Stenting versus Endarterectomy for Treatment of Carotid-Artery Stenosis

Abstract

BACKGROUND Carotid-artery stenting and carotid endarterectomy are both options for treating carotid-artery stenosis, an important cause of stroke. METHODS We randomly assigned patients with symptomatic or asymptomatic carotid stenosis to undergo carotid-artery stenting or carotid endarterectomy. The primary composite end point was stroke, myocardial infarction, or death from any cause during the periprocedural period or any ipsilateral stroke within 4 years after randomization. RESULTS For 2502 patients over a median follow-up period of 2.5 years, there was no significant difference in the estimated 4-year rates of the primary end point between the stenting group and the endarterectomy group (7.2% and 6.8%, respectively; hazard ratio with stenting, 1.11; 95% confidence interval, 0.81 to 1.51; P = 0.51). There was no differential treatment effect with regard to the primary end point according to symptomatic status (P = 0.84) or sex (P = 0.34). The 4-year rate of stroke or death was 6.4% with stenting and 4.7% with endarterectomy (hazard ratio, 1.50; P = 0.03); the rates among symptomatic patients were 8.0% and 6.4% (hazard ratio, 1.37; P = 0.14), and the rates among asymptomatic patients were 4.5% and 2.7% (hazard ratio, 1.86; P = 0.07), respectively. Periprocedural rates of individual components of the end points differed between the stenting group and the endarterectomy group: for death (0.7% vs. 0.3%, P = 0.18), for stroke (4.1% vs. 2.3%, P = 0.01), and for myocardial infarction (1.1% vs. 2.3%, P = 0.03). After this period, the incidences of ipsilateral stroke with stenting and with endarterectomy were similarly low (2.0% and 2.4%, respectively; P = 0.85). CONCLUSIONS Among patients with symptomatic or asymptomatic carotid stenosis, the risk of the composite primary outcome of stroke, myocardial infarction, or death did not differ significantly in the group undergoing carotid-artery stenting and the group undergoing carotid endarterectomy. During the periprocedural period, there was a higher risk of stroke with stenting and a higher risk of myocardial infarction with endarterectomy. (ClinicalTrials.gov number, NCT00004732.)

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

“…ICSS is also in agreement with other randomised trials that have previously reported increased risks in procedure-related strokes that did not lead to disability associated with stenting, 49,50,53 and in the MRI substudy of ICSS there was a higher incidence of cerebral infarction 1 month after stenting compared with endarterectomy, even where this was not associated with a clinical event. 44 This excess of periprocedural non-disabling strokes accounts for the difference in the combined outcome measure of procedural stroke or death, or stroke in the ipsilateral carotid territory thereafter, in favour of surgery.…”

“…52 In the Carotid Revascularisation Endarterectomy versus Stenting Trial (CREST), there was a trend of an increased risk for major ipsilateral stroke in the stent group (1.4%) compared with the endarterectomy group (0.5%) occurring up to 4 years after treatment (p = 0.05), and including both patients with symptomatic and asymptomatic carotid stenosis. 53 This inclusion of asymptomatic patients in CREST probably also accounts for the lower overall event rates reported in that trial. The data from ICSS support these findings; the risk of having a severe stroke remains low after endarterectomy or stenting even after the first 2-4 years of follow-up and, in ICSS, does not differ between stenting and endarterectomy up to 10 years after randomisation.…”

“…In a separate analysis restricted to ICSS patients who were randomised to and completed stenting treatment, age was an independent predictor of the risk of stroke, MI or death within 30 days of stenting. In an analysis of CREST, age also significantly modified the risk of stenting versus endarterectomy, 53 whereas a pooled analysis of the data from ICSS with data from EVA-3S and SPACE, as well as a meta-analysis of all the existing trials, have confirmed that patients over the age of 70 years have a higher risk of stroke or death with stenting, but patients below the age of 70 have a similar risk with stenting compared with endarterectomy. 58,59 The analysis of the risk of baseline and procedural-related factors in ICSS showed that the use of an open-cell stent conferred higher risk than use of a closed-cell stent (RR 1.92, 95% CI 1.11 to 3.33), but the use of a cerebral protection device did not modify the risk.…”

Choice and Selection of Treatment Modalities for Cardiac Patients: An Interventional Cardiology Perspective

“…However, the caveats to a fair comparison of the 2 strategies in the literature include a lower than optimal utilization of emboli protection devices as well as relatively inexperienced operators included as a part of these earlier trials 42. The pivotal Carotid Revascularization Endarterectomy versus Stenting (CREST) trial randomly assigned patients with symptomatic or asymptomatic carotid stenosis to undergo CEA or CAS and compared the occurrence of primary composite end point of stroke, myocardial infarction (MI), or death from any cause during the periprocedural period or any ipsilateral stroke within 4 years after randomization 43. Although the primary outcome was similar between the 2 groups, there was an increased rate of stroke with CAS that was offset by a reduced rate of MI as compared to CEA 43.…”

“…The pivotal Carotid Revascularization Endarterectomy versus Stenting (CREST) trial randomly assigned patients with symptomatic or asymptomatic carotid stenosis to undergo CEA or CAS and compared the occurrence of primary composite end point of stroke, myocardial infarction (MI), or death from any cause during the periprocedural period or any ipsilateral stroke within 4 years after randomization 43. Although the primary outcome was similar between the 2 groups, there was an increased rate of stroke with CAS that was offset by a reduced rate of MI as compared to CEA 43. The question of equivalence of MI and stroke outcomes following carotid revascularization has been the crux of the debate following CREST.…”