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Table 1 Inclusion/Exclusion Criteria for Carotid Endarterectomy Trials
NASCET [9] Inclusion Symptoms of focal cerebral ischemia ipsilateral to a stenosis of <70% (moderate group) or ≥70% (severe group) within 180 days, as shown on angiography Symptoms lasting <24 hours or producing nondisabling stroke (Rankin score <3) Exclusion Age >80 years (initial phase of moderate and severe stenosis; continuing study of moderate stenosis included these patients) Lack of angiographic visualization of symptomatic artery Lack of informed consent Intracranial stenosis more severe than the cervical stenosis Other disease limiting life expectancy to <5 years Cerebral infarction limiting useful function in the affected arterial territory Nonatherosclerotic carotid disease Cardiac lesions likely to cause cardioembolism History of ipsilateral carotid endarterectomy ACAS [8] Inclusion Age 40–79 years Compatible history and findings on physical and neurologic examination Acceptable laboratory and electrocardiogram results Arteriography within the previous 60 days indicating stenosis of at least 60% reduction in diameter (if arteriography performed 61–364 days before randomization, repeat Doppler showing artery still patent) or Doppler examination within 60 days showing a frequency or velocity greater than the instrument-specific cut point with 95% positive predictive value or Doppler examination showing a frequency or velocity greater than the instrument-specific 90% positive predictive value cut point confirmed by ocular pneumoplethysmographic examination within the previous 60 days Exclusion Cerebrovascular event in the distribution of the affected carotid artery or the vertebrobasilar system Symptoms referable to the contralateral cerebral hemisphere within the previous 45 days Contraindication to aspirin therapy Any disorder that could seriously complicate surgery Any condition that could prevent continuing participation or likely to produce death or disability within 5 years Lack of informed consent Table 2 Inclusion/Exclusion Criteria for the SAPPHIRE Trial of Carotid Stent Placement
Inclusion Asymptomatic stenosis >80% or symptomatic stenosis >50% by angiography or ultrasonography and at least one of the following conditions that would result in high surgical risk: Age >80 years Congestive heart failure (class III/IV) and/or left ventricular ejection fraction <30% Open heart surgery needed within 6 weeks Recent myocardial infarction (>24 hours and <4 weeks) Unstable angina (CCS class III/IV) Severe chronic obstructive pulmonary disease Contralateral carotid occlusion Contralateral laryngeal nerve palsy Severe tandem lesions Lesions distal or proximal to the usual location Previous endarterectomy with restenosis Previous radiation therapy or radical neck surgery Exclusion Acute ischemic neurologic event within past 48 hours Total occlusion of the target carotid artery Surgical or interventional procedure planned within the next 30 days Common carotid ostial lesion Table 3 Thresholds for Indications, Technical Success, and Complications
Neurologic complication Complications Threshold Asymptomatic Patient (%) Symptomatic Patient (%) Inappropriate comparison of the thresholds in this table to the reported incidences of complications after CEA might lead to an erroneous conclusion that higher rates of neurologic complications are acceptable for CAS compared with lower rates for CEA: (a) A “threshold” is not intended to represent a desirable incidence of complications. A “threshold” implies a complication rate that is significantly above the expected rate of complications, such that an audit should be conducted to examine the cause of the unexpectedly high incidence of complications. (b) These thresholds are significantly higher than the complication rates for CEA published in the randomized ACAS and NASCET trials. Those trials included only low-risk patients. The thresholds in this document pertain only to high-risk patients. Except for patients treated as part of an approved investigational trial, patients considered to have normal risk of CEA do not fall within the acceptable indications for carotid artery angioplasty and stent placement as defined in this document. (c) The thresholds described in this document are comparable with the incidences of complications resulting from CEA performed on similar high-risk patients. (d) The thresholds described in this document do not apply to low-risk patients treated under an approved investigational trial. Lower thresholds, comparable with the well-established experience with CEA in low-risk patients, would apply for CAS performed under these conditions. (e) The definitions for the neurologic complications on which these thresholds are based differ from those used in many reported series. No accepted, standardized methodology for reporting all neurologic complications exists. The neurologic complications defined in this document should be applicable to a broad range of cerebrovascular interventions and surgery. (f) The thresholds described in this document reflect complications occurring within 30 days of CAS, not immediate postoperative results. (g) Thresholds for the reversible stroke categories are based on the expectation that reversible deficits are likely to be slightly more common than permanent strokes. We recognize that there is not yet adequate scientific literature to confirm this. * At present, there are minimal and insufficient data available to suggest threshold values for transient deficits after CAS. We believe that these data should be collected and reported to further our understanding of CAS and, perhaps, to help to decrease the incidence of permanent neurologic complications. When adequate data about transient neurologic complications become available, this document will be revised to include threshold values for such transient complications. † All deaths should be reviewed. Minor transient deficit * * Major transient deficit * * Minor reversible stroke 3.5 6 Major reversible stroke 2 3 Minor permanent stroke 3 4.5 Major permanent stroke 2 3 Death 0† 0† Indications Meets the indications listed in section III.A 95% Technical success 90%
