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Carotid artery stenting in a single center, single operator, single type of device and 15 years of follow-up

Carotid artery stenting in a single center, single operator, single type of device and 15 years... Background: Revascularization with carotid stent (CAS) is considered the therapeutic alternative to endarterectomy (CEA). However, its role compared to CEA remains questioned, mainly due of the heterogeneity of long-term results. The objective of this study was to report the efficacy and durability of CAS in terms of stroke prevention in a “real world experience”. Method: This was a single-center retrospective analysis of 344 patients treated with CAS between January 2001 and December 2015. The primary outcome of the trial was stroke, myocardial infarction, or death during a periprocedural period or any stroke event over a 15-year follow-up. The secondary aim was to identify risk factors for 30-day complications, long-term neurological complications, and intra-stent restenosis. Results: The primary composite end point (any stroke, myocardial infarction, or death during the periprocedural period) was 2.3%. The use of an EPD was protective against major complications. Long-term follow-up was achieved in 294 patients (85,5%) with a median of 50 months (range 0-155 months). Fifty-six (16,3%) died within this period, most commonly of nonvascular causes (4 patients had stroke-related deaths). During the follow-up period, 8 strokesand 3TIAswerediagnosed (3.2%). ISR determined by sequential ultrasound was assessed in 4.4% of the patients and remained asymptomatic in all but 2 patients (0.6%). All patients with restenosis underwent revascularization with balloon angioplasty. Conclusion: The long-term follow-up results of our study validate CAS as a safe and durable procedure with which to prevent ipsilateral stroke, with an acceptable rate of restenosis, recurrence and mortality. Keywords: Neurointervention, Endovascular treatment, Carotid stenting, Revascularization, Carotid artery, Carotid artery stenosis, Stroke, Long-term follow-up Background with this stroke subtype associated with the highest rate Cerebrovascular disease is an increasing global health of recurrence (Coutts et al., 2008). problem, responsible for 10% of deaths, worldwide The American Heart Association/American Stroke (Dorn et al., 2012). Carotid artery stenosis due to athero- Association (AHA/ASA) (Kernan et al., 2014) considers sclerotic disease is liable for approximately 20–30% of revascularization with stent to be a therapeutic alterna- these strokes (Chaturvedi et al., 2005; Roger et al., 2011), tive to surgery to prevent stroke, in select patients with symptomatic carotid artery stenosis, although in many centers surgery is still considered as the gold standard. * Correspondence: vickymayoral@gmail.com While this recommendation is supported by multiple GITMI (Grupo de Investigación en Tecnicas de Minima Invasión) del large randomized clinical trials, including CREST Gobierno de Aragon, Zaragoza, Spain (Bonati et al., 2015; Brott et al., 2016), we currently lack Servicio de Radiología intervencionista, Hospital Clínico Universitario Lozano Blesa, Avenida San Juan Bosco 15, 50009 Zaragoza, Spain long-term outcome data for CAS procedures. Further, Full list of author information is available at the end of the article © The Author(s). 2018 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. Mayoral Campos et al. CVIR Endovascular (2018) 1:3 Page 2 of 8 critics of CAS cite that this approach fails to remove the with daily oral entericoated aspirin (100 mg per day) and plaque, which can result in restenosis and potentially clopidogrel (75 mg per day) at least 3 days prior to the new stroke events. With an aging population and an procedure. Patients using long-term anticoagulation had increasing life expectancy, long-term outcomes following their treatment converted to heparin. CAS are now needed to guide treatment appropriately. The objective of this study was to report the efficacy Procedure protocol and durability of CAS in terms of stroke prevention. The CAS procedures were performed by 2 interventional primary outcome of the trial was stroke, myocardial radiologists, one with more than 30 years of experience infarction (MI), or death during a periprocedural period in endovascular techniques. In most patients, and when (30 days after treatment), or any stroke event over a practicable in the hospital setting, endovascular treat- 15-year follow-up. The secondary aim was to identify ments were performed within the first 2 weeks of risk factors for 30-day complications, long-term neuro- becoming symptomatic (76,4%), except in those cases logical complications, and intra-stent restenosis (ISR). where there was a high risk of bleeding and hyperperfu- sion syndrome (Kernan et al., 2014; Furie et al., 2011; Methods Sacco et al., 2006). This paper has been approved by the Ethics Committee The right common femoral artery (CFA) is the pre- in our Hospital. ferred access for CAS. The left CFA and the brachial artery were alternative accesses if the right CFA was not Patients possible. A 6 French sheath and a 0.035″ hydrophilic An observational retrospective study was performed using wire (Terumo Europe) is advanced into the aorta under material retrieved from a database describing a direct fluoroscopy. A multiside-hole pigtail catheher single-center patient cohort. The study included 344 (Cook Medical, Bloomington, IN) was placed over the patients treated with CAS between January 2001 and guide wire and positioned in the aortic arch. An aorto- December 2015. All patients had carotid artery stenosis gram was obtained with 30 cm of contrast at 15 ml/s documented by duplex ultrasound (toshiba aplio 300) and (Ioversol 320 mg/ml). confirmed by angiography. In those cases in which the Catheter selection for CCA was chosen depending on diagnosis was doubtful or unreliable, CT-angiography the aortic arch anatomy. The used catheter was a 5 Fr (36,3%) or MRI-angiography (45,3%) was performed. Vertebral (Terumo, Europe). Selection of great vessels in Inclusion criteria were: age > 18 years, with no upper the setting of Type III arch typically required a reverse limit; symptomatic stenosis > 50%; asymptomatic sten- curve catheter type Simmons II (Terumo Europe) or a osis > 60%, with more than one risk factor for future brachial approach when femoral access was not possible. embolism (i.e. progressive carotid stenosis, silent stroke A carotid angiography was performed in AP, lateral, and documented by neuroimaging, contralateral carotid intra-cerebral (Towne and lateral views). occlusion with high-risk carotid plaque, or microemboli A 260 cm safety “J” guidewire was advanced to the detected by transcranial duplex ultrasound). ECA, and a 6 Fr - 90 cm guiding catheter (Flexor - Cook Exclusion criteria included: life expectancy < 1 year; Medical, Bloomington, IN) was then placed in the CCA. intracranial hemorrhage or major surgery within 30 days Anticoagulation was infused with a bolus of 80 IU/kg of of the procedure; uncontrolled arterial hypertension or UFH. In scenarios of appropriate anatomic conditions coagulopathy; contraindications to heparin or antiplate- an embolic protection device (EPD; Accunet, Abbott let therapy; a lack of percutaneous vascular access. Vascular, Santa Clara, CA) was deployed distally (4.5– 6.5 mm). The authors tried to use EPD in all patients re- Pretreatment evaluation gardless of the type of plaque. A self-expanding carotid The human group that worked as a team in all the pro- stent system (Acculink, Abbott Vascular, Santa Clara, cedures was formed by neurologists and interventional CA) was then placed across the stenosis. radiologists, with whom an anesthetist collaborated. The Predilation of the stenosis after the placement of the team performs a joint assessment of each case to deter- EPD and before stent deployment was controversial. The mine the most appropriate treatment for each patient. IR’s performed predilatation when the stent cannot be Pretreatment evaluation included an assessment of the safely advanced. If predilation was desired, a 5 × 20 mm degree of stenosis using noninvasive imaging, a neuro- diameter balloon should suffice and atropine was given logical assessment (NIH stroke scale), laboratory results, prophylactically if bradycardia ensues (procedure was and a 12-lead ECG. Any changes in medication were perform always with an anesthesiologist). agreed by the medical team. A repeat arteriogram was performed. Any residual All patients agreed to, and provided, written (signed) stenosis exceeding 30% was treated with a 5 × 20 mm informed consent. Patients received antiplatelet therapy diameter balloon angioplasty and atropine was given Mayoral Campos et al. CVIR Endovascular (2018) 1:3 Page 3 of 8 prophylactically. Two antiplatelet agents, clopidogrel Statistical analyses were with the SPSS software (Re- (75 mg for 4 to 6 weeks), and aspirin (100 mg; used leased 2012; IBM SPSS Statistics for Macintosh; Version indefinitely), 21.0. Armonk, NY: IBM Corp). Normality was tested using the Kolmogorov-Smirnoff test. Quantitative vari- Data collection and follow-up ables were expressed as mean values with standard devi- We retrospectively collected all clinical, angiographic, ations. Qualitative data were expressed as the total and procedural data. A neurological specialist performed number of events with percentages. Continuous vari- the clinical follow-ups, with carotid ultrasound at 1, 3, 6, ables were analyzed using either the Student’s t-test or and 12 months after the intervention, and annually the Mann-Whitney U test. The Chi-squared and Fisher’s thereafter. If there was any alteration in carotid ultra- exact tests, or likelihood ratios, were used for categorical sound (PSV > 200 or ICA/CCA ratio > 3), a selective variables. Survival curves were calculated using the angiogram was performed. Kaplan-Meier method and were compared with the All patients were treated with BMT. We made strict log-rank test. All tests were considered statistically control of blood pressure to keep levels < 120/80, LDL significant if the p value was less than 0.05. cholesterol to keep levels < 70 and blood sugar control to keep levels of HbA1c < 7%. We make patients aware of a healthy lifestyle attempting to be physically active, Results non-smokers and trying to maintain a healthy body From January 2001 through December 2015, a total of weight. 344 patients with a median age of 70.79 years (range 44–86) were treated with CAS. The procedure was more Definitions common among men than women, with 86% of patients Patients were considered symptomatic if they presented male. All but 35 (10.2%) patients were symptomatic. with ipsilateral amaurosis fugax, transient ischemic at- Demographics, risk factors, and patient morbidities are tack (TIA), or ischemic stroke within 4 months of the listed in Table 1. Hypertension, dyslipidemia, and smok- procedure. Stroke was defined as a neurological deficit ing were the most potent, prevalent, and treatable risk of cerebrovascular cause that persists beyond 24 h, or a factors for stroke. new cerebrovascular lesion in neuroimaging. TIA was The carotid stent deployed was the Acculink with no defined as a focal neurologic deficit that resolves com- procedures aborted before insertion of the stent. Protec- pletely within 24 h. A MI component was defined on the tion devices were used for 60.2% of patients. Post-stent basis of elevated myocardial enzymes plus either symp- balloon dilatation was performed in 73.8% of patients, toms or electrocardiographic evidence of an event. with predilatation necessary for 20/344 arteries (5.8%). Technical success was defined as restoration of cerebral Technical success was achieved in 335 of the 344 flow through the lesion, with a > 20% improvement in arteries (97.4%) treated. Although it was possible to pass stenosis and a residual stenosis of < 50%. Major compli- a wire through the stenosis in 9 patients, complete stent cations included death, stroke or MI. Minor complica- expansion was not achieved for this group. tions were defined as all those that do not require any The primary composite end point was 2.3% (Table 2). intervention. Global complications were defined as the Strokes occurred in 8 patients, with the only death sum of major and minor complications. Restenosis was related to severe bleeding in the context of a hyperperfu- classified when the intra-stent stenosis was greater than sion syndrome. None of the stroke events were the 50% (Higashida et al., 2009). Efficacy was defined as the result of an acute stent thrombosis. There were no absence of stroke during follow-up. Neurological death patients with MI. was defined as that caused by stroke or associated with We undertook exploratory analyses of the composite procedural complications. Vascular death was defined as outcome of stroke, death, or procedural myocardial in- that caused by MI or peripheral artery disease (PAD). farction. These analyses suggested that use of an EPD was protective against major complications (Table 3). In Aims and statistical analysis addition, EPD-use led to a reduction in major complica- The primary aim of the study was to analyze stroke, MI, tions, falling from 5,1% without the use of EPDs to 0.5% or death during the periprocedural period (30 days after with EPDs (p = 0.005). treatment), or any stroke-event over a 15-year follow-up. For long-term analysis, patients were followed for a We also evaluated the long-term behavior of the median of 50 months (range 0-155 months). A total implanted carotid stents in terms of patency rate and of 50 patients were lost to follow-up (Table 4), with the need for reintervention. Our secondary aim was to long-term follow-up achieved in 294 patients (85.5%). identify predictive risk factors for 30-day complications, Fifty-six (16.3%) patients died within this period, long-term neurological complications, and ISR. including 4 stroke-related deaths, and 52 non-lesion Mayoral Campos et al. CVIR Endovascular (2018) 1:3 Page 4 of 8 Table 1 Baseline characteristics of patients Vascular risk factors Men (n = 296) Women (n = 48) Total (n = 344) p X2 Hypertension 69,6% 70,8% 69,8% 0,862 x2 PAD 27,7% 16,7% 26,2% 0,107 Previous TIA 7,1% 4,2% 6,7% 0,754 Previous Stroke 10,1% 8,3% 9,9% > 0,999 x2 Dyslipidemia 59,1% 64,6% 59,9% 0,474 x2 Smoking 41,6% 10,4% 37,2% < 0,001 Alcohol 3,4% 0,0% 2,9% 0,368 x2 DM 33,8% 25,0% 32,6% 0,228 x2 Obesity 18,9% 29,2% 20,3% 0,102 x2 Arrhythmias 9,1% 18,8% 10,5% 0,043 x2 Ischemic heart disease 26,0% 14,6% 24,4% 0,087 Cervical radiotherapy 2,4% 2,1% 2,3% > 0,999 X2: Chi-squared test; F: Fisher’s exact tests related deaths due to comorbidity. Two patients died Discussion from intraparenchymal hemorrhage and two from is- Stroke is a major cause of mortality and morbidity in in- chemic stroke, one ipsilateral to the treated carotid dustrialized countries. These data, combined with an artery and the other, contralateral to the treated ca- ever-increasing life expectancy, necessitates that we con- rotid artery. Among the non-neurological deaths, duct more detailed analyses of whether carotid revascular- there were 5 cases of vascular death: 3 cases due to ization is a safe and effective treatment with which to chronic ischemia of the lower extremities, and 2 due prevent stroke. to acute myocardial infarction (Fig 1). In our series, the 30-day outcomes after CAS show During the follow-up period, 8 strokes and 3 TIAs that carotid stenting is an effective treatment in prevent- were diagnosed (3.2%). The majority of the strokes ing future vascular events, with a low incidence of peri- (75%) were contralateral to the treated carotid artery procedural complications: 2.3% for disabling stroke, and most were ischemic. We did not identify any pre- death, or MI. Previous systematic reviews of nonrando- dictive risk factors or any procedural characteristics mized cases series (Kastrup et al., 2003), as well as sev- for ipsilateral neurological complication. eral studies (Castriota et al., 2002; Cremonesi et al., ISR was assessed in 4.4% of the patients and 2003; Garg et al., 2009; Giri et al., 2015), have shown remained asymptomatic in all but 2 patients (0.6%). that EPD-use appears to reduce the incidence of new All patients with restenosis underwent revasculariza- ischemic lesions. However, various reports have also crit- tion with balloon angioplasty. No stent fracture was icized the use of EPDs in CAS as these devices must observed. Pre-stent angioplasty was significantly asso- pass through the arterial stenosis, which might itself ciated with the incidence of ISR (Table 5). Risk provoke complications (Reimers et al., 2004; Wu et al., factors were neither related to neurological complica- 2011) and a greater incidence of microemboli (El-Koussy tions nor ISR. Further, there were significant differ- et al., 2007). Nevertheless, the results of our series show ences between the degree of restenosis and the time a decreased rate of major complications when EPDs are of its appearance: the greater the degree of restenosis, used (p = 0.005), which therefore classifies these devices the shorter the post-procedure time period (r = − 0.426; as protective against stroke. p = 0.038). We found no association between restenosis To our knowledge, our study comprises the largest and recurrent events. patient cohort, with the longest national follow-up to compare stroke prevention in patients treated by the same surgical team. In our series, stenting was per- Table 2 Peri-procedural complications formed electively as an alternative to endarterectomy. Complications n % This is because the committee composed by neurologist, radiologist, and interventional radiologist (vascular sur- Majors 8 2,3% geons refused to participate) decided, more than 15 years MI 0 0,0% ago to send patients directly to CAS, depending on the Stroke 7 2,0% poor results of the surgery department. Thus, our indi- Fatal Stroke (death) 1 0,3% cations were not limited to patients at a high surgical Mayoral Campos et al. CVIR Endovascular (2018) 1:3 Page 5 of 8 Table 3 The influence of procedural characteristics on peri-procedural complications Variable Major complicatons Minor complications n% p n % p F x2 Ulcer No 8 3,3% 0,111 No 96 39,7% 0,109 Yes 0 0,0% Yes 50 49,0% F x2 Pre-stent angioplasty No 8 2,5% > 0,999 No 131 40,4% 0,002 Yes 0 0,0% Yes 15 75,0% X2 x2 EPD No 7 5,1% 0,005 No 46 33,6% 0,007 Yes 1 0,5% Yes 100 48,3% F x2 Post-stent angioplasty No 2 2,2% > 0,999 No 34 37,8% 0,297 Yes 6 2,4% Yes 112 44,1% X2: Chi-squared test; F: Fisher’s exact tests risk. Nevertheless, the risk of periprocedural complica- Endoarterectomy Trial Collaboration, 1991). However, tion was low, and similar to data from surgical registries our patient population was closely monitored in terms of with more stringent inclusion criteria (North American risk factors, which may have lowered our rate of complica- Symptomatic Carotid Endoarterectomy Trial Collaboration, tion. Regarding risk factors, Donato et al. (de Donato 1991; Executive Committee for the Asymptomatic Carotid et al., 2008) and Brooks et al. (Brooks et al., 2014)found Atherosclerosis Study, 1995). that being symptomatic at the time of enrollment and The CREST study showed no significant differences intervention was a good predictor of early and late neuro- between stent and endarterectomy in terms of the risk logical complication. We failed to find any risk factor of stroke or death over its 10-year follow-up. Indeed, the associated with late neurological complications, although higher risk of stroke reported for CAS can be attributed this may be related to our low recurrence rate. to the periprocedural differences between the two Prevention of ipsilateral stroke is the ultimate goal of groups (Brott et al., 2016; Brott et al., 2010), and the any treatment for carotid stenosis. However, durability, infrequent use of EPDs (El-Koussy et al., 2007). Other defined as patency determined by Doppler ultrasound, randomized trials comparing both techniques have been may also serve as a useful definition of therapeutic util- reported, and showed no significant differences after ity. Our analysis of long-term outcomes showed that the long-term follow-up (Bonati et al., 2015; Gurm et al., long-term rate of restenosis after stenting was low 2008; Mas et al., 2008). (4.4%), and comparable, or even lower, than those Our data appears to indicate that CAS is preventive achieved with CEA. However, direct comparisons are against ipsilateral stroke with a low long-term risk of complicated by the criteria used to make a diagnosis in severe stroke The recurrence rate in our series of 3.2% Doppler sonography. Of the restenosis cases, only 2 primarily involved strokes contralateral (75%) to the (0.6%) were symptomatic. We found no association treated carotid artery, and most were ischemic. This between restenosis and recurrent events, but pre-stent finding has also been reported in previous related studies angioplasty was significantly associated with the inci- in which no significant difference in cumulative rates of dence of ISR. This is difficult to interpret given the small fatal or disabling stroke were found for stenting vs. end- number of recurrent events, pre-stent angioplasty, and arterectomy (Bonati et al., 2015; Mas et al., 2008). It is restenoses seen in our study. A certain amount of con- interesting to note that our observed stroke rate of troversy surrounds the issue of long-term rates of 3.2% is (fairly) consistent with, and even lower than restenosis after stenting vs. endarterectomy. Some the 8.5% reported in the ECST at 3 years (European trials (Bonati et al., 2015;Brott et al., 2016;Mas Carotid Surgery Trial, 1998), and the 13% rate of the et al., 2008) have demonstrated no differences when NASCET (North American Symptomatic Carotid comparing both techniques. For example, 5-year risks of 10.8% vs. 8.6%, 3-year risks of 3.3% vs. 2.8%, and Table 4 Follow-up period 2-year risks of 6.0% vs. 6.3%, for stenting vs. endarter- Follow-up (months) n % Average SD Median (IQR) ectomy, have been reported, respectively. In contrast, the CAVATAS (Bonati et al., 2009) and SPACE trials Keep in follow-up 238 69,19% 56,40 36,30 48,90 (59,50) (Eckstein et al., 2008) reported higher rates of resten- Loss to follow-up 50 14,53% 34,08 29,28 30,04 (41,50) osis 2 years after treatment in the stenting group vs. Neurological death 4 1,16% 10,36 10,69 8,14 (19,25) endarterectomy group (10.7% vs. 4.6%). Consequently, No neurological death 52 15,12% 38,33 31,28 35,53 (44,50) further studies are needed to compare the rate of Mayoral Campos et al. CVIR Endovascular (2018) 1:3 Page 6 of 8 Fig. 1 Survival curves for vascular and non vascular deaths restenosis and to investigate the association between effective in terms of long-term functional outcome and restenosis and recurrent stroke. risk of fatal or disabling stroke. Post CAS restenosis was The current study has several limitations. The main infrequent, and, in the majority of cases, asymptomatic. limitation was its small sample size and retrospective Abbreviations design. Moreover, results obtained in this study were CAS: Carotid artery stent; CCA: Common carotid artery; CEA: Carotid artery compared with the literature, as it was not possible to endarterectomy; CFA: Common femoral artery; CT: Computerized axial undertake a randomized comparison of CAS versus tomography scan; ECA: External carotid artery; EPD: Embolic protection device; IRs: Interventional radiologists; ISR: Intra-stent restenosis; CEA. Further, the efficacy of the EPDs could not be eval- MI: Myocardial infarction; MRI scans: Magnetic resonance imaging; uated throughout the entirety of this study as these PAD: Peripheral artery disease; PSV: Peak systolic velocity; TIA: Transient devices were not available until 2005. ischemic attack Acknowledgements Conclusion Not applicable. The long-term follow-up results of our study validate CAS as a safe and durable procedure with which to pre- Ethical approval vent ipsilateral stroke. Our data also suggest that CAS is The study has been approved by the Ethics Committee in our Hospital. Availability of data and materials Table 5 The influence of procedural characteristics on Authors confirm that all relevant data are included in the article and/or its restenosis supplementary information files: The authors declare that the data supporting Proceure Reestenosis n % p the findings of this study are available within the article [and its supplementary x2 information files]. Peri-procedural complications No 142 6,8% 0,866 Yes 152 7,2% Authors’ contributions LR Pre-stent angioplasty No 322 5,6% 0,001 VMC conceived of the study, and participated in its design and coordination, and draft the manuscript. JAGO participated in the design of the study and Yes 20 25,0% helped to performed the statistical analysis. CTJ, MJGP and CPL conceived of LR Post-stent angioplasty No 77 9,1% 0,353 the study, and participated in its design and coordination. IDBG performed the statistical analysis and helped to draft the manuscript. MAGA conceived Yes 254 6,3% of the study, and participated in its design and coordination and helped to X2: Chi-squared test; LR: likelihood ratios draft the manuscript. All authors read and approved the final manuscript. Mayoral Campos et al. CVIR Endovascular (2018) 1:3 Page 7 of 8 Consent for publication protected angioplasty versus carotid endarterectomy (SPACE) study to treat All patients agreed to, and provided, written (signed) informed consent symptomatic stenoses at 2 years: a multinational, prospective, randomised which included consent to publish the results as long as it was anonymous. trial. 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Acta Cardiol 66:453–458 http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png CVIR Endovascular Springer Journals

Carotid artery stenting in a single center, single operator, single type of device and 15 years of follow-up

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Springer Journals
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Copyright © 2018 by The Author(s)
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Medicine & Public Health; Medicine/Public Health, general; Imaging / Radiology; Interventional Radiology
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2520-8934
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10.1186/s42155-018-0008-2
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Abstract

Background: Revascularization with carotid stent (CAS) is considered the therapeutic alternative to endarterectomy (CEA). However, its role compared to CEA remains questioned, mainly due of the heterogeneity of long-term results. The objective of this study was to report the efficacy and durability of CAS in terms of stroke prevention in a “real world experience”. Method: This was a single-center retrospective analysis of 344 patients treated with CAS between January 2001 and December 2015. The primary outcome of the trial was stroke, myocardial infarction, or death during a periprocedural period or any stroke event over a 15-year follow-up. The secondary aim was to identify risk factors for 30-day complications, long-term neurological complications, and intra-stent restenosis. Results: The primary composite end point (any stroke, myocardial infarction, or death during the periprocedural period) was 2.3%. The use of an EPD was protective against major complications. Long-term follow-up was achieved in 294 patients (85,5%) with a median of 50 months (range 0-155 months). Fifty-six (16,3%) died within this period, most commonly of nonvascular causes (4 patients had stroke-related deaths). During the follow-up period, 8 strokesand 3TIAswerediagnosed (3.2%). ISR determined by sequential ultrasound was assessed in 4.4% of the patients and remained asymptomatic in all but 2 patients (0.6%). All patients with restenosis underwent revascularization with balloon angioplasty. Conclusion: The long-term follow-up results of our study validate CAS as a safe and durable procedure with which to prevent ipsilateral stroke, with an acceptable rate of restenosis, recurrence and mortality. Keywords: Neurointervention, Endovascular treatment, Carotid stenting, Revascularization, Carotid artery, Carotid artery stenosis, Stroke, Long-term follow-up Background with this stroke subtype associated with the highest rate Cerebrovascular disease is an increasing global health of recurrence (Coutts et al., 2008). problem, responsible for 10% of deaths, worldwide The American Heart Association/American Stroke (Dorn et al., 2012). Carotid artery stenosis due to athero- Association (AHA/ASA) (Kernan et al., 2014) considers sclerotic disease is liable for approximately 20–30% of revascularization with stent to be a therapeutic alterna- these strokes (Chaturvedi et al., 2005; Roger et al., 2011), tive to surgery to prevent stroke, in select patients with symptomatic carotid artery stenosis, although in many centers surgery is still considered as the gold standard. * Correspondence: vickymayoral@gmail.com While this recommendation is supported by multiple GITMI (Grupo de Investigación en Tecnicas de Minima Invasión) del large randomized clinical trials, including CREST Gobierno de Aragon, Zaragoza, Spain (Bonati et al., 2015; Brott et al., 2016), we currently lack Servicio de Radiología intervencionista, Hospital Clínico Universitario Lozano Blesa, Avenida San Juan Bosco 15, 50009 Zaragoza, Spain long-term outcome data for CAS procedures. Further, Full list of author information is available at the end of the article © The Author(s). 2018 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. Mayoral Campos et al. CVIR Endovascular (2018) 1:3 Page 2 of 8 critics of CAS cite that this approach fails to remove the with daily oral entericoated aspirin (100 mg per day) and plaque, which can result in restenosis and potentially clopidogrel (75 mg per day) at least 3 days prior to the new stroke events. With an aging population and an procedure. Patients using long-term anticoagulation had increasing life expectancy, long-term outcomes following their treatment converted to heparin. CAS are now needed to guide treatment appropriately. The objective of this study was to report the efficacy Procedure protocol and durability of CAS in terms of stroke prevention. The CAS procedures were performed by 2 interventional primary outcome of the trial was stroke, myocardial radiologists, one with more than 30 years of experience infarction (MI), or death during a periprocedural period in endovascular techniques. In most patients, and when (30 days after treatment), or any stroke event over a practicable in the hospital setting, endovascular treat- 15-year follow-up. The secondary aim was to identify ments were performed within the first 2 weeks of risk factors for 30-day complications, long-term neuro- becoming symptomatic (76,4%), except in those cases logical complications, and intra-stent restenosis (ISR). where there was a high risk of bleeding and hyperperfu- sion syndrome (Kernan et al., 2014; Furie et al., 2011; Methods Sacco et al., 2006). This paper has been approved by the Ethics Committee The right common femoral artery (CFA) is the pre- in our Hospital. ferred access for CAS. The left CFA and the brachial artery were alternative accesses if the right CFA was not Patients possible. A 6 French sheath and a 0.035″ hydrophilic An observational retrospective study was performed using wire (Terumo Europe) is advanced into the aorta under material retrieved from a database describing a direct fluoroscopy. A multiside-hole pigtail catheher single-center patient cohort. The study included 344 (Cook Medical, Bloomington, IN) was placed over the patients treated with CAS between January 2001 and guide wire and positioned in the aortic arch. An aorto- December 2015. All patients had carotid artery stenosis gram was obtained with 30 cm of contrast at 15 ml/s documented by duplex ultrasound (toshiba aplio 300) and (Ioversol 320 mg/ml). confirmed by angiography. In those cases in which the Catheter selection for CCA was chosen depending on diagnosis was doubtful or unreliable, CT-angiography the aortic arch anatomy. The used catheter was a 5 Fr (36,3%) or MRI-angiography (45,3%) was performed. Vertebral (Terumo, Europe). Selection of great vessels in Inclusion criteria were: age > 18 years, with no upper the setting of Type III arch typically required a reverse limit; symptomatic stenosis > 50%; asymptomatic sten- curve catheter type Simmons II (Terumo Europe) or a osis > 60%, with more than one risk factor for future brachial approach when femoral access was not possible. embolism (i.e. progressive carotid stenosis, silent stroke A carotid angiography was performed in AP, lateral, and documented by neuroimaging, contralateral carotid intra-cerebral (Towne and lateral views). occlusion with high-risk carotid plaque, or microemboli A 260 cm safety “J” guidewire was advanced to the detected by transcranial duplex ultrasound). ECA, and a 6 Fr - 90 cm guiding catheter (Flexor - Cook Exclusion criteria included: life expectancy < 1 year; Medical, Bloomington, IN) was then placed in the CCA. intracranial hemorrhage or major surgery within 30 days Anticoagulation was infused with a bolus of 80 IU/kg of of the procedure; uncontrolled arterial hypertension or UFH. In scenarios of appropriate anatomic conditions coagulopathy; contraindications to heparin or antiplate- an embolic protection device (EPD; Accunet, Abbott let therapy; a lack of percutaneous vascular access. Vascular, Santa Clara, CA) was deployed distally (4.5– 6.5 mm). The authors tried to use EPD in all patients re- Pretreatment evaluation gardless of the type of plaque. A self-expanding carotid The human group that worked as a team in all the pro- stent system (Acculink, Abbott Vascular, Santa Clara, cedures was formed by neurologists and interventional CA) was then placed across the stenosis. radiologists, with whom an anesthetist collaborated. The Predilation of the stenosis after the placement of the team performs a joint assessment of each case to deter- EPD and before stent deployment was controversial. The mine the most appropriate treatment for each patient. IR’s performed predilatation when the stent cannot be Pretreatment evaluation included an assessment of the safely advanced. If predilation was desired, a 5 × 20 mm degree of stenosis using noninvasive imaging, a neuro- diameter balloon should suffice and atropine was given logical assessment (NIH stroke scale), laboratory results, prophylactically if bradycardia ensues (procedure was and a 12-lead ECG. Any changes in medication were perform always with an anesthesiologist). agreed by the medical team. A repeat arteriogram was performed. Any residual All patients agreed to, and provided, written (signed) stenosis exceeding 30% was treated with a 5 × 20 mm informed consent. Patients received antiplatelet therapy diameter balloon angioplasty and atropine was given Mayoral Campos et al. CVIR Endovascular (2018) 1:3 Page 3 of 8 prophylactically. Two antiplatelet agents, clopidogrel Statistical analyses were with the SPSS software (Re- (75 mg for 4 to 6 weeks), and aspirin (100 mg; used leased 2012; IBM SPSS Statistics for Macintosh; Version indefinitely), 21.0. Armonk, NY: IBM Corp). Normality was tested using the Kolmogorov-Smirnoff test. Quantitative vari- Data collection and follow-up ables were expressed as mean values with standard devi- We retrospectively collected all clinical, angiographic, ations. Qualitative data were expressed as the total and procedural data. A neurological specialist performed number of events with percentages. Continuous vari- the clinical follow-ups, with carotid ultrasound at 1, 3, 6, ables were analyzed using either the Student’s t-test or and 12 months after the intervention, and annually the Mann-Whitney U test. The Chi-squared and Fisher’s thereafter. If there was any alteration in carotid ultra- exact tests, or likelihood ratios, were used for categorical sound (PSV > 200 or ICA/CCA ratio > 3), a selective variables. Survival curves were calculated using the angiogram was performed. Kaplan-Meier method and were compared with the All patients were treated with BMT. We made strict log-rank test. All tests were considered statistically control of blood pressure to keep levels < 120/80, LDL significant if the p value was less than 0.05. cholesterol to keep levels < 70 and blood sugar control to keep levels of HbA1c < 7%. We make patients aware of a healthy lifestyle attempting to be physically active, Results non-smokers and trying to maintain a healthy body From January 2001 through December 2015, a total of weight. 344 patients with a median age of 70.79 years (range 44–86) were treated with CAS. The procedure was more Definitions common among men than women, with 86% of patients Patients were considered symptomatic if they presented male. All but 35 (10.2%) patients were symptomatic. with ipsilateral amaurosis fugax, transient ischemic at- Demographics, risk factors, and patient morbidities are tack (TIA), or ischemic stroke within 4 months of the listed in Table 1. Hypertension, dyslipidemia, and smok- procedure. Stroke was defined as a neurological deficit ing were the most potent, prevalent, and treatable risk of cerebrovascular cause that persists beyond 24 h, or a factors for stroke. new cerebrovascular lesion in neuroimaging. TIA was The carotid stent deployed was the Acculink with no defined as a focal neurologic deficit that resolves com- procedures aborted before insertion of the stent. Protec- pletely within 24 h. A MI component was defined on the tion devices were used for 60.2% of patients. Post-stent basis of elevated myocardial enzymes plus either symp- balloon dilatation was performed in 73.8% of patients, toms or electrocardiographic evidence of an event. with predilatation necessary for 20/344 arteries (5.8%). Technical success was defined as restoration of cerebral Technical success was achieved in 335 of the 344 flow through the lesion, with a > 20% improvement in arteries (97.4%) treated. Although it was possible to pass stenosis and a residual stenosis of < 50%. Major compli- a wire through the stenosis in 9 patients, complete stent cations included death, stroke or MI. Minor complica- expansion was not achieved for this group. tions were defined as all those that do not require any The primary composite end point was 2.3% (Table 2). intervention. Global complications were defined as the Strokes occurred in 8 patients, with the only death sum of major and minor complications. Restenosis was related to severe bleeding in the context of a hyperperfu- classified when the intra-stent stenosis was greater than sion syndrome. None of the stroke events were the 50% (Higashida et al., 2009). Efficacy was defined as the result of an acute stent thrombosis. There were no absence of stroke during follow-up. Neurological death patients with MI. was defined as that caused by stroke or associated with We undertook exploratory analyses of the composite procedural complications. Vascular death was defined as outcome of stroke, death, or procedural myocardial in- that caused by MI or peripheral artery disease (PAD). farction. These analyses suggested that use of an EPD was protective against major complications (Table 3). In Aims and statistical analysis addition, EPD-use led to a reduction in major complica- The primary aim of the study was to analyze stroke, MI, tions, falling from 5,1% without the use of EPDs to 0.5% or death during the periprocedural period (30 days after with EPDs (p = 0.005). treatment), or any stroke-event over a 15-year follow-up. For long-term analysis, patients were followed for a We also evaluated the long-term behavior of the median of 50 months (range 0-155 months). A total implanted carotid stents in terms of patency rate and of 50 patients were lost to follow-up (Table 4), with the need for reintervention. Our secondary aim was to long-term follow-up achieved in 294 patients (85.5%). identify predictive risk factors for 30-day complications, Fifty-six (16.3%) patients died within this period, long-term neurological complications, and ISR. including 4 stroke-related deaths, and 52 non-lesion Mayoral Campos et al. CVIR Endovascular (2018) 1:3 Page 4 of 8 Table 1 Baseline characteristics of patients Vascular risk factors Men (n = 296) Women (n = 48) Total (n = 344) p X2 Hypertension 69,6% 70,8% 69,8% 0,862 x2 PAD 27,7% 16,7% 26,2% 0,107 Previous TIA 7,1% 4,2% 6,7% 0,754 Previous Stroke 10,1% 8,3% 9,9% > 0,999 x2 Dyslipidemia 59,1% 64,6% 59,9% 0,474 x2 Smoking 41,6% 10,4% 37,2% < 0,001 Alcohol 3,4% 0,0% 2,9% 0,368 x2 DM 33,8% 25,0% 32,6% 0,228 x2 Obesity 18,9% 29,2% 20,3% 0,102 x2 Arrhythmias 9,1% 18,8% 10,5% 0,043 x2 Ischemic heart disease 26,0% 14,6% 24,4% 0,087 Cervical radiotherapy 2,4% 2,1% 2,3% > 0,999 X2: Chi-squared test; F: Fisher’s exact tests related deaths due to comorbidity. Two patients died Discussion from intraparenchymal hemorrhage and two from is- Stroke is a major cause of mortality and morbidity in in- chemic stroke, one ipsilateral to the treated carotid dustrialized countries. These data, combined with an artery and the other, contralateral to the treated ca- ever-increasing life expectancy, necessitates that we con- rotid artery. Among the non-neurological deaths, duct more detailed analyses of whether carotid revascular- there were 5 cases of vascular death: 3 cases due to ization is a safe and effective treatment with which to chronic ischemia of the lower extremities, and 2 due prevent stroke. to acute myocardial infarction (Fig 1). In our series, the 30-day outcomes after CAS show During the follow-up period, 8 strokes and 3 TIAs that carotid stenting is an effective treatment in prevent- were diagnosed (3.2%). The majority of the strokes ing future vascular events, with a low incidence of peri- (75%) were contralateral to the treated carotid artery procedural complications: 2.3% for disabling stroke, and most were ischemic. We did not identify any pre- death, or MI. Previous systematic reviews of nonrando- dictive risk factors or any procedural characteristics mized cases series (Kastrup et al., 2003), as well as sev- for ipsilateral neurological complication. eral studies (Castriota et al., 2002; Cremonesi et al., ISR was assessed in 4.4% of the patients and 2003; Garg et al., 2009; Giri et al., 2015), have shown remained asymptomatic in all but 2 patients (0.6%). that EPD-use appears to reduce the incidence of new All patients with restenosis underwent revasculariza- ischemic lesions. However, various reports have also crit- tion with balloon angioplasty. No stent fracture was icized the use of EPDs in CAS as these devices must observed. Pre-stent angioplasty was significantly asso- pass through the arterial stenosis, which might itself ciated with the incidence of ISR (Table 5). Risk provoke complications (Reimers et al., 2004; Wu et al., factors were neither related to neurological complica- 2011) and a greater incidence of microemboli (El-Koussy tions nor ISR. Further, there were significant differ- et al., 2007). Nevertheless, the results of our series show ences between the degree of restenosis and the time a decreased rate of major complications when EPDs are of its appearance: the greater the degree of restenosis, used (p = 0.005), which therefore classifies these devices the shorter the post-procedure time period (r = − 0.426; as protective against stroke. p = 0.038). We found no association between restenosis To our knowledge, our study comprises the largest and recurrent events. patient cohort, with the longest national follow-up to compare stroke prevention in patients treated by the same surgical team. In our series, stenting was per- Table 2 Peri-procedural complications formed electively as an alternative to endarterectomy. Complications n % This is because the committee composed by neurologist, radiologist, and interventional radiologist (vascular sur- Majors 8 2,3% geons refused to participate) decided, more than 15 years MI 0 0,0% ago to send patients directly to CAS, depending on the Stroke 7 2,0% poor results of the surgery department. Thus, our indi- Fatal Stroke (death) 1 0,3% cations were not limited to patients at a high surgical Mayoral Campos et al. CVIR Endovascular (2018) 1:3 Page 5 of 8 Table 3 The influence of procedural characteristics on peri-procedural complications Variable Major complicatons Minor complications n% p n % p F x2 Ulcer No 8 3,3% 0,111 No 96 39,7% 0,109 Yes 0 0,0% Yes 50 49,0% F x2 Pre-stent angioplasty No 8 2,5% > 0,999 No 131 40,4% 0,002 Yes 0 0,0% Yes 15 75,0% X2 x2 EPD No 7 5,1% 0,005 No 46 33,6% 0,007 Yes 1 0,5% Yes 100 48,3% F x2 Post-stent angioplasty No 2 2,2% > 0,999 No 34 37,8% 0,297 Yes 6 2,4% Yes 112 44,1% X2: Chi-squared test; F: Fisher’s exact tests risk. Nevertheless, the risk of periprocedural complica- Endoarterectomy Trial Collaboration, 1991). However, tion was low, and similar to data from surgical registries our patient population was closely monitored in terms of with more stringent inclusion criteria (North American risk factors, which may have lowered our rate of complica- Symptomatic Carotid Endoarterectomy Trial Collaboration, tion. Regarding risk factors, Donato et al. (de Donato 1991; Executive Committee for the Asymptomatic Carotid et al., 2008) and Brooks et al. (Brooks et al., 2014)found Atherosclerosis Study, 1995). that being symptomatic at the time of enrollment and The CREST study showed no significant differences intervention was a good predictor of early and late neuro- between stent and endarterectomy in terms of the risk logical complication. We failed to find any risk factor of stroke or death over its 10-year follow-up. Indeed, the associated with late neurological complications, although higher risk of stroke reported for CAS can be attributed this may be related to our low recurrence rate. to the periprocedural differences between the two Prevention of ipsilateral stroke is the ultimate goal of groups (Brott et al., 2016; Brott et al., 2010), and the any treatment for carotid stenosis. However, durability, infrequent use of EPDs (El-Koussy et al., 2007). Other defined as patency determined by Doppler ultrasound, randomized trials comparing both techniques have been may also serve as a useful definition of therapeutic util- reported, and showed no significant differences after ity. Our analysis of long-term outcomes showed that the long-term follow-up (Bonati et al., 2015; Gurm et al., long-term rate of restenosis after stenting was low 2008; Mas et al., 2008). (4.4%), and comparable, or even lower, than those Our data appears to indicate that CAS is preventive achieved with CEA. However, direct comparisons are against ipsilateral stroke with a low long-term risk of complicated by the criteria used to make a diagnosis in severe stroke The recurrence rate in our series of 3.2% Doppler sonography. Of the restenosis cases, only 2 primarily involved strokes contralateral (75%) to the (0.6%) were symptomatic. We found no association treated carotid artery, and most were ischemic. This between restenosis and recurrent events, but pre-stent finding has also been reported in previous related studies angioplasty was significantly associated with the inci- in which no significant difference in cumulative rates of dence of ISR. This is difficult to interpret given the small fatal or disabling stroke were found for stenting vs. end- number of recurrent events, pre-stent angioplasty, and arterectomy (Bonati et al., 2015; Mas et al., 2008). It is restenoses seen in our study. A certain amount of con- interesting to note that our observed stroke rate of troversy surrounds the issue of long-term rates of 3.2% is (fairly) consistent with, and even lower than restenosis after stenting vs. endarterectomy. Some the 8.5% reported in the ECST at 3 years (European trials (Bonati et al., 2015;Brott et al., 2016;Mas Carotid Surgery Trial, 1998), and the 13% rate of the et al., 2008) have demonstrated no differences when NASCET (North American Symptomatic Carotid comparing both techniques. For example, 5-year risks of 10.8% vs. 8.6%, 3-year risks of 3.3% vs. 2.8%, and Table 4 Follow-up period 2-year risks of 6.0% vs. 6.3%, for stenting vs. endarter- Follow-up (months) n % Average SD Median (IQR) ectomy, have been reported, respectively. In contrast, the CAVATAS (Bonati et al., 2009) and SPACE trials Keep in follow-up 238 69,19% 56,40 36,30 48,90 (59,50) (Eckstein et al., 2008) reported higher rates of resten- Loss to follow-up 50 14,53% 34,08 29,28 30,04 (41,50) osis 2 years after treatment in the stenting group vs. Neurological death 4 1,16% 10,36 10,69 8,14 (19,25) endarterectomy group (10.7% vs. 4.6%). Consequently, No neurological death 52 15,12% 38,33 31,28 35,53 (44,50) further studies are needed to compare the rate of Mayoral Campos et al. CVIR Endovascular (2018) 1:3 Page 6 of 8 Fig. 1 Survival curves for vascular and non vascular deaths restenosis and to investigate the association between effective in terms of long-term functional outcome and restenosis and recurrent stroke. risk of fatal or disabling stroke. Post CAS restenosis was The current study has several limitations. The main infrequent, and, in the majority of cases, asymptomatic. limitation was its small sample size and retrospective Abbreviations design. Moreover, results obtained in this study were CAS: Carotid artery stent; CCA: Common carotid artery; CEA: Carotid artery compared with the literature, as it was not possible to endarterectomy; CFA: Common femoral artery; CT: Computerized axial undertake a randomized comparison of CAS versus tomography scan; ECA: External carotid artery; EPD: Embolic protection device; IRs: Interventional radiologists; ISR: Intra-stent restenosis; CEA. Further, the efficacy of the EPDs could not be eval- MI: Myocardial infarction; MRI scans: Magnetic resonance imaging; uated throughout the entirety of this study as these PAD: Peripheral artery disease; PSV: Peak systolic velocity; TIA: Transient devices were not available until 2005. ischemic attack Acknowledgements Conclusion Not applicable. The long-term follow-up results of our study validate CAS as a safe and durable procedure with which to pre- Ethical approval vent ipsilateral stroke. Our data also suggest that CAS is The study has been approved by the Ethics Committee in our Hospital. Availability of data and materials Table 5 The influence of procedural characteristics on Authors confirm that all relevant data are included in the article and/or its restenosis supplementary information files: The authors declare that the data supporting Proceure Reestenosis n % p the findings of this study are available within the article [and its supplementary x2 information files]. Peri-procedural complications No 142 6,8% 0,866 Yes 152 7,2% Authors’ contributions LR Pre-stent angioplasty No 322 5,6% 0,001 VMC conceived of the study, and participated in its design and coordination, and draft the manuscript. JAGO participated in the design of the study and Yes 20 25,0% helped to performed the statistical analysis. CTJ, MJGP and CPL conceived of LR Post-stent angioplasty No 77 9,1% 0,353 the study, and participated in its design and coordination. IDBG performed the statistical analysis and helped to draft the manuscript. MAGA conceived Yes 254 6,3% of the study, and participated in its design and coordination and helped to X2: Chi-squared test; LR: likelihood ratios draft the manuscript. All authors read and approved the final manuscript. Mayoral Campos et al. CVIR Endovascular (2018) 1:3 Page 7 of 8 Consent for publication protected angioplasty versus carotid endarterectomy (SPACE) study to treat All patients agreed to, and provided, written (signed) informed consent symptomatic stenoses at 2 years: a multinational, prospective, randomised which included consent to publish the results as long as it was anonymous. trial. Lancet Neurol 7:893–902 El-Koussy M, Schroth G, Do DD, Gralla J, Nedeltchev K, von Bredow F, Remonda Competing interests L, Brekenfeld C (2007) Periprocedural embolic events related to carotid artery The authors declare no financial and non-financial competing interests. stenting detected by diffusion-weighted MRI: comparison between proximal and distal embolus protection devices. J Endovasc Ther 14:293–303 European Carotid Surgery Trial (1998) Randomised trial of endarterectomy for Publisher’sNote recently symptomatic carotid stenosis: final results of the MRC European Springer Nature remains neutral with regard to jurisdictional claims in carotid surgery trial (ECST). Lancet 351:1379–1387 published maps and institutional affiliations. Executive Committee for the Asymptomatic Carotid Atherosclerosis Study (1995) Endarterectomy for asymptomatic carotid artery stenosis. 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Acta Cardiol 66:453–458

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CVIR EndovascularSpringer Journals

Published: Jul 17, 2018

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