RT Journal Article
SR Electronic
T1 Prospective study on embolization of intracranial aneurysms with the pipeline device: the PREMIER study 1 year results
JF Journal of NeuroInterventional Surgery
JO J NeuroIntervent Surg
FD BMJ Publishing Group Ltd.
SP 62
OP 66
DO 10.1136/neurintsurg-2019-015091
VO 12
IS 1
A1 Ricardo A Hanel
A1 David F Kallmes
A1 Demetrius Klee Lopes
A1 Peter Kim Nelson
A1 Adnan Siddiqui
A1 Pascal Jabbour
A1 Vitor M Pereira
A1 Istvan Szikora István
A1 Osama O Zaidat
A1 Chetan Bettegowda
A1 Geoffrey P Colby
A1 Maxim Mokin
A1 Clemens Schirmer
A1 Frank R Hellinger
A1 Curtis Given II
A1 Timo Krings
A1 Philipp Taussky
A1 Gabor Toth
A1 Justin F Fraser
A1 Michael Chen
A1 Ryan Priest
A1 Peter Kan
A1 David Fiorella
A1 Don Frei
A1 Beverly Aagaard-Kienitz
A1 Orlando Diaz
A1 Adel M Malek
A1 C Michael Cawley
A1 Ajit S Puri
YR 2020
UL http://jnis.bmj.com/content/12/1/62.abstract
AB 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.