PAPER Carotid Angioplasty and Stenting vs Carotid Endarterectomy for Treatment of Asymptomatic Disease Single-Center Experience Gale L. Tang, MD; Jon S. Matsumura, MD; Mark D. Morasch, MD; William H. Pearce, MD; Antoinette Nguyen, BS; Daniel Amaranto, MD; Mark K. Eskandari, MD Background: Carotid angioplasty and stenting (CAS) Interventions: Carotid angioplasty and stenting was with embolic protection is an acceptable alternative to performed using self-expanding nitinol stents coupled carotid endarterectomy (CEA) in selected patients with with a mechanical embolic protection system. Carotid symptomatic cervical carotid artery disease. Whether out- endarterectomy was performed using general anesthe- comes after CAS are comparable to those after CEA in sia with selective shunting based on carotid stump the larger population of patients with asymptomatic dis- pressure. ease is unclear. Main Outcome Measures: Stroke, myocardial infarc- Hypothesis: Carotid angioplasty and stenting per- formed in patients with asymptomatic disease will re- tion, and death rates at 30 days after surgery. sult in early outcomes equivalent to those with CEA per- formed in patients with asymptomatic disease at our center Results: At 30 days after surgery, there was no statisti- and in 2 landmark studies of CEA. cal difference between outcomes after CAS (2 strokes [1.7%], 2 myocardial infarctions [1.7%], and 1 death Design: Single-center retrospective review. [0.8%]) compared with CEA (2 strokes [1.0%], 3 myo- cardial infarctions [1.5%], and no deaths). Setting: Urban hospital. Conclusion: Vascular surgeons who have advanced cath- Patients: Three hundred twenty-six patients (202 men [62%] and 124 women [38%]; mean age, 71 years) with eter-based skills can safely perform CAS in patients with asymptomatic carotid artery stenoses treated with either asymptomatic disease with periprocedural results com- CAS (n=120) or CEA (n=206) between January 1, 2001, parable to those with CEA. and December 31, 2006. Overall mean degree of steno- sis was 81.2%. Arch Surg. 2008;143(7):653-658 T IS WELL ESTABLISHED THAT PA- Approximately two-thirds of CEA pro- tients with severe carotid artery cedures in the United States are per- stenosis are at risk for primarily formed in patients with asymptomatic embolic stroke within the carotid disease.7 Risk reduction when CEA is per- distribution. Several major ran- formed because of asymptomatic disease Idomized trials have been performed to as- is less than that for symptomatic disease. sess the effect of carotid endarterectomy The Asymptomatic Carotid Atherosclero- (CEA) on the risk of stroke in patients with sis Study3 demonstrated a 5-year stroke rate varying degrees of symptomatic and asymp- of 5% compared with 11% for medical tomatic carotid artery stenosis.1-5 These management,3 and more recently, the studies suggest that CEA is appropriate for Asymptomatic Carotid Surgery Trial4 dem- treatment of symptomatic stenosis of 50% onstrated a 5-year risk of stroke of 6.4% or greater and asymptomatic stenosis of after CEA compared with 11% after medi- Author Affiliations: Division of 60% or greater, assuming that the major cal management of asymptomatic steno- 4 Vascular Surgery, Northwestern complication rates, especially of stroke, sis of 60% or greater. Inasmuch as the University Feinberg School of myocardial infarction (MI), and death, are 5-year risk of stroke with medical man- Medicine, Chicago, Illinois. low after CEA.6 agement is only approximately 2% per year, (REPRINTED) ARCH SURG/ VOL 143 (NO. 7), JULY 2008 WWW.ARCHSURG.COM 653 ©2008 American Medical Association. All rights reserved. Downloaded From: https://jamanetwork.com/ on 09/29/2021 any carotid intervention because of asymptomatic dis- Carotid Endarterectomy ease must have low perioperative morbidity and mortal- ity to provide an adequate risk-benefit ratio for patients. All procedures were performed using general anesthesia by In addition, patients must have a reasonable life expec- 1 of 4 experienced, board-certified vascular surgeons ( J.S.M., tancy to benefit from carotid intervention. M.D.M., W.H.P., or M.K.E.) using standard endarterectomy with Carotid angioplasty and stenting (CAS) has been patch closure or eversion endarterectomy. Selective shunting used as an alternative to CEA for stroke prevention. based on carotid stump pressure measurement was used at the discretion of the operating surgeon. Although multiple trials comparing CAS with CEA and For both procedures, patients were monitored in the post- CAS registries including patients with asymptomatic dis- operative anesthesia care unit and then transferred to the stan- 7-15 ease have been published or are ongoing, the role of dard postoperative ward if they did not exhibit any hypoten- CAS in treating asymptomatic disease remains unclear. sion or hypertension requiring vasoactive medications. Patients Medicare recently rejected a proposed expansion of cov- requiring continuous intravenous vasoactive medications were erage to include patients with asymptomatic stenosis of transferred to the intensive care unit. Selected patients at high 80% or greater. Carotid angioplasty and stenting cover- risk were transferred to the intensive care unit for monitoring age for asymptomatic disease remains limited to clinical postoperatively at the discretion of the attending surgeon. trials. We report a single-center experience with CAS and OUTCOME MEASURES CEA used to treat asymptomatic disease during the past Primary outcomes measures were stroke, MI (troponin I level 5 years in a mixed population of patients at high and stan- Ն dard risk. We hypothesized that our 30-day early out- 0.5 ng/mL [to convert to micrograms per liter, multiply by 1.0]), and death. Secondary outcomes measures were length of stay af- comes for stroke, MI, and death would be equivalent with ter the procedure and other major and minor adverse events. The CAS and CEA. most serious complication per patient was recorded and used for analysis. Neurologic examinations were performed by the op- METHODS erating surgeon in the immediate postoperative period. If the pa- tient was enrolled in an investigational trial, a neurologist evalu- ated the patient both preoperatively and postoperatively. PATIENTS Otherwise, a neurology consultation was obtained for any new noncranial nerve neurologic deficit in the immediate postopera- All CAS and CEA procedures performed because of asymptom- tive period. Any death or major or minor adverse event occur- atic disease at Northwestern Memorial Hospital, Chicago, Illi- ring within 30 days after either procedure was recorded. A “ma- nois, between January 1, 2001, and December 31, 2006, were jor stroke” was defined as a new neurologic deficit discovered retrospectively reviewed using our institutional review board pro- in the postoperative period that persisted longer than 24 hours tocol. Patients who underwent another operation during the same and/or increased the National Institutes of Health Stroke Scale hospital stay were excluded from the study. Patients underwent score by 3 points. A “minor stroke” was defined as a deficit last- CAS or CEA because of carotid stenosis of 70% or greater dem- ing longer than 24 hours without increasing the National Insti- onstrated by 1 or more of the following examinations: angiog- tutes of Health Stroke Scale by more that 3 points. A transient raphy, duplex ultrasonography, magnetic resonance angiogra- ischemic attack was defined as any neurologic deficit that re- phy, or computed tomographic angiography. Patients were solved within 24 hours after onset. A “major adverse event” was evaluated for both CAS and CEA. Patients underwent CAS if they defined as an event that required either endovascular or surgi- were at high surgical risk, desired CAS, or qualified for 1 of the cal reintervention between 24 and 48 hours after the index pro- ongoing CAS trials or registries at our center. High surgical risk cedure, caused an unplanned increase in the level of care (not was defined on the basis of anatomic criteria (surgically inac- including intensive care unit monitoring owing to vasoactive cessible lesion, ipsilateral neck irradiation, contralateral carotid medications because this was, in general, self-limited and lasted occlusion, current tracheostomy, contralateral laryngeal nerve Ͻ12 hours), led to prolongation of hospital stay by more than paralysis, previous ipsilateral carotid surgery, or previous ipsi- 48 hours, or caused some permanent serious sequela. A “minor lateral radical neck surgery and irradiation) or clinical or physi- adverse event” was defined as an event that required no further ologic criteria (age Ն80 years, end-stage liver disease, severe coro- therapy and, at most, caused an unplanned extension of hospital nary or valvular heart disease, or severe pulmonary disease stay of less than 48 hours for observation. Hematomas were de- requiring home oxygen). fined as substantial if they were at least 5 cm in diameter, prompted an additional study to rule out another vascular complication, or PROCEDURES caused a delay in discharge for observation of the patient. Carotid Angioplasty and Stenting STATISTICAL ANALYSIS All procedures were performed by at least 1 of 3 endovascular The t test was used for comparison between the 2 groups. Data Յ surgeons (J.S.M., M.D.M., or M.K.E.) with a 0.014-wire small- are given as mean (SD). All P values were 2-tailed, and P .05 vessel endovascular experience with 20 to 30 proctored CAS was considered statistically significant.