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Assessment: Carotid Endarterectomy ― An Evidence-Based Review

Assessment: Carotid Endarterectomy ― An Evidence-Based Review. Report of the Therapeutics and Technology Subcommittee of the American Academy of Neurology

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Assessment: Carotid Endarterectomy ― An Evidence-Based Review

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  1. Assessment: Carotid Endarterectomy―An Evidence-Based Review Report of the Therapeutics and Technology Subcommittee of the American Academy of Neurology S Chaturvedi MD, A Bruno MD, T Feasby MD, R Holloway MD, O Benavente MD, SN Cohen MD, R Cote MD, D Hess MD, J Saver MD, JD Spence MD, B Stern MD, J Wilterdink MD Published in Neurology 2005;65:794-801

  2. Objective • The objective of this report isto provide an updated statement on the efficacy of carotid endarterectomy (CE) for stroke prevention in asymptomatic and symptomatic patients with internal carotid artery stenosis.(Updates previous guideline Neurology 1990;40:682)

  3. Introduction • Depending on the population, extracranial internal carotid artery (ICA) stenosis accounts for 15-20% of ischemic strokes. • CE is the most frequently performed operation to prevent stroke. • Since 1990 guideline, several multi-center trials have been completed. This statement reflects an update on major developments.

  4. Methods • Vascular neurologists were appointed by the Therapeutics and Technology Assessment Subcommittee (TTA) of the AAN. • Nine clinical questions were identified and selected due to clinical importance. • A systematic search was performed for articles from 1990-2001. • Additional articles from 2002-2004 were included using pre-specified criteria.

  5. Methods • Case reports, review articles, technical studies, and single surgeon case series were excluded. • After exclusions, total of 186 articles were reviewed independently by 2 committee members. • Number needed to treat (NNT) and number needed to harm (NNH) were evaluated in studies. • Recommendations generated based on application of levels of evidence to the abstracted articles using AAN schemes.

  6. AAN Strength of Evidence

  7. AAN Strength of Evidence

  8. Translation of Evidence to Recommendation Level

  9. Translation of Evidence to Recommendation Level

  10. Clinical Question Does CE benefit symptomatic and asymptomatic patients?

  11. Analysis of the EvidenceSymptomatic patients

  12. Analysis of the EvidenceSymptomatic patients

  13. Analysis of the EvidenceSymptomatic patients

  14. Clinical Question Does CE benefit asymptomatic patients?

  15. Analysis of the Evidence Asymptomatic patients • 3 Class I studies are available • Asymptomatic Carotid Atherosclerosis Study (ACAS), Veterans Affairs Study, Asymptomatic Carotid Surgery Trial (ACST) • 2 other studies were completed or planned but were stopped prematurely or had a suboptimal study design • Mayo Clinic trial stopped due to a high rate of MI (22%) in the surgical group, CASANOVA

  16. Analysis of the EvidenceAsymptomatic patients • Asymptomatic Carotid Atherosclerosis Study (ACAS) • 1662 patients, 60-99% stenosis angiographically-proven for the surgical group primarily-proven with ultrasound for the medical group • Enrollment 1993-2003 with planned10 year follow-up • Eligibility = carotid artery diameter reduction of at least 60%,no symptoms within the past six months • Patients were randomized to best medical TX (BMT) or BMT + CE

  17. Analysis of the EvidenceAsymptomatic patients • Asymptomatic Carotid Atherosclerosis Study (ACAS) • 5 year projected rate of ipsilateral stroke • medically treated patients 11.0% • surgically treated patients 5.1% • relative risk reduction 53%

  18. Clinical Question Is emergent CE beneficial in patients with progressing stroke of <24 hours?

  19. Analysis of the EvidenceEmergent CE • Four Class IV studies met the criteria • In 3 studies, neurological improvement was noted in 81-93% of patients who underwent emergent CE • Studies were fairly small in size, lacked objective evaluation of the reported neurological outcomes, and one study was clouded by coexisting treatments including emergent thrombolysis

  20. Clinical Question What are the most important clinical variables that impact the risk/benefit ratio?

  21. Analysis of the EvidenceClinical Variables • None of the trials had clinical variables that impact risk/benefit as predetermined endpoints • In post-hoc analyses 2 variables stand out: gender and nature of the presenting symptoms • In NASCET 50-69% stenosis group & ACAS no benefit shown for CE in women • NASCET showed lower subsequent stroke risk in patients w/ retinal ischemia compared to patients with hemispheric events

  22. Clinical Question What are the most important radiologic factors that impact the risk/benefit ratio?

  23. Analysis of the EvidenceRadiologic Factors • Several studies addressed issues (status of the contralateral carotid artery, angiographic appearance of the ICA, and other factors). • NASCET and ACAS studies had highest level data on contralateral occlusion. • For symptomatic patients: • Contralateral occlusion present: surgical complication rate is higher than if the contralateral ICA is patent • Better outcome compared to medical management for patients with 70-99% stenosis • For asymptomatic patients: • Contralateral occlusion present: randomized evidence suggests that patients do slightly better with medical management (2.0% absolute increase in risk with CE at 5 years)

  24. Clinical Question What is the ideal dose of aspirin preoperatively in patients undergoing CE?

  25. Analysis of the EvidenceAspirin therapy • Aspirin and Carotid Endarterectomy trial (ACE) • 2,849 subjects, double-blind randomized clinical trial • Compared aspirin before carotid endarterectomy & continued for 3 months at doses 81 mg, 325 mg, 650 mg and 1300 mg • Primary outcome = combined rate of stroke, myocardial infarction, and death was the • Outcome lower in the low-dose groups (81 mg and 325 mg) than in the high-dose groups (650 mg and 1300 mg) at 30 days and 3 months

  26. Clinical Question How long should one wait after a stroke to perform CE?

  27. Analysis of the EvidenceTime to CE surgery • 6 retrospective cohort studies comparing timing of CE in patients after a stroke. Significant limitations in the designs of these studies. • 4 of the studies defined early surgery as < 6 weeks from the stroke. • 2 studies defined early surgery as < four weeks from the stroke. • None of the studies found differencesin the outcomes in terms of operative morbidity and longer-term follow-up.

  28. Recommendations

  29. Recommendations

  30. Recommendations

  31. Recommendations

  32. Recommendations

  33. Recommendations

  34. TTA Subcommittee Members Therapeutics and Technology Assessment Subcommittee Members: Douglas S. Goodin, MD (Chair); Yuen T. So, MD, PhD (Vice-Chair); Carmel Armon, MD; Richard M. Dubinsky, MD: Mark Hallett, MD; David Hammond, MD; Cynthia Harden, MD; Chung Hsu, MD, PhD (ex-officio); Andres M. Kanner, MD (ex-officio); David S. Lefkowitz, MD ;Janis Miyasaki, MD; Michael A. Sloan, MD; James C. Stevens, MD

  35. COMMENTTHANK YOU Published in Neurology 2005;65:794-801

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