Atherosclerosis, Carotid Artery Stenosis, Stroke
Conditions
Keywords
Internal Carotid Artery Stenosis, Carotid Endarterectomy, Stroke, Cerebrovascular, Atherosclerosis
Brief summary
The aim of this study is to determine whether optimal medical treatment can postpone carotid endarterectomy.
Detailed description
It is well known that risk of fatal and non-fatal stroke is increased in patients with significant carotid atherosclerosis. For asymptomatic patients, AHA guidelines recommend carotid endarterectomy (CEA) for stenosis 60% to 99%, if the risk of perioperative stroke or death is less than 3%. Although clinical trial data support CEA in asymptomatic patients with carotid stenosis 60% to 79%, the AHA guidelines indicate that some physicians delay revascularization until there is greater than 80% stenosis in asymptomatic patients. Our study is designed to determine whether optimal medical therapy alone reduces the risk of death and nonfatal stroke in patients with carotid artery stenosis as compared with CEA coupled with optimal medical therapy.
Interventions
PROCEDURECarotid Endarterectomy
CEA involves a neck incision and physical removal of the plaque from the inside of the artery
DRUGatorvastatin, aspirin, losartan, amlodipine
aspirin 100 mg/day, atorvastatin 10 mg/day, losartan 50 mg/day, amlodipine 5 mg/day
Sponsors
Russian Cardiology Research and Production Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Unilateral or bilateral carotid artery stenosis that was considered to be severe (carotid artery diameter reduction 70%-79% on ultrasound) * This stenosis had not caused any stroke, transient cerebral ischaemia, or other relevant neurological symptoms in the past 6 months * Both doctor and patient were substantially uncertain whether to choose immediate CEA, or deferral of any CEA until a more definite need for it was thought to have arisen * The patient had no known circumstance or condition likely to preclude long-term follow-up * Neurologist's explicit consent to potentially perform CEA
Exclusion criteria
* Previous ipsilateral CEA * Expectation of poor surgical risk (e.g., because of recent acute myocardial infarction) * Some probable cardiac source of emboli (because the main stroke risk might then be from cardiac, not carotid, emboli) * Inability to provide informed consent * Underlying disease other than atherosclerosis (inflammatory or autoimmune disease) * Life expectancy \< 6 months * Advanced dementia * Advanced renal failure (serum creatinine \> 2.5 mg/dL) * Unstable severe cardiovascular comorbidities (e.g., unstable angina, heart failure) * Restenosis after prior CAS or CEA * Atrial fibrillation * Allergy or contraindications to study medications (statins, ASA, losartan, amlodipine)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| composite of nonfatal stroke, nonfatal composite of nonfatal stroke, nonfatal myocardial infarction and death | 5 years |
Secondary
| Measure | Time frame |
|---|---|
| composite of nonfatal stroke, nonfatal MI, carotid/coronary revascularization and death | 5 years |
Countries
Russia
Outcome results
None listed