon occlusion
Distal filters
Proximal balloon occlusion

30. Distal Filter Angioguard

31. Distal Filter MedNova

32. Carotid Stenting Early Results
30 day Study No. TIA Stroke Death Death/Stroke Wholey % 2.9 % 1.3 % 4.2 % Dangas % 2.6 % 0 % 2.6 % Roubin % 1.6 % 7.4 % Parodi % 0 % 4.3 % Henry % 2.9 % 0.3 % 3.2 % Wholey % 4.2 % 0.8 % 5.0 %

33. CEA vs. CAS Alberts, et al. Stroke 2001
First multicenter, randomized prospective study
Wallstent, no protection
CAS vs. CEA:
30 day complication % vs. 4.5%
ipsi stroke/ death (1 year) % vs. 3.6%
any major stroke (1 year) - 3.7% vs. 0.9%
Study terminated early based on futility analysis

34. CAS Trials CREST (NIH) – symptomatic, mimic NASCET
ICAROS – Imaging: CAS & risk of stroke
Cordis – Angioguard & Smart
MedNova – MedNova stent&filter
CAFÉ USA (phase 2): Wallstent & Percusurge
Many more to come: CAVATAS II, EVA, …
Databanks: EUROCAST,….

35. The CREST Trial (2010)
Methods: Randomized trial comparing CEA and CAS in 2502 patients with CA stenosis (both symptomatic and asymptomatic)
Composite end point- stroke, MI or death from any cause during 30 days post-op or any ipsilateral stroke within 4 yrs of treatment
Results:
No significant difference in composite primary end point after 4 yrs
No difference for symptom status or sex
4 year rate of stroke or death in asymptomatic patients 4.5% in CAS and 2.7% in CEA
Higher rates of MI in CEA group (1.1% CAS vs. 2.3% CEA)
Higher rates of stroke in CAS group (4.1% CAS vs. 2.3% CEA)
Higher rates of Cranial Nerve Palsies in CEA (0.3% CAS vs. 4.7% CEA)

36. CREST Results Cont. Differential effects of Age:
Outcomes were slightly better after CAS for patients aged <70 years and better after CEA for patients aged >70 years.
Quality of Life Survey:
At 1 year, periprocedural stroke had an effect on the physical component summary scale of the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36)
Periprocedural MI had no effect
Rates of Restenosis:
Similar rates of restenosis/occlusion (6.0% CAS vs. 6.3% CEA)
Note: smoking predicted increased restenosis rate after CEA only

37. Brott TG et al. N Engl J Med 2010;363:11-23.
Primary End Point, According to Treatment Group.
Figure 2. Primary End Point, According to Treatment Group. The primary end point was a composite of stroke, myocardial infarction, or death from any cause during the periprocedural period or ipsilateral stroke within 4 years after randomization. Panel A shows the Kaplan–Meier curves for patients undergoing carotid-artery stenting (CAS) and those undergoing carotid endarterectomy (CEA) in whom the primary end point did not occur, according to year of follow-up. Panel B shows the hazard ratios for the primary end point, as calculated for the CAS group versus the CEA group, according to age at the time of the procedure. The hazard ratios were estimated from the proportional-hazards model with adjustment for sex and symptomatic status. Dashed lines indicate the 95% confidence intervals. Panel C shows the numbers of patients in each age group.
Brott TG et al. N Engl J Med 2010;363:11-23.

38. In what groups might we consider CAS?
SAPPHIRE Trial (NEJM 2006) – non-inferiority study
Patients (asymptomatic and symptomatic) with carotid stenosis and other co-morbidities placing them at high risk for surgery. At least one of the following criteria were required
Clinically significant heart disease
Severe pulmonary disease
Contralateral carotid occlusion
Contralateral laryngeal nerve palsy
Previous radical neck surgery or radiation therapy
Recurrent stenosis after endarterectomy
Age >80 yrs

39. Relative Contraindications for CEA
History of prior neck irradiation
Concurrent tracheostomy
Prior radical neck dissection with or without radiation
Contralateral vocal cord paralysis from prior endarterectomy
Atypical lesion location, either high or low that is surgically inaccessible
Severe recurrent carotid stenosis
Unacceptably high medical risk

43. SVS guidelines
The committee recommends CEA as the first-line treatment for most symptomatic patients with stenosis of 50% to 99% and asymptomatic patients with stenosis of 60% to 99%.
CAS should be reserved for symptomatic patients with stenosis of 50% to 99% at high risk for CEA for anatomic or medical reasons.
CAS is not recommended for asymptomatic patients at this time
Asymptomatic patients at high risk for intervention or with <3 years life expectancy should be considered for medical management as the first-line therapy

44. Future
The Carotid Revascularization Endarterectomy Stenting Trial 2 (CREST 2) is currently recruiting subjects with asymptomatic carotid artery stenosis and ≥70% stenosis. The study will compare either OMT alone versus OMT plus CEA or OMT alone versus OMT plus CAS.
The Stent-Protected Angioplasty in Asymptomatic Carotid Artery Stenosis versus Endarterectomy (SPACE-2) study aims to recruit about 3,500 patients and randomly assign them to OMT alone or CEA or CAS.

45. Thank You !