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 are at high risk for surgery.”
Also at the late-breaking session, Marc Sapoval (Hôpital Européen Georges Pompidou, Paris, France) presented the six-month results of the first-in-man study of endovascular ultrasound renal denervation for the treatment of resistant hypertension. He explained that the Paradise system (Percutaneous Renal Denervation System, ReCor Medical) induces thermal necrosis (as with radiofrequency ablation) to achieve renal denervation via circumferentially emitted ultrasound energy. He added the characteristics of the ultrasound allowed for a water balloon to be inflated around the transducer and this balloon cooled the arterial wall—minimising damage to non-target tissues.
The RECORD study evaluated the use of the Paradise system in 15 patients with resistant hypertension. Sapoval said that the system was “really very efficient” and explained that it was associated with an immediate, significant, and sustained reduction in both home and office blood pressure. He added: “Circumferential ultrasound heating is potentially a more uniform and effective method for performing renal denervation.”
Among the other studies presented in the late-breaking session, Toshihiro Tanaka (Nara Medical University, Kashihara, Japan) reported that pre-ablated, super-selective bland transcatheter arterial embolization was superior to post-ablation embolization (in an animal study).
Also, Kai Kallenberg (Neuroradiology, Universitatsklinikum Dusseldorf, Germany) presented the results of a study evaluating the Aperio thromboectomy device. He said there was a good clinical outcome >50% of cases and that successful revascularisation was achieved in >80% of cases. He added: “The use of the Aperio device seems to be safe and effective, and easy.”