Journal of Clinical Neuroscience 22 (2015) 189–194

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Journal of Clinical Neuroscience journal homepage: www.elsevier.com/locate/jocn

Clinical Study

Ischemic complications after tailored carotid artery stenting in different subpopulations with high-grade stenosis: Feared but rare José E. Cohen a,b,⇑, J. Moshe Gomori b, Eyal Itshayek a, Stylianos Pikis a, Galina Keigler c, Roni Eichel c, Ronen R. Leker c a b c

Department of Neurosurgery, Hadassah-Hebrew University Medical Center, POB 12000, Jerusalem 91120, Israel Department of Radiology, Hadassah-Hebrew University Medical Center, Jerusalem, Israel Department of Neurology, Hadassah-Hebrew University Medical Center, Jerusalem, Israel

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Article history: Received 3 September 2014 Accepted 13 September 2014

Keywords: Atherosclerosis Carotid artery Myocardial infarction Stenting Stroke

a b s t r a c t Although the procedural and postoperative safety profile of carotid artery stenting (CAS) has been steadily improving, many centers still recommend carotid endarectomy (CEA) over CAS. We assessed outcomes (procedural and postoperative stroke) following tailored CAS in a cohort of patients managed at a single academic medical center. Outcomes for patients with carotid artery stenosis treated from 2005–2013 with CAS were retrospectively reviewed. Stenosis was assessed with Doppler ultrasonography and/or CT angiogram, and angiography. Symptomatic and asymptomatic patients were dichotomized (based on the North American Symptomatic Carotid Endarterectomy Trial [NASCET] and the Asymptomatic Carotid Atherosclerosis Study [ACAS]). CAS technique was chosen based on angiographic and clinical characteristics; procedures were performed with/without pre-angioplasty, cerebral protection, and postdilation. Endpoints were cumulative incidence of ipsilateral stroke, myocardial infarction, and death within 30 days (primary) or 12 months (secondary). Overall 249 patients (151 men/98 women; mean age 69.9 years) with 254 carotid stenoses were included; 148 lesions (58%) were asymptomatic, and 106 (42%) were symptomatic. CAS was successfully performed in all lesions. At 30 days, ipsilateral transient ischemic attack (TIA)/minor stroke was seen in 6/104 (5.8%) symptomatic patients and no asymptomatic patients; there was no myocardial infarction or ipsilateral major stroke. At 12 months, there was ipsilateral TIA/minor stroke in an additional 3/98 (3.1%) symptomatic and 1/127 (0.8%) asymptomatic patients, and major stroke in 1/98 (1%). The incidence of stroke after CAS compares favorably with rates reported after CEA. The majority of peri-procedural ischemic events following CAS are TIA/minor strokes causing only transient or minor functional impact; major disabling stroke is rare with current techniques. Ó 2014 Elsevier Ltd. All rights reserved.

1. Introduction While the effectiveness of carotid endarterectomy (CEA) and carotid artery stenting (CAS) have been found to be comparable in the management of carotid artery stenosis, studies tend to dictate technique superiority based on procedural safety, that is, comparing the incidence of stroke, myocardial infarction (MI) and death [1–8] with the two management strategies. In 2010, the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST), the largest randomized controlled trial to compare the efficacy of CEA and CAS, showed equivalent outcomes for a composite end point encompassing postoperative stroke, MI, or death [8,9]. Agencies such as the US Food and Drug Administration ⇑ Corresponding author. Tel.: +972 2 677 7092; fax: +972 2 641 6281. E-mail address: [email protected] (J.E. Cohen). http://dx.doi.org/10.1016/j.jocn.2014.09.005 0967-5868/Ó 2014 Elsevier Ltd. All rights reserved.

Circulatory System Device Panel subsequently expanded the indications for CAS in standard-risk patients [10,11]. However, many centers still recommend CEA over CAS, arguing that CAS has a higher risk of postoperative stroke while CEA has a higher risk of MI, and the outcome of patients after stroke is worse than outcomes after MI [12]. We aimed to compare the incidence of death, stroke, and MI following CAS in a cohort of patients with carotid artery stenosis who were managed at a single academic medical center. 2. Materials and methods This retrospective study included patients with carotid artery stenosis who were treated at our center between January 2005 and January 2013. The Institutional Review Board approved the study design and waived the requirement for informed consent.

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Symptomatic and asymptomatic patients were dichotomized based on North American Symptomatic Carotid Endarterectomy Trial (NASCET) [13] and Asymptomatic Carotid Atherosclerosis Study (ACAS) [14] criteria. Carotid artery stenosis was initially diagnosed by Doppler sonography, using peak systolic velocity of >230 cm/s as the criterion for >70% stenosis; [15] it was confirmed by CT angiography (CTA) when possible, and by angiography in all cases. The degree of carotid stenosis was determined at angiography and CTA based on NASCET criteria [13]. Patients aged >18 years who were symptomatic and presented with an ulcerated atherosclerotic stenosis and >50% occlusion, or a non-ulcerated atherosclerotic stenosis with >70% occlusion or who were asymptomatic with >80% occlusion, were included in the study. Patients with post-endarterectomy restenosis, postradiation stenosis, or contralateral carotid occlusion who were managed with CAS were included if they were symptomatic with a >50% occlusion or asymptomatic with >80% carotid occlusion demonstrated on angiography and based on NASCET criteria. Patients presenting vascular anatomy that was unsuitable for endovascular management, those without adequate percutaneous vascular access, those with uncontrolled coagulopathy, and individuals with major contraindications to heparin or antiplatelet therapy were excluded; patients with tandem stenoses requiring intracranial stenting and those with acute carotid occlusion were also excluded.

All patients signed the informed consent form according to our protocol. Patients were kept on their usual medications except for specific anticoagulants and diabetic medications, and were instructed to take aspirin (100 mg per day) and clopidogrel (75 mg per day) for at least 4 days before the procedure. When this was not possible, they received a loading dose of clopidogrel (300 mg) and aspirin (300 mg) on the day of the procedure. Since 2010, thrombocyte inhibition levels have been evaluated using the VerifyNow P12Y12 assay (Accumetrics, San Diego, CA, USA). Patients were treated only when the thrombocyte inhibition level was above 30%. If the response was lower and without resistance, additional loading doses or increased daily doses (for example, 150 mg daily) were administered. If clopidogrel resistance was detected, clopidogrel was discontinued and ticlopidine, ticagrelor, or prasugrel was prescribed. All patients underwent pre and postoperative neurological evaluations by specialized neurovascular physicians. In addition, patients with low cardiovascular risk underwent a baseline electrocardiogram and echocardiogram; those with a high-risk cardiovascular profile were evaluated by senior cardiologists before the endovascular procedure, and had tailored complementary cardiovascular evaluations and medications based on this evaluation.

5. Angioplasty procedure 3. Study definitions The primary end point was the cumulative incidence of death, ipsilateral stroke, or MI within 30 days after CAS. The secondary end point was the cumulative incidence of ipsilateral stroke and/ or death between 31 days and 12 months after the procedure. Stroke was defined as a neurological deficit that persisted for >24 hours. Major or disabling stroke was defined as major stroke on the basis of clinical data or if the National Institutes of Health Stroke Scale (NIHSS) score was P10 at 3 months after the procedure. Minor or non-disabling stroke was defined as a new neurological deficit that changed the NIHSS score by 80% was an indication for repeat intervention. Hemodynamic instability was defined as systolic blood pressure

Ischemic complications after tailored carotid artery stenting in different subpopulations with high-grade stenosis: feared but rare.

Although the procedural and postoperative safety profile of carotid artery stenting (CAS) has been steadily improving, many centers still recommend ca...
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