Long-Term Results of Carotid Stenting versus Endarterectomy in High-Risk Patients

Gurm, Hitinder S.; Yadav, Jay S.; Fayad, Pierre; Katzen, Barry T.; Mishkel, Gregory; Bajwa, Tanvir; Ansel, Gary M.; Strickman, Neil E.; Wang, Hong; Cohen, Sidney A.; Massaro, Joseph M.; Cutlip, Donald E.

doi:10.1056/nejmoa0708028

Cited by 740 publications

(503 citation statements)

References 16 publications

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“…This study showed that the survival rate at 5 years was 73%, which is similar to the long‐term results observed in the SAPPHIRE trial (Gurm et al, 2008) and in CEA in patients ≥75 years old (Alozairi et al., 2003). …”

Section: Discussionsupporting

confidence: 87%

“…This study shows that 90% of our patients survived up to 3 years and 73% to 5 years. The average mortality rate was similar to the long‐term results reported in the SAPPHIRE trial (Gurm et al., 2008). It suggests that CAS is a reasonable option for most elderly patients because of the high percentage of 3‐year and 5‐year survival rate.…”

Section: Discussionmentioning

confidence: 99%

“…In recent years, carotid artery stenting (CAS) has emerged as an alternative procedure for stroke reduction in patients who are considered too high risk to undergo CEA (Gurm et al., 2008). However, CAS in octogenarians is a still a debated subject, given the unsatisfactory results observed in multicenter randomized controlled trials (RCTs) (e.g., EVA 3S,SPACE, ICSS) and the fact that some researchers see increasing age as a predictor of poor outcomes.…”

Section: Introductionmentioning

confidence: 99%

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Immediate and late outcomes of stenting for severe extracranial internal carotid artery stenosis in octogenarian patients

Duan

Dai

et al. 2017

Brain and Behavior

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BackgroundMultiple studies suggest that internal carotid artery stenting can be performed safely in octogenarians with low periprocedural complication rates. However, great concern still exists as to whether these patients will gain long‐term benefits from this procedure given their advanced age and uncertain life expectancy. We decided to conduct a retrospective study to determine short‐and long‐term clinical outcomes and to analyze survival duration in this population.Methods and ResultsSixty‐nine consecutive elderly patients with either symptomatic or asymptomatic stenosis ≥70% underwent 86 procedures. Immediate and late outcomes, as well as survival data, were analyzed retrospectively. Mean age was 83.1 ± 2.7 years. Mean survival was 49.3 ± 10.1 months. A complete neurological assessment was obtained at 1 and 2 years in 100% of patients, at 3 years in 90.7% of patients and at 5 years in 84.8% of patients. Two major and one minor ischemic strokes occurred during the periprocedural period. No death, myocardial infarction or intracranial hemorrhage was recorded. The mean follow‐up period was 55.4 ± 24.6 months. Four patients experienced a minimum of 1 year of follow‐up, and the longest is 8 years. Among the patients with the longest follow‐up time, 6 had ischemic strokes, of which 2 were fatal. In total, 17 deaths occurred. Four patients experienced dementia without stroke. Survival at 3 and 5 years was estimated to be 90% and 73%, respectively.ConclusionThis study demonstrated that stenting in octogenarians was safe and effective during the periprocedural period. Long‐term follow‐up showed a low rate of fatal and nonfatal stroke, and patients survived long enough to benefit from the procedure. However, it was associated with a relatively high rate of long‐term event. Though carotid artery stenting is a minimally invasive procedure, it should still be performed with great caution and only in carefully selected patients. The present study suggested that in this age population, carotid artery stenting might be considered as a revascularization option.

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Section: Discussionsupporting

confidence: 87%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Immediate and late outcomes of stenting for severe extracranial internal carotid artery stenosis in octogenarian patients

Duan

Dai

et al. 2017

Brain and Behavior

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“…The trial was stopped prematurely because of slow enrollment, and many potential participants were excluded because they were considered to be at exceedingly high risk for complications if randomized to undergo CEA. 50 The primary endpoint (the composite of MI, stroke, or death within 30 days plus death because of neurological causes or ipsilateral stroke between 31 days and 1 year) occurred in 12.2% of patients assigned to CAS and 20.1% of those assigned to CEA (p50.004 for noninferiority and p50.053 for superiority). In patients with symptomatic stenosis, the occurrence of the primary endpoint was similar after CAS and CEA (16.8% versus 16.5%,…”

Section: Comparative Assessment Of Carotid Endarterectomy and Stentingmentioning

confidence: 99%

2011 ASA/ACCF/AHA/AANN/AANS/ACR/ASNR/CNS/SAIP/SCAI/SIR/SNIS/SVM/SVS Guideline on the Management of Patients With Extracranial Carotid and Vertebral Artery Disease: Executive summary

Brott

Halperin

Abbara

et al. 2011

Cathet Cardio Intervent

184

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“…Since patients had unrestricted access to carotid endarterectomy (CEA), a proven surgical option with low expected morbidity and mortality, initial investigations in CAS were undertaken in patients with comorbid conditions and/or anatomical features that increased the risk of adverse events (AEs) during CEA. In the past decade, the US Food and Drug Administration (FDA) approved all stent systems studied for an indication of CAS revascularization in these high-surgical-risk patients, based on both randomized controlled and singlearm clinical investigational device exemption (IDE) trials conducted during that period [1][2][3][4][5][6][7][8].…”

Section: Introductionmentioning

confidence: 99%

The impact of regulatory approval and Medicare coverage on outcomes of carotid stenting

Gray

Verta

2013

Cathet Cardio Intervent

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Background Carotid artery stenting (CAS) was introduced in the United States nearly a decade ago as a novel treatment of severe carotid stenosis. Voluminous and high‐quality prospective data permit analysis of longitudinal trends in CAS outcomes. Methods Outcomes from all prospective trials with the Food and Drug Administration (FDA) oversight from 2000–2011 were reviewed, as were the subset of studies using a single CAS system. All studies shared common inclusion/exclusion criteria, endpoints, independent assessment/adjudication of neurological events, and were conducted in accordance with FDA regulations. Death and stroke (DS) rates from FDA‐approved studies in high‐surgical‐risk patients were assessed. Results Between 2000 and 2011, two distinct periods with clustered and differentiated outcomes in CAS IDE trials were observed, separated by FDA approval and Centers for Medicare and Medicaid Services (CMS) coverage in 2004–2005. The mean 30‐day DS rate in the first wave (2000–2004) of CAS trials was 5.3% (95% CI: 4.6–6.2%), and fell significantly to 2.6% (95% CI: 1.9–3.7%; P = 0.0001) in the second wave (2006–2011). This decline occurred during a simultaneous, independent 24‐fold increase in monitored CAS activity. This decline in DS rates was observed in symptomatic and asymptomatic patients, alike independent of device tested. Conclusions Declines in periprocedural DS rates in CAS appear linked to regulatory and coverage approvals leading to increased operator experience along with continued regulatory oversight, and provide insight into the introduction of other novel therapies. © 2013 Wiley Periodicals, Inc.

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Long-Term Results of Carotid Stenting versus Endarterectomy in High-Risk Patients

Cited by 740 publications

References 16 publications

Immediate and late outcomes of stenting for severe extracranial internal carotid artery stenosis in octogenarian patients

Immediate and late outcomes of stenting for severe extracranial internal carotid artery stenosis in octogenarian patients

2011 ASA/ACCF/AHA/AANN/AANS/ACR/ASNR/CNS/SAIP/SCAI/SIR/SNIS/SVM/SVS Guideline on the Management of Patients With Extracranial Carotid and Vertebral Artery Disease: Executive summary

The impact of regulatory approval and Medicare coverage on outcomes of carotid stenting

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