Carotid artery stenting in high surgical risk patients using the FiberNet® embolic protection system: The EPIC trial results

Objective: The multicenter EPIC (FiberNet Embolic Protection System in Carotid Artery Stenting Trial) single‐arm trial evaluated the 30‐day outcomes of a new design concept for embolic protection during carotid artery stenting (CAS). Background: Embolic protection filters available for use during CAS include fixed and over‐the‐wire systems that rely on embolic material capture within a “basket” structure. The FiberNet® Embolic Protection System (EPS), which features a very low crossing profile, consists of a three‐dimensional fiber‐based filter distally mounted on a 0.014 inch guidewire with integrated aspiration during filter retrieval. Methods: The trial enrolled 237 patients from 26 centers. Demographics, clinical and lesion characteristics, as well as adverse events through a 30‐day follow‐up were recorded. The mean age of the patients was 74 years, 64% were male and 20% had symptomatic carotid artery disease. Results: The combined major adverse event (MAE) rate at 30 days for all death, stroke, and myocardial infarction was 3.0%. There were three major strokes (two ischemic and one hemorrhagic) and two minor strokes (both ischemic) for a 2.1% 30‐day stroke rate. The procedural technical success rate was 97.5% and macroscopic evidence of debris was reported in 90.9% of the procedures. Conclusions: The FiberNet EPS, used with commercially available stents, produced low stroke rates following CAS in high surgical risk patients presenting with carotid artery disease. The unique filter design including aspiration during retrieval may have contributed to the low 30‐day stroke rate reported during CAS in patients considered at high risk for complications following carotid endarterectomy (CEA). © 2009 Wiley‐Liss, Inc.     

Carotid stenting in high-risk patients: early and late outcomes

Purpose: Some patients with severe carotid stenosis have anatomical or clinical comorbidities that place them at high risk for carotid endarterectomy (CEA). The early and late outcomes after carotid artery stenting (CAS) were evaluated in patients at high risk for CEA. Methods: Between 2002 and 2009, 186 patients were enrolled in a high‐risk CAS institutional registry. The primary outcome was major adverse cardiac and cerberovascular events (MACCEs) at 30 days, including death, stroke, and myocardial infarction. Secondary outcomes were technical, procedural, and clinical success; nonstroke neurological events; and death and ipsilateral stroke at 5 years. Results: Twenty‐five patients (13.2%) were symptomatic. Thirty day MACCE occurred in 2.6%, including death in 1 (0.5%), stroke in 3 (1.6%), and myocardial infraction in 1 (0.5%) patient. Strokes were nonfatal in 3 (1.6%), major in 2 (1.1%), and minor in 1 (0.5%) patients. Other neurological events included transient ischemic attack in 9 (4.7%) and retinal artery occlusion in 2 (1.1%) patients. After stroke, 2 patients had complete resolution of neurological deficit within 30 days, and 1 patient had improvement in neurological deficit. By Kaplan–Meier analysis, all‐cause mortality was 47.5% and ipsilateral stroke was 4.5% at 5 years. Conclusions: In patients who are high risk for CEA, CAS can be performed with low MACCE at 30 days and ipsilateral stroke at 5 years. However, nearly half of these patients die within 5 years from causes unrelated to stroke. (J Interven Cardiol 2011;24:247–253)     

Neuroprotection during carotid artery stenting using the GORE flow reversal system: 30‐day outcomes in the EMPiRE Clinical Study

Background : Each of the embolic protection devices used in carotid artery stenting (CAS) has advantages and disadvantages. The prospective, multicenter, single‐arm EMPiRE Clinical Study investigated a proximally placed device (GORE Flow Reversal System) that provides distal neuroprotection during CAS by reversing blood flow in the internal carotid artery, thereby directing emboli away from the brain. Methods : The study evaluated 30‐day outcomes in 245 pivotal high‐surgical‐risk patients (mean age, 70 years; 32% symptomatic; 16% ≥80‐years old) with carotid stenosis who underwent CAS using the flow reversal system. The primary endpoint was a major adverse event (MAE; stroke, death, myocardial infarction, or transient ischemic attack) within 30 days of CAS. The MAE rate was compared with an objective performance criterion (OPC) derived from CAS studies that included embolic protection. Results : The MAE rate was 4.5% (11 patients; P = 0.002 compared with the OPC). The stroke and death rate was 2.9%. No patient had a major ischemic stroke. Six patients (2.4%) had intolerance to flow reversal. The death and stroke rates in the symptomatic, asymptomatic, and octogenarian subgroups were 2.6, 3, and 2.6%, respectively, meeting American Heart Association guidelines for carotid endarterectomy. Conclusion : The stroke and death rate in this study was among the lowest in CAS trials. The results indicate that the flow reversal system is safe and effective when used for neuroprotection during CAS and that it provides benefits in a broad patient population. © 2010 Wiley‐Liss, Inc.     

Double Filtration During Carotid Artery Stenting Using a Novel Post-Dilation Balloon With Integrated Embolic Protection

Objectives

This study evaluated the safety and performance of the Paladin System, a novel angioplasty balloon with an integrated embolic protection filter designed to increase embolic protection during post-dilation.

Carotid angioplasty and stenting in octogenarians: Is it safe?

Purpose: Elderly patients have a higher risk of complications in carotid endarterectomy. The aim of the study was to evaluate whether carotid artery stenting (CAS) performed in octogenarians also increases the procedure related risk. Methods: 870 patients (male 626) mean age 70.9 ± 9.3 years underwent 930 CAS for de novo lesions (n = 851) restenoses (n = 54) post radiation (n = 14) inflammatory arteritis (n = 9) post trauma aneurysms (n = 2). Indications for treatment: symptomatic carotid stenosis ≥ 70% (n = 577) or asymptomatic stenosis ≥ 80%. Patients were separated into two age groups: <80 years (749 patients, 806 CAS) and >80 years (121 patients, 124 CAS). 187 CAS performed without protection (N.P?) 6 patients >80 years, 743 with protection (NP+) (occlusion balloon: 334, filters: 404, reversal flow: 6) 118 patients >80 years. Data analysis included neurological complications, death and myocardial infarction (MI) rate at 30 days, anatomical particularities. Technical points will be described depending on the age of the patient. Results: Technical success 804/806 in patients <80 years, 123/124 in patients >80 years (NS). 30 days outcomes: in the patient group <80 years we observed 9 TIA (1.1%) 3 without NP (1.7%) 6 with NP (0.9%), 5 minor strokes (0.6%) 2 without NP (1.1%) 3 with NP (0.5%), 3 major strokes: 2 without NP (1.1%) 1 with NP (0.2%), 5 deaths (0.6%) 2 without NP (1.1%) 3 with NP (0.5%). Death/stroke/MI: 14 (1.8%) 6 without NP (3.3%), 8 with NP (1.3%). In the group >80 years, we observed 2 TIA (1.7%) 1 without NP 1 with NP (0.92%) 1 minor stroke without NP (17%) no major stroke, no death. Death/stroke/MI 1 without NP (17%). Conclusion: CAS can be performed in elderly patients without higher risk than in younger patients. But good indications, a meticulous technique, protection devices are mandatory and some technical points must be pointed out to avoid neurological complications and failures. © 2008 Wiley‐Liss, Inc.     

Carotid artery stent placement is safe in the very elderly (≥80 years)

Background: Carotid artery stent (CAS) placement is an alternative to carotid endarterectomy (CEA) for stroke prevention. Clinical adoption of CAS depends on its safety and efficacy compared to CEA. There are conflicting reports in the literature regarding the safety of CAS in the elderly. To address these safety concerns, we report our single‐center 13‐year CAS experience in very elderly (≥80 years of age) patients. Methods: Between 1994 and 2007, 816 CAS procedures were performed at the Ochsner Clinic Foundation. Very elderly patients, those ≥80 years of age, accounted for 126 (15%) of all CAS procedures. Independent neurologic examination was performed before and after the CAS procedure. Results: The average patient age was 82.9 ± 2.9 years. Almost one‐half (44%) were women and 40% were symptomatic from their carotid stenoses. One‐third of the elderly patients met anatomic criteria for high surgical risk as their indication for CAS. The procedural success rate was 100% with embolic protection devices used in 50%. The 30‐day major adverse coronary or cerebral events (MACCE) rate was 2.7% (n = 3) with all events occurring in the symptomatic patient group [death = 0.9% (n = 1), myocardial infarction = 0%, major (disabling) stroke = 0.9% (n = 1), and minor stroke = 0.9% (n = 1)]. Conclusion: Elderly patients, ≥80 years of age, may undergo successful CAS with a very low adverse event rate as determined by an independent neurological examination. We believe that careful case selection and experienced operators were keys to our success. © 2008 Wiley‐Liss, Inc.     

Mandatory Diagnostic Angiography for Carotid Artery Stenosis Prior to Carotid Artery Intervention

Introduction: Revascularization is an important strategy for reducing stroke risk in patients with severe carotid atherosclerosis. Magnetic resonance angiography (MRA) and/or carotid ultrasound have traditionally been used as the only diagnostic modalities prior to revascularization. Patients undergoing CEA frequently have no further assessments of carotid anatomy prior to surgery. Evaluation with carotid ultrasound and MRA can often overestimate the degree of stenosis. We sought to determine if noninvasive imaging was sufficient for determining whether a patient should be referred for carotid intervention.
Methods: We performed an analysis of 101 patients referred for carotid artery stenting (CAS). All patients had previously been evaluated with carotid ultrasound and 94% had undergone MRA as well. We sought to determine if noninvasive diagnostic imaging for carotid stenosis was sufficient to determine the necessity for endovascular intervention.
Results: Of the 101 patients referred for carotid intervention, 36 (36%) were shown to have <70% stenoses and did not require intervention. Of those who had significant disease, 49 (75%) underwent successful CAS, 15 (23%) underwent CEA, and 1 patient was treated medically for a total occlusion. Three of the 36 patients not requiring carotid intervention were found to have subclavian stenosis. Two (4%) of the patients undergoing CAS and 4 (27%) of the patients undergoing CEA had minor complications. No patients suffered a major stroke, MI, or death at follow-up.
Conclusion: This analysis demonstrates that 36% of patients referred for endovascular intervention based on noninvasive imaging did not meet criteria by angiography. This emphasizes the need for carotid angiography prior to carotid intervention.     

Carotid artery stenting in clinical practice results from the Carotid Artery Stenting (CAS)-registry of the Arbeitsgemeinschaft Leitende Kardiologische Krankenhausarzte (ALKK)

Summary Background Carotid artery stenting (CAS) for symptomatic and asymptomatic carotid stenosis seems to be on the doorstep of more widespread use. However, its feasibility and safety in clinical practice at a broad spectrum of hospitals needs to be determined. Methods We analyzed data of the prospective multi-centre Carotid Artery Stenting (CAS) Registry of the German Arbeitsgemeinschaft Leitende Kardiologische Krankenhausärzte (ALKK). Results From 7/1996 to 5/2004 1888 patients from 28 hospitals were included in the CAS Registry. The median hospital stay from CAS until hospital discharge was 3 days (quartiles: 2–6 days). Median patients age was 70 years (quartiles: 64–76 years) with 72.1% males. CAS for symptomatic stenosis was performed in 55% of cases. Patients treated with CAS suffered from coronary artery disease in 66.5%, had arterial hypertension in 91.7%, hyperlipidemia in 86.3% and 34.2% were diabetics. The intended CAS procedure was completed in 98.1% of cases. A stent was implanted in 97.3% of completed cases. The median intervention time was 43 min (quartiles: 30–60 min). During the hospital stay death rate was 0.3% (5/1888) and the rate of ipsilateral stroke 3.2% (58/1840). A contralateral ischemic event occurred in 1.4% (26/ 1840) of patients. The combined rate of all death or strokes was 3.8% (70/1841). Between 1996 and 2004 there was a steady increase in the use of protection devices during CAS (0% in 1996 and 97.9% in 2004; p for trend <0.0001). There was also an increase in the proportion of patients treated for asymptomatic stenoses (p for trend <0.0001). We observed a decrease of the combined endpoint of death or stroke from 6.3% in 1996 to 1.9% in 2004 (p for trend=0.021). Conclusion The multi-centre ALKK CAS Registry data confirm the feasibility and shot-term safety of CAS even in daily clinical practice. There was a rapid penetration of the use of embolic protection devices, an increase in treatment of asymptomatic carotid stenoses and a decrease in acute complication rates from 1996 to 2004.For the Arbeitsgemeinschaft Leitende Kardiologische Krankenhausärzte (ALKK)     

Carotid Revascularization: A Systematic Review of the Evidence

Objective and Background

The aim of this study is to provide an evidence‐based review of the periprocedural safety and long‐term effectiveness of carotid artery stenting (CAS) compared to carotid endarterectomy (CEA), with particular attention paid to the use of embolic protection devices and patients at high risk for CEA.

Methods

Electronic databases (Ovid Medline, Cochrane central register of controlled trials, Pubmed, and Embase) were searched to identify: (1) randomized controlled trials (RCT) comparing outcomes of CEA and CAS, and (2) prospective clinical trials assessing the safety of CAS in patients at high surgical risk. Pooled incidence rates and one‐sided 95% confidence interval for the periprocedural and long‐term composite end‐point of stroke, myocardial infarction, or death among high surgical risk patients were generated and compared to objective performance criteria (OPC) reported by previous trials.

Results

Six RCTs and 14 prospective clinical trials met our search criteria. Selected RCTs showed inconsistency in reported periprocedural and long‐term outcome rates. Pooled incidence rates of the periprocedural and long‐term composite end‐point of stroke, myocardial infarction or death in high surgical risk candidates were 5.59% and 7.92%, respectively. These results were noninferior to selected OPCs (P‐value <0.001).

Conclusions

CAS represents a safe and effective stroke prevention strategy in high surgical risk patients when compared with CEA. The inconsistent results from the RCTs and the improved outcomes in the prospective clinical trials are likely related to variability in operator experience, use of embolic protection devices, and patient selection strategies.

     

Safety and efficacy of carotid stenting in the very elderly

Background : Carotid artery stenting (CAS) has emerged as an alternative to carotid endarterectomy (CEA) in patients at high risk for complications from surgery. The very elderly (≥80‐year‐old) are one subgroup of patients identified as being at increased risk for carotid surgery. However, there is concern that the very elderly are also at increased risk for complications of CAS. A stroke and death rate of 12% was reported in very elderly patients during the roll‐in phase of Carotid Revascularization Endarterectomy versus Stent Trial (CREST). We are reporting on a large clinical series of CAS with independent neurological assessment in the very elderly. Methods : Between 1994 and 2008, a consecutive series of 418 CAS patients (≥80‐year‐old) were treated at four high‐volume centers with extensive CAS experience. Independent neurologic assessment was performed after CAS procedures. Thirty‐day follow‐up information was available in 389 patients. Results : The average age was 83.2 ± 2.8 years. Most patients were male (63.2%), and the target lesion carotid stenosis was asymptomatic in two‐thirds (68.2%) of patients. The majority of patients treated with CAS had a history of coronary artery disease (74.4%), hypertension (87.8%), and dyslipidemia (71.1%). One third (30.1%) were diabetic and more than half (56.5%) were current or former smokers. Embolic protection devices (EPD) were used in 78.7% of cases with the CAS procedure being performed before EPD availability being the most common reason for not using them. The overall 30‐day incidence of stroke and death was 2.8% (11/389). The cumulative incidence of major cardiovascular events (stroke, death, or myocardial infarction) during that time period was 3.3% (13/389). Conclusions : This large series of CAS with independent neurologic assessment is convincing evidence that the very elderly (≥80 years) can safely undergo CAS with stroke and death rates comparable to younger patients. The key to obtaining these excellent results is that CAS be performed by high volume, experienced operators who exercise restraint regarding patient selection. © 2009 Wiley‐Liss, Inc.     

Carotid artery stenting in octogenarians: results from the ALKK Carotid Artery Stent (CAS) Registry.

AIMS: We tried to determine the influence of age on complication rates of carotid artery stenting (CAS). METHODS AND RESULTS: Two thousand seven hundred eighty CAS procedures were included in the registry. Median age of the patients was 70.8 years, with a proportion of octogenarians of 11.2% and a significant increase between 1996 (5.9%) and 2005 (13.7%; P for trend = 0.002). In octogenarians, a symptomatic stenosis was a more frequent indication for CAS (60.7% vs. 48%, P < 0.001), the CAS procedure was aborted more frequently (6.9% vs. 2.2%; P < 0.001) and the duration of intervention was longer (Median 45 vs. 40 min; P = 0.008). Increasing age was associated with a significant increase in the in-hospital death or stroke rate (P for trend: 0.001). In-hospital death or stroke rate was also higher in octogenarians compared with younger patients (5.5 vs. 3.2%; P = 0.032, OR = 1.79; 95%CI: 1.04-3.06). Logistic regression analysis showed that age analysed as a continuous variable was a strong predictor of in-hospital death or stroke (P < 0.001), whereas octogenarians had only a trend towards a higher event rate (P = 0.062). CONCLUSION: CAS in octogenarians is performed in an increasing proportion of patients. In-hospital stroke or death rates increase significantly with older age; however, there was no excess complication rate in octogenarians.     

Carotid artery stenting without post-dilation

Introduction: The aim of this study is to report the feasibility, safety, and 1‐year restenosis rate of carotid artery stenting (CAS) without post‐dilation. Methods: Between April 2006 and November 2009, 254 consecutive patients (68.7 ± 8.5 years old, 31% symptomatic) underwent 308 CAS procedures with the intention of avoiding post‐dilation (eligibility criteria were stenosis of less than 30% after stent placement with no overt signs of calcification). Comparison and analysis of mid‐term clinical outcomes and restenosis rates of CAS with or without post‐dilation was performed retrospectively. Results: Overall, 27 patients (study group) were eligible for treatment without post‐dilation. No significant difference in adverse events was found between the study and control group. In the study group, 2 transient ischemic attacks (7.4%) occurred immediately after the procedure and no other neurological complications were reported during the 30‐day, 6‐month, and 1‐year follow‐ups (3 patients died from causes unrelated to the procedure). Two asymptomatic restenosis cases were diagnosed in the study group within the first 12‐months after the procedure compared to 16 significant restenosis cases diagnosed in the control group (7.4% vs 5.7%, NS). All of them were successfully treated with repeated intervention. Conclusion: We suggest that CAS without post‐dilation is feasible and probably safe with a low rate of cerebrovascular events and restenosis in a selected group of patients. We also suggest that CAS with postdeployment stenosis of less than 20% and without overt signs of severe calcification might be performed without post‐dilation. (J Interven Cardiol 2012;25:190–196)     

Carotid angioplasty and stenting versus carotid endarterectomy: randomized trial in a community hospital.

OBJECTIVES: The goal of this study was to determine whether carotid angioplasty and stenting (CAS) is equivalent to carotid endarterectomy (CEA) in patients with symptomatic carotid stenosis >70% by a randomized, controlled trial in a community hospital. BACKGROUND: Carotid angioplasty and stenting has been suggested to be as effective as CEA for treatment of symptomatic carotid artery stenosis. METHODS: A total of 104 patients presenting with cerebrovascular ischemia ipsilateral to carotid stenosis were selected randomly for CEA or carotid stenting and followed for two years. RESULTS: Stenosis decreased to an average of 5% after CAS. The patency of the reconstructed artery remained satisfactory regardless of the technique as determined by sequential ultrasound. One death occurred in the CEA group (1/51); one transient ischemic attack occurred in the CAS group (1/53); no individual sustained a stroke. The perception of procedurally related pain/discomfort was similar. Hospital stay was similar, although the CAS group tended to be discharged earlier (mean = 1.8 days vs. 2.7 days). Complications associated with CAS prolonged hospitalization when compared with those sustaining a CEA-related complication (mean = 5.6 days vs. 3.8 days). Return to full activity was achieved within one week by 80% of the CAS group and 67% of the patients receiving CEA. Hospital charges were slightly higher for CAS. CONCLUSIONS: Carotid stenting is equivalent to CEA in reducing carotid stenosis without increased risk for major complications of death/stroke. Because of shortened hospitalization and convalescence, CAS challenges CEA as the preferred treatment of symptomatic carotid stenosis if a reduction in costs can be achieved.     

Carotid artery stenting in asymptomatic and surgically high-risk patients: single-centre, single-operator results

BACKGROUND:

Stroke represents the third leading cause of death in developed countries and the leading cause of disability in the elderly. Because asymptomatic, surgically high-risk patients have been systematically excluded from randomized trials of carotid endarterectomy and medical therapy, the management of this group of patients is still controversial. A single-centre, single-operator registry was analyzed to evaluate feasibility and safety of carotid artery stenting (CAS) with distal protection devices in consecutive, asymptomatic, surgically high-risk patients who were scheduled for endovascular treatment of significant carotid stenoses.

METHODS:

A total of 122 consecutive, surgically high-risk, asymptomatic patients (150 carotid arteries, 59% men, mean [± SD] age 69±9 years) with severe carotid stenosis and one or more high-risk features for carotid endarterectomy were scheduled for CAS. All procedures were performed in a single centre by a single operator. All patients were prospectively asked to undergo a clinical 30-day follow-up.

RESULTS:

A total of 154 stents were implanted in 150 carotid arteries. The primary success rate was 98.7%. The rates of stenosis before and after direct CAS were 81%±9% and 10%±13%, respectively. The median of fluoroscopic time of direct CAS was 6 min (range 2.5 min to 31.5 min). At 30 days, data were available in all patients. The combined 30-day mortality and stroke rate was 1.3%.

CONCLUSIONS:

Short-term outcomes of CAS in asymptomatic, surgically high-risk patients treated by a single operator suggest a low periprocedural complication rate.     

Carotid artery disease: Stenting versus endarterectomy

Atherosclerotic carotid artery stenosis is a major cause of disabling stroke or death. Although carotid endarterectomy (CEA) is currently considered to be the standard of care for patients with a severe symptomatic stenosis and selected patients with an asymptomatic carotid stenosis, carotid angioplasty and stenting (CAS) is increasingly being used as an alternative treatment modality. This article briefly summarizes the current trial data on CEA and CAS. More importantly, potential risk factors for CEA and CAS are reviewed and the complementary role of these techniques in the management of the individual patient is discussed.     

New distal embolic protection device the FiberNet 3 dimensional filter: first carotid human study.

OBJECTIVE: Evaluate the performance and safety of the FiberNet Embolic Protection System during carotid artery intervention. BACKGROUND: Carotid Angioplasty and Stenting (CAS) can be proposed to treat the majority of carotid stenoses. Brain embolization takes place and routine use of Embolic Protection Devices (EPD) is warranted. Many EPDs have significant limitations, which may be addressed by a new EPD, the FiberNet (Lumen Biomedical, Plymouth, MN). METHODS: The system consists of a 3-dimensional expandable filter made of fibers, which expand radially, mounted onto a 0.014' wire and retrieval catheter. FiberNet can capture particles as small as 40 microm without compromising flow. RESULTS: 35 lesions treated in 34 patients. Male 67.6%. Age: 71.4 +/- 8.8 (50-85). Average stenosis 84.5% +/- 7.9 (70-99). 29.4% were symptomatic. Technical success: 34/35 (97%). No stroke or death within 30 days. Neurological events: two permanent amaurosis, one amaurosis fugax. All samples visually contained significant amounts of emboli. The mean surface area of debris caught was 63.8 mm(2) (37.7-107.5). Comparisons were made with other EPDs. The mean surface area of debris caught was 12.2 mm(2) (2.7-34.3). No changes were noted in CT/MRI at 30-day post procedure. CONCLUSION: The first human use of this new novel EPD in carotid artery stenting is encouraging. The FiberNet was easy to use and confirmed the ability to capture particles less than 100 microm. The feasibility of the FiberNet has been demonstrated. Additional patients will demonstrate the overall safety and efficacy of this new EPD device.     

Carotid Endarterectomy versus Carotid Stenting or Best Medical Treatment in Asymptomatic Patients with Significant Carotid Stenosis: A meta-analysis

BackgroundThis meta-analysis aimed to evaluate randomized trials (RTs) that compare outcomes among asymptomatic patients with significant carotid stenosis undergoing carotid endarterectomy (CEA) versus carotid stenting (CAS) or best medical treatment (BMT).Material and methodsThe Pubmed, Embase, Scopus and Cochrane Library databases were systematically searched to identify eligible studies. Data were analyzed by using the StatsDirect Statistical software (Version 2.8.0, StatsDirect Ltd). Odds ratios (OR) were used to determine effect size, along with 95% confidence interval (CI). PRISMA guidelines for conducting meta-analyses were utilized.ResultsOverall, 10 RTs including 8771 asymptomatic patients were evaluated. Compared to CAS, 30-day all stroke risk was found to be lower after CEA (pooled OR = 0.56; CI 95% [0.312–0.989]; P = 0.046). However, other early and late outcomes were not different between CEA and CAS. Furthermore, 30-day all stroke (pooled OR = 3.43; CI 95% [1.810–6.510]; P = 0.0002), death (pooled OR = 4.75; CI 95% [1.548–14.581]; P = 0.007) and myocardial infarction (MI) (pooled OR = 9.18; CI 95% [1.668–50.524]; P = 0.011) risks were higher after CEA compared to BMT, as expected. Additionally, 30-day all stroke/death and all stroke/death/MI risks were higher after CEA compared to BMT as well. Regarding long-term results, ipsilateral stroke risk was lower after CEA compared to BMT (pooled OR = 0.46; CI 95% [0.361–0.596]; P < 0.0001) although death due to stroke risk was not different (pooled OR = 0.57; CI 95% [0.223–1.457]; P = 0.240). Unfortunately, no study comparing CAS to BMT was found.ConclusionsCEA is associated with a lower early all stroke risk compared to CAS although other early or late outcomes did not show any difference between the two methods. Additionally, CEA seems to have a benefit over BMT against long-term ipsilateral stroke, although early outcomes are worse after CEA. No studies are available comparing CAS to BMT alone.     

Comparative Review of the Treatment Methodologies of Carotid Stenosis

The treatment of carotid stenosis entails three methodologies, namely, medical management, carotid angioplasty and stenting (CAS), as well as carotid endarterectomy (CEA). The North American Symptomatic Carotid Endarterectomy Trial (NASCET) and European Carotid Surgery Trial (ECST) have shown that symptomatic carotid stenosis greater than 70% is best treated with CEA. In asymptomatic patients with carotid stenosis greater than 60%, CEA was more beneficial than treatment with aspirin alone according to the Asymptomatic Carotid Atherosclerosis (ACAS) and Asymptomatic Carotid Stenosis Trial (ACST) trials. When CAS is compared with CEA, the CREST resulted in similar rates of ipsilateral stroke and death rates regardless of symptoms. However, CAS not only increased adverse effects in women, it also amplified stroke rates and death in elderly patients compared with CEA. CAS can maximize its utility in treating focal restenosis after CEA and patients with overwhelming cardiac risk or prior neck irradiation. When performing CEA, using a patch was equated to a more durable result than primary closure, whereas eversion technique is a new methodology deserving a spotlight. Comparing the three major treatment strategies of carotid stenosis has intrinsic drawbacks, as most trials are outdated and they vary in their premises, definitions, and study designs. With the newly codified best medical management including antiplatelet therapies with aspirin and clopidogrel, statin, antihypertensive agents, strict diabetes control, smoking cessation, and life style change, the current trials may demonstrate that asymptomatic carotid stenosis is best treated with best medical therapy. The ongoing trials will illuminate and reshape the treatment paradigm for symptomatic and asymptomatic carotid stenosis.     

Interventional Management of Asymptomatic Extracranial Carotid Stenosis

Carotid artery stenosis is a major risk factor for stroke and transient ischemic attack. Although carotid endarterectomy is the established gold standard for carotid revascularization, carotid artery angioplasty and stenting (CAS)—proven by large randomized clinical trials and rigorous registries and supported by improving stent designs, embolic protection, and increasing neurointerventionalist experience—is developing into a safer and more efficacious method of stroke prevention. Today, protected CAS is approved for symptomatic and asymptomatic patients with severe carotid stenosis with high surgical risk. We reviewed recently published data regarding new developments in the use of protected CAS, particularly in patients with carotid stenosis who are either asymptomatic or at low surgical risk.     

Peri-procedural outcome of series of 104 carotid artery stenting procedures

BackgroundManagement of carotid artery stenosis is considered an important strategy for stroke prevention. Carotid artery stenting (CAS) has been introduced as an acceptable alternative to surgical carotid endarterectomy (CEA) in the treatment of internal carotid artery (ICA) stenosis.ObjectiveAssessment of peri-procedural outcome of CAS in 104 consecutive procedures.MethodsThe study included 104 consecutive CAS procedures. Included patients had ⩾50% ICA stenosis in the symptomatic group and ⩾70% stenosis in the asymptomatic group. Procedures were performed in cath. labs of Catania and Ragusa hospitals-Italy.ResultsIncluded procedures were done in 100 consecutive eligible patients with ICA stenosis. Four patients had undergone CAS procedures in both sides in 2 separate sessions. Patients were 71 males and 29 females, mean age was 71.9 ± 7.85 years, and 21 patients were ⩾80 years old (octogenarians). The majority of patients had asymptomatic ICA stenosis (76%) and was diagnosed accidentally during medical checkup. Twenty-four patients had symptomatic ICA stenosis (ipsilateral TIA or stroke). Technical success was obtained in 103 procedures (99%). Embolic protection devices were used in all succeeded cases. Combined cerebrovascular events had occurred in 5 patients with estimated rate = 4.8%. No cases of amaurosis fugax, MI or death had occurred. Adverse events was 4.1% in the symptomatic group and 1.3% in the asymptomatic group with no significant statistical difference (P = 0.064).ConclusionCAS with EPDs seems a feasible and safe procedure and could be performed with an acceptable rate of periprocedural adverse events.