Abstract :
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.
