Status:
Randomization is complete with 5-year results published in May of 2004. Follow-up will continue through 2008. Commenced April 1993 (follow-up ongoing for publication of 10-year results in 2007/2008, but recruitment closed in 2003).
Purpose:
To compare the efficacy of carotid endarterectomy (CAE) performed in conjunction with best medical treatment (BMT) with that of BMT alone in prolonging stroke-free survival time in patients with asymptomatic carotid stenosis.
Interventions:
Endarterectomy, carotid
Surgical therapy to remove atherosclerotic plaque in narrowed carotid arteries.
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Location(s):
Bulgaria, Cyprus, England, Germany, Ireland, Israel, Italy, Netherlands, Norway, Poland, Portugal, Spain, Sweden, Yugoslavia
Year Started:
1993
Year Finished:
2008
Year Presented:
2008
Design:
International, multi-center, prospective, randomized trial.
Inclusion Criteria
Patients with unilateral or bilateral carotid stenosis considered appropriate for surgery, who have experienced no ipsilateral transient ischemic attack (TIA), amaurosis fugax, or stroke within the past 6 months, who have no history of ipsilateral disabling stroke or severe contralateral stroke, and who have no clear indication or contraindication for CEA, will be eligible for this trial.
Exclusion Criteria
Patients whose carotid plaques are smooth, calcified, and not significantly stenotic, who have a severe, life-threatening comorbidity other than stroke, who have recent acute myocardial infarction (MI), intracerebral neoplasia, intracerebral aneurysm, or whose carotid arteries are restenosed following a previous CEA, will be excluded from this trial.
Patient Involvement:
Prior to enrollment, all patients will undergo Duplex sonography and a clinical interview. Eligible patients will be randomized to receive either BMT or BMT combined with CEA. Patients in the BMT group will receive as many of the following treatments as are indicated: smoking cessation counseling and treatment, antihypertensives (if blood pressure is consistently > 160/100 mmHg), screening and treatment for diabetes, screening and treatment for coronary artery disease, treatment for hyperlipidemia (if cholesterol is > 5.0 mmol/L), and anticoagulant or antiplatelet drugs. Patients in the BMT/CAE group will receive the same medical treatment as the BMT cohort, and will also undergo CAE as soon as possible after enrollment. All patients will undergo repeat carotid duplex scans and clinical interviews at 4 months post-randomization and annually thereafter, for a period of 5 years.
Primary Outcome:
Mortality rate, incidence of stroke, and carotid stenosis (measured by Duplex sonography) at 4 months, 1, 2, 3, 4, and 5 years post-randomization.
Results:
Comparing all patients randomized to immediate CEA versus all patients randomized to deferral (combining the perioperative events and non-perioperative strokes), the net 5 year stroke risks were 6.4% vs 11.8% for all strokes (net gain 5.4% [3.0-7.8], p < 0.0001) and 3.5% vs 6.1% for fatal or disabling strokes (net gain 2.5% [0.8-4.3], p < 0.004) and 2.1% vs 4.2% for only fatal strokes (net gain 2.1% [0.6-3.6], p=0.006). The risk of stroke or death within 30 days of CEA was 3.1% (95% CI 2.3-4.1). Comparing all patients excluding such perioperative events, the 5 year stroke risks were 3.8% vs 11% (gain 7.2% [95% CI 5.0-9.4], p<0.0001). Most of this gain was from carotid territoy ischemic strokes - 2.7% vs 9.5% (gain 6.8% [4.8-8.8], p<0.0001). Half of which were disabling or fatal - 1.6% vs 5.3% (gain 3.7% [2.1-5.2], p<0.0001).
The results were separately significant for males and females, those with 70-90% carotid artery narrowing on ultrasound, and for those under 65 and 65-74 years old.
Ten year results will be available in 2008.
Source of Information:
Published protocol, 1994. Abstracts of major ongoing stroke trials. Stroke. 1998; 29: 2225; Stroke. 2000;31:2536 Correspondence with trial coordinator (Feb, 2002). Lancet. 2004; 363: 1491-1502.
Abstract presented @ International Stroke Conference (February 2008).
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