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Unprotected Carotid Artery Stenting in Symptomatic Patients with High-Grade Stenosis: Results and Long-Term Follow-Up in a Single- ORIGINAL RESEARCH Center Experience

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Unprotected Carotid Artery Stenting in Symptomatic Patients with High-Grade Stenosis: Results and Long-Term Follow-Up in a Single- ORIGINAL RESEARCH Center Experience Published March 15, 2012 as 10.3174/ajnr.A2951 Unprotected Carotid Artery Stenting in Symptomatic Patients with High-Grade Stenosis: Results and Long-Term Follow-Up in a Single- ORIGINAL RESEARCH Center Experience R. Oteros BACKGROUND AND PURPOSE: The use of cerebral protection during CAS is an extended practice. E. Jimenez-Gomez Paradoxically it is open to question because it can lead to potential embolic complications. The aim of this study was to evaluate the safety and efficacy of CASWPD in patients with severe symptomatic F. Bravo-Rodriguez carotid artery stenosis. J.J. Ochoa R. Guerrero MATERIALS AND METHODS: A prospective study was performed including 210 consecutive patients (201 symptomatic and 9 asymptomatic) with carotid artery stenosis Ͼ70%. All patients were treated F. Delgado by CASWPD. Angiographic results and neurologic complications were recorded during the procedure and within 30 days after it. All patients underwent clinical evaluation and Doppler sonography follow-up at 3, 6, and 12 months after the procedure. RESULTS: Two hundred twenty carotid arteries were treated. The average degree of stenosis was 88.9%. The procedure was successfully completed in 212 (96.4%) arteries. After stent placement, 98.6% of arteries showed no residual stenosis or Ͻ30%. Balloon angioplasty dilation before stent placement was performed in 16% of cases. During the 30-day periprocedural period, there were 3 major complications (1.4%), including 1 disabling ischemic stroke, 1 acute stent thrombosis, and 1 MI. The last 2 patients died from these complications. At 1-year follow-up 24 (12.8%) restenoses, 2 new ipsilateral strokes, 1 contralateral stroke, and 5 deaths (2.7%) had occurred. None of these deaths were related to the initial stroke. CONCLUSIONS: In our study, unprotected stent placement in symptomatic patients with severe carotid artery stenosis has demonstrated a low incidence of complications. We believe that this is due to the reduction of maneuvering and manipulation through the stenosis and to the protective effect of INTERVENTIONAL the stent placement before angioplasty balloon dilation. ABBREVIATIONS: CAS ϭ carotid artery stent placement; CEA ϭ carotid endarterectomy; CASWPD ϭ carotid artery stent placement without distal protection device; CAVATAS ϭ Carotid and Vertebral Artery Transluminal Angioplasty Study; MI ϭ myocardial infarction; SPACE ϭ Stent Protected Angioplasty versus Carotid Endarterectomy study ORIGINAL RESEARCH n the early 1990s, the NASCET and European Carotid Sur- tems has widely increased, and it is recommended as a good Igery Trials established CEA as the first-choice treatment for practice. Many reviews and meta-analyses have shown that the symptomatic carotid artery stenosis Ͼ70%.1,2 Ten years later, combined rate of stroke and death is lower in patients treated the first randomized trial comparing surgical-versus-endovas- by CAS and protection devices than those treated by cular treatment, CAVATAS, was published.3 The results of this CASWPD.8,9 However, in past years, a discussion has emerged study showed no significant difference between procedures, regarding the use of distal protection devices during CAS. A though in the endovascular therapy group, 80% of patients subanalysis of data from the SPACE trial has shown other were treated by angioplasty and only 20%, by stent placement. results that did not support the need for protection devices.10 Since then, several randomized trials have unsuccessfully as- On the other hand, several uncontrolled reports have shown 4-7 sessed the noninferiority of CAS versus CEA. Despite this excellent results in patients treated by unprotected stent place- outcome, CAS has been established as an alternative to CEA. ment techniques.11-15 The most feared complication of the stent placement tech- We performed a study to assess the safety and efficacy of nique is embolism caused by atherosclerotic plaque dislodg- unprotected CAS. The aim of this study was to establish the ment during the procedure. Several cerebral protection de- cumulative incidence of stroke, death, or myocardial infarc- vices have been developed to avoid or reduce the risk of tion within 30 days after the procedure and at 1-year periprocedural complications. Nowadays, the use of these sys- follow-up. Received July 9, 2011; accepted after revision October 18. Materials and Methods From the Departments of Neuroradiology (R.O., E.J-G., F.B-R., F.D.), Neurology (J.J.O.) and All patients with symptomatic severe carotid artery stenosis treated at Intensive Care Unit (R.G.), Hospital Universitario Reina Sofía, Co´rdoba, Spain. our center between January 2002 and January 2011 were prospectively Please address correspondence to Rafael Oteros Ferna´ndez, MD, Unidad de Neurorra- diología, Servicio de Radiodiagno´stico, Hospital Universitario Reina Sofía, Mene´ndez Pidal included in our study. s/n, 14004 Co´rdoba, Spain; e-mail: [email protected] Inclusion criteria were the following: age Ͼ18 years, with no up- http://dx.doi.org/10.3174/ajnr.A2951 per limit; symptomatic patients with a Ն70% atherosclerotic stenosis AJNR Am J Neuroradiol ●:● ͉ ● 2012 ͉ www.ajnr.org 1 Copyright 2012 by American Society of Neuroradiology. demonstrated by angiography, according to NASCET criteria; symp- Table 1: Baseline characteristics of patients and stenoses tomatic patients with a 50%–70% stenosis despite antiplatelet ther- Characteristics No. % apy; and asymptomatic patients with progressive Ն70% stenosis and Patients 210 100 contralateral carotid occlusion. Men 178 85 Exclusion criteria were the following: intracranial hemorrhage or Women 32 15 major surgery within 30 days before the procedure, uncontrolled ar- Mean age (yr) 66.2 (Ϯ9.6) terial hypertension, uncontrolled coagulopathy, contraindications to Vascular risk factors heparin or antiplatelet therapy, lack of percutaneous vascular access, Hypertension 145 69.4 and stenosis secondary to radiation therapy. Diabetes mellitus 86 41.1 A baseline CT scan was performed in all patients. If an acute isch- Dyslipidemia 84 40.2 Coronary artery disease 38 18.2 emic infarction was detected on CT, stent placement was delayed at Peripheral artery disease 36 17.2 least 21 days after the clinical event to avoid bleeding complications. Smoker 41 19.6 Carotid artery stenosis was initially diagnosed by Doppler sonog- Carotid arteries raphy. MR angiography, including 3D gradient-echo and contrast- Stenosis 220 100 enhanced T1 sequences, was performed whenever possible. Doppler Ͻ70 % 6 2.7 criterion for Ն70% stenosis was a peak systolic velocity of Ͼ230 70%–79% 51 23.2 cm/s.16,17 Stenosis degree was confirmed by angiography in all cases. 80%–89% 23 10.5 90%–99% 121 55.0 Stenosis degree was established by the NASCET criteria in both an- Pseudo-occlusion 18 8.2 giography and MR angiography. Occlusion 1 0.5 Preparation ogist within 24 hours. Dual antiplatelet therapy was prescribed during All patients agreed and signed the informed consent according to our the first month poststenting; then, a single antiplatelet agent was con- protocol. Patients received antiplatelet therapy with clopidogrel (75 tinued indefinitely. Follow-up was performed by neurologic evalua- mg per day) and aspirin (100 mg per day) at least 4 days before the tion and Doppler sonography examination at 3, 6, and 12 months procedure. When this was not possible, they received a loading dose of after the procedure. All data were included on an Access data base clopidogrel (300 mg) and aspirin (300 mg) the day of the procedure. (Microsoft, Bothell, Washington) created for this purpose. We performed a descriptive observational study. Continuous val- Procedure ues were expressed as mean and nominal variables as counts and Angiography was performed with the patient under local anesthesia percentages. The primary end point was to determine the cumulative through a femoral or brachial approach by using a 5F diagnosis cath- incidence of death, stroke, or myocardial infarction within 30 days eter. Location, length, and degree of stenosis; plaque characteristic; after intervention. The secondary end point was to establish the inci- flow compensation through the circle of Willis or pial branches; and dence of ipsilateral stroke and/or death between 31 days and 1 year the presence of anastomoses between the internal and external carotid after the procedure. arteries were evaluated. After the intravenous heparin bolus admin- istration of 5000 IU, a 90-cm 6F introducer sheath (Super Arrow-Flex Results percutaneous sheath; Arrow International, Cleveland, Ohio) was ad- Two hundred ten patients, 178 men and 32 women, with a vanced into the distal common carotid artery over an exchange guide- mean age of 66.2 years (range, 20–84 years) were included in wire placed in the external carotid artery. A 0.014-in guidewire (Plat- the study (Table 1). All patients were symptomatic except 9; 4 inum EX Transend; Boston Scientific, Natick, Massachusetts) was presented with Ͼ70% stenosis and 5 had a stenosis between used to cross the stenosis until the guidewire reached the carotid 90% and 99%. In these 9 patients, stent placement was con- cavernous artery; then, the stent-delivery system (carotid Wallstent; sidered because of repeated syncope in 5, bilateral progressive Schneider Boston Scientific, Galway, Ireland, as first choice) was stenosis (Ͼ70%) in 2, and contralateral carotid occlusion in 2. smoothly advanced through the stenosis over the guidewire. Finally, A Doppler sonography examination was performed in all the stent was deployed, and the residual stenosis degree was evaluated. cases, and MR angiography, in 114 patients (51.8%). The de- When it was not possible to get through the stenosis with the stent- gree of stenosis was always confirmed by angiography. From delivery system, a predilation was performed by using a 2- to 4-mm the 220 carotid arteries treated, 163 (74.1%) had Ͼ80% steno- angioplasty balloon (Gateway PTA balloon catheter; Boston Scien- sis, 140 (63.6%) had Ͼ90% stenosis, 18 (8.2%) showed pseu- tific, Fremont, California) at 6 atm. When residual stenosis was do-occlusions, and 1 was totally occluded (0.5%).
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