Elsevier

The Lancet

Volume 357, Issue 9270, 2 June 2001, Pages 1729-1737
The Lancet

Articles
Endovascular versus surgical treatment in patients with carotid stenosis in the Carotid and Vertebral Artery Transluminal Angioplasty Study (CAVATAS): a randomised trial

https://doi.org/10.1016/S0140-6736(00)04893-5Get rights and content

Summary

Background

Percutaneous transluminal angioplasty and tenting (endovascular treatment) can be used to treat carotid stenosis, but risks and benefits are uncertain. We therefore compared endovascular treatment with conventional carotid surgery.

Methods

In a multicentre clinical trial, we randomly assigned 504 patients with carotid stenosis to endovascular treatment (n=251) or carotid endarterectomy (n=253). For endovascular patients treated successfully, we used stents in 55 (26%) and balloon angioplasty alone in 158 (74%). An independent neurologist followed up patients. Analysis was by intention to treat.

Findings

The rates of major outcome events within 30 days of first treatment did not differ significantly between endovascular treatment and surgery (6·4% vs 5·9%, respectively, for disabling stroke or death; 10·0% vs 9·9% for any stroke lasting more than 7 days, or death). Cranial neuropathy was reported in 22 (8·7%) surgery patients, but not after endovascular treatment (p<0·0001). Major groin or neck haematoma occurred less often after endovascular treatment than after surgery (three [1·2%] vs 17 [6·7%], p<0·0015). At 1 year after treatment, severe (70–99%) ipsilateral carotid stenosis was more usual after endovascular treatment (25 [14%] vs seven [4%], p<0·001). However, no substantial difference in the rate of ipsilateral stroke was noted with survival analysis up to 3 years after randomisation (adjusted hazard ratio=1·04, 95% CI 0·63–1·70, p=0·9).

Interpretation

Endovascular treatment had similar major risks and effectiveness at prevention of stroke during 3 years compared with carotid surgery, but with wide CIs. Endovascular treatment had the advantage of avoiding minor complications.

Introduction

Atherosclerotic stenosis of the carotid artery, which is close to the carotid bifurcation in the neck, causes about 20% of all ischaemic strokes and transient ischaemic attacks. In patients with a short-term history of symptoms associated with severe carotid stenosis, the risk of recurrent stroke in the following 2 years is 20% or more if they are treated medically. Findings from two large randomised clinical trials, European Carotid Surgery Trial (ECST)1 and North American Symptomatic Carotid Endarterectomy Trial (NASCET),23 have shown that the risks of stroke are significantly reduced by carotid surgery in suitable patients with recent symptoms and severe carotid stenosis. The results of these trials have convincingly established carotid surgery as the standard treatment for severe symptomatic carotid artery stenosis. However, surgery has the disadvantage of an incision in the neck that could lead to cranial or superficial nerve injury and wound complications.4 Although such treatment has overall benefits, there is also a risk of a stroke, which might be fatal. Additionally, there is a small risk of myocardial infarction, because many patients with carotid stenosis also have ischaemic heart disease. Carotid surgery is often done under general anaesthesia, increasing the potential for complications.

Treatment of carotid stenosis by endovascular techniques (balloon dilation or use of a stent) is advantageous because it avoids surgical incision and requires only local anaesthetic for insertion of the catheter in the groin. The costs may be less than those of surgery, because of a shorter hospital stay and the reduced use of high dependency or intensive care beds. However, the procedure also carries a risk of stroke. Although early series suggested that endovascular treatment had an acceptable complication rate,5 there remained concern that the risks would be much greater than those in surgery in patients who were fit for an operation.67 One small randomised trial8 of carotid stenting at a single centre in Leicester, UK, was stopped after only 20 patients had been recruited, because of an unacceptable stroke rate at the time of stenting. Unlike carotid endarterectomy, endovascular techniques do not remove the atheromatous plaque, and the long-term efficacy of these techniques in prevention of stroke was unknown. We therefore established the Carotid and Vertebral Artery Transluminal Angioplasty Study, (CAVATAS), a randomised multicentre clinical trial to investigate the risks and benefits of endovascular treatment for carotid and vertebral artery stenosis compared with conventional treatment. Our hypothesis was that endovascular treatment would have the same major complication rates and less minor morbidity than surgery. We report the main results of our analysis of the safety of treatment and rate of major events up to 3 years after randomisation in patients with carotid stenosis suitable for surgery. We also separately randomly assigned patients with carotid artery stenosis or vertebral artery stenosis, who were not suitable for surgery, to endovascular treatment or medical care alone. Only a few patients were randomly assigned in these two groups and the results will be the subject of a future report.

Section snippets

Trial centres

22 centres in Europe, Australia, and Canada collaborated in the random assignment of patients with carotid stenosis (see end of this report). Centres were required to have a designated vascular surgeon or neurosurgeon with expertise in carotid endarterectomy, a designated radiologist (or radiologists) who had received training in neuroradiology and the techniques of angioplasty (but not necessarily in the carotid artery), and a consultant neurologist or physician with an interest in

Results

505 patients were randomly assigned in the group of patients with carotid stenosis fit for surgery. One patient was included in error, after angiography had shown carotid occlusion, not stenosis. This patient was therefore excluded from the analysis, which left 251 patients randomly assigned to endovascular treatment and 253 to surgery (figure 1). 85–1% (10–2) in the surgery groups (figure 2). These values convert to identical stenosis severity measured by the ECST1 method and 77–3% and 75–2%,

Discussion

Our findings showed no difference in the major risks of endovascular treatment (balloon angioplasty or stenting) compared with carotid surgery. The risk of stroke or death within 30 days of treatment was almost identical in both groups. The time to death or disabling stroke or any ipsilateral stroke during follow-up in the primary analysis did not differ between groups after correction for stenosis severity, age, sex, and trial centre. Although CAVATAS included substantial numbers of patients,

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