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

Ricardo A. Hanel, David F. Kallmes, Demetrius Klee Lopes, Peter Kim Nelson, Adnan Siddiqui, Pascal Jabbour, Vitor M. Pereira, Istvan Szikora István, Osama O. Zaidat, Chetan Bettegowda, Geoffrey P. Colby, Maxim Mokin, Clemens Schirmer, Frank R. Hellinger, Curtis Given, Timo Krings, Philipp Taussky, Gabor Toth, Justin F. Fraser, Michael ChenRyan Priest, Peter Kan, David Fiorella, Don Frei, Beverly Aagaard-Kienitz, Orlando Diaz, Adel M. Malek, C. Michael Cawley, Ajit S. Puri

Research output: Contribution to journalArticle

10 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)62-66
Number of pages5
JournalJournal of neurointerventional surgery
Volume12
Issue number1
DOIs
StatePublished - Jan 1 2020

Keywords

  • aneurysm
  • artery
  • brain
  • flow diverter
  • intervention

ASJC Scopus subject areas

  • Surgery
  • Clinical Neurology

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    Hanel, R. A., Kallmes, D. F., Lopes, D. K., Nelson, P. K., Siddiqui, A., Jabbour, P., Pereira, V. M., Szikora István, I., Zaidat, O. O., Bettegowda, C., Colby, G. P., Mokin, M., Schirmer, C., Hellinger, F. R., Given, C., Krings, T., Taussky, P., Toth, G., Fraser, J. F., ... Puri, A. S. (2020). Prospective study on embolization of intracranial aneurysms with the pipeline device: The PREMIER study 1 year results. Journal of neurointerventional surgery, 12(1), 62-66. https://doi.org/10.1136/neurintsurg-2019-015091