RESUMO
OBJECTIVE: We performed prospective randomized comparison of clinical and surgical outcomes of flow diversion versus PVO and bypass in patients with complex anterior circulation aneurysms. PATIENTS AND METHODS: Open, prospective, randomized, parallel group, multicenter study of complex intracranial aneurysms treatment was conducted. Patients with complex intracranial aneurysms of anterior circulation with neck is more than 4â¯mm wide, dome/neck ratio is equal or less than 2:1, which is suitable for flow diversion and occlusion with bypass were included in the study. A total of 111 potential participants were enrolled since March 2015. Additional propensity score matching was performed with 40 patients in each group selected for analysis. RESULTS: 39 out of 40 patients (97.5%) from matched FD group reached good clinical outcome. In the matched bypass group acceptable outcome was achieved in 32 (80%) out of 40 patients (difference between groups pâ¯=â¯0.029). The morbidity and mortality rates were 15% and 5%, respectively. Difference in the rates of favorable outcomes, compared by χ2 met statistical significance (pâ¯=â¯0.014). The rate of complete aneurysm occlusion at 6 months was 42.5% in the FD group and 95% in surgical group (pâ¯<â¯0.0001). The rate of complete occlusion at 12 months was 65% in the FD group and 97.5% in surgical group. The difference between groups was still significant (pâ¯=â¯0.001). There were no significant differences between groups by occurrence of ischemic (pâ¯=â¯0.108) and hemorrhagic (pâ¯=â¯0.615) complications. CONCLUSION: The study demonstrated superior clinical outcomes for endovascular flow diversion in comparison with bypass surgery in treatment of complex aneurysms. Though, both techniques grant similar percentage of major neurologic complications and comparable cure rate for cranial neuropathy. Nevertheless, flow diversion is associated with significantly lower early obliteration rate, thus possesses patient for risks of prolonged dual antiplatelet regimen and delayed rupture. Hence, it's important to stratify patient by the natural risk of aneurysm rupture prior to treatment selection.
Assuntos
Aneurisma Roto/cirurgia , Artérias/cirurgia , Aneurisma Intracraniano/cirurgia , Fatores de Tempo , Embolização Terapêutica/métodos , Procedimentos Endovasculares/métodos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Pontuação de Propensão , Estudos Prospectivos , Stents , Resultado do TratamentoRESUMO
Utilization of flow diverting devices is accompanied with dual antiplatelet therapy to reduce the risk of thromboembolic events, even though this increases the risk of hemorrhagic complications. The updated Pipeline Flex embolization device with Shield Technology has been created using a phosphorylcholine coating that reduces thrombogenicity and possibly reduces the need for dual antiplatelet therapy. However, because of the potential risk to patients of utilizing a pipeline embolization device without dual antiplatelet therapy, the pipeline embolization device with Shield Technology has not been tested in human subjects without dual antiplatelet therapy, and its contribution to preventing thromboembolic events is therefore unknown. We report a case in which a patient, following complications that limited his absorption of dual antiplatelet therapy, had low levels of dual antiplatelet therapy medications in his bloodstream following treatment for an intracranial aneurysm with a pipeline embolization device with Shield Technology. The patient recovered without signs of luminal stenosis or thromboembolic event.