Carotid and Vertebral Artery Transluminal Angioplasty Study - CAVATAS

Sep 08, 2009
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Trial Sponsor:
British Heart Foundation, UK National Health Service Management Executive, and UK Stroke Association
Date Presented:
01/01/2001
Date Published:
01/01/2001
Date Updated:
09/08/2009
Original Posted Date:
09/08/2009
References

Description:

CAVATAS was a randomized, prospective, multicenter, exploratory, clinical trial designed to compare endovascular treatment (percutaneous transluminal angioplasty and stenting) with conventional surgery in patients with severe carotid artery stenosis.

Hypothesis:

Endovascular treatment would have the same major complication rates and less minor morbidity than conventional surgery in patients with severe carotid artery stenosis.

Study Design

Study Design:

Mean Follow Up: Up to 3 years
Mean Patient Age: 67 ± 8.5
Female: 30

Patient Populations:

Severe stenosis of the carotid (common carotid, bifurcation, or internal carotid) that needed treatment and was suitable for both endarterectomy and endovascular treatment

Exclusions:

Patients unsuitable for surgery because of medical or surgical risk factors (e.g., recent myocardial infarction, uncontrolled hypertension or diabetes mellitus, renal disease, respiratory failure, inaccessible carotid stenosis, or severe cervical spondylosis); patients unwilling to undergo the procedure, unable to give consent, or who had prior disabling stroke with no recovery; or patients with thrombus in the carotid artery, severe intracranial carotid stenosis, or anatomy unsuitable for endovascular treatment because of excessive vessel tortuosity

Primary Endpoints:

Death or stroke (disabling or lasting more than 7 days) up to 3 years after the procedure

Secondary Endpoints:

Cranial neuropathy, major groin or neck hematoma, and 1-year ipsilateral carotid restenosis

Drug/Procedures Used:

Percutaneous transluminal angioplasty and stenting compared to conventional surgery (carotid endarterectomy)

Concomitant Medications:

The protocol specified that patients should be treated as soon as possible after randomization. Surgeons did carotid endarterectomy by the technique they routinely used, and requirements for use of anesthesia, shunts or patches, or heparin during the procedure were not specified. Patients in the endovascular treatment arm were given aspirin (minimum dose 150 mg daily), or an alternative antiplatelet agent, for at least 24 hours before the procedure, followed by systemic heparin for anticoagulation at the time of the procedure and for a minimum of 24 hours afterwards, unless contraindicated. Antiplatelet therapy was continued throughout follow-up in both groups (up to 3 years).

Principal Findings:

A total of 251 patients were randomly assigned to endovascular treatment (stents in 55 [26%] and balloon angioplasty only in 158 [74%]), and 253 were assigned to surgery. Patients were well matched for symptoms, presence of concomitant risk factors, and degree of carotid artery stenosis (mean 86.4% in the endovascular and 85.1% in the surgery groups).

There was no difference in the rates of death or disabling stroke within 30 days of treatment (6% for endovascular vs. 6% for surgery) or death or any stroke lasting more than 7 days (10% for endovascular vs. 10% for surgery). Cranial neuropathy occurred in 0% of endovascular patients vs. 8.7% of surgery patients (p < 0.0001), and major groin or neck hematoma occurred less often in endovascular patients (1.2% vs. 6.7%, p < 0.0015).

At 1 year after treatment, severe ipsilateral carotid stenosis was more common in the endovascular group (14% vs. 4%, p < 0.001). However, there was no substantial difference in the rate of ipsilateral stroke up to 3 years after randomization (adjusted hazard ratio 1.04, 95% confidence interval 0.63-1.70, p = 0.9).

At 5 years, restenosis was 30.7% after endovascular therapy versus 10.5% after surgery. However, within the endovascular group, patients who received a stent had a marked reduction in restenosis compared with angioplasty alone (p = 0.04). The cumulative incidence of death or disabling stroke at 8 years was 50.4% vs. 45.2% (p = NS), respectively.

Interpretation:

Among patients with severe carotid stenosis, endovascular treatment was as effective as surgery for prevention of stroke during 3 years, but with wide confidence intervals. The rate of major complications was similar between the two groups, whereas minor complications were less frequent in the endovascular group.

A significant limitation of this trial is that stents were used in a relatively small number of patients. This was important since stents were subsequently shown to reduce the incidence of restenosis. In general, revascularization of the carotid artery should not take place by balloon angioplasty alone.

References:

Bonati LH, Ederle J, McCabe DJ, et al. Long-term risk of carotid restenosis in patients randomly assigned to endovascular treatment or endarterectomy in the Carotid and Vertebral Artery Transluminal Angioplasty Study (CAVATAS): long-term follow-up of a randomised trial. Lancet Neurol 2009;8:908-17.

Ederle J, Bonati LH, Dobson J, et al. Endovascular treatment with angioplasty or stenting versus endarterectomy in patients with carotid artery stenosis in the Carotid and Vertebral Artery Transluminal Angioplasty Study (CAVATAS): long-term follow-up of a randomised trial. Lancet Neurol 2009;8:898-907.

The CAVATAS Investigators. Endovascular versus surgical treatment in patients with carotid stenosis in the Carotid and Vertebral Artery Transluminal Angioplasty Study (CAVATAS): a randomised trial. Lancet 2001;357:1729-37.

Keywords: Stroke, Cranial Nerve Diseases, Endarterectomy, Carotid, Risk Factors, Carotid Arteries, Constriction, Pathologic, Hematoma, Carotid Stenosis, Angioplasty, Balloon, Coronary, Groin, Stents


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