Purpose To present results of HYBRID study, whether second generation hydrogel coils (HGC) for the treatment of intracranial aneurysms improves outcomes compared with bare platinum coils.
Material and Methods HYBRID study is investigator-initiated, prospective, randomized, multicenter trial with open label treatment, blinded endpoint evaluation in Japan (NCT01516658). Inclusion criteria are 20–80 age, 7–20 mm size, unruptured or ruptured with WFNS grade I-III. For hydrogel coil arm (H group), recommended to use HGC 50% length or more with maximum effort and for bare platinum coil arm (B group) prohibited to use any HGC and surface modificated coil. Primary endpoint is recanalization, evaluated on DSA at 1-year after embolization, and late aneurysm rupture, re-treatment and adverse events are secondary endpoints.
Results 431 cases enrolled in 44 centers in Japan since March 2012 to March 2016, and completed last follow-up on March 2017. Background data, age, gender, aneurysm size, dome/neck ratio, VER were not significant different in both arms, and mean and median length% of used HGC was 68.6 and 69.9 in H Group and 1.2 and 0 in B Group. Primary endpoint in H group (3.3%, 7/214) couldn’t show significant difference (p=0.083) with that in B group (7.1%, 15/211). However, evaluation by same definition with previously published report, showed major recanalization at 1 year after procedure in H group (2.3%, 5/214) was significantly lower (p=0.039) than B group (6.6%, 14/211). And also, adverse event in H group is significantly lower than that in B group and no aneurysm rupture in both groups.
Conclusion Second generation hydrogel coils decreases adverse outcomes including recanalization and unfavorable clinical events in endovascular treatment for intracranial aneurysms.
Disclosures N. Sakai: 1; C; Terumo/Microvntion, Medtronic, Neurovasc, Daiichi-Sankyo. 2; C; Asahi Intec, Biomedical Solutions, Johnson&Johnson/Cerenovus, Medtronic, Neurovasc, Penumbra, Stryker, Terumo. H. Imamura: 2; C; Medtronic. C. Sakai: None. A. Hyodo: None. Y. Ito: None. Y. Matsumaru: None. S. Miyachi: None. S. Yoshimura: None. M. Sasaki: None. K. Ogasawara: None. S. Miyamoto: None. S. Miyamoto: None. M. Ezura: None. I. Nakahara: None. A. Ishii: None. T. Higashi: None.
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