Journal of neurointerventional surgery · 2019
Prospective study on embolization of intracranial aneurysms with the pipeline device: the PREMIER study 1 year results.
Клиническое исследованиеСтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Hanel Ricardo A, Kallmes David F, Lopes Demetrius Klee, Nelson Peter Kim, Siddiqui Adnan, Jabbour Pascal, Pereira Vitor M, Szikora István Istvan, Zaidat Osama O, Bettegowda Chetan, Colby Geoffrey P, Mokin Maxim, Schirmer Clemens, Hellinger Frank R, Given Ii Curtis, Krings Timo, Taussky Philipp, Toth Gabor, Fraser Justin F, Chen Michael, Priest Ryan, Kan Peter, Fiorella David, Frei Don, Aagaard-Kienitz Beverly, Diaz Orlando, Malek Adel M, Cawley C Michael, Puri Ajit S
Аннотация
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.
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.