Safety and efficacy of endovascular treatment for carotid artery stenoses using proximal protection systems: 30-day follow-up

Introduction. Although surgical endarterectomy remains the treatment of choice for carotid artery stenosis, carotid artery stenting (CAS) with use of proximal protection systems (PPS) plays an important role as alternative treatment modality, especially in high risk patients. This study was aimed at the assessment of safety of CAS with use of the PPS and also at identification of risk factors associated with this procedure. Material and methods. This was a post hoc analysis, with 30-day follow-up. We analysed results of treatment of 94 patients who underwent 97 CAS with PPS, 47 such procedures in asymptomatic, and 50 in symptomatic individuals. Results. There were 0 strokes during 30-day follow-up. Transient ischaemic attacks occurred in 2 patients (2%) in symptomatic group. Risk factors of these adverse events comprised: tortuosity of the managed artery, chronic obstructive pulmonary disease, long lesion of the internal carotid artery and history of myocardial infarction. Conclusions. CAS with the use of PPS seems to be a relatively very safe procedure in high risk patients.Introduction. Although surgical endarterectomy remains the treatment of choice for carotid artery stenosis, carotid artery stenting (CAS) with use of proximal protection systems (PPS) plays an important role as alternative treatment modality, especially in high risk patients. This study was aimed at the assessment of safety of CAS with use of the PPS and also at identification of risk factors associated with this procedure. Material and methods. This was a post hoc analysis, with 30-day follow-up. We analysed results of treatment of 94 patients who underwent 97 CAS with PPS, 47 such procedures in asymptomatic, and 50 in symptomatic individuals. Results. There were 0 strokes during 30-day follow-up. Transient ischaemic attacks occurred in 2 patients (2%) in symptomatic group. Risk factors of these adverse events comprised: tortuosity of the managed artery, chronic obstructive pulmonary disease, long lesion of the internal carotid artery and history of myocardial infarction. Conclusions. CAS with the use of PPS seems to be a relatively very safe procedure in high risk patients

Personalising treatment in patients with carotid disease

Approximately 10-15% of all ischaemic strokes are caused by atherosclerotic stenosis of the carotid artery. Conventionally, carotid stenosis was treated by surgical removal of the atherosclerotic plaque (carotid endarterectomy). Since the introduction of carotid artery stenting as a less invasive treatment alternative almost 20 years ago, the choice of the optimal treatment for the individual patient with carotid stenosis has remained controversial. This PhD thesis consisted of three individual projects and aimed to enable personalised treatment decisions for individual patients with carotid disease and explore parameters specifically linked to the mechanisms of stroke occurring as a complication of both revascularisation procedures. The first project consisted of a systematic review and meta-analysis with the aim to compare short-term risks and long-term effects on stroke prevention between carotid stenting and endarterectomy in patients with symptomatic or asymptomatic carotid stenosis. To this end, we performed a systematic Cochrane Review of all published randomised trials comparing carotid stenting versus endarterectomy to obtain precise overall estimates of procedural risks and long-term stroke recurrence rates. We found that in patients with symptomatic carotid stenosis, stenting and endarterectomy are equally effective in preventing recurrent stroke in the long-term, while stenting is associated with a higher risk of procedure related stroke or death. In patients with asymptomatic carotid stenosis, there may be a small increase in the risk of procedure related stroke or death associated with stenting. However, more data from randomised trials are needed. Concerning the durability of carotid stenting in the long-term, only limited data are currently available for asymptomatic patients and the existing evidence does not yet allow any firm conclusions. The second project comprised the systematic assessment of the anatomy of all supra-aortic arteries and pre-defined stenosis characteristics in order to investigate the association between vascular anatomy and the occurrence of procedure-related cerebral ischaemia after carotid artery stenting or carotid endarterectomy in patients with symptomatic carotid stenosis. We identified complex vascular anatomy as an important predictor for cerebral ischaemia during stenting, but not during endarterectomy. The third and fourth projects consisted of an individual patient data meta-analysis of four randomised clinical trials comparing carotid artery stenting versus endarterectomy for treatment of symptomatic carotid stenosis. This work resulted in two separate manuscripts. Within the first, we investigated whether the temporal distribution of stroke or death occurring within 30 days of treatment differed between the two procedures. In the second, we investigated if the procedural risks associated with carotid stenting and carotid endarterectomy within the examined trials had decreased over time. Our analysis revealed that the excess occurrence of stroke or death associated with stenting is limited to the day of treatment. In our analysis of temporal trends in procedure related risks, we were able to show that carotid revascularisation procedures became safer over time within the examined trials. This decline in risk was particularly apparent for endarterectomy

Changes in Cognition, Depression and Quality of Life after Carotid Stenosis Treatment

Background: Although several studies have evaluated the change of cognitive performance after severe carotid artery stenosis, the results still remain elusive. The objective of this study was to assess changes in cognitive function, depressive symptoms and Health Related Quality of Life (HRQoL) after carotid stenosis revascularisation and Best Medical Treatment (BMT). Methods: Study involved 213 patients with ≥70% carotid stenosis who underwent assessment of cognitive function using Montreal Cognitive Assessment scale (MoCA), depressive symptoms - using Patient Health Questionnaire-9 (PHQ-9) and HRQoL - using Medical Outcome Survey Short Form version 2 (SF-36v2). The assessment was performed before and at 6 and 12 months followup periods in patients who had Carotid Endarterectomy (CEA), Carotid Artery Stenting (CAS) or received BMT only. Results: Improvement in the total MoCA scores was observed after 6 and 12 months (p<0.001, Kendall's W=0.28) in the CEA group. In the CAS group - after 12 months (p=0.01, Kendall's W=0.261) whereas in the BMT group - no significant changes (p=0.295, Kendall's W=0.081) were observed. Reduction of depressive symptoms was not found in any of the study groups. Comparing mean SF-36v2 scores in the CEA group, there was no significant difference in any of 10 subscales. Likewise in the CAS group - no significant difference in 9 of 10 subscales (p=0.028, η2=0.343) was observed. Three subscales worsened in the BMT group during the 1-year follow-up period. Conclusion: Patients with severe carotid stenosis who underwent revascularisation enhanced their cognitive performance without exerting significant change of depressive symptoms. Preoperative HRQoL may be maintained for at least one year in the CEA group.publishersversionPeer reviewe

Carotid Artery Disease

This book will bring out the state of art of carotid stenosis in the basic and clinical approaches for better understanding of the mechanisms and useful therapies for these disease. We hope that would be a new current trend understanding new aspects regarding this scientific problematic involving not only anatomical, functional but also clinical questions

Secondary Stroke Prevention in Women

In a meta-analysis of results from 21 randomized trials comparing antiplatelet therapy with placebo in 18,270 patients with prior stroke or transient ischemic attack, antiplatelet therapy was associated with a 28% relative odds reduction in nonfatal strokes and a 16% reduction in fatal strokes, while another trial for secondary prevention with atorvastastin 80 mg showed a 16% risk reduction in time to first occurrence of stroke (adjusted hazard ratio: 0·84, 95% CI: 0·71–0·99). However, few studies have examined the sex differences regarding the efficacy of these treatments. Specifically, recent studies have reported higher rates of perioperative complications during endarterectomy in women. Nonetheless, to date, the data on the effects of carotid artery stenting in women, coming from diverse studies and meta-analyses, have been limited owing to the small number of female patients examined. Owing to this, the evidence of the benefit for women is unclear. Peculiar pathophysiological aspects of stroke, the h..

Carotid artery stenting vs. endarterectomy

Randomized clinical trials have demonstrated that carotid endarterectomy (CEA) is superior to medical management for stroke prevention in patients with symptomatic and, to a lesser degree, asymptomatic internal carotid artery stenosis. However, large-scale registries have shown that the adverse event rates following CEA are commonly higher than observed in the trials. In the last decade, carotid artery stenting (CAS) has emerged as a less invasive alternative to surgery. In order to address the efficacy of CAS, we performed a meta-analysis of 10 randomized trials comparing CAS with CEA in 4648 mainly symptomatic patients. The analysis showed that CAS was associated with a statistically significant increased death or stroke rate at 30 days compared with CEA (odds ratio 1.60, 95% confidence interval 1.26-2.02). However, most of the trials had inadequate requirements in terms of endovascular expertise and did not mandate the use of emboli protection devices. Beyond 30 days, long-term follow-up of the trials previously reported suggest that both revascularization techniques are equivalent in terms of stroke prevention. Conversely, large-scale high-quality CAS registries—mostly with independent neurological assessment and clinical event committee adjudication—have reported results in the range of current recommendation for CEA in over 20 000 patients, despite the fact that the majority of patients were at high risk for surgery. Until further data become available, the performance of CAS should be limited to protocols or centres of excellence and targeted especially to patients at high risk for surger

Early and long-term outcomes of carotid stenting and carotid endarterectomy in women

Background: The role of carotid revascularization in women remains intensely debated because of the lower benefit and higher perioperative risks concerning the male counterpart. Carotid artery endarterectomy (CEA) and stenting (CAS) represent the two most valuable stroke prevention techniques due to large vessel disease. This study investigates the early and late outcomes in female sex in a real-world everyday clinical practice.Methods: Data were retrospectively analyzed from a single-center database prospectively compiled. A total of 234 procedures, both symptomatic and asymptomatic, were identified (98 CEAs and 136 CASs). Perioperative risks of death, cerebral ischemic events, and local complications were analyzed and compared between the two groups. Long-term outcomes were evaluated in overall survival, freedom from ipsilateral stroke/transient ischemic attack, and freedom from restenosis (&gt;50%) and reintervention.Results: Women who underwent CAS and CEA did not differ in perioperative ischemic cerebral events (2.2 vs. 0%, p = 0.26) and death (0.8 vs. 0%, p = 1). Other perioperative and 30-day outcomes were similarly distributed within the two groups. Kaplan-Meier curves between CAS and CEA groups highlighted no statistical differences at 6 years in overall survival (77.4 vs. 77.1%, p = 0.47) of ipsilateral stroke/transient ischemic attack (94.1 vs. 92.9%, p = 0.9). Conversely, significant differences were showed in 6 years freedom from restenosis (93.1 vs. 83.3%, p = 0.03) and reinterventions (97.7 vs. 87.8%, p = 0.015).Conclusion: Our results revealed that both CEA and CAS have acceptable perioperative risk in women. Long-term outcomes highlighted favorable indications for both procedures, especially for CAS, which seemed to be an excellent alternative to CEA in female patients when performed by well-trained operators

Carotid endarterectomy and carotid artery stenting utilization trends over time

<p>Abstract</p> <p>Background</p> <p>Carotid endarterectomy (CEA) has been the standard in atherosclerotic stroke prevention for over 2 decades. More recently, carotid artery stenting (CAS) has emerged as a less invasive alternative for revascularization. The purpose of this study was to investigate whether an increase in stenting parallels a decrease in endarterectomy, if there are specific patient factors that influence one intervention over the other, and how these factors may have changed over time.</p> <p>Methods</p> <p>Using a nationally representative sample of US hospital discharge records, data on CEA and CAS procedures performed from 1998 to 2008 were obtained. In total, 253,651 cases of CEA and CAS were investigated for trends in utilization over time. The specific data elements of age, gender, payer source, and race were analyzed for change over the study period, and their association with type of intervention was examined by multiple logistic regression analysis.</p> <p>Results</p> <p>Rates of intervention decreased from 1998 to 2008 (P < 0.0001). Throughout the study period, endarterectomy was the much more widely employed procedure. Its use displayed a significant downward trend (P < 0.0001), with the lowest rates of intervention occurring in 2007. In contrast, carotid artery stenting displayed a significant increase in use over the study period (P < 0.0001), with the highest intervention rates occurring in 2006. Among the specific patient factors analyzed that may have altered utilization of CEA and CAS over time, the proportion of white patients who received intervention decreased significantly (P < 0.0001). In multivariate modeling, increased age, male gender, white race, and earlier in the study period were significant positive predictors of CEA use.</p> <p>Conclusions</p> <p>Rates of carotid revascularization have decreased over time, although this has been the result of a reduction in CEA despite an overall increase in CAS. Among the specific patient factors analyzed, age, gender, race, and time were significantly associated with the utilization of these two interventions.</p

Temporal trends in safety of carotid endarterectomy in asymptomatic patients

Objective: To systematically review temporal changes in perioperative safety of carotid endarterectomy (CEA) in asymptomatic individuals in trial and registry studies. Methods: The MEDLINE and EMBASE databases were searched using the terms “carotid” and “endarterectomy” and “asymptomatic” from 1947 to August 23, 2014. Articles dealing with 50%–99% stenosis in asymptomatic individuals were included and low-volume studies were excluded. The primary endpoint was 30-day stroke or death and the secondary endpoint was 30-day all-cause mortality. Statistical analysis was performed using random-effects meta-regression for registry data and for trial data graphical interpretation alone was used. Results: Six trials (n = 4,431 procedures) and 47 community registries (n = 204,622 procedures) reported data between 1983 and 2013. Registry data showed a significant decrease in postoperative stroke or death incidence over the period 1991–2010, equivalent to a 6% average proportional annual reduction (95% credible interval [CrI] 4%–7%; p < 0.001). Considering postoperative all-cause mortality, registry data showed a significant 5% average proportional annual reduction (95% CrI 3%–9%; p < 0.001). Trial data showed a similar visual trend. Conclusions: CEA is safer than ever before and high-volume registry results closely mirror the results of trials. New benchmarks for CEA are a stroke or death risk of 1.2% and a mortality risk of 0.4%. This information will prove useful for quality improvement programs, for health care funders, and for those re-examining the long-term benefits of asymptomatic revascularization in future trials