In a late-breaking abstract session at CIRSE 2012, Marc Bosiers (AZ St-Blasius, Dendermonde, Belgium) presented the results of the ASTI trial, which showed the Adapt carotid stent (Boston Scientific)—with the FilterWire EZ distal protection catheter—to be a safe and effective treatment for patients with carotid artery stenosis who are at high-risk of carotid endarterectomy.
Bosier said: “It was a prospective, single-arm trial, looking at 30-day and 12-month follow-up—clinically, neurologically, and on duplex ultrasound. The primary endpoint was the composite of adjusted death, stroke, and myocardial infarction at ≤30 days.” He added that patients in the study, who had carotid artery stenosis, were all at high-risk of complications from carotid endarterectomy and said: “The majority of patients were included not because of anatomical risks but because of comorbidity risk [eg, age ≥80 years, myocardial infarction in past 30 days, or left ejection fraction ≤30%].” All patients received the Adapt stent, which was used in conjunction with the Filterwire EZ.
Of the 100 patients enrolled in the study (32 were symptomatic and 63 were asymptomatic), 30-day follow-up data was available for 92% of them. Bosiers said that the rate of the primary endpoint was 5.1% at 30 days and was 12.2% at one year. He commented that all of the events at 30 days were strokes (ie, no deaths or myocardial infarctions) and the majority of events at one year were also strokes, adding: “It is important to remember the background of these patients when you see these results. These patients were very sick patients.”
Bosiers reported that the conclusion of the study was that “The Adapt carotid stent, when used in conjunction with the FilterWire EZ is a safe and effective treatment option for patients with carotid artery stenosis who at high risk for surgery.”