1. Managing Carotid Disease After Crest - Carotid Endarterectomy (CEA):
Cardiovascular Research Technology (CRT) 2011
Washington, DC, Feb 27 – March 1, 2011
7 min
Managing Carotid Disease After Crest - Carotid Endarterectomy (CEA):
If Not Dead, Is Seriously Damaged
Neurovascular & Stroke Management3/1/2011 8:00:00 AM3/1/2011 8:07:00 AMDebate: Managing Carotid Disease After Crest - Carotid Endarterectomy (CEA): If Not Dead, Is Seriously DamagedPalladian BallroomSpeaker
Management of Carotid Disease Moderators: Mark H. Wholey, MD & Jay S. Yadav, MD
Debate: Managing Carotid Disease After CREST
8:00 AM If Not Dead, Is Seriously Damaged Horst Sievert, MD
8:07 AM CEA: Still the Gold Standard David H. Deaton, MD
8:14 AM Discussion
D. Deaton, H. Sievert
8:20 AM Reevaluation of the 80% or Greater Stenosis (Carotid) in the Asymptomatic Patient Kenneth Rosenfield, MD
8:30 AM Live Case Demonstration from Clinica Montevergine, Mercogliano, Italy
Live Case Moderator: Mark H. Wholey, MD
Live Case Operator: Eugenio Stabile, MD, PhD
Panelists: D. Deaton, S. Ramee, K. Rosenfield, H. Sievert
9:00 AM Coffee Break .
Horst Sievert, Nina Wunderlich
CardioVascular Center Frankfurt
Frankfurt, Germany
8:00 AMDebate: Managing Carotid Disease After Crest - Carotid Endarterectomy (CEA): If Not Dead, Is Seriously DamagedHorst Sievert, MD 8:07 AMDebate: Managing Carotid Disease After Crest - CEA: Still the Gold StandardDavid H. Deaton, MD 8:14 AMDebate: Managing Carotid Disease After Crest - DiscussionDavid H. Deaton, MD (Panelist) Horst Sievert, MD (Panelist)

2. Conflict of Interest Statement
Physician name
Company
Relationship
Horst Sievert
Access Closure, AGA, Ardian, Arstasis, Atritech, Atrium, Avinger, Bard, Boston Scientific, Bridgepoint, CardioKinetix, CardioMEMS, Coherex, Contego, CSI, EndoCross, Epitek, Evalve, ev3, FlowCardia, Gore, Guidant, Lumen Biomedical, HLT, Kyoto Medical, Lifetech, Lutonix, Medinol, Medtronic, NDC, NMT, Occlutech, Osprey, Ovalis, pfm Medical Mepro GmbH, ReCor, Rox Medical, Sorin, Spectranetics, SquareOne, TriReme Medical, Trivascular, Veryan Medical, Viacor
Consulting fees,
Travel expenses,
Study honoraria
Cardiokinetix, Access Closure, CoAptus, Lumen Biomedical, Coherex
Stock options,
Stocks 1

3. ... but it is under constant resussitation since 30+ years
Carotid Endarterectomy (CEA) was seriously damaged already before CREST...
... but it is under constant resussitation since 30+ years

4. Yes, CEA is a procedure with a very high level of evidence!

5. Symptomatic Carotid Stenoses - Randomised Trials -
Stroke %
P<0.001
P<0.01
P<0.01
NASCET ECST VA
18 Months Months Months
N= N= N=131
medical
surgery

6. Asymptomatic Carotid Stenoses - Randomised Trials -
Stroke %
P<0.06
P<0.006
P<
VA ACAS ACST
48 Months Months Months
N= N= N=3101
medical
Surgery

7. .... but carotid stenting has shown almost identical results
With very few exceptions

8. CAVATAS: Survival free of disabling stroke or death
1.00
0.75
0.50
PTA / Stent
Endarterectomy
0.25
0.00 1 2
Years 3

9. CAVATAS : Survival free of stroke: 8 year FU
0.25
0.00
0.50
0.75
1.00 2 1 3 4 5 6 7 8
Proportion of survivors free of stroke
Years from randomisation
Number of subjects remaining
504
253 11
Endovascular
Surgical
Unaudited data
Courtesy P. Gaines

10. SAPPHIRE MAE at 1080 Days CEA 30.3% Stent 25.5% Days: 360 720 1080
360
720
1080
CEA:
167
150 (90%)
139 (83%)
117 (70%)
Stent:
161 (96%)
154 (92%)
Gurm HS et al. N Engl J Med Apr 10;358(15):1572-9

11. SPACE Primary Endpoint: Ipsilateral Stroke and Death @ 30 Days
n.s.

12. Randomized trials with better results of CEA compared to stenting
2 exceptions
Randomized trials with better results of CEA compared to stenting

13. CAS is good but not that good
EVA 3S ICSS
CAS is good but not that good
Both trials had been designed to test whether unexperienced interventionalists can compete with experienced surgeons
Is carotid stenting so good, that it does require only minimal operator training?

14. EVA-3S Primary Endpoint 30 d
Carotid Stenting vs Endarterectomy
Endpoint
Stenting
(n=261)
RR (95% CI)
unadjusted
Relative Risk
± 95% CI
CEA
(n=259)
p-value
Death
1.2%
0.8%
0.7 ( )
0.68
Stroke
2.7%
8.8%
3.3 ( )
0.004
Death/Stroke
Angiomax was also found superior to heparin and as effective as the combination of heparin plus GP IIb/IIIa with respect to the triple endpoint of death. MI. urgent revascularization
3.9%
9.6%
2.5 ( )
0.01
CEA better
Stenting
better
Mas JL et al. N Engl J Med 2006

15. ICSS Interim analysis: stroke, death, or procedural myocardial infarction

16. ICSS predefined endpoint Interim analysis: disabling stroke or death @ 120 Days
n.s.

17. Very limited operator experience in both trials
ICSS
Only 50 stents in any vessel territory and only 10 carotid stents
Those who did not fulfill these criteria could enrol patients with the support of a proctor
EVA 3S
only 12 carotid stents
Or only 5 carotid stents + 35 other stents
Or with support of a proctor

18. Overall, CAS was already in a strong position even before CREST
This was just not recognized

19. There are 7 reasons why CEA was still there before CREST
Limited operator experience in some trials
FDA
CMS
Conventional surgeons
Non-interventional surgeons
Conservative surgeons
Older surgeons
So it was not David Deatons fault!

20. CREST Carotid Revascularization Endarterectomy vs Stent Trial

24. CREST Multi center randomized trial 2502 patients
CAS vs CEA
2502 patients
Symptomatic and asymptomatic stenoses
ACCULINK stent and ACCUNET filter
Primary results based upon a mean follow-up of 2.8 years
A.J. Sheffet; Journal compilation 2010 World Stroke Organization; International Journal of Stroke Vol 5, Feb. 2010, p

25. CREST: Operator Experience
Step one
Evaluation based on their prior experience with carotid stenting
Patients´ evaluation
Procedure reports and outcomes
Lal and Brott; JOURNAL OF VASCULAR SURGERY, Vol 50, Number 5, Sep. 2009, p

26. CREST: Operator Experience
Step two – Lead-in phase
Training with study devices
Included the use of animal models
Performance of up to 20 CAS lead-in cases
1565 lead-in cases total
Lal and Brott; JOURNAL OF VASCULAR SURGERY, Vol 50, Number 5, Sep. 2009, p

27. CREST Composite Primary Endpoint (any stroke, MI, or death within peri-procedural period plus ipsilateral stroke thereafter) %
n.s.
Brott et International Stroke Conference 2010

28. n.s. 27

29. CREST 30 Day Results: Stroke%
P<0.01
Driven by minor strokes,
no difference regarding major stroke
Brott et International Stroke Conference 2010

30. CREST 30 Day Results: Myocardial Infarction%
P<0.05
Brott et International Stroke Conference 2010

31. CREST 30 Day Results: Cranial Nerve Palsy%
P<0.0001
Brott et International Stroke Conference 2010

32. Other important findings
No differences between symptomatic and asymptomatic stenoses
No differences between male and female patients
Patients ≤ 70 years showed fewer adverse outcomes with stenting
Patients ≥ 70 years showed fewer adverse outcomes with surgery 31

33. CREST: Surgery better in elderly patients, stenting better in younger patients
Primary outcome – 4 year 32

34. How did scientific societies and regulatory react?

36. New Guidelines – just in time

39. Carotid Endarterectomy (CEA) is seriously damaged
So the answer is "yes!"
Carotid Endarterectomy (CEA) is seriously damaged
.... even more after CREST

40. It's not David Deatons Fault

42. Back-up

43. "MI is not important but stroke is"

44. Peri-procedural Stroke
CAS vs. CEA
Hazard Ratio 95% CI
P-Value
All Stroke
4.1 vs. 2.3%
HR = 1.79; 95% CI:
0.01
Major Stroke
0.9 vs. 0.6%
HR = 1.35; 95% CI:
0.52 43

45. CREST: Quality of Life

47. "Carotid stenting is less good than CEA in the elderly"
The answer is:
CREST was not powered to detect differences in subgroups

48. CREST: Surgery better in elderly patients, stenting better in younger patients
Primary outcome – 4 year 47

49. CREST: Surgery better in elderly patients, stenting better in younger patients
Primary outcome – 4 year 48 79
In 90% of CREST patients no difference between CAS and CEA 48

51. Overall, differences between CAS and CEA are very small ...
... and not relevant in daily practice

52. Carotid Stenting Differences between centers
Major stroke, death: %
Differences
between centers
Deutsche Qualitätssicherung

53. Differrences Between Centers
Death/stroke vs annual volume %
CAS/yr
ProCAS Registry, W. Theiss 2008 52

54. Outcome differences between centers (and operators) are much more important than differences between CAS and CEA

56. In any case, patients have their own way to make decisions