Endarterectomy versus Stenting in patients with symptomatic severe carotid stenosis

1. Endarterectomy versus Stenting in patients with symptomatic severe carotid stenosis

2. Background Carotid stenting is less invasive than carotid endarterectomy This trial was conducted to evaluate the risks of carotid stenting and its long-term efficacy To prove that stenting was not inferior to CEA.

3. Design 30 hospitals in France November 2000 � September 2005 Each hospital assigned a �carotid� team One neurologist One vascular surgeon (each had to have done at least 25 CEAs in last 12/12) One interventional physician (needed to have done 12 CAS or 35 + Supra-aortic endovascular procedures OR needed to be supervised till number reached)

4. Patients 18+ TIA or non-disabling CVA. Stenosis 60 � 99% + symptomatic (follows NASCET guidelines + was re-evaluated in Oct 2003 from 70-99%) Confirmed on angiography alone OR combined duplex and MRA All patients had to be suitable for both CEA and stenting Follows data from �analysis of pooled data from the randomised controlled trials of endarterectomy for symptomatic carotid stenosis� Lancet 2003, Rothwell et al. Follows data from �analysis of pooled data from the randomised controlled trials of endarterectomy for symptomatic carotid stenosis� Lancet 2003, Rothwell et al.

5. Exclusion criteria Severe disability Non-atherosclerotic lesions NON-cervical vessel disease Previous stent/CEA Bleeding diathesis Uncontrolled NIDDM/HTN Unstable coronary disease Pts who could not be anticoagulated Recent OT Life expectancy < 2 years

6. Organisation Computer generated randomisation to CEA or angio + stent Specifically for stents Standardised access for angioplasty All devices pre-approved by committee and proceduralist had to be familiar with device Protective devices used after 2003.

7. Data collection Neurologist assessment at: 48 hours 30 days 6 months

8. End points Primary end points CVA death Secondary end points

9. Patient characteristics Good age match More patients were over age 75 in CEA group Good correlation for Systolic BP BMI Elevated cholesterol Smoking A greater number had been on oral hypoglycaemics in the CEA group(24.7% vs 20.3%), had had a CVA in the past (20.1% vs 12.6) and were on antiplatelet therapy pre-op (52.5% vs 49%) While a contralateral carotid occlusion was more likely in the stenting group, a contralateral carotid stenosis 60 � 99% was more likely in the CEA group. None of the patients in the stenting group who had a contralateral occlusion had a post-operative stroke. None of the patients in the stenting group who had a contralateral occlusion had a post-operative stroke.

11. 30 day incidence of stroke or death CI for both significant RR 2.5 (sig CI) AR increase 5.7% Confidence intervals significant for both percentages and for the comparison. No significant difference between centres due to numbers of patients done at that centre. (some had <21 pts, some 21-40, some >40 30 day incidence of CVA was no different if the operator was experienced or needed supervision. Confidence intervals significant for both percentages and for the comparison. No significant difference between centres due to numbers of patients done at that centre. (some had <21 pts, some 21-40, some >40 30 day incidence of CVA was no different if the operator was experienced or needed supervision.

12. Risk of CVA on the day of operation A greater proportion of CVAs occurred on the day of operation in the stenting group than the CEA group. P = 0.05

13. Effect of protective devices 91.9% stenting procedures involved a cerebral protection device The risk was significantly reduced cf stenting alone (p = 0.03)

14. Overall risk of CVA or death

15. Others No significant difference in systemic complications Local complications Higher incidence of cranial nerve injury with CEA (7.7% vs 1.1% p<0.001) Hospital stay shorter with stenting (3 days vs 4 days, p<0.01)

16. Conclusion 30 day stroke death risk for CEA lower than in other trials ? Decreased risk compared to original trials? Acknowledge bias of learning curve

17. Analysis Clear outcome. Had intended to show that stenting was not significantly inferior to CEA because previous studies had shown a much smaller incidence of nonfatal stroke and death for stenting (4% vs 5.6% for CEA). Superiority analysis for relative risks Breslow �day test for homogeneity among centres Kaplan-meier method for estimation of stroke/death rates. Two-sided p-values, not adjusted for multiple testing No mention of attrition other than 2 patients with non-related death Longer follow-up needed