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 Chen; Ryan Priest; Peter Kan; David Fiorella; Don Frei; Beverly Aagaard-Kienitz; Orlando M. Diaz; Adel M. Malek; C. Michael Cawley; Ajit S. Puri

doi:10.1136/neurintsurg-2019-015091

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 M. Diaz, Adel M. Malek, C. Michael Cawley, Ajit S. Puri

Research output: Contribution to journal › Article › peer-review

238 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 language	English (US)
Pages (from-to)	62-66
Number of pages	5
Journal	Journal of neurointerventional surgery
Volume	12
Issue number	1
DOIs	https://doi.org/10.1136/neurintsurg-2019-015091
State	Published - Jan 1 2020

Keywords

aneurysm
artery
brain
flow diverter
intervention
Prospective Studies
Follow-Up Studies
Humans
Middle Aged
Embolization, Therapeutic/instrumentation
Retreatment/trends
Male
Treatment Outcome
Intracranial Aneurysm/diagnostic imaging
Blood Vessel Prosthesis/trends
Adult
Female
Aged
Self Expandable Metallic Stents/trends

ASJC Scopus subject areas

Clinical Neurology
Surgery

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10.1136/neurintsurg-2019-015091

Cite this

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

Hanel, RA, Kallmes, DF, Lopes, DK, Nelson, PK, Siddiqui, A, Jabbour, P, Pereira, VM, Szikora István, I, Zaidat, OO, Bettegowda, C, Colby, GP, Mokin, M, Schirmer, C, Hellinger, FR, Given, C, Krings, T, Taussky, P, Toth, G, Fraser, JF, Chen, M, Priest, R, Kan, P, Fiorella, D, Frei, D, Aagaard-Kienitz, B, Diaz, OM, Malek, AM, Cawley, CM & Puri, AS 2020, 'Prospective study on embolization of intracranial aneurysms with the pipeline device: The PREMIER study 1 year results', Journal of neurointerventional surgery, vol. 12, no. 1, pp. 62-66. https://doi.org/10.1136/neurintsurg-2019-015091

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

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.",

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

note = "Publisher Copyright: {\textcopyright} Author(s) (or their employer(s)) 2020.",

year = "2020",

month = jan,

day = "1",

doi = "10.1136/neurintsurg-2019-015091",

language = "English (US)",

volume = "12",

pages = "62--66",

journal = "Journal of neurointerventional surgery",

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TY - JOUR

T1 - Prospective study on embolization of intracranial aneurysms with the pipeline device

T2 - The PREMIER study 1 year results

AU - Hanel, Ricardo A.

AU - Kallmes, David F.

AU - Lopes, Demetrius Klee

AU - Nelson, Peter Kim

AU - Siddiqui, Adnan

AU - Jabbour, Pascal

AU - Pereira, Vitor M.

AU - Szikora István, Istvan

AU - Zaidat, Osama O.

AU - Bettegowda, Chetan

AU - Colby, Geoffrey P.

AU - Mokin, Maxim

AU - Schirmer, Clemens

AU - Hellinger, Frank R.

AU - Given, Curtis

AU - Krings, Timo

AU - Taussky, Philipp

AU - Toth, Gabor

AU - Fraser, Justin F.

AU - Chen, Michael

AU - Priest, Ryan

AU - Kan, Peter

AU - Fiorella, David

AU - Frei, Don

AU - Aagaard-Kienitz, Beverly

AU - Diaz, Orlando M.

AU - Malek, Adel M.

AU - Cawley, C. Michael

AU - Puri, Ajit S.

N1 - Publisher Copyright: © Author(s) (or their employer(s)) 2020.

PY - 2020/1/1

Y1 - 2020/1/1

N2 - 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.

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.

KW - aneurysm

KW - artery

KW - brain

KW - flow diverter

KW - intervention

KW - Prospective Studies

KW - Follow-Up Studies

KW - Humans

KW - Middle Aged

KW - Embolization, Therapeutic/instrumentation

KW - Retreatment/trends

KW - Male

KW - Treatment Outcome

KW - Intracranial Aneurysm/diagnostic imaging

KW - Blood Vessel Prosthesis/trends

KW - Adult

KW - Female

KW - Aged

KW - Self Expandable Metallic Stents/trends

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U2 - 10.1136/neurintsurg-2019-015091

DO - 10.1136/neurintsurg-2019-015091

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SN - 1759-8478

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JO - Journal of neurointerventional surgery

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

Abstract

Keywords

ASJC Scopus subject areas

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