scholarly journals Carotid artery stenting compared with endarterectomy in patients with symptomatic carotid stenosis (International Carotid Stenting Study): a randomised controlled trial with cost-effectiveness analysis

2016 ◽  
Vol 20 (20) ◽  
pp. 1-94 ◽  
Author(s):  
Roland L Featherstone ◽  
Joanna Dobson ◽  
Jörg Ederle ◽  
David Doig ◽  
Leo H Bonati ◽  
...  
Keyword(s):  
Relative Risk ◽  
Carotid Artery ◽  
Carotid Stenosis ◽  
Health Technology ◽  
Symptomatic Carotid ◽  
Symptomatic Carotid Stenosis ◽  
Randomised Controlled ◽  
Stroke Death

BackgroundCarotid artery stenting (CAS) is an alternative to carotid endarterectomy (CEA) for the treatment of carotid stenosis, but safety and long-term efficacy were uncertain.ObjectiveTo compare the risks, benefits and cost-effectiveness of CAS versus CEA for symptomatic carotid stenosis.DesignInternational, multicentre, randomised controlled, open, prospective clinical trial.SettingHospitals at 50 centres worldwide.ParticipantsPatients older than 40 years of age with symptomatic atheromatous carotid artery stenosis.InterventionsPatients were randomly allocated stenting or endarterectomy using a computerised service and followed for up to 10 years.Main outcome measuresThe primary outcome measure was the long-term rate of fatal or disabling stroke, analysed by intention to treat (ITT). Disability was assessed using the modified Rankin Scale (mRS). A cost–utility analysis estimating mean costs and quality-adjusted life-years (QALYs) was calculated over a 5-year time horizon.ResultsA total of 1713 patients were randomised but three withdrew consent immediately, leaving 1710 for ITT analysis (853 were assigned to stenting and 857 were assigned to endarterectomy). The incidence of stroke, death or procedural myocardial infarction (MI) within 120 days of treatment was 8.5% in the CAS group versus 5.2% in the CEA group (72 vs. 44 events) [hazard ratio (HR) 1.69, 95% confidence interval (CI) 1.16 to 2.45;p = 0.006]. In the analysis restricted to patients who completed stenting, age independently predicted the risk of stroke, death or MI within 30 days of CAS (relative risk increase 1.17% per 5 years of age, 95% CI 1.01% to 1.37%). Use of an open-cell stent conferred higher risk than a closed-cell stent (relative risk 1.92, 95% CI 1.11 to 3.33), but use of a cerebral protection device did not modify the risk. CAS was associated with a higher risk of stroke in patients with an age-related white-matter changes score of 7 or more (HR 2.98, 95% CI 1.29 to 6.93;p = 0.011). After completion of follow-up with a median of 4.2 years, the number of patients with fatal or disabling stroke in the CAS and CEA groups (52 vs. 49), and the cumulative 5-year risk did not differ significantly (6.4% vs. 6.5%) (HR 1.06, 95% CI 0.72 to 1.57;p = 0.776). Stroke of any severity was more frequent in the CAS group (15.2% vs. 9.4% in the CEA group) (HR 1.712, 95% CI 1.280 to 2.300;p < 0.001). There was no significant difference in long-term rates of severe carotid restenosis or occlusion (10.8% in the CAS group vs. 8.6% in the CEA group) (HR 1.25, 95% CI 0.89 to 1.75;p = 0.20). There was no difference in the distribution of mRS scores at 1-year, 5-year or final follow-up. There were no differences in costs or QALYs between the treatments.LimitationsPatients and investigators were not blinded to treatment allocation. Interventionists’ experience of stenting was less than that of surgeons with endarterectomy. Data on costs of managing strokes were not collected.ConclusionsThe functional outcome after stenting is similar to endarterectomy, but stenting is associated with a small increase in the risk of non-disabling stroke. The choice between stenting and endarterectomy should take into account the procedural risks related to individual patient characteristics. Future studies should include measurement of cognitive function, assessment of carotid plaque morphology and identification of clinical characteristics that determine benefit from revascularisation.Trial registrationCurrent Controlled Trials ISRCTN25337470.FundingThis project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 20, No. 20. See the NIHR Journal Library website for further project information. Further funding was provided by the Medical Research Council, Stroke Association, Sanofi-Synthélabo and the European Union.

Results using a self-expanding stent alone in the treatment of severe symptomatic carotid bifurcation stenosis

2008 ◽  
Vol 109 (3) ◽  
pp. 454-460 ◽  
Author(s):  
Miguel Bussière ◽  
David M. Pelz ◽  
Paul Kalapos ◽  
Donald Lee ◽  
Irene Gulka ◽  
...  
Keyword(s):  
Carotid Artery ◽  
Carotid Stenosis ◽  
Multivariable Analysis ◽  
Balloon Dilation ◽  
Peak Systolic Velocity ◽  
Stent Insertion ◽  
Symptomatic Carotid ◽  
Symptomatic Carotid Stenosis ◽  
The Mean

Object Conventional endovascular therapy for carotid stenosis involves placement of an embolic protection device followed by stent insertion and angioplasty. A simpler approach may be placement of a stent alone. The authors determined how often this approach could be used to treat patients with carotid stenosis, and assessed which factors would preclude this approach. Methods Over a period of 6 years, 97 patients with symptomatic carotid stenosis were treated with the intention of using a “stent-only” approach. Arteries in 77 patients (79%) were treated with stents alone, 13 required preinsertion balloon dilation, 6 postinsertion dilation, and 1 both pre- and postinsertion dilation. Results The mean stenosis according to North American Symptomatic Carotid Endarterectomy Trial criteria was reduced from 82 to 40% in the stent-only group and from 89 to 37% in the stent and balloon angioplasty group. The 30-day stroke and death rate was 7.2%. Patients were followed for a mean of 15 months. In the stent-alone group, the mean preoperative Doppler peak systolic velocity (PSV) was 409 cm/second, with an internal carotid artery/common carotid artery (ICA/CCA) ratio of 7.2. At follow-up review, the PSV decreased to 153 cm/second and the ICA/CCA ratio to 2.1. In the angioplasty group the mean preoperative PSV was 496 cm/second and the ICA/CCA ratio was 9.2, decreasing to 163 cm/second and 2, respectfully, at follow-up evaluation. Restenosis occurred in 12.8% of patients at 6 months and in 15.9% at 1 year. One stroke occurred during the follow-up period in each group. Using multivariable analysis, factors precluding the “stent-only” approach were as follows: severity of stenosis, circumferential calcification, and no history of hyperlipidemia. Conclusions Balloons may not be required to treat all patients with carotid stenosis. A stent alone was feasible in 79% of patients, and 79% of patients were alive and free from ipsilateral stroke or restenosis at 1 year. Restenosis rates with this approach are higher than with conventional angioplasty and stent insertion. Carotid arteries with very severe stenoses (> 90%) and circumferential calcification may be more successfully treated with angioplasty combined with stent placement.

Carotid Artery Stenting May Be Losing the Battle against Carotid Endarterectomy for the Management of Symptomatic Carotid Artery Stenosis, But the Jury Is Still Out

Vascular ◽  
2009 ◽  
Vol 17 (4) ◽  
pp. 183-189 ◽  
Author(s):  
Kosmas I. Paraskevas ◽  
Dimitri P. Mikhailidis ◽  
Frank J. Veith
Keyword(s):  
Carotid Artery ◽  
Carotid Endarterectomy ◽  
Carotid Stenosis ◽  
Carotid Artery Stenosis ◽  
Carotid Artery Stenting ◽  
Artery Stenosis ◽  
Long Term Results ◽  
Symptomatic Carotid ◽  
Symptomatic Carotid Stenosis

Carotid artery stenting (CAS) has emerged as a potential alternative to carotid endarterectomy (CEA) for the management of carotid artery stenosis. The purpose of this article is to provide an evaluation and critical overview of the trials comparing the early and later results of CAS with CEA for symptomatic carotid stenosis. The Cochrane Controlled Trials Register, PubMed/Medline, and EMBASE databases were searched up to February 1, 2009, to identify trials comparing the long-term outcomes of CAS with CEA. The MeSH terms used were “carotid artery stenting,” “carotid endarterectomy,” “symptomatic carotid artery stenosis,” “treatment,” “clinical trial,” “randomized,” and “long-term results,” in various combinations. One single-center and three multicenter randomized studies reporting their long-term results from the comparison of CAS with CEA for symptomatic carotid stenosis were identified. All four studies independently reached the conclusion that CAS may not provide results equivalent to those of CEA for the management of symptomatic carotid stenosis. A higher incidence of recurrent stenosis and peri- and postprocedural events accounted for the inferior results reported for CAS compared with CEA. Current data from randomized studies indicate that CAS provides inferior long-term results compared with CEA for the management of symptomatic carotid artery stenosis. However, it can be argued that all of these trials were performed when both CAS equipment and CAS operators had not evolved to their current status. Given that current equipment and mature experience are required for CAS before comparing it with the current “gold standard” procedure (CEA), the results of soon-to-be reported trials (Carotid Revascularization Endarterectomy vs Stenting Trial [CREST], International Carotid Stenting Study [ICSS], or others) may alter the current impression that CAS is inferior to CEA for the treatment of symptomatic carotid stenosis.

Abstract T MP26: Progression Of Asymptomatic Carotid Stenosis: Incidence Of Symptoms And Predictive Factors

Stroke ◽  
2015 ◽  
Vol 46 (suppl_1) ◽  
Author(s):  
Tarun Singh ◽  
Christopher L Kramer ◽  
Giuseppe Lanzino ◽  
Alejandro A Rabinstein
Keyword(s):  
Carotid Stenosis ◽  
Medical Therapy ◽  
Previous History ◽  
Multivariate Logistic Regression Analysis ◽  
Asymptomatic Carotid ◽  
Symptomatic Carotid ◽  
Symptomatic Carotid Stenosis ◽  
Bilateral Carotid

Background: Given the uncertainty regarding clinical applicability of early treatment trials and lack of data on long-term disease progression, we evaluated the progression of stenosis and development of symptoms on patients with asymptomatic carotid artery stenosis (ACAS) treated with contemporary medical therapy over a prolonged follow up. Methods: Retrospective review of bilateral carotid arteries from consecutive patients diagnosed with moderate or severe ACAS, at our institution between 2000 and 2001. Patient vascular risk factors and treatments, cerebrovascular imaging, ipsilateral symptoms, and revascularization were recorded. Progression of stenosis was defined by change category of stenosis. Factors associated with symptomatic carotid disease were sought using univariate and multivariate logistic regression analysis. Results: We identified 214 patients (58.8% men; median age 70 years) and collected data on 349 vessels. Severe stenosis (>70%) upon diagnosis was present in 92(26.4%) vessels. All patients were on antithrombotics, 97% on antihypertensives, and 95% on statins. Median length of follow up was 13 years (range 5-14) and the mean number of time points with follow-up imaging was 8.1±3.9. Progression of stenosis was observed in 237(67.9%) vessels. 72(20.6%) patients developed symptomatic carotid stenosis (TIA in 14.4%, non-disabling stroke in 4%, and disabling stroke in 2.2%). Median time to appearance of first symptom was 6 years (range 1-13). Revascularization procedures were performed in 118(33.8%) vessels, including 73(61.9%) vessels which had become symptomatic. On multivariate analysis, baseline stenosis (OR 1.65, 95%CI 1.12-2.44), intracranial stenosis > 50% (OR 2.87, 95%CI 1.46-5.62), plaque ulceration (OR 3.41, 95%CI 1.34-8.69), silent infarction (OR 4.25, 95%CI 2.30-7.83), and previous history of TIA/stroke (OR 2.73, 95%CI 1.14-6.54) were associated with development of TIA/stroke ipsilateral to the carotid stenosis. Conclusions: There is a substantial rate of progression of stenosis in patients with asymptomatic carotid atherosclerosis over time despite adequate medical therapy. Over long-term follow up, one in five patients with ACAS developed ipsilateral TIA/stroke.

scholarly journals The Asymptomatic Carotid Surgery Trial-2 (ACST-2): an ongoing randomised controlled trial comparing carotid endarterectomy with carotid artery stenting to prevent stroke

2017 ◽  
Vol 21 (57) ◽  
pp. 1-40 ◽  
Author(s):  
Richard Bulbulia ◽  
Alison Halliday
Keyword(s):  
Carotid Artery ◽  
Carotid Stenosis ◽  
Controlled Trial ◽  
Carotid Stenting ◽  
Carotid Surgery ◽  
Asymptomatic Carotid ◽  
Randomised Controlled ◽  
Surgery Trial

Background A successful open surgical operation to remove atheromatous carotid artery narrowing that has not yet caused a stroke (asymptomatic carotid stenosis) carries some procedural risk but, if completed successfully, halves patients’ future annual stroke risk for at least 10 years. A newer, less invasive alternative is carotid stenting, which also carries some procedural risk, especially if the carotid lesion has recently given rise to a stroke (symptomatic carotid stenosis). For both surgery and stenting, improvements in technique (and in medication) have reduced risk. Early studies showed that treating carotid narrowing by stenting, particularly for symptomatic lesions, caused more procedural minor strokes than surgery, but more recent trials in symptomatic and in asymptomatic patients found that both procedures might now be equally safe and effective. However, low patient numbers, short follow-up of the long-term effects on stroke rates and wide confidence intervals mean that worldwide uncertainty persists between carotid surgery and carotid stenting, and national and international guidelines remain unclear as to which is generally better. Objectives The second Asymptomatic Carotid Surgery Trial (ACST-2) compares carotid endarterectomy (CEA) with carotid artery stenting (CAS) directly, randomising patients with asymptomatic carotid stenosis for whom a carotid procedure is considered definitely necessary; both procedures seem anatomically feasible, and there is substantial uncertainty as to which of the two would be better for such individuals. Although it will compare procedural risks, the trial’s primary aim is to compare the long-term durability of protection against strokes occurring in the years post procedure due to any remaining or recurrent carotid disease. Design Randomised controlled trial comparing CEA with CAS. Setting Hospitals in the UK and worldwide, in which carotid procedures are common. Participants Men and women with severely stenotic atherosclerotic carotid artery disease, with or without previous stroke but with no recent symptoms from the randomised artery. Interventions CEA and CAS. Outcomes (1) Periprocedural risk defined as myocardial infarction, stroke or death within 30 days after the randomised procedure and (2) long-term rates of disabling or fatal stroke during follow-up of patients. Measurement of costs and outcomes Measurement of intervention costs and stroke costs (periprocedural and during follow-up) and of quality of life [EuroQol-5 Dimensions (EQ-5D®)] for patients in the top six recruiting countries (UK, Italy, Belgium, Germany, Serbia and Sweden), who currently constitute 85% of those randomised. Progress so far By the end of March 2016, ACST-2 had included 2125 patients, nearly two-thirds of the planned recruitment of 3600; 1061 were randomly allocated to CEA and 1064 to CAS. Conclusions Further funding has been secured and recruitment continues, with completion anticipated by the end of 2019. ACST-2 will report initial results in 2021. Trial registration Current Controlled Trials ISRCTN21144362. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 57. See the NIHR Journals Library website for further project information. Funding was also received from BUPA Foundation [BUPAF/33(a)/05].

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