One-Year ASTI Data Support Boston Scientific's Adapt Carotid Stent With FilterWire EZ Distal Protection in High-Surgical-Risk Patients

April 8, 2015—Marc Bosiers, MD, et al published results of the European ASTI trial in CardioVascular and Interventional Radiology (2015;38:295–303). ASTI is a prospective, multicenter, nonrandomized study evaluating the periprocedural and 1-year outcomes in high-surgical-risk patients with carotid artery stenosis treated with the Adapt carotid stent plus FilterWire EZ distal protection catheter (Boston Scientific Corporation).

The ASTI investigators concluded that the 1-year results showed that carotid artery stenting with the Adapt and FilterWire EZ devices is safe and effective in high-risk-surgical patients. 

As summarized in CardioVascular and Interventional Radiology, the ASTI study enrolled 100 patients (32 symptomatic, 63 asymptomatic, 5 unknown) at high risk for carotid endarterectomy due to prespecified anatomical criteria and/or medical comorbidities. Thirty-day and 1-year follow-up included clinical evaluation, carotid duplex ultrasound, and independent neurologic and NIH stroke scale assessments.

The follow-up included clinical evaluation, carotid duplex ultrasound, and independent neurologic and NIH stroke scale assessments. One-year endpoints included the composite rate of major adverse events (MAE), defined as death, stroke, and myocardial infarction (MI), and the rates of late ipsilateral stroke (31–365 days), target lesion revascularization, and in-stent restenosis. Of the 100 enrolled patients, the technical success rate was 90.9% (90/99). 

The 30-day MAE rate of 5.1% consisted of major stroke (2%) and minor stroke (3.1%). There were no deaths or MIs reported. The 1-year MAE rate of 12.2% consisted of death (4.4%), MI (3.3%), and stroke (8.9%), and the late ipsilateral stroke rate was 1.1%. Compared with asymptomatic patients, symptomatic patients had higher rates of death (11.1% vs 1.7%) and MI (7.4% vs 1.7%), but lower rates of major (7.4% vs 10%) and minor stroke (0% vs 6.7%), reported the ASTI investigators in CardioVascular and Interventional Radiology.