TY - JOUR
T1 - Hydrogel coils in intracranial aneurysm treatment
T2 - a multicenter, prospective, randomized open-label trial
AU - Imamura, Hirotoshi
AU - Sakai, Nobuyuki
AU - Sakai, Chiaki
AU - Hyodo, Akio
AU - Ito, Yasushi
AU - Matsumaru, Yuji
AU - Miyachi, Shigeru
AU - Yoshimura, Shinichi
AU - Sasaki, Makoto
AU - Hirai, Toshinori
AU - Kinouchi, Hiroyuki
AU - Miyamoto, Susumu
AU - Okada, Yasushi
AU - Komiyama, Masaki
AU - Ogasawara, Kuniaki
AU - Toyoda, Kazunori
AU - Daimon, Takashi
AU - Ezura, Masayuki
AU - Nakahara, Ichiro
AU - Ishii, Akira
AU - Matsumoto, Yasushi
AU - Tanabe, Kenichiro
PY - 2025/6/1
Y1 - 2025/6/1
N2 - OBJECTIVE: Studies have demonstrated the effectiveness of hydrogel-coated coils (HGCs) to achieve the composite endpoint of decreased recanalization rates and greater safety. Herein, the authors aimed to assess the true ability of second-generation HGCs to prevent recanalization. METHODS: This randomized controlled study, the HYBRID (Hydrocoil Versus Bare Platinum Coil in Recanalization Imaging Data) trial, comparing HGCs with bare platinum coils (BPCs), was conducted in 43 Japanese institutions. The aneurysm diameter range was 7-20 mm. HGCs were used in 4 patients in the BPC arm, and at least one HGC was used in each patient in the HGC arm, excluding 3 patients. Additionally, an HGC length ≥ 50% of the length of all the coils used was strongly recommended. The primary endpoint was recanalization 1 year after embolization, according to core laboratory evaluation. Angiographic change was also classified as further thrombosis, unchanged, or recanalization. Changes in cases with both initial and 1-year posttreatment angiographic images were compared. In the post hoc analysis, major recanalization was defined as any change, from complete occlusion or a neck remnant at the end of the procedure to body filling (BF) on the 1-year posttreatment angiogram or any increase in the size of BF in patients with BF at the end of the procedure, and its rate was compared between the two treatment arms. RESULTS: Recruitment ended when 432 patients were randomized; 217 and 215 patients were allocated to the HGC and BPC arms, respectively. The recanalization rates in the HGC and BPC arms were 3.3% and 7.1%, respectively (risk difference -3.8%, 95% CI -8.6 to 0.5), with no statistically significant difference (p = 0.083). Regarding aneurysm occlusion within 1 year, there was significantly more thrombosis and less recanalization in the HGC group (p = 0.043). The major recanalization rates were 2.3% and 6.6% in the HGC and BPC arms, respectively, with a significant difference between the two (p = 0.036). CONCLUSIONS: The study results did not confirm the effectiveness of second-generation HGCs using recanalization imaging data. However, these coils may induce more thrombosis and less recanalization for medium-sized cerebral aneurysms. Clinical trial registration no.: UMIN000006748 (www.umin.ac.jp/ctr/).
AB - OBJECTIVE: Studies have demonstrated the effectiveness of hydrogel-coated coils (HGCs) to achieve the composite endpoint of decreased recanalization rates and greater safety. Herein, the authors aimed to assess the true ability of second-generation HGCs to prevent recanalization. METHODS: This randomized controlled study, the HYBRID (Hydrocoil Versus Bare Platinum Coil in Recanalization Imaging Data) trial, comparing HGCs with bare platinum coils (BPCs), was conducted in 43 Japanese institutions. The aneurysm diameter range was 7-20 mm. HGCs were used in 4 patients in the BPC arm, and at least one HGC was used in each patient in the HGC arm, excluding 3 patients. Additionally, an HGC length ≥ 50% of the length of all the coils used was strongly recommended. The primary endpoint was recanalization 1 year after embolization, according to core laboratory evaluation. Angiographic change was also classified as further thrombosis, unchanged, or recanalization. Changes in cases with both initial and 1-year posttreatment angiographic images were compared. In the post hoc analysis, major recanalization was defined as any change, from complete occlusion or a neck remnant at the end of the procedure to body filling (BF) on the 1-year posttreatment angiogram or any increase in the size of BF in patients with BF at the end of the procedure, and its rate was compared between the two treatment arms. RESULTS: Recruitment ended when 432 patients were randomized; 217 and 215 patients were allocated to the HGC and BPC arms, respectively. The recanalization rates in the HGC and BPC arms were 3.3% and 7.1%, respectively (risk difference -3.8%, 95% CI -8.6 to 0.5), with no statistically significant difference (p = 0.083). Regarding aneurysm occlusion within 1 year, there was significantly more thrombosis and less recanalization in the HGC group (p = 0.043). The major recanalization rates were 2.3% and 6.6% in the HGC and BPC arms, respectively, with a significant difference between the two (p = 0.036). CONCLUSIONS: The study results did not confirm the effectiveness of second-generation HGCs using recanalization imaging data. However, these coils may induce more thrombosis and less recanalization for medium-sized cerebral aneurysms. Clinical trial registration no.: UMIN000006748 (www.umin.ac.jp/ctr/).
KW - aneurysms
KW - endovascular neurosurgery
KW - hydrogel coil
KW - randomized controlled trial
KW - vascular disorders
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UR - http://www.scopus.com/inward/citedby.url?scp=105008304173&partnerID=8YFLogxK
U2 - 10.3171/2024.8.JNS232369
DO - 10.3171/2024.8.JNS232369
M3 - Article
C2 - 39823584
AN - SCOPUS:105008304173
SN - 0022-3085
VL - 142
SP - 1803
EP - 1809
JO - Journal of neurosurgery
JF - Journal of neurosurgery
IS - 6
ER -