Title

Prospective study on embolization of intracranial aneurysms with the pipeline device: the PREMIER study 1 year results

UMMS Affiliation

New England Center for Stroke Research, Department of Radiology

Publication Date

2019-07-15

Document Type

Article

Disciplines

Analytical, Diagnostic and Therapeutic Techniques and Equipment | Cardiovascular Diseases | Cardiovascular System | Health Services Administration | Neurology | Radiology

Abstract

BACKGROUND: Preliminary clinical studies on the safety and efficacy of the pipeline embolization device (PED) for the treatment of small/medium aneurysms have demonstrated high occlusion rates with low complications.

OBJECTIVE: To evaluate the safety and effectiveness of the PED for treatment of wide necked small and medium intracranial aneurysms.

METHODS: PREMIER is a prospective, multicenter, single arm trial. Patients were treated with the PED for unruptured wide necked aneurysms, measuring < /=12 mm along the internal carotid artery or vertebral artery, between July 2014 and November 2015. At 1 year post-procedure, the primary effectiveness endpoint was complete occlusion (Raymond grade 1) without major parent vessel stenosis ( < /=50%) or retreatment, and the primary safety endpoint was major stroke in the territory supplied by the treated artery or neurologic death.

RESULTS: A total of 141 patients were treated with PEDs (mean age 54.6+/-11.3 years, 87.9% (124/141) women). Mean aneurysm size was 5.0+/-1.92 mm, and 84.4% (119/141) measured < 7 mm. PED placement was successful in 99.3% (140/141) of patients. Mean number of PEDs implanted per patient was 1.1+/-0.26; a single PED was used in 92.9% (131/141) of patients. At 1 year, 97.9% (138/141) of patients underwent follow-up angiography with 76.8% (106/138) of patients having met the study's primary effectiveness endpoint. The combined major morbidity and mortality rate was 2.1% (3/140).

CONCLUSIONS: Treatment of wide necked small/medium aneurysms with the PED results in high rates of complete occlusion without significant parent vessel stenosis and low rates of permanent neurologic complications.

TRIAL REGISTRATION: NCT02186561.

Keywords

aneurysm, artery, brain, flow diverter, intervention

DOI of Published Version

10.1136/neurintsurg-2019-015091

Source

J Neurointerv Surg. 2019 Jul 15. pii: neurintsurg-2019-015091. doi: 10.1136/neurintsurg-2019-015091. [Epub ahead of print] Link to article on publisher's site

Journal/Book/Conference Title

Journal of neurointerventional surgery

Comments

Full author list omitted for brevity. For the full list of authors, see article.

Related Resources

Link to Article in PubMed

PubMed ID

31308197

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