Carotid endarterectomy in SAPPHIRE-eligible high-risk patients: implications for selecting patients for carotid angioplasty and stenting.

OBJECTIVES: Carotid angioplasty and stenting (CAS) has been proposed as an alternative to carotid endarterectomy (CEA) in patients excluded from the North American Symptomatic Carotid Endarterectomy Trial and the Asymptomatic Carotid Atherosclerosis Study and in those considered at high risk for CEA. In light of recently released CAS data in patients at high risk, we reviewed our experience with CEA.
METHODS: The records for consecutive patients who underwent CEA between 1998 and 2002 were retrospectively reviewed, and risk was stratified according to inclusion and exclusion criteria from a "high-risk" or CAS-CEA trial, The Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy (SAPPHIRE) trial.
RESULTS: Of 776 CEAs performed, 323 (42%) were considered high risk, on the basis of criteria including positive stress test (n = 109, 14%), age older than 80 years (n = 85, 11%), contralateral carotid occlusion (n = 66, 9%), pulmonary dysfunction (n = 56, 7%), high cervical lesion (n = 36, 5%), and repeat carotid operation (n = 27, 3%). Other high-risk criteria included recent myocardial infarction (MI), cardiac surgery, or class III or IV cardiac status; left ventricular ejection fraction less than 30%; contralateral laryngeal palsy; and previous neck irradiation (each <1.5%). Clinical presentation was similar in the high-risk and low-risk groups: asymptomatic (73% versus 73%), transient ischemic attack (23% vs 22%), and previous stroke (4% vs 5%). The overall postoperative stroke rate was 1.4% (symptomatic, 2.9%; asymptomatic, 0.9%). Comparison of high-risk and low-risk CEAs demonstrated no statistical difference in the stroke rate. Factors associated with significantly increased stroke risk included cervical radiation therapy, class III or IV angina, symptomatic presentation, and age 60 years or younger. Overall mortality was 0.3% (symptomatic, 0.5%; asymptomatic, 0.2%), not significantly different between the high-risk (0.6%) and low-risk groups (0.0%). Non-Q-wave MI was more frequent in the high-risk group (3.1 vs 0.9%; P <.05). A composite cluster of adverse clinical events (death, stroke, MI) was more frequent in the symptomatic high-risk group (9.3% vs 1.6%; P <.005), but not in the asymptomatic cohort. There was a trend for more major cranial nerve injuries in patients with local risk factors, such as high carotid bifurcation, repeat operation, and cervical radiation therapy (4.6% vs 1.7%; P <.13). In 121 patients excluded on the basis of synchronous or immediate subsequent operations, who also would have been excluded from SAPPHIRE, the overall rates for stroke (1.65%; P =.69), death (1.65%; P =.09), and MI (0.83%; P =.71) were not significantly different from those in the study population.
CONCLUSIONS: CEA can be performed in patients at high risk, with stroke and death rates well within accepted standards. These data question the use of CAS as an alternative to CEA, even in patients at high risk.