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European Carotid Surgery Trial - ECST
Description:
Carotid endarterectomy for ischemic stroke in symptomatic patients.
Hypothesis:
For mild, moderate, and severe stenosis, surgery can reduce the long-term and short-term risks of ischemic stroke or death.
Study Design
Study Design:
Patients Screened: Not given
Patients Enrolled: 2,200
Mean Follow Up: 6.1 years
Mean Patient Age: 60
Female: 30
Patient Populations:
Minor carotid symptoms affecting the eye or the brain in the previous 6 months.
Some degree of stenosis at the origin of the symptomatic internal carotid artery.
Exclusions:
Do not want to enter the trial after hearing explanation.
Poor general health, making them poor surgical candidates.
Symptomatic internal carotid artery is occluded, or if there is more severe disease distally than at the origin of the symptomatic carotid artery.
The stenotic lesion is considered technically inoperable.
More likely sources of embolism to the brain, such as atrial fibrillation.
Only vertebrobasilar events.
Symptomatic artery has been previously operated on.
Primary Endpoints:
Stroke; in particular, ischemic stroke which is ipsilateral to the previously symptomatic artery.
Secondary Endpoints:
Fatal strokes.
Nonfatal strokes which cause symptoms that last more than 7 days.
Nonfatal strokes which leave the patient dependent on others for activities of daily living six months later.
Nonstroke deaths.
Any death occurring within 30 days of surgery.
Drug/Procedures Used:
For surgical group, endarterectomy.
For all patients, management of risk factors (hypertension, cigarette smoking etc.) and appropriate use of antithrombotic drugs, usually aspirin.
Principal Findings:
For 374 patients with only mild stenosis (0-29%), there was little 3-year risk of ipsilateral ischemic stroke, even in the absence of surgery.
For 778 patients with severe stenosis (70-99%), the risks of surgery were significantly outweighed by the later benefits. Although 7.5% had a stroke (disabling or non-disabling) or died within 30 days of surgery, during the next 3 years, the risks of ipsilateral ischemic stroke were, by life-table analysis, an extra 2.8% for surgery-allocated and 16.8% for control patients (a six-fold reduction, p < 0.0001).
There was also a small reduction in other strokes. At 3 years the total risk of surgical death, surgical stroke, ipsilateral ischemic stroke, or any other stroke was 12.3% for surgery patients and 21.9% for control (difference 9.6% SD 3.3, 2p <0.01).
The main concern was to avoid disabling or fatal events. Among severe stenosis patients, 3.7% had a disabling stroke or died within 30 days of surgery, an extra 1.1% of surgery patients and 8.4% of control patients (p < 0.0001) had a disabling or fatal ipsilateral ischemic stroke by 3 years, and the total 3-year risk of any disabling or fatal stroke (or surgical death) was 6.0% for surgery vs 11.0% for control (overall difference 5.0%, SD 2.3, 2p < 0.05).
For disabling or fatal stroke, the control risks seemed to diminish after the first year, so delay of surgery by just a few months after clinical presentation might make this overall difference non-significant.
At the end of the study, major stroke or death had occurred in 669 (37.0%) surgery-group patients and 442 (36.5%) control-group patients. The risk of major stroke or death complicating surgery (7.0%) did not vary substantially with severity of stenosis.
Interpretation:
Carotid endarterectomy is indicated for most patients with a recent non-disabling carotid-territory ischaemic event when the symptomatic stenosis is greater than about 80%. Age and sex should also be taken into account in decisions on whether to operate.
The balance of risk vs. benefit in patients with moderate stenosis (30-69%) is still unclear.
References:
1. Lancet 1991;337:1235-43
2. Journal des Maladies Vasculaires 1993;18:198-201
3. Lancet 1998;351(9113):1379-87. Final results
Keywords: Stroke, Cerebrovascular Disorders, Endarterectomy, Carotid, Risk Factors, Constriction, Pathologic, Carotid Stenosis, Carotid Artery, Internal, Hypertension, Smoking
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