PURPOSE: Proponents of carotid angioplasty and stenting suggest that "high risk" patients, defined as patients excluded from the North American Symptomatic Carotid Endarterectomy Trial (NASCET) and Asymptomatic Carotid Atherosclerosis Study (ACAS), may have a significantly higher risk of stroke with carotid endarterectomy (CEA). However, this selected patient cohort has been poorly studied. METHODS: A retrospective review of patients who underwent CEA during a 2-year period at a tertiary referral institution was performed. Each patient was evaluated and categorized, according to the exclusion criteria, by NASCET and ACAS standards. Statistical analysis using chi(2) and Fisher exact tests was performed. RESULTS: There were 366 CEAs performed on 348 patients, including 32 (8.7%) for recurrent stenosis. A subgroup of 169 (46.2%) patients were trial ineligible. Focal ipsilateral symptoms were present in 148 (40.4%) of the patients. There were 9 (2.5%) strokes and 1 (0.3%) death, secondary to a major stroke, for an overall stroke and death rate of 2.5%. Trial-eligible patients had a stroke/death rate of 1.5% (3/197) while trial-ineligible patients had a 3.6% (6/169) stroke/death rate (P = .17). CONCLUSION: Patients who were considered high risk for CEA as defined by trial ineligibility were common, comprising approximately half of our patients. Although trial-ineligible patients had a nonsignificant trend toward higher neurologic morbidity when compared with the eligible group, the risks were still comparable with NASCET/ACAS results. CEA was a safe procedure even in this "high risk" group. As such, ineligibility for a randomized carotid intervention trial should not be employed as a "de novo" indication for carotid stenting.
RCT Entities:
PURPOSE: Proponents of carotid angioplasty and stenting suggest that "high risk" patients, defined as patients excluded from the North American Symptomatic Carotid Endarterectomy Trial (NASCET) and Asymptomatic Carotid Atherosclerosis Study (ACAS), may have a significantly higher risk of stroke with carotid endarterectomy (CEA). However, this selected patient cohort has been poorly studied. METHODS: A retrospective review of patients who underwent CEA during a 2-year period at a tertiary referral institution was performed. Each patient was evaluated and categorized, according to the exclusion criteria, by NASCET and ACAS standards. Statistical analysis using chi(2) and Fisher exact tests was performed. RESULTS: There were 366 CEAs performed on 348 patients, including 32 (8.7%) for recurrent stenosis. A subgroup of 169 (46.2%) patients were trial ineligible. Focal ipsilateral symptoms were present in 148 (40.4%) of the patients. There were 9 (2.5%) strokes and 1 (0.3%) death, secondary to a major stroke, for an overall stroke and death rate of 2.5%. Trial-eligible patients had a stroke/death rate of 1.5% (3/197) while trial-ineligible patients had a 3.6% (6/169) stroke/death rate (P = .17). CONCLUSION:Patients who were considered high risk for CEA as defined by trial ineligibility were common, comprising approximately half of our patients. Although trial-ineligible patients had a nonsignificant trend toward higher neurologic morbidity when compared with the eligible group, the risks were still comparable with NASCET/ACAS results. CEA was a safe procedure even in this "high risk" group. As such, ineligibility for a randomized carotid intervention trial should not be employed as a "de novo" indication for carotid stenting.
Authors: Judith H Lichtman; Sara B Jones; Yun Wang; Emi Watanabe; Norrina B Allen; Pierre Fayad; Larry B Goldstein Journal: Cerebrovasc Dis Date: 2009-12-01 Impact factor: 2.762