1. Dr. Quan, Dr. Mirhashemi, Dr. Chiang
Endarterectomy versus Stenting in Patients with Symptomatic Severe Carotid Stenosis
Dr. Quan, Dr. Mirhashemi, Dr. Chiang
N Engl J Med 2006; 355:

2. Objective
Know when to send patients for carotid artery stenting vs endarterectomy
Learn about Relative Risk
Know when is Relative Risk significant

3. Overview Step 1 – Get patients with symptomatic carotid stenosis
Step 2 – Send patients to have carotid stenting or endarterectomy
Step 3 – Evaluate 30-day stroke or death of both groups

4. Purpose
To evaluate the efficacy of carotid stenting vs endarterectomy in patients with symptomatic carotid-artery stenosis

5. Time and Place November 2000 to September 2005
20 academic and 10 non-academic centers in France
Approved by ethics committee

6. Centers and Investigators
1+ Neurologist
1+ Vascular Surgeon
Performed 25 endarterectomies
1+ Interventional Physician
Performed 12 carotid-stenting or
Performed 35 stenting procedures in supraaortic trucks (5 in carotid artery)

7. Patients
18+ years old
Hemispheric or retinal TIA or nondisabling stroke within 120 days
Carotid Artery Stenosis of 60 to 99%
Confirmed by angiography or both duplex scanning and MRA

8. Reference: http://neuro.wehealny.org/endo/proc_stents-angioplasty.asp

9. Reference: http://www. diagnosticclinic

10. Excluded Patients Modified Rankin score of 3+
Nonatherosclerotic carotid disease
Severe tandem lesions (proximal common carotid artery or intracranial artery that was more severe than carotid lesion)
Previous revascularization
History of bleeding disorder

11. Excluded Patients Uncontrolled HTN or DM Unstable Angina
Contraindication to heparin, ticlopidine, or clopidogrel
Life expectancy of less than 2 years
Percutaneous or surgical intervention within 30 days

13. Standard Procedures
Surgeons performed endarterectomy according to customary practice
Carotid stenting via femoral route with the use of cerebral protection device (01/2003 approved by safety committee)

14. Cerebral Protection Device
Reference:

15. Endarterectomy
Reference:

19. Anticoagulation Aspirin 100-300mg qd Clopidogrel 75 mg qd or
Ticlopidine 500mg qd
Take 3 days before and 30 days after stenting

20. Follow-up 48 hours 30 days 6 months after treatment
Then every 6 months thereafter

21. End Points
Any stroke or death occurring within 30 days after treatment

22. Results

23. Predicted Statistics
Require 872 patients whether stenting was not inferior to endarterectomy with regard to the 30-day incidence of stroke or death
Expected 30-day incidence of stroke or death (Endarterectomy 5.6%, Stent 4%)

26. Local Injuries
Cranial-nerve injury was significantly more common after endarterectomy than after stenting (7.7% vs 1.1%, P<0.001)
Median hospital stay (stent, 3 days, endarterectomy – 4 days, P=0.01)

27. Weakness
by Dr. Mirhashemi

28. Strengths
Baseline patients characteristics in stenting vs endarterectomy are statistical similar

31. Adjusted Relative Risk
Age – 2.4
History of stroke – 2.6
More patients in the stenting group had contralateral carotid occlusion; none of them had a stroke after stenting

32. Strength
Computer-generated sequence randomly assigned to undergo endarterectomy or stenting
Operator independent

33. Learning Curve
No significant differences in outcome related to the number of stenting procedures performed in individual centers or to the experience of the interventional physicians
Experience with any new device was required before its use in the trial

34. Effects of Cerebral Protection
30-day incidence of stroke or death was lower among patients who underwent stenting with cerebral protection (7.9%) than stenting alone (25%)
However, the RR over endarterectomy did not differ significantly (2.0 before and 3.4 after)

35. Antiplatelet Therapy
30-day incidence of stroke or death after stenting didn’t differ significantly between pts who received dual antiplatelet therapy (19 of 211, 9.0%) and those who received single antiplatelet therapy (4 of 36, 11.1%, P=0.75)

36. Strengths
The events committee assess the occurrence of stroke, death, and other outcomes, unaware of the treatment assignments

37. Discussion Lower surgical risk in our study
Previous trials – 30-day incidence of stroke or death after endovascular repair of the carotid artery is 8.1% (51 of 632)

38. Stenting
30-day incidence of stroke after stenting in our study 9.2% which was higher than SAPPHIRE trial 3.6% (most patients had asymptomatic stenosis)

40. Safety and Futility
September 2005, safety committee recommended stopping enrollment due to increased risk of stroke or death after stenting and requiring to enroll more than 4000 patients to test the noninferiority of stenting

41. Conclusion
Patients with symptomatic carotid stenosis of 60% or more, treatment with endarterectomy results in lower rates of stroke or death at 30days and 6 months than does stenting.

42. THANK YOU…