By Matthew E. Fink, MD, Editor
Feil Professor and Chairman, Department of Neurology, and Assistant Dean of Clinical Affairs, Weill Cornell Medical College; Neurologist-in-Chief, New York Presbyterian Hospital
Dr. Fink reports he is a consultant for Procter & Gamble.
Flow Diversion for Intracranial Aneurysms
Ricardo Hanel, from Jacksonville, FL, presented the results of PREMIER, a prospective, multicenter study of flow diversion using the Pipeline stent for treatment of small and medium-sized intracranial aneurysms. The Pipeline stent has been validated for the treatment of patients who have large wide-neck intracranial aneurysms and has become a standard treatment for such patients. PREMIER was designed to evaluate the safety and effectiveness of the Pipeline device for treatment of unruptured, small and medium-sized, wide-neck intracranial aneurysms. It was a prospective, single-arm, multicenter trial in patients with unruptured wide-neck intracranial aneurysms measuring ≤ 12 mm and located in the internal carotid artery up to its terminus, or the vertebral artery segment up to and including the PICA. The primary outcome was complete aneurysm occlusion and absence of significant stenosis of the parent artery at one year follow-up. The primary safety endpoint was occurrence of major stroke in the territory supplied by the treated artery, or death, up to one year following treatment. A total of 141 patients, mean age of 54.6 years, were enrolled at 22 centers. Mean aneurysm diameter was 5.0 mm, and 84% were smaller than 7 mm. Technical success was achieved in 99.3% of patients. At 30 days after intervention, major stroke or death occurred in 1.4% of patients, and from 30 days to one year following intervention, 0.7% of patients had stroke or death. At the end of one year, 83.5% of patients showed complete occlusion of the aneurysm without significant parent artery stenosis. The combined major stroke or death rate at one year was 2.1%. In conclusion, the primary safety and efficacy endpoints of the study were met at one year using the Pipeline device for occlusion of small and medium-sized aneurysms in the internal carotid or vertebral artery distribution.
These articles are based on the editor's personal interactions as a participant at the International Stroke Conference in Houston, Feb. 22-24, 2017. All interpretations and opinions are exclusively those of the editor.
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