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Jean-Louis Mas, M.D. et al.. "Endarterectomy versus Stenting in Patients with Symptomatic Severe Carotid Stenosis". N Engl J Med. 2006. 355:1660-1671.
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Clinical Question

To evaluate whether stenting is not inferior to endarterectomy with regard to the risks of the procedure and its long-term efficacy in patients with symptomatic severe carotid stenosis (>60% NASCET).

Bottom Line

In this randomized trial of patients with symptomatic carotid stenosis of 60% or more (NASCENT), patients who underwent endarterectomy had lower rates of death or stroke at 1 month and 6 months than patients who underwent stenting.

  • The 30-day incidence of any stroke or death was 3.9% (95% CI, 2.0 to 7.2) after endarterectomy and 9.6% (95% CI, 6.4 to 14.0) after stenting, with a relative risk of 2.5 (95% CI, 1.2 to 5.1).
    • The absolute risk increase was 5.7%, suggesting that one additional stroke or death resulted when 17 patients underwent stenting rather than endarterectomy.
  • The 30-day incidence of disabling stroke or death was 1.5% (95% CI, 0.5 to 4.2) after endarterectomy and 3.4% (95% CI, 1.7 to 6.7) after stenting, resulting in a relative risk of 2.2 (95% CI, 0.7 to 7.2)
  • A greater proportion of strokes occurred on the day of the procedure in the stenting group than in the endarterectomy group (17 of 24 vs. 3 of 9, P=0.05).

Major Points

Carotid Artery Stenting had RR of 2.5 vs. CEA for any stroke/death at 30 days (P=0.01).

Guidelines

Design

  • N= 520 patients were included in the analysis of the 30-day risk of stroke or death.
    • Endarterectomy (n=257)
    • Stenting (n=247)
  • Setting: Conducted in 20 academic and 10 nonacademic centers in France
  • Enrollment: Nov. 2000 - Sep. 2005
  • Mean follow-up: Neurology follow-up evaluations at 48 hours, 30 days, 6 months after treatment, and every 6 months thereafter.
  • Analysis:
  • Primary outcome:
    • Any stroke or death occurring within 30 days after treatment. Functional disability from cranial-nerve injury was categorized as absent, mild, moderate, or severe at the 30-day follow-up visit.

Population

Inclusion Criteria

  • 18 years of age or older
  • Had a hemispheric or retinal transient ischemic attack or a nondisabling stroke (or retinal infarct) within 120 days before enrollment
  • Had a stenosis of 60 to 99% in the symptomatic carotid artery, as determined by the North American Symptomatic Carotid Endarterectomy Trial (NASCET) method.

Exclusion Criteria

Patients were excluded if one of the following was present:

  • A modified Rankin score of 3 or more (disabling stroke) (on a scale of 0 to 5, with higher scores indicating more severe disability)
  • Nonatherosclerotic carotid disease
  • Severe tandem lesions (stenosis of proximal common carotid artery or intracranial artery that was more severe than the cervical lesion)
  • Previous revascularization of the symptomatic stenosis
  • History of bleeding disorder
  • Uncontrolled hypertension or diabetes
  • Unstable angina
  • Contraindication to heparin, ticlopidine, or clopidogrel
  • Life expectancy of less than 2 years
  • Percutaneous or surgical intervention within 30 days before or after the study procedure.

Interventions

Patients who were suitable candidates for both techniques were randomly assigned to undergo endarterectomy or stenting

  • The goal was for endarterectomy and stenting to be performed within 2 weeks after randomization.
  • Carotid stenting had to be carried out through the femoral route with the use of stents and protection devices approved by the accreditation committee.
  • The daily use of aspirin (100 to 300 mg) and clopidogrel (75 mg) or ticlopidine (500 mg) for 3 days before and 30 days after stenting was also recommended.

Outcomes

Presented as endarterectomy vs. stenting. RR means relative risk. Statistics only given when provided by authors.

Primary Outcome

30-day incidence of any stroke or death:

  • 3.9% (95% CI, 2.0 to 7.2) vs. 9.6% (95% CI, 6.4 to 14.0) RR: 2.5 (95% CI, 1.2 to 5.1).
  • Absolute risk increase was 5.7%, suggesting that one additional stroke or death resulted when 17 patients underwent stenting rather than endarterectomy.

30-day incidence of disabling stroke or death

  • 1.5% (95% CI, 0.5 to 4.2) vs. 3.4% (95% CI, 1.7 to 6.7) RR: 2.2 (95% CI, 0.7 to 7.2)

Strokes occurring on the day of procedure

  • 17 of 24 vs. 3 of 9, P=0.05

Secondary Outcomes

Any stroke or death at 30 days plus ipsilateral stroke between 31 days and 6 mo

  • 4.2% vs. 10.2% (P=0.008)

Any stroke or death at 30 days plus any stroke between 31 days and 6 mo

  • 4.6% vs. 10.9% (P=0.007)

Any stroke or death within 6 mo

  • 6.1% vs. 11.7% (P=0.02)

Bradycardia or hypotension: 0 vs. 4.2 (P=<0.001)

Myocardial infarction: .8 vs. .4 (P=0.26)

Transient Ischemic Attack: .8 vs. 2.3 (P=0.28)

Systemic Complications: 3.1 vs. 1.9 (P=0.42)

Major local complications: 1.2 vs. 3.1 (P=0.22)

Subgroup Analysis

30-day incidence of stroke or death among patients who underwent stenting with cerebral protection than among those treated with stenting alone

  • 7.9% vs. 25% (P=0.03).
    • However, the relative risk of stroke or death for stenting over endarterectomy did not differ significantly before systematic use of a cerebral protection device was recommended (2.0; 95% CI, 0.8 to 5.0) or after (3.4; 95% CI, 1.1 to 10.0; P=0.50).

Adverse Events

  • Cranial-nerve injury was significantly more common after endarterectomy than after stenting (7.7% vs. 1.1%, P<0.001).
  • The median duration of the hospital stay was shorter after stenting (3 days; interquartile range, 2 to 5) than after endarterectomy (4 days; interquartile range, 3 to 5; P=0.01).

Criticisms

Funding

Supported by a grant from the Programme Hospitalier de Recherche Clinique of the French Ministry of Health (AOM 97066), Assistance Publique–Hôpitaux de Paris.

Dr. Beyssen reports having received lecture fees from ev3 and Guidant; and Dr. Becquemin, lecture fees from Cordis, Guidant, and Cook. No other potential conflict of interest relevant to this article was reported.

Further Reading