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Comparison of Carotid Endarterectomy vs. Stenting - NEJM 2006

Explore the efficacy and complications of carotid stenting vs. endarterectomy in patients with severe carotid stenosis. Learn about the randomized trial results and implications for clinical practice.

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Comparison of Carotid Endarterectomy vs. Stenting - NEJM 2006

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  1. Journal ClubAni Balmanoukian and Peter Benjamin November 9, 2006

  2. Endarterectomy versus Stenting in Patients with Symptomatic Severe Carotid Stenosis Mas et al. NEJM 355;16 October 19, 2006

  3. Background • Carotid Endarterectomy is the standard treatment for symptomatic or asymptomatic high-grade(> 60% or 70%) internal carotid artery stenosis. • Carotid artery stenting has become another option

  4. Carotid Endarterectomy • NASCET and ECST trials have demonstrated the efficacy in symptomatic patients • Complications include local nerve injury and stroke www.vascular.co.nz

  5. Carotid Stenting • Less invasive than CEA • Can be done under local anesthesia and sedation • Less costly than CEA • Risk of stroke and local complications • Long term efficacy not well known yet http://radinfo.musc.edu/~stringes/carotidimage25.jpg

  6. Hypothesis/Goal: Evaluate whether stenting is not inferior to endarterectomy with regard to the risks of the procedure and long-term efficacy in patients with symptomatic carotid stenosis. • Design: Randomized, noninferiority trial. • Setting: 20 academic and 10 non-academic centers in France.

  7. Investigators: Each center had to have a team of physicians consisting of 1 Neurologist 1 Vascular surgeon: had to have performed at least 25 CEAs 1 Interventional physician: had to have performed at least 12 carotid stenting procedures or at least 35 stenting procedures in the supraaortic trunks, of which 5 were in the carotid artery.

  8. Participants:527 patients >18 y/o, with history of a hemispheric or retinal TIA or a nondisabling stroke within 120 days before enrollment. Stenosis of 60-99% in the symptomatic carotid artery. Exclusion: disabling stroke, nonatherosclerotic carotid disease, previous revascularization, bleeding disorder, uncontrolled HTN or diabetes, unstable angina, life expectancy <2 years.

  9. Figure 1. Mas et al, Endarterectomy vs. stenting in patients with symptomatic severe carotic stenosis. NEJM 2006;355:1660-71

  10. Data Collection: Evaluation by Neurologist at 48 hrs, 30 days, 6 months after treatment and 6 months thereafter. • Outcome: Primary: Any stroke or death occurring within 30 days after treatment. Secondary: MI, TIA, cranial nerve injury, major local complications, and systemic complications within 30 days. • Analysis: Kaplan-Meier method, intention to treat principle.

  11. Table 1. Baseline Characteristics of the Patients. • Key Points • Patients overall very similar • Only differences: • More patients older than 75 yo in CEA group (40.5% • vs. 32.2%) • More patients with h/o stroke in CEA group • (20.1% vs 12.6%) • Higher proportion of contralateral carotid occlusion • in stenting group (none of these had a stroke after • stenting)

  12. Table 3: Risk of stroke or death and other outcomes • within 30 days • Key Points: • Unadjusted RR of stroke/death is 2.5 for stenting vs CEA • (Number Needed to Harm: 17) • No significant correlation between RR of stroke/death and • number of patients treated at each center • No significant difference in stroke/death outcomes • between interventionalists who were experienced, tutored • during training, tutored after training • Decreased incidence in stroke/death in pts who had • cerebral protection along with stenting vs stenting alone • RR stroke/death adjusted for age was 2.4, h/o stroke 2.6 • Cranial nerve injury much more likely with CEA (7.7% vs • 1.1%)

  13. Conclusions/Implications • In pts with symptomatic carotid stenosis >60%, CEA has lower rates of stroke/death through 6 months • These results agree with some (e.g. SPACE), but not all (e.g. SAPPHIRE) prior studies • Taken together, pending further evidence, stenting should be limited to symptomatic pts with >70% stenosis who are high surgical risk

  14. Strengths • Large, Multicenter RCT • All patients accounted for at conclusion • Groups were similar at start of trial

  15. Weaknesses • Required minimal experience for interventionalists doing procedure • Didn’t indicate differences in complications based on experience • Anesthesiology or periop differences? • No standardization of stenting device used (5 different stents, 7 different cerebral protection systems used)

  16. Discussion • What are unique aspects of a noninferiority trial • What is the significance of an intention to treat analysis • Intricacies in a surgical rct that are unique • How to minimize differences in surgeon/interventionalist experience? • How to minimize effects of other aspects (e.g. anesthesia, postop care, etc) • Can you standardize experience level differences between CEA and carotid stenting? • Any way to blind such a trial?

  17. References • Mas JL et al. Endarterectomy versus stenting in patients with symptomatic severe carotid stenosis. N Engl J Med. 2006 Oct 19;355(16):1660-71. • North American Symptomatic Carotid Endarterectomy Trial Collaborators. Beneficial effect of carotid endarterectomy in symptomatic patients with high-grade carotid stenosis. N Engl J Med 1991; 325:445-53.

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