1. The Management of Carotid Artery Disease: Who and When?
CRT
Washington, DC
February 24, 2013
The Management of Carotid Artery Disease: Who and When?
Michael R. Jaff, DO, FACC
Associate Professor of Medicine
Harvard Medical School
Chair, MGH Institute for Heart, Vascular, and Stroke Care
Boston, Massachusetts

2. Michael R. Jaff, DO Consultant Abbott Vascular (non-compensated)
American Genomics, Inc
Becker Venture Services Group
Bluegrass Vascular Therapies
Cordis Corporation(non-compensated)
Covidien (non-compensated)
Ekos Corporation (DSMB)
Hansen Medical
Medtronic (non-compensated)
Micell, Incorporated
Primacea
Trivascular, Inc.
Equity
Access Closure, Inc
Embolitech, Inc
Hotspur, Inc
Icon Interventional, Inc
I.C.Sciences, Inc
Janacare, Inc
Northwind Medical, Inc.
PQ Bypass, Inc
Primacea
Sadra Medical
Sano V, Inc.
TMI/Trireme, Inc
Vascular Therapies, Inc
Board Member
VIVA Physicians (Not For Profit
501(c) 3 Organization)

3. Let Me Show You All My Cards Before We Start…
I am not a vascular surgeon
I am not an interventionist
I am not a neurologist
So, what the heck am I doing here?

4. What Is My Goal?
Provide just the facts, and let you make your decision

5. Stroke Statistics—Is This Really a Big Problem?
~795,000 new/recurrent strokes each year
610,000 first stroke
185,000 recurrent events
Circulation 2012;125:e2-e220

6. The Stroke Mortality Map
Circulation 2012;125:e2-e220

7. Stroke Stats Fourth leading cause of death in the US
134,138 deaths in 2008
1 out of 18 deaths due to stroke in US
One American dies of a stroke every 4 minutes
Most common cause of adult disability
31% of stroke survivors receive outpatient rehabilitation
50% with some hemiparesis
30% unable to walk without some assistance
26% dependent in ADLs
35% depressed
26% institutionalized in a nursing home
Circulation 2012;125:e2-e220

8. $1.52 Trillion---Non-Hispanic Whites $313 Billion---Hispanics
Stroke Costs
Total cost of stroke care (in 2005 dollars)
$1.52 Trillion---Non-Hispanic Whites
$313 Billion---Hispanics
$379 Billion---Blacks
Circulation 2012;125:e2-e220

9. Add Up All The Stroke Risk Factors….
Circulation 2012;125:e2-e220

10. Recommendations for Primary Stroke Prevention
ASA
SBP <140 mmHg/DBP <90 mmHg
Abstinence from cigarette smoking
Diabetes
Hypertension
JNC VII Blood Pressure Control (ACEI/ARB)
Hypercholesterolemia
Statins for LDL goal NCEP/ATP III Goals
Stroke 2011;42:517-84

11. Carotid Endarterectomy

12. What We Know about CEA vs Medical Therapy
Circulation 2012;126:

13. What About Treatment of Carotid Artery Stenosis for Stroke Prevention?
NASCET/ACAS—CEA for Stroke Prevention

14. Why Carotid Endarterectomy?
Procedure has been around for a long time (over 50 years)
Techniques perfected
Results repeatedly solid
The gold standard
Patients often discharged within 24 hours
Never see the inside of an ICU

15. Lancet 2004;363:1491

16. 3120 Patients
Lancet 2010;376:1074

17. Are There Patients at High Risk for CEA?
Circulation 2012;126:

18. Carotid Artery Stent

19. No need for general anesthesia Conscious Sedation
Why Carotid Stenting?
No surgical incision
No need for general anesthesia
Conscious Sedation
Useful in patients at high risk for CEA

20. Clinical Trials Evaluating CAS
FDA Approval for Standard Risk Patients
FDA Approval for High Risk Patients
ARCHeR N = 581
CAPTURE
N = 4,225
SECuRITY N = 305
EXACT
N = 2,145
SAPPHIRE N = 747
PROTECT N = 322
CAPTURE 2 N = 6,361
High risk
CHOICE N = 6,872 (enrolling)
Standard risk
SPACE (EU) N = 1,183 sym
SPACE (EU) N = 1,183 sym
AHA Guidelines (pub.1995)
EVA-3s (EU) N = 527 sym
NASCET N = 2,885
ICSS (EU) N = 1,710 sym
CREST N = 2,502
ACAS N = 828
ACST N = 3120
ACT I N = 1,372 (enrolling)
ACT I N = 1,372 (enrolling)
1980
1990
1995
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
CEA
CAS High Risk
CAS Standard Risk 20
Source:

21. All Leading Up to the Mother of All Carotid Trials…
N Engl J Med 2010;363:11-23

22. CREST Primary Endpoint*
This Should Have Settled
Any Debate, Shouldn’t it?
*Periprocedural Death, Stroke, MI PLUS
Ipsilateral Stroke at 4 Years
N Engl J Med 2010;363:11-23

23. Why Didn’t CREST End the Debate?
Surgeons feel that carotid revascularization is performed for stroke prevention
CEA reduced stroke risk more than CAS
Excess MI rate with CEA less of an issue
Interventionists feel that CAS performed as safely as CEA
Excess stroke risk was minor stroke only
MI risk of CEA is important
Neurologists feel that although outcomes were low, medical therapy is more effective than any revascularization

24. CREST So, This is the Issue: Should Myocardial Infarction
Have Been Included as a Component of the
Primary Endpoint?
N Engl J Med 2010;363:11-23

25. J Am Coll Cardiol 2003;42:

26. J Am Coll Cardiol 2003;42: 26

27. Stroke 2012;43

28. What is Public Opinion?

29. Is Dr. Abbott’s Analysis Accurate?
If the systematic review’s analysis had adjusted for minimum % stenosis, or had included more recent studies (REACH and ACST) the trend in stroke rates would have been in the opposite direction (p = 0.55)
Largest and most recent REACH study (N = 3164) published after the systematic review contradicts the review findings
The Change in Minimum Stenosis Thresholds in Studies Over Time Mirrors the Reported Decline In Stroke Rates
Trend sensitive to effects of early study
with more complex patients
Aichner FT, et al. Eur J Neurol 2009; 16:

30. Enough Controversy? Oh No….

31. CREST: No Difference in Cost-Effectiveness

32. Stroke 2012;43:

33. We Have Got To Stop Debating in the Lay Press….

34. So, Can I Make Sense of the Data?
Firstly, it still never ceases to amaze me how even after Level A
Multicenter Randomized Trials that Meet the Primary Endpoint,
Physicians Don’t Agree on the Interpretation
Options for Patients with Carotid Artery Disease
CEA: Effective when performed by skilled surgeons with excellent track record
CAS: Effective when performed by skilled interventionists
Medical Therapy: Still must be tested head-to-head with revascularization, but impact likely improving—

35. Current and Future Investigation: What’s on the Horizon???
Asymptomatic Patients (standard surgical risk):
ACT I study to complete 1658 patient randomized enrollments CAS vs. CEA
NO!!! ACT I JUST STOPPED

36. Current and Future Investigation: What’s on the Horizon???
Asymptomatic Patients (standard surgical risk):
ACT I study to complete 1658 patient randomized enrollments CAS vs. CEA
ACST2 and SPACE2 underway in Europe
High surgical risk:
New US studies to enroll shortly for:
Proximal protection via direct carotid access (Silk Road)
Mesh-covered stent (WL Gore)
CREST 2 application for funding pending 2nd review by NIH
Asymptomatic patients with OMT vs. revascularization + OMT

38. Potential Inputs and Outputs
PrOE Appropriateness tool
Procedure Scheduling
Pre-populated data fields (NLP search)
Appropriateness Indications & Decision support
Internal Performance Dashboards
LMR, OnCall
EMR
Public Reporting
Appropriateness Data Repository
Data storage
RPM, RPDR, CDR, EMPI
Billing and Prior Authorization
Copy of appropriateness results placed in LMR and CDR
Measurement & analysis of appropriateness and outcomes inform guidelines and indications in real-time
Personalized consent form
Existing registries
PCI, CABG, Vascular, Harris Joint
Data passback to registries (Web service)