Substudy (effects of silent infarcts on cognition after carotid revascularization) of International Carotid
Stenting Trial.
|
Purpose:
To compare the frequency of new cerebral ischemic lesions after carotid endarterectomy or stenting for symptomatic stenosis of the internal carotid artery, and to test their impact on cognitive function and quality of life. Cerebral ischemic damage will be assessed before the intervention, and at one day and one month thereafter with (diffusion-weighted) MRI. The scans will be evaluated blinded to treatment assignment and neurological outcome.
Interventions:
Carotid Artery Stenting
Procedure in which the surgeon inserts a slender, metal-mesh tube, called a stent, which expands inside your carotid artery to increase blood flow in areas blocked by plaque.
|
Carotid Endarterectomy
An operation during which the surgeon removes the inner lining of your carotid artery if it has become thickened or damaged. Plaque is removed this way.
|
Location(s):
University Medical Center in Utrecht; Academic Medical
Center in Amsterdam, the Netherlands
Year Started:
2007
Design:
Randomised controlled trial.
Inclusion Criteria
Symptomatic stenosis of the internal carotid artery of at least 50% that is suitable for both stenting and surgery.
Patient Involvement:
Patients are randomized to either CEA or CAS. Cognitive impairment will be tested with a detailed neuropsychological examination in the week preceding the intervention, and six months thereafter. Quality of life will be assessed at the same points in time by means of the Stroke-Specific Quality of Life Scale. The results of the neuropsychological evaluation will be related with the number of new ischemic lesions detected with MRI.
Primary Outcome:
Cognitive function at six months after CEA or CAS.
Secondary Outcome:
Quality of life at six months and ischemic damage as assessed with MRI at one day and one month.
Results:
231 patients (124 in the stenting group and 107 in the endarterectomy group) had MRI before and after treatment. 62 (50%) of 124 patients in the stenting group and 18 (17%) of 107 patients in the endarterectomy group had at least one new DWI lesion detected on post-treatment scans done a median of 1 day after treatment (adjusted odds ratio [OR] 5.21, 95% CI 2.78-9.79; p<0.0001). At 1 month, there were changes on fluid-attenuated inversion recovery sequences in 28 (33%) of 86 patients in the stenting group and six (8%) of 75 in the endarterectomy group (adjusted OR 5.93, 95% CI 2.25-15.62; p=0.0003). In patients treated at a centre with a policy of using cerebral protection devices, 37 (73%) of 51 in the stenting group and eight (17%) of 46 in the endarterectomy group had at least one new DWI lesion on post-treatment scans (adjusted OR 12.20, 95% CI 4.53-32.84), whereas in those treated at a centre with a policy of unprotected stenting, 25 (34%) of 73 patients in the stenting group and ten (16%) of 61 in the endarterectomy group had new lesions on DWI (adjusted OR 2.70, 1.16-6.24; interaction p=0.019). INTERPRETATION: About three times more patients in the stenting group than in the endarterectomy group had new ischaemic lesions on DWI on post-treatment scans. The difference in clinical stroke risk in ICSS is therefore unlikely to have been caused by ascertainment bias. Protection devices did not seem to be effective in preventing cerebral ischaemia during stenting. DWI might serve as a surrogate outcome measure in future trials of carotid interventions
|
Source of Information:
Presented at the 2009 International Stroke Conference (February 2009).
|
Web Links and Publications:
|
|
This information last updated on: 5/7/2010
Reviewed on: 05/07/2010.
|
Trials
Directories