Endarterectomy versus Stenting in patients with symptomatic severe carotid stenosis

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Endarterectomy versus Stenting in patients with
symptomatic severe carotid stenosis
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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.

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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)

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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

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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 lt 2 years

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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.

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Data collection

• Neurologist assessment at
• 48 hours
• 30 days
• 6 months

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End points

• Primary end points
• CVA
• death
• Secondary end points

Occurring with 30 days of treatment
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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.

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(No Transcript)
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30 day incidence of stroke or death

• CI for both significant
• RR 2.5 (sig CI)
• AR increase 5.7

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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

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Effect of protective devices

• 91.9 stenting procedures involved a cerebral
  protection device
• The risk was significantly reduced cf stenting
  alone (p 0.03)

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Overall risk of CVA or death
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Others

• No significant difference in
• systemic complications
• Local complications
• Higher incidence of cranial nerve injury with CEA
  (7.7 vs 1.1 plt0.001)
• Hospital stay shorter with stenting (3 days vs 4
  days, plt0.01)

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Conclusion

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

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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