CAVATAS
Carotid and Vertebral Transluminal Angioplasty Study
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Status:
Trial complete. Results published in June of 2001. ICSS trial is follow-on to CAVATAS.
Purpose:
To compare carotid angioplasty (with or without stenting) to carotid endarterectomy.
Location(s):
Europe, North America, and Australia
Year Started:
1992
Year Finished:
1997
Year Presented:
1999
Design:
Randomized trial of 504 patients at 24 centers.
Inclusion Criteria
Symptomatic and asymptomatic cerebrovascular disease.
Exclusion Criteria
Exclusion criteria included patients unable or unwilling to undergo one of the alternative treatment strategies, or who were unable to give informed consent, or if they had a disabling stroke with no useful recovery of function within the region supplied by the treatable artery. Patients were not eligible for the study if angiography showed thrombus in the affected artery, severe intracranial stenosis beyond the skull base, or a stenosis unsuitable for endovascular treatment e.g. because of tortuous vascular anatomy. However, patients did not need to have catheter angiography if a reliable non-invasive investigation had confirmed stenosis. Patients were not excluded if contraindications were noted after random assignment. There was no age limit.
Patient Involvement:
Patients were randomized to receive carotid angioplasty or carotid endarterectomy. Antiplatelet agents started 24 hrs before treatment and anticoagulation during and 24 hrs after treatment.
Primary Outcome:
Recurrent stroke, death, restenosis and safety over 3 year period.
Secondary Outcome:
Any stroke or death within 30 days of treatment, myocardial infarction within 30 days of treatment, treatment-related cranial nerve palsy or haematoma requiring reoperation or prolonging hospital stay. Stenosis (>70%) and occlusion on ultrasound follow-up. Stroke during follow-up. Further treatment procedure. Quality of life and economic measures.
Results:
504 patients with stenosis of the carotid artery (90% symptomatic) were randomly assigned to endovascular treatment (n=251) or surgery (n=253). Within 30 days of treatment, there were more minor strokes that lasted less than 7 days in the endovascular group (8 vs 1) but the number of other strokes in any territory or death was the same (25 vs 25). There were more cranial nerve palsies (22 vs 0) in the endarterectomy group than in the endovascular group. Median length of follow up in both groups was 5 years (IQR 2-6). By comparing endovascular treatment with endarterectomy after the 30-day post-treatment period, the 8-year incidence and hazard ratio (HR) at the end of follow-up for ipsilateral non-perioperative stroke was 11.3% versus 8.6% (HR 1.22, 95% CI 0.59-2.54); for ipsilateral non-perioperative stroke or TIA was 19.3% versus 17.2% (1.29, 0.78-2.14); and for any non-perioperative stroke was 21.1% versus 15.4% (1.66, 0.99-2.80). In conclusion, more patients had stroke during follow-up in the endovascular group than in the surgical group, but the rate of ipsilateral non-perioperative stroke was low in both groups and none of the differences in the stroke outcome measures was significant. However, the study was underpowered and the confidence intervals were wide. More long-term data are needed from the on going stenting versus endarterectomy trials.
Source of Information:
Presented at the 24th International Joint Conference on Stroke and Cerebral Circulation (February 1999). Stroke. 2000;31:2536. CAVATAS web site.
Articles in Lancet Neurology August 2009.
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Web Links and Publications:
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This information last updated on: 9/2/2009
Reviewed on: 10/19/2009.
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