Secular Trends in Procedural Stroke or Death Risks of Stenting Versus Endarterectomy for Symptomatic Carotid Stenosis (original) (raw)
Related papers
Stroke, 2017
Patients undergoing carotid endarterectomy (CEA) for symptomatic stenosis of the internal carotid artery benefit from early intervention. Heterogeneous data are available on the influence of timing of carotid artery stenting (CAS) on procedural risk. We investigated the association between timing of treatment (0-7 days and >7 days after the qualifying neurological event) and the 30-day risk of stroke or death after CAS or CEA in a pooled analysis of individual patient data from 4 randomized trials by the Carotid Stenosis Trialists' Collaboration. Analyses were done per protocol. To obtain combined estimates, logistic mixed models were applied. Among a total of 4138 patients, a minority received their allocated treatment within 7 days after symptom onset (14% CAS versus 11% CEA). Among patients treated within 1 week of symptoms, those treated by CAS had a higher risk of stroke or death compared with those treated with CEA: 8.3% versus 1.3%, risk ratio, 6.7; 95% confidence inte...
Circulation. Cardiovascular interventions, 2014
Given the controversy regarding whether carotid endarterectomy (CEA) or carotid artery stenting (CAS) may be superior for stroke prevention, it is uncertain how recent clinical evidence, guidelines, and reimbursement policies have influenced the volume and outcomes after these procedures. We conducted a serial, cross-sectional study with time trends of patients undergoing CAS (n=124 265) and CEA (n=1 260 647) between 2001 and 2010 from the Nationwide Inpatient Sample database. During the 10-year period, the frequency of CEA declined, whereas CAS use slowly increased. After multivariate propensity score-matched analysis, CAS was associated with an increased risk of death (odds ratio [OR], 1.69; 95% confidence interval [CI], 1.40-2.04), stroke (OR, 1.43; 95% CI, 1.23-1.66), and major adverse events including death, stroke, and myocardial infarction (OR, 1.25; 95% CI, 1.13-1.39). In asymptomatic patients, there was no significant difference in major adverse events (OR, 1.08; 95% CI, 0....
Journal of Vascular Surgery, 2008
Objective: Carotid endarterectomy (CEA) remains the procedure of choice for treatment of patients with severe carotid artery stenosis. The role of carotid artery stenting (CAS) in this patient group is still being defined. Prior single and multicenter studies have demonstrated economic savings associated with CEA compared with CAS. The purpose of this study was to compare surgical outcomes and resource utilization associated with these two procedures at the national level in 2005, the first year in which a specific ICD-9 procedure code for CAS was available. Methods: All patient discharges for carotid revascularization for the year 2005 were identified in the Nationwide Inpatient Sample based on ICD9-CM procedure codes for CEA (38.12) and CAS (00.63). The primary outcome measures of interest were in-hospital mortality and postoperative stroke; secondary outcome measures included total hospital charges and length of stay (LOS). All statistical analyses were performed using SAS version 9.1 (Cary, NC), and data are weighted according to the Nationwide Inpatient Sample (NIS) design to draw national estimates. Univariate analyses of categorical variables were performed using Rao-Scott 2 , and continuous variables were analyzed by survey weighted analysis of variance (ANOVA). Multivariate logistic regression was performed to evaluate independent predictors of postoperative stroke and mortality. Results: During 2005, an estimated 135,701 patients underwent either CEA or CAS nationally. Overall, 91% of patients underwent CEA. The mean age overall was 71 years. Postoperative stroke rates were increased for CAS compared with CEA (1.8% vs 1.1%, P < .05), odds ratio (OR) 1.7; (95% confidence interval [CI] 1 . Overall, mortality rates were higher for CAS compared with CEA (1.1% vs 0.57%, P < .05) this difference was substantially increased in regard to patients with symptomatic disease (4.6% vs 1.4%, P < .05). By logistic regression, CAS trended toward increased mortality, OR 1.5; (95% CI .96-2.5). Overall, the median total hospital charges for patients that underwent CAS were significantly greater than those that underwent CEA ($30,396 vs $17,658 P < .05). Conclusions: Based on a large representative sample during the year 2005, CEA was performed with significantly lower in-hospital mortality, postoperative stroke rates, and lower median total hospital charges than CAS in US hospitals. As the role for CAS becomes defined for the management of patients with carotid artery stenosis, clinical as well as economic outcomes must be continually evaluated. ( J Vasc Surg 2008;48:1442-50.)
Journal of Vascular Surgery, 2011
Background and Purpose-The comparison between carotid endarterectomy and carotid artery stenting (CAS) remains a debated field, especially in the context of long-term outcomes. Methods-Concerning the short-term (30-day) analysis, the numbers of outcomes per arm were abstracted, whereas outcomes per arm and hazard ratios were abstracted for long-term (Ն1-year) results. Results-Thirteen randomized trials (3723 carotid endarterectomy and 3754 CAS patients) were eligible. Regarding short-term outcomes, CAS was associated with elevated risk for stroke and "death or stroke." CAS also exhibited a marginal trend toward higher death and "death or disabling stroke" rates. Carotid endarterectomy presented with higher rates of myocardial infarction and cranial nerve injury. Concerning long-term outcomes, CAS was associated with higher rates of stroke (pooled OR, 1.37; 95% CI, 1.13 to 1.65) and "death or stroke" (pooled OR, 1.25; 95% CI, 1.06 to 1.48). These findings were replicated at the level of pooled hazard ratios and marginally regarding secondary preventive efficacy. The difference in long-term stroke rates was particularly sizeable in patients Ͼ68 years, but little difference in rates was observed in those Ͻ68 years. No statistically significant heterogeneity became evident. Metaregression did not reveal any significant modifying effect mediated by symptomatic/asymptomatic status, distal protection, early termination of trials, area of study origin, or CAS learning curve. Conclusions-This meta-analysis points to the significantly less frequent stroke events after carotid endarterectomy at the long-term context. The outcomes of carotid endarterectomy seem superior to CAS, but there may be subgroups, particularly younger patients, in whom the results seem equivalent. (Stroke. 2011;42:687-692.)
Journal of Vascular Surgery, 2007
Objective: Although carotid endarterectomy (CEA) is the gold standard for the treatment of carotid artery stenosis, the recent United States Food and Drug Administration approval of carotid artery stenting (CAS) may have led to its widespread use outside of clinical trials and registries. This study compared in-hospital postoperative stroke and mortality rates after CAS and CEA at the national level. Methods: The Nationwide Inpatient Sample (NIS) was queried to identify all patient-discharges that occurred for revascularization of carotid artery stenosis. The International Classification of Diseases, 9th Revision, Clinical Modification procedure codes for CEA (38.12), CAS (00.63), and insertion of noncoronary stents (39.50, 39.90) were used in conjunction with the diagnostic codes for carotid artery stenosis, with (433.11) and without (433.10) stroke. Primary outcome measures included in-hospital postoperative stroke and death rates. Multivariate logistic regressions were performed to evaluate independent predictors of postoperative stroke and mortality. Adjustment was made for age, sex, medical comorbidities, admission diagnosis, procedure type, year, and hospital type. Results: During the calendar years 2003 and 2004, an estimated 259,080 carotid revascularization procedures were performed in the United States. CAS had a higher rate of in-hospital postoperative stroke (2.1% vs 0.88%, P < .0001) and higher postoperative mortality (1.3% vs 0.39%) than CEA. For asymptomatic patients (92%), the postoperative stroke rate was significantly higher for CAS than CEA (1.8% vs 0.86%, P < .0001), but the mortality rate was similar (0.44% vs 0.36%, P ؍ .36). For symptomatic patients (8%), the rates for postoperative stroke (4.2% vs 1.1%, P < .0001) and mortality (7.5% vs 1.0%, P < .0001) were significantly higher after CAS. By multivariate regression, CAS was independently predictive of postoperative stroke (odds ratio [OR], 2.49; 95% confidence interval [CI], 1.91 to 3.25). CAS was also associated with in-hospital postoperative mortality for asymptomatic (OR, 2.37; 95% CI, 1.46 to 3.84) and symptomatic (OR, 2.64; 95% CI, 1.89 to 3.69) patients. Conclusions: As determined from a large representative national sample including the years 2003 and 2004, the in-hospital stroke rate after CAS for asymptomatic patients was twofold higher than after CEA. For symptomatic patients, the respective in-hospital stroke and mortality rates were fourfold and sevenfold higher. These unexpected results indicate that further randomized controlled trials with homogenous symptomatic and asymptomatic patient groups should be performed. ( J Vasc Surg 2007;46:1112-8.)
European Journal of Vascular and Endovascular Surgery, 2023
Background: It is currently unclear if carotid artery stenting (CAS) is as safe as carotid endarterectomy (CEA) for patients with significant asymptomatic stenosis. The aim of our study was to perform a systematic review and meta-analysis of trials comparing CAS with CEA. Methods: On March 17, 2017, a search for randomized controlled trials was performed in MEDLINE and Scopus databases with no time limits. We performed meta-analyses with Peto odds ratios (ORs) and 95% confidence intervals (CIs). Quality of evidence was assessed with the Grading of Recommendations Assessment, Development, and Evaluation method. The primary safety and efficacy outcome measures were stroke or death rate at 30 days and ipsilateral stroke at 1 year (including ipsilateral stroke and death rate at 30 days), respectively. Perioperative stroke, ipsilateral stroke, myocardial infarction (MI), and cranial nerve injury (CNI) were all secondary outcome measures. Results: The systematic review of the literature identified nine randomized controlled trials reporting on 3709 patients allocated into CEA (n ¼ 1479) or CAS (n ¼ 2230). Stroke or death rate at 30 days was significantly higher for CAS (64/2176
Clinical results of carotid artery stenting compared with carotid endarterectomy
Journal of Vascular …, 2008
Objectives: Carotid artery stenting (CAS) is an alternative to carotid endarterectomy (CEA) for treating carotid artery stenosis. We conducted a systematic review and meta-analysis of the clinical trials to date comparing these two procedures to determine their relative safety and efficacy. Methods: Searches of the Cochrane Controlled Trials Register, MEDLINE, and EMBASE identified two cohort studies and eight randomized, controlled trials (RCTs) comparing CEA and CAS. Meta-analysis was performed for the primary outcome of 30-day stroke or death, using an intention-to-treat analysis. Between-trial heterogeneity was assessed using the 2 test, and fixed-effects models were used to pool estimates in the absence of heterogeneity. Meta-regression was conducted to investigate potential effect differences by patient, intervention, and trial characteristics. To evaluate the effect of study design and inclusion criteria, sensitivity and subgroup analyses were performed. Results: Ten trials encompassing 3580 patients were analyzed. Patients who underwent CAS had a higher risk of 30-day stroke/death relative to patients who underwent CEA (risk ratio [RR], 1.30; 95% CI, 1.01-1.67). Meta-analysis and meta-regression demonstrated no between-trial heterogeneity. Sensitivity analysis of only RCTs showed similar higher risk for stroke/death (RR, 1.38; 95% CI, 1.06-1.79) in CAS patients. Subgroup analysis of trials enrolling only symptomatic patients showed higher risk of 30-day stroke/death (RR, 1.63; 95% CI, 1.18-2.25), but trials enrolling both symptomatic and asymptomatic patients showed no significant differences (RR, 0.89; 95% CI, 0.59-1.35). Conclusions: Meta-analysis of trials to date shows CAS is associated with higher 30-day risk of stroke/death compared with CEA. Thus, for the patient at average surgical risk, the role of CAS is unproven, especially for symptomatic patients. And for the patient at high surgical risk, the role of any intervention is uncertain in the setting of competing comorbidities. The results of ongoing clinical trials in this area will likely provide additional evidence to support treatment choices for carotid artery stenosis. ( J Vasc Surg 2008;47:343-9.)
The Lancet. Neurology, 2018
The risk of stroke associated with carotid artery restenosis after stenting or endarterectomy is unclear. We aimed to compare the long-term risk of restenosis after these treatments and to investigate if restenosis causes stroke in a secondary analysis of the International Carotid Stenting Study (ICSS). ICSS is a parallel-group randomised trial at 50 tertiary care centres in Europe, Australia, New Zealand, and Canada. Patients aged 40 years or older with symptomatic carotid stenosis measuring 50% or more were randomly assigned either stenting or endarterectomy in a 1:1 ratio. Randomisation was computer-generated and done centrally, with allocation by telephone or fax, stratified by centre, and with minimisation for sex, age, side of stenosis, and occlusion of the contralateral carotid artery. Patients were followed up both clinically and with carotid duplex ultrasound at baseline, 30 days after treatment, 6 months after randomisation, then annually for up to 10 years. We included pa...
Journal of Vascular Surgery, 2008
Background: Carotid endarterectomy (CEA) has been shown to be effective in stroke prevention for patients with symptomatic or asymptomatic carotid artery stenosis. Although several prospective randomized trials indicate that carotid artery stenting (CAS) is an alternative but not superior treatment modality, there is still a significant lack of long-term data comparing CAS with CEA. This study presents long-term results of a prospective, randomized, single-center trial. Methods: Between August 1999 and April 2002, 87 patients with a symptomatic high-grade internal carotid artery stenosis (>70%) were randomized to CAS or CEA. After a median observation time of 66 ؎ 14.2 months (CAS) and 64 ؎ 12.1 months (CEA), 42 patients in each group were re-evaluated retrospectively by clinical examination and documentation of neurologic events. Duplex ultrasound imaging was performed in 61 patients (32 CAS, 29 CEA), and patients with restenosis >70% were re-evaluated by angiography. Results: During the observation period, 23 patients (25.2%) died (10 CAS, 13 CEA), and three were lost to follow up. The incidence of strokes was higher after CAS, with four strokes in 42 CAS patients vs none in 42 CEA patients. One transient ischemic attack occurred in each group. A significantly higher rate of restenosis >70% (6 of 32 vs 0 of 29) occurred after CAS compared with CEA. Five of 32 CAS patients (15.6%) presented with high-grade (>70%) restenosis as an indication for secondary intervention or surgical stent removal, and three presented with neurologic symptoms. No CEA patients required reintervention (P < .05 vs CAS). A medium-grade (<70%) restenosis was detected in eight of 32 CAS patients (25%) and in one of 29 CEA patients (3.4%). In five of 32 CAS (15.6%) and three of 29 CEA patients (10.3%), a high-grade stenosis of the contralateral carotid artery was observed and treated during the observation period. Conclusion: The long-term results of this prospective, randomized, single-center study revealed a high incidence of relevant restenosis and neurologic symptoms after CAS. CEA seems to be superior to CAS concerning the development of restenosis and significant prevention of stroke. However, the long-term results of the ongoing multicenter trials have to be awaited for a final conclusion.