Aims: To investigate long-term outcomes achieved in high-surgical-risk patients and other clinically-relevant subgroups after carotid stenting with the NexStent and Filterwire EX/EZ devices.
Methods and results: CABERNET, a prospective, multicentre, single-arm trial, enrolled 454 patients with extracranial internal carotid artery stenosis (symptomatic > or =50%, n=110; asymptomatic > or =60%, n=344). Early outcomes at one year have been reported. The 3-year Kaplan-Meier estimated event rates were: 7.2%, all stroke; 2.8%, major stroke; 4.8%, ipsilateral stroke; 17.7%, all death; 7.1%, myocardial infarction; 4.4%, target vessel revascularisation. Asymptomatic patients had significantly fewer major strokes than symptomatic patients (1.9% vs. 5.7%, P=0.03) and patients <80 years had significantly fewer ipsilateral strokes than those > or =80 years (3.2% vs. 10.7%, P=0.002). Stroke outcomes did not differ significantly between patients with anatomical risk factors compared with those with comorbid medical risk factors.
Conclusions: Long-term outcomes achieved in high-surgical-risk patients with the NexStent and Filterwire EX/EZ devices are favourable. Outcomes may be better in asymptomatic patients or those younger than 80 years of age. These data will be helpful in estimating short-term risks of carotid stenting and balancing these risks against the long-term benefit of stroke prevention.
Trial registration: ClinicalTrials.gov NCT00600327.