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Home , Angioplasty, Carotid endarterectomy

PAPER Carotid and Stenting vs Carotid 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 coupled (CEA) in selected patients with with a mechanical embolic protection system. Carotid symptomatic cervical carotid 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: , myocardial infarc- Hypothesis: Carotid angioplasty and stenting per- formed in patients with asymptomatic disease will re- tion, and death rates at 30 days after . 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 [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- 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 domizedI 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 .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 , Northwestern complication rates, especially of stroke, sis of 60% or greater. Inasmuch as the University Feinberg School of (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,

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©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 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 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 ( 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 . 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 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. cases. All operations were performed using the femoral ap- proach in an operating angiosuite with dedicated endovascu- RESULTS lar capabilities. Embolic protection devices (wire-base filter, dis- tal occlusion, or proximal balloon occlusion) were used in 117 of 120 procedures (94.2%). Self-expanding nitinol stents PATIENT CHARACTERISTICS were used in all procedures. All patients received local anes- thesia and monitored anesthesia care. Procedural details have Between January 1, 2001, and December 31, 2006, 326 been reported previously.16,17 of 607 carotid interventions were performed because of

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©2008 American Medical Association. All rights reserved. Downloaded From: https://jamanetwork.com/ on 09/29/2021 Table 1. Patient Demographic Data Table 2. High-Risk Criteria Met by Patients Who Underwent CAS or CEA No. (%) No. (%) CAS CEA Variable (n=120) (n=206) P Value CAS CEA Age Ն80 y 31 (25.8) 28 (13.6) .009 Criteria (n=120) (n=206) P Value Congestive heart failure 8 (6.6) 10 (4.9) .51 Anatomic 57 (47.5) 14 (6.8) Ͻ.001 COPD 13 (10.7) 21 (10.2) .86 Previous CEA or other carotid 24 (20) 6 (2.9) .001 Hypertension 106 (88.4) 169 (82.0) .11 surgery Current tobacco use 19 (15.7) 53 (25.7) .03 Neck surgery or irradiation 11 (9.2) 0 .007 Diabetes mellitus 38 (31.4) 60 (29.1) .63 Irradiation 2 (1.7) 0 .16 Dyslipidemia 84 (70.2) 138 (67.0) .57 Inaccessible lesion 7 (5.8) 0 .007 ESRD 1 (0.8) 2 (1.0) .67 Tracheostomy 3 (2.5) 0 .08 ASA classification Contralateral occlusion 10 (8.3) 8 .12 II 15 (12.5) 39 (18.9) .11 Contralateral RLN palsy 1 (0.83) 0 .32 III 95 (79.2) 141 (68.4) .03 Clinical or physiologic 60 (50) 37 (18) Ͻ.001 IV 4 (3.3) 6 (2.9) .84 CAD or valve 24 (20) 6 (2.9) Ͻ.001 Pulmonary 3 (2.5) 0 .08 Abbreviations: ASA, American Society of Anesthesiologists; CAS, carotid Age Ն80 y 31 (25.8) 29 (14.1) .01 angioplasty and stenting; CEA, carotid endarterectomy; COPD, chronic ESLD 2 (1.7) 2 (0.97) .61 obstructive pulmonary disease; ESRD, end-stage renal disease. More than 2 high-risk criteria 30 (25) 6 (2.9) Ͻ.001

Abbreviations: CAD, ; CAS, carotid angioplasty and asymptomatic disease. Asymptomatic disease was the in- stenting; CEA, carotid endarterectomy; ESLD, end-stage liver disease; RLN, recurrent laryngeal nerve. dication in 121 of 189 CAS procedures (64.0%). Data for 1 patient in the CAS group were excluded because an- other operation was performed during the same hospi- tal stay. Therefore, included in the analysis were 120 CAS Table 3. Primary Outcome Events Within 30 Days procedures performed in 117 patients; 3 patients under- After Intervention went sequential bilateral operations. Most CAS proce- dures (55.8%) were performed as part of a clinical trial No. (%) or registry. Asymptomatic disease was the indication in 238 of 418 CEA procedures (56.9%). Data for 32 pa- CAS CEA Adverse Event (n=120) (n=206) P Value tients in the CEA group were excluded because another operation was performed during the same hospital stay. Stroke 2 (1.7) 2 (1.0) .61 Minor 2 (1.7) 2 (1.0) .61 Therefore, the analysis was carried for 206 CEA proce- Major 0 0 dures performed in 192 patients; 14 patients underwent MI 2 (1.7) 3 (1.5) .88 sequential bilateral operations. Mean age in the CAS group Death 1 (0.8) 0 .15 was significantly higher compared with the CEA group: Stroke or death 3 (2.5) 2 (1.0) .34 72.4 (9.5) years (median age, 72.2 years; age range, 49-91 Stroke, MI, or death 5 (4.2) 5 (2.4) .41 years) vs 70.4 (8.5) years (median age, 71.4 years; age range, 47-88 years; P =.047). In the 2 groups, sex Abbreviations: CAS, carotid angioplasty and stenting; CEA, carotid endarterectomy; MI, myocardial infarction. (65.0 % vs 60.7% male; P=.43) and sidedness of the le- sion (46.3% right vs 53.4% left; P=.19) were similar. Other baseline patient characteristics are given in Table 1. Pa- tients undergoing CEA were more likely to be current converted to CEA. None of the 4 patients had an ad- smokers. More patients older than 80 years underwent verse outcome related to attempted CAS or a primary out- CAS, and the American Society of Anesthesiologists clas- come event of stroke, MI, or death. sification overall was higher in patients in the CAS group. Otherwise, differences between baseline patient charac- THIRTY-DAY OUTCOME teristics were not significant. High-risk criteria met in both groups are given in Table 2. The primary outcomes of stroke, MI, and death are given Carotid angioplasty and stenting was performed suc- in Table 3. No significant differences were found be- cessfully in 120 of 124 patients, for a technical success tween the 2 groups at 30-day follow-up. Two strokes oc- rate of 96.8%. One patient had a bovine arch and an ex- curred in the CAS group, both in patients who had dis- ternal carotid artery occlusion, and the operating sur- tal embolic protection. One of these patients developed geon was unable to advance the guiding sheath into the expressive aphasia and right-sided hemiparesis 30 min- ; 2 patients had preocclusive le- utes after the procedure was completed; a posterior middle sions that could not be crossed with a wire; and 1 pa- cerebral artery distribution stroke was seen at diffusion- tient had a preocclusive lesion that was crossed with a weighted magnetic resonance imaging. Symptoms had wire but could not be crossed with the filter device ap- almost completely resolved by 30-day follow-up. In the proved for the clinical trial in which she was a partici- other patient, right-sided homonymous hemianopsia was pant. All 4 CAS procedures with technical failures were detected on the morning of postoperative day 1. At mag-

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©2008 American Medical Association. All rights reserved. Downloaded From: https://jamanetwork.com/ on 09/29/2021 Table 4. Postprocedure Morbidity

CAS, No. (%) CEA, No. (%) Variable (n=120) Variable (n=206) P Value Major adverse events 13 (10.8) 16 (7.8) .37 PSA requiring thrombin injection 1 (0.8) Hematoma evacuation 3 (1.5) Contrast agent–related nephropathy 2 (1.7) Reintubation 1 (0.5) Readmission 2 (1.7) Readmission 2 (1.0) Delay in discharge because of hypertension 2 (1.7) Delay in discharge because of hypertension 2 (1.0) or hypotension or hypotension SBO 1 (0.8) Intraoperative CCA dissection 1 (0.5) Hematoma; patient transferred to ICU 1 (0.5) DVT 1 (0.5) Minor adverse events 29 (24.2) 40 (19.4) .41 Urinary retention 1 (0.8) Urinary retention 8 (3.9) Hypotension 17 (13.3) Hypotension 7 (4.4) Hypertension 1 (0.8) Hypertension 5 (2.9) Hematoma 3 (2.5) Hematoma 3 (1.5) Troponin leak 2 (1.7) Troponin leak 2 (1.0) Transient ischemic attack 1 (0.8) Transient ischemic attack 2 (1.0) Retroperitoneal bleeding 2 (1.7) Bradycardia 1 (0.5) Visual defect 1 (0.8) Cranial nerve injury 8 (3.9) Headache 1 (0.8) Hyponatremia 1 (0.5) 1 (0.5) Corneal abrasion 1 (0.5) Chipped tooth 1 (0.5)

Abbreviations: CAS, carotid angioplasty and stenting; CCA, common carotid artery; CEA, carotid endarterectomy; DVT, deep venous thrombosis; ICU, intensive care unit; PSA, ; SBO, small-bowel obstruction.

netic resonance imaging, multiple infarcts were noted in ease, in preparation for coronary artery bypass grafting and the left posterior cerebral artery and left middle cerebral aortic valve replacement surgery, that had been discov- artery distributions and in the right cerebellar hemi- ered after admission because of a non-ST elevation MI. Ad- sphere. The patient was readmitted 17 days later be- ditional comorbidities in this patient included pulmo- cause of hemorrhagic transformation of the left poste- nary fibrosis and chronic renal insufficiency (baseline rior cerebral artery distribution infarct. creatinine concentration, 1.9 mg/dL [to convert to micro- Two strokes occurred in the CEA group. One of these moles per liter, multiply by 88.4]). No deaths were ob- patients was noted to have left upper and lower extrem- served in the CEA group. ity weakness on emerging from general anesthesia. Re- Other adverse events are given in Table 4. As has been peated exploratory surgery was performed, with no oc- previously noted,18 substantially more patients were ob- clusion or defect found at intraoperative angiography and served to have hypotension after CAS compared with CEA. no infarct seen at magnetic resonance imaging. There was There were 8 cranial nerve injuries (3.9%) in the CEA full resolution of symptoms at 30-day follow-up. The other group: 4 marginal mandibular, 3 hypoglossal, and 1 re- patient was noted to have slurred speech and left-sided current laryngeal nerve palsy. Mean (SD) length of stay facial drooping on postoperative day 1; however, a sec- after the procedure was longer in the CAS group (1.85 ond exploratory surgery was not performed. Indetermi- [3.58]; median. 1 day) compared with the CEA group nate age changes were seen at head computed tomogra- (1.26 [0.68]; median, 1 day). phy; magnetic resonance imaging was not performed because the patient had a pacemaker. One death occurred in the CAS group (0.8%) as a re- COMMENT sult of an MI. This patient had severe bilateral carotid ste- nosis and 3-vessel coronary artery disease for which coro- Recently, there has been great interest in CAS as an al- nary artery bypass grafting had been offered but only if ternative to CEA for stroke prevention. There are sev- the patient underwent successful carotid intervention. This eral advantages to CAS in patients who have undergone patient was home oxygen–dependent because of amioda- previous neck operations or neck irradiation, which puts rone-associated pulmonary fibrosis, had severe periph- them at higher risk for cranial nerve injury during CEA. eral vascular disease with a right-sided toe ulcer due to dia- Carotid angioplasty and stenting is a percutaneous pro- betes mellitus, and had recently been admitted because of cedure performed with the patient under local anesthe- a non-ST elevation MI earlier in the month. The patient sia, which suggests that it should be better tolerated in had a postoperative MI with cardiogenic shock and died patients at high risk for surgery such as those with se- 2 days after the CAS procedure. The other patient had a vere coronary artery disease, congestive heart failure, and large postoperative MI and died 35 days after the CAS pro- severe chronic obstructive pulmonary disease. How- cedure after developing multiple organ system failure. The ever, 2 large recent multicenter randomized trials have CAS was performed because of severe bilateral carotid dis- failed to show improved short-term outcomes after CEA

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©2008 American Medical Association. All rights reserved. Downloaded From: https://jamanetwork.com/ on 09/29/2021 in patients with symptomatic disease19,20 despite the use not be applicable to other centers. In addition, the avail- of embolic protection devices. ability of multiple high-risk carotid trials and reg- Carotid angioplasty and stenting for treatment of asymp- istries may have caused direction of patients at high risk tomatic disease has been less well studied. High-risk pa- toward CAS and away from CEA, artificially improving tients and standard-risk patients with asymptomatic dis- the CEA results. ease were included in 3 randomized trials that showed This series lends support to the hypothesis that CAS noninferiority of CAS to CEA.7,8,14 Two single-center re- can be performed safely and with equivalent morbidity and ports, 1 randomized and the other a retrospective review, mortality outcomes as with CEA in patients with asymp- demonstrated equivalent results for CEA and CAS.9,21 Vari- tomatic disease. The surgical principle of careful patient ous industry-sponsored registry trials suggest that pa- selection must still apply, however, for centers to main- tients with asymptomatic disease undergoing CAS fare bet- tain acceptably low complication rates after carotid inter- ter than those with symptomatic disease.10,11,13 However, ventions to treat asymptomatic disease. Randomized con- registry trials fail to include either a CEA or a medical man- trolled trials such as the Carotid and agement arm, relying on historical controls. Endarterectomy vs Stent Trial and the Asymptomatic Ca- The CAS combined stroke and death rate of 2.5% in rotid Surgery Trial II are needed to definitively answer the our study compares favorably with the stroke and death question of whether CAS is comparable to CEA for treat- rate for CEA from the same surgeons (1%), the Asymp- ment of asymptomatic carotid disease. tomatic Carotid Study (2.3%), and the Asymptomatic Carotid Surgery Trial (2.8%). Myocardial Accepted for Publication: February 4, 2008. infarction was not reported for the Asymptomatic Ca- Correspondence: Mark K. Eskandari, MD, Division of rotid Atherosclerosis Study, but the Asymptomatic Ca- Vascular Surgery, Northwestern University Feinberg rotid Surgery Trial combined stroke, MI, and death rate School of Medicine, 201 E Huron St, Galter 10-105, Chi- was 3.5%. Although the combined stroke, MI, and death cago, IL 60611 ([email protected]). rate of 4.2% in our CAS group was higher than the 2.4% Author Contributions: Dr Eskandari had full access to in the CEA group, the results were not statistically sig- all of the data in the study and takes responsibility for nificant. This may be an effect of small sample size but more the integrity of the data and the accuracy of the data analy- likely reflects the mixed cohort of high-risk and standard- sis. Study concept and design: Tang, Morasch, and Eskan- risk patients in the CAS group. The major and minor ad- dari. Acquisition of data: Tang, Matsumura, Morasch, verse event rates were higher in patients older than 80 years Pearce, Nguyen, Amaranto, and Eskandari. Analysis and in the CAS group compared with the CEA group (16.7% interpretation of data: Tang, Morasch, Amaranto, and Es- and 26.7% vs 6.9% and 17.2%, respectively), but these dif- kandari. Drafting of the manuscript: Tang, Nguyen, and ferences were not statistically significant owing to small Eskandari. Critical revision of the manuscript for impor- sample size (31 patients in the CAS group and 28 pa- tant intellectual content: Tang, Matsumura, Morasch, tients in the CEA group). Pearce, Amaranto, and Eskandari. Statistical analysis: Both major and minor adverse event rates were higher Tang, Amaranto, and Eskandari. Administrative, techni- for CAS than for CEA, although the results did not reach cal, and material support: Tang, Matsumura, Morasch, statistical significance. This may reflect that patients in Pearce, Nguyen, Amaranto, and Eskandari. Study super- the CAS group had more comorbidities (as evidenced by vision: Morasch and Eskandari. their overall older age and higher American Society of Financial Disclosure: None reported. Anesthesiologists classification). Especially of note were Funding/Support: Dr Matsumura has been a consultant the 16.5% of patients who developed hypotension (sys- and paid speaker and has received research support from tolic pressure Ͻ90 mm Hg). Indeed, 10.8% of patients Abbott Vascular Devices, and W. L. Gore & Associates; in the CAS group were transferred to the intensive care has been a consultant and received grant and research unit overnight for observation, volume resuscitation, or support from Cook Medical, Cordis Corp, and ev3 Inc; pharmacologic support because of hypotension com- and has received grant or research support from C. R. pared with 2.4% of patients in the CEA group. The ef- Bard, Inc, Bolton, Lumen Biomedical, Inc, and Medtronic, fects of this sustained hypotension and the measures used Inc. Dr Morasch receives research support from W. L. to treat it may account for the relatively high MI and death Gore & Associates, Inc, Guidant Corp, Cook Inc, and rates seen in high-risk trials for CAS despite the percu- Medtronic, Inc; and receives honoraria for serving as a taneous nature of the procedure. These effects almost cer- training course director for W. L. Gore & Associates, Inc, tainly had a role in the deaths in this series and probably and as consultant for King Pharmaceuticals, Inc, and Vas- also contributed to the MIs. cular Surgery division support for serving as training There are several limitations to this study. It was rela- course director for Abbott Vascular. Dr Eskandari serves tively small and the data were retrospectively analyzed. as a consultant for Cook Inc, Cordis Corp, Abbott Vas- Patients were not randomized, and the patient groups were cular Devices, Medtronic, Inc, Boston Scientific Corp, not strictly comparable. The results may not be appli- Terumo Medical Corp, and W. L. Gore & Associates, Inc. cable to other low-volume centers that do not routinely Previous Presentation: This paper was presented at the perform CAS because there is a relatively steep learning 115th Annual Meeting of the Western Surgical Associa- curve for this procedure.22 The low stroke, MI, and death tion; November 6, 2007; Colorado Springs, Colorado; and rate from CEA observed in this series despite general an- is published after peer review and revision. The discus- esthesia in all cases may be owing to the availability of sions that follow this article are based on the originally specialized cardiovascular anesthesiologists and also may submitted manuscript and not the revised manuscript.

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©2008 American Medical Association. All rights reserved. Downloaded From: https://jamanetwork.com/ on 09/29/2021 sus stenting in patients with symptomatic severe carotid stenosis. N Engl J Med. REFERENCES 2006;355(16):1660-1671. 20. Ringleb PA, Allenberg J, Bruckmann H, et al; Space Collaborative Group. Thirty- 1. European Carotid Surgery Trialists’ Collaborative Group. MRC European day results from the SPACE trial of stent-protected angioplasty versus carotid Carotid Surgery Trial: interim results for symptomatic patients with severe endarterectomy in symptomatic patients: a randomised non-inferiority trial [pub- (70-99%) or with mild (0-29%) carotid stenosis. Lancet. 1991;337(8752): lished correction appears in Lancet. 2006;368(9543):1238]. Lancet. 2006; 1235-1243. 368(9543):1239-1247. 2. North American Symptomatic Carotid Endarterectomy Trial Collaborators. Ben- 21. Marine LA, Rubin BG, Reddy R, Sanchez LA, Parodi JC, Sicard GA. Treatment of eficial effect of carotid endarterectomy in symptomatic patients with high-grade asymptomatic carotid artery disease: similar early outcomes after carotid stent- carotid stenosis. N Engl J Med. 1991;325(7):445-453. ing for high-risk patients and endarterectomy for standard-risk patients. J Vasc 3. Executive Committee for the Asymptomatic Carotid Atherosclerosis Study. Surg. 2006;43(5):953-958. Endarterectomy for asymptomatic carotid artery stenosis. JAMA. 1995;273 22. Ahmadi R, Willfort A, Lang W, et al. Carotid artery stenting: effect of learning (18):1421-1428. curve and intermediate-term morphological outcome. J Endovasc Ther. 2001; 4. Halliday A, Mansfield A, Marro J, et al. Prevention of disabling and fatal strokes 8(6):539-546. by successful carotid endarterectomy in patients without recent neurological symp- toms: randomised controlled trial [published correction appears in Lancet. 2004;364(9432):416]. Lancet. 2004;363(9420):1491-1502. DISCUSSION 5. Hobson RW II, Weiss DG, Fields WS, et al; Veterans Affairs Cooperative Study Group. Efficacy of carotid endarterectomy for asymptomatic carotid stenosis. M. Ashraf Mansour, MD, Grand Rapids, Michigan: This ar- N Engl J Med. 1993;328(4):221-227. ticle reviews the outcomes of CAS and CEA in patients with 6. Meschia JF, Brott TG, Hobson RW II. Diagnosis and invasive management of asymptomatic disease. In this case-controlled study, approxi- carotid atherosclerotic stenosis. Mayo Clin Proc. 2007;82(7):851-858. mately one-third of the patients underwent CAS and two- 7. CaRESS Steering Committee. Carotid revascularization using endarterectomy or thirds underwent CEA. The overall combined stroke and death stenting systems (CaRESS) phase I clinical trial: 1-year results. J Vasc Surg. 2005; rate, 2.5% for CAS and 1% for CEA, is outstanding, reflecting 42(2):213-219. the skill and expertise of the surgeons. I have 3 questions. 8. CAVATAS Investigators. Endovascular versus surgical treatment in patients with First, it is now routine and customary to use an embolic pro- carotid stenosis in the Carotid and Vertebral Artery Transluminal Angioplasty Study tection device in all carotid stent procedures; however, you note (CAVATAS): a randomised trial. Lancet. 2001;357(9270):1729-1737. 9. Brooks WH, McClure RR, Jones MR, Coleman TL, Breathitt L. Carotid angio- that in 6% of the cases an embolic protection device was not plasty and stenting versus carotid endarterectomy for treatment of asymptom- used. Were any of the strokes in the CAS group related to the atic carotid stenosis: a randomized trial in a community hospital. Neurosurgery. use or lack of use of the embolic protection device? Second, in 12 2004;54(2):318-325. a previous report by Hobson et al, patients older than 80 years 10. Gray WA, Hopkins LN, Yadav S, et al. Protected in high-surgical- had worse outcomes with stenting. Based on your data, is CEA risk patients: the ARCHeR results [published correction appears in J Vasc Surg. better than CAS in this age group? Third, as a surgeon per- 2007;45(1):226]. J Vasc Surg. 2006;44(2):258-268. forming both CAS and CEA, can you justify carotid stenting 11. Gray WA, Yadav JS, Verta P, et al. The CAPTURE registry: results of carotid stent- in a patient at good surgical risk with asymptomatic disease? ing with embolic protection in the post approval setting. Cardiovasc Interv. Dr Tang: In answer to the first question about embolic pro- 2007;69(3):341-348. tection devices, 3 of the cases that did not have distal embolic pro- 12. Hobson RW II, Howard VJ, Roubin GS, et al. Carotid artery stenting is associ- tection were very early in our experience before it became clear ated with increased complications in octogenarians: 30-day stroke and death rates that distal embolic protection decreased the stroke rate. In 2 pa- in the CREST lead-in phase. J Vasc Surg. 2004;40(6):1106-1111. 13. Katzen BT, Criado FJ, Ramee SR, et al. Carotid artery stenting with emboli pro- tients, we were unable to pass the filter device and they did not tection surveillance study: thirty-day results of the CASES-PMS study. Catheter receive embolic protection. None of the strokes were related to Cardiovasc Interv. 2007;70(2):316-323. difficulty with embolic protection devices, and the 2 strokes oc- 14. Yadav JS, Wholey MH, Kuntz RE, et al; Stenting and Angioplasty With Protec- curred in patients who did have distal embolic protection. tion in Patients at High Risk for Endarterectomy Investigators. Protected carotid- In patients older than 80 years, we did not see any increase artery stenting versus endarterectomy in high-risk patients. N Engl J Med. 2004; in either stroke or complication rate. However, these were small 351(15):1493-1501. groups: only 30 patients in the CAS group and 28 patients in 15. White CJ, Iyer SS, Hopkins LN, Katzen BT, Russell ME; BEACH Trial Investiga- the CEA group. These numbers are too small to enable us to tors. Carotid stenting with distal protection in high surgical risk patients: the BEACH draw any conclusions. The literature suggests that in patients trial 30 day results. Catheter Cardiovasc Interv. 2006;67(4):503-512. older than 80 years, the stroke rate is increased with CAS; there- 16. Eskandari MK, Longo GM, Vijungco JD, Morasch MD, Pearce WH. Does carotid fore, until larger trials are completed, I think the best advice is stenting measure up to endarterectomy? a vascular surgeon’s experience. Arch to proceed with caution in these older patients. Surg. 2004;139(7):734-738. 17. Eskandari MK, Longo GM, Matsumura JS, et al. Carotid stenting done exclu- In answer to your third question, I think our results sug- sively by vascular surgeons: first 175 cases. Ann Surg. 2005;242(3):431-438. gest that even patients who are at good surgical risk have a low 18. Brooks WH, McClure RR, Jones MR, Coleman TC, Breathitt L. Carotid angio- risk of stroke, MI, or death after CAS. From our experience, plasty and stenting versus carotid endarterectomy: randomized trial in a com- those patients could undergo CAS without difficulty. munity hospital. J Am Coll Cardiol. 2001;38(6):1589-1595. 19. Mas JL, Chatellier G, Beyssen B, et al; EVA-3S Investigators. Endarterectomy ver- Financial Disclosure: None reported.

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