February 24, 2005

Carotid Angioplasty and Stenting Allows Treatment Of Higher Risk Patients While Maintaining Equal Outcomes Compared With Carotid Endarterectomy

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Abstract 18

Peter L. Faries, MD, Susan M. Trocciola, MD, Jason Rhee, BA, Stephanie Lin, MD, Rajeev Dayal, MD, Brian G DeRubertis, MD, Rabin Chaer, MD, Harry L. Bush, Jr., MD, Nicholas J. Morrissey, MD, James F. McKinsey, MD, K Craig Kent, MD.
New York Presbyterian Hospital, New York, NY, USA.

Introduction: Patients with significant cardiac disease, advanced age, prior neck irradiation or previous ipsilateral carotid endarterectomy (CEA) are considered to be at increased risk for CEA. This study stratified patients according to risk factors and compared the results of CEA to carotid angioplasty and stenting (CAS).
Materials: Between 1997 and 2004, 541 patients with carotid stenosis were treated; 445 underwent CEA and 97 underwent CAS. Cerebral protection devices including EPI Filterwire, Percusurge, Accunet and Angioguard were utilized in 94 / 97 CAS cases. Self-expanding stents (Wallstent, NexStent, Acculink, Precise) were used in all cases. 47 / 97 CAS procedures were performed under industry-sponsored investigational protocols. For patients undergoing CEA general anesthesia was used in 87%, EEG monitoring was used in 63% and shunting was performed in 64%. Significant differences were present in patient age (CAS=73.4±11.0 years vs. CEA=69.6±9.6 years, P<0.001) and the degree of carotid stenosis (CAS=88.5±10.1% vs. CEA=79.2±14.4%, P=0.02). No significant difference (P=NS) was observed in the incidence of preoperative neurological symptoms (CAS=35.1% vs. CEA=37.7%, P=NS), male : female ratio (CAS=65% male, CEA=64% male), hypertension (CAS=82%, CEA=74%), diabetes mellitus (CAS=27%, CEA=23%), hypercholesterolemia (CAS=57%, CEA=54%) or smoking history (CAS=59%, CEA=58%).
Results: Patients undergoing CAS had significantly increased preoperative risk factors (Table I).

Table I	Age ≥ 80 Years	Prior Ipsilateral CEA	Neck XRT	Cardiac Risk		Total (All High Risk)
				Goldman Class II	Goldman Class III
CAS (N=97)	35.1%	15.5%	6.2%	46.3%	17.5%	84.2%
CEA (N=445)	15.2%	3.1%	1.1%	11.8%	1.5%	29.7%
P-Value	<0.001	<0.001	<0.001	<0.001	<0.001	<0.001

Mean modified Goldman Scores were 21.1±14.8 (95% CI = 18,24) for CAS and 6.3±6.8 95% CI = 5.7, 6.9) for CEA (P<0.001). There was no difference in the incidence of periprocedural complications between patients treated with CAS as compared to CEA (Table II).

Table II	CVA with residual symptoms	CVA no residual symptoms	All CVA	Myocardial Infarction	Mortality	CVA / MI / Death
CAS (N=97)	0	2.1%	2.1%	3.1%	0	4.1%
CEA (N=445)	1.1%	1.0%	2.2%	1.1%	0.4%	4.0%
P-Value	NS	NS	NS	NS	NS	NS

In addition, when stratified by preoperative risk factors (age ≥80, Goldman class, prior CEA, XRT) no significant difference in outcome measures (CVA, MI, death) was present in patients treated with CAS. Mean follow-up was 6.6 months for CAS and 8.7 months for CEA. Restenosis requiring reintervention occurred in 10 (2%) CEA patients and 0 CAS patients.
Conclusions: CAS and CEA may each be performed with equal success for the treatment of carotid stenosis. CAS allows for the successful treatment of patients who are considered to be at increased risk for CEA.