Title: International Carotid Stenting Study (ICSS)
Trial Sponsor: Medical Research Council, the Stroke Association, Sanofi-Synthйlabo, European Union
Year Presented: 2009
Year Published 2010
Topic(s): General Cardiology, Interventional Cardiology, Prevention/Vascular
Summary Posted: 2/28/2010
Writer: Anthony A. Bavry, M.D., M.P.H., F.A.C.C.
Author Disclosure: This author has nothing to disclose.
Reviewer: Deepak L. Bhatt, M.D., M.P.H., F.A.C.C.
Author Disclosure: Research/Research Grants: Astra Zeneca; Consultant Fees/Honoraria: Duke Clinical Research Institute; Research/Research Grants: Heartscape; Research/Research Grants: PLx Pharma; Research/Research Grants: Cogentus; Research/Research Grants: Sanofi Aventis; Data Safety Monitoring Board (Gov’t/Nonprofit): Duke Clinical Research Institute; Research/Research Grants: Bristol Myers Squibb; Research/Research Grants: Eisai; Research/Research Grants: Takeda; Research/Research Grants: The Medicines Company; Research/Research Grants: Ethicon
Related Resources
Related Trial: Carotid Revascularization Endarterectomy vs. Stenting Trial (CREST)
Related Trial: Endarterectomy Versus Angioplasty in Patients With Symptomatic Severe Carotid Stenosis (EVA-3S: 30-Day and 4-Year Results)
Related Trial: Stent-Protected Angioplasty Versus Carotid Endarterectomy (SPACE: 30-Day and 2-Year Results)
Journal Scan: Carotid Artery Stenting Compared With Endarterectomy in Patients With Symptomatic Carotid Stenosis (International Carotid Stenting Study): An Interim Analysis of a Randomised Controlled Trial
Description
The goal of the trial was to evaluate treatment with carotid artery stenting compared with carotid endarterectomy among patients with recently symptomatic carotid artery stenosis.
Hypothesis
Carotid artery stenting would be more effective at preventing major cerebrovascular accidents.
Drugs/Procedures Used
Patients with recently symptomatic carotid artery stenosis were randomized to carotid artery stenting (n = 855) versus carotid endarterectomy (n = 858). The use of an embolic protection device was encouraged, but not mandatory during stenting.
Concomitant Medications
Patients who received a carotid stent were pretreated with aspirin and clopidogrel, and for 30 days after the procedure.
Principal Findings
Overall, 1,713 patients were randomized. In the stent group, the mean age was 70 years, 30% were women, the degree of carotid stenosis was 70-99% in 89% of patients, 32% had a recent transient ischemic attack, and 46% had a recent ischemic hemispheric stroke. Carotid stenting was performed at experienced centers in 88% and carotid endarterectomy was performed at experienced centers in 89%.
At 4 months, the composite outcome of death, stroke, or procedural myocardial infarction occurred in 8.5% of the stent group versus 5.2% of the endarterectomy group (p = 0.006). Similarly, any stroke occurred in 7.7% versus 4.1% (p = 0.002), any stroke or death 8.5% versus 4.7% (p = 0.001), any stroke or procedural death 8.0% versus 4.2% (p = 0.001), disabling stroke or death 4.0% versus 3.2% (p = 0.34), and all-cause death 2.3% versus 0.8% (p = 0.017), respectively for stent versus endarterectomy.
In the stent group, most of the strokes within 4 months were ipsilateral and ischemic in etiology (non-disabling and lasting more than 7 days). Cranial nerve palsy occurred in 1 versus 34 (p < 0.0001), and severe hematoma occurred in 9 versus 28 (p = 0.0007), respectively.
Interpretation
Among patients with a recent transient ischemic attack or stroke attributable to significant carotid artery stenosis, the use of carotid stenting was not superior to endarterectomy. Carotid artery stenting was associated with an increased hazard of death, stroke, or myocardial infarction within 4 months. There was also an excess of: 1) any stroke, 2) any stroke or death, 3) any stroke or procedural death, and 4) all-cause death among patients who received a carotid stent. There were fewer cranial nerve palsies and hematomas in the stent group. In the stent group, most strokes were ipsilateral, ischemic in etiology, and non-disabling, although lasting for >7 days.
The investigators performed a meta-analysis on three trials that enrolled symptomatic patients with carotid stenosis (EVA-3S, SPACE, and ICSS) and documented increased hazard of death, stroke, or myocardial infarction at 30 days with carotid stenting (p = 0.0002).
The recently presented CREST trial, which enrolled asymptomatic and symptomatic patients with carotid artery stenosis, found a similar incidence of death, stroke, or myocardial infarction within 30 days; however, minor strokes were increased with stenting, and myocardial infarctions were increased with carotid endarterectomy.
Conditions
• Carotid stenosis
• Cerebrovascular disease
• Prevention
Therapies
• Stent
• Carotid endarterectomy
Study Design
Randomized. Blinded. Parallel. Stratified.
Patients Enrolled: 1,713
Mean Follow-Up: 3 years
Mean Patient Age: 70 years
% Female: 30%
Primary Endpoints
3-year composite of fatal or disabling stroke in any territory
Secondary Endpoints
4-month composite of death, stroke, or procedural myocardial infarction
Any stroke
Any stroke or death
Any stroke or procedural death
Disabling stroke or death
All-cause death
Patient Population
Patients at least 40 years of age
Carotid artery stenosis >50%
Symptoms attributable to the carotid artery stenosis within the preceding 12 months
Exclusions:
Major stroke without recovery of function
Previous carotid artery stenting or endarterectomy or any contraindication for either procedure
Planned coronary artery bypass grafting or other major surgery
References: International Carotid Stenting Study Investigators. Carotid artery stenting compared with endarterectomy in patients with symptomatic carotid stenosis (International Carotid Stenting Study): an interim analysis of a randomised controlled trial. Lancet 2010;Feb 26:[Epub ahead of print].