Jun C Takahashi1, Takeshi Funaki1, Kiyohiro Houkin1, Tooru Inoue1, Kuniaki Ogasawara1, Jyoji Nakagawara1, Satoshi Kuroda1, Keisuke Yamada1, Susumu Miyamoto2. 1. From the Department of Neurosurgery (J.C.T.) and Integrative Stroke Imaging Center (J.N.), National Cerebral and Cardiovascular Center, Suita, Japan; Department of Neurosurgery, Kyoto University Graduate School of Medicine, Kyoto, Japan (T.F., K.Y., S.M.); Department of Neurosurgery, Hokkaido University Graduate School of Medicine, Sapporo, Japan (K.H.); Department of Neurosurgery, Faculty of Medicine, Fukuoka University, Fukuoka, Japan (T.I.); Department of Neurosurgery, Iwate Medical University, Morioka, Japan (K.O.); and Department of Neurosurgery, Graduate School of Medicine and Pharmaceutical Sciences, University of Toyama, Toyama, Japan (S.K.). 2. From the Department of Neurosurgery (J.C.T.) and Integrative Stroke Imaging Center (J.N.), National Cerebral and Cardiovascular Center, Suita, Japan; Department of Neurosurgery, Kyoto University Graduate School of Medicine, Kyoto, Japan (T.F., K.Y., S.M.); Department of Neurosurgery, Hokkaido University Graduate School of Medicine, Sapporo, Japan (K.H.); Department of Neurosurgery, Faculty of Medicine, Fukuoka University, Fukuoka, Japan (T.I.); Department of Neurosurgery, Iwate Medical University, Morioka, Japan (K.O.); and Department of Neurosurgery, Graduate School of Medicine and Pharmaceutical Sciences, University of Toyama, Toyama, Japan (S.K.). miy@kuhp.kyoto-u.ac.jp.
Abstract
BACKGROUND AND PURPOSE: The primary results of the Japan Adult Moyamoya Trial revealed the statistically marginal superiority of bypass surgery over medical treatment alone in preventing rebleeding in moyamoya disease. The purpose of this analysis is to test the prespecified subgroup hypothesis that the natural course and surgical effects vary depending on the hemorrhagic site at onset. METHODS: The hemorrhagic site, classified as either anterior or posterior, was the only stratifying variable for randomization. Statistical analyses were focused on the assessment of effect modification according to the hemorrhagic site and were based on tests of interaction. RESULTS: Of 42 surgically treated patients, 24 were classified as anterior hemorrhage and 18 as posterior hemorrhage; of 38 medically treated patients, 21 were classified as anterior and 17 as posterior. The hazard ratio of the primary end points (all adverse events) for the surgical group relative to the nonsurgical group was 0.07 (95% confidence interval, 0.01-0.55) for the posterior group, as compared with 1.62 (95% confidence interval, 0.39-6.79) for the anterior group (P=0.013 for interaction). Analysis within the nonsurgical group revealed that the incidence of the primary end point was significantly higher in the posterior group than in the anterior group (17.1% per year versus 3.0% per year; hazard ratio, 5.83; 95% confidence interval, 1.60-21.27). CONCLUSIONS: Careful interpretation of the results suggests that patients with posterior hemorrhage are at higher risk of rebleeding and accrue greater benefit from surgery, subject to verification in further studies. CLINICAL TRIAL REGISTRATION: URL: http://www.umin.ac.jp/ctr/index.htm. Unique identifier: C000000166.
RCT Entities:
BACKGROUND AND PURPOSE: The primary results of the Japan Adult Moyamoya Trial revealed the statistically marginal superiority of bypass surgery over medical treatment alone in preventing rebleeding in moyamoya disease. The purpose of this analysis is to test the prespecified subgroup hypothesis that the natural course and surgical effects vary depending on the hemorrhagic site at onset. METHODS: The hemorrhagic site, classified as either anterior or posterior, was the only stratifying variable for randomization. Statistical analyses were focused on the assessment of effect modification according to the hemorrhagic site and were based on tests of interaction. RESULTS: Of 42 surgically treated patients, 24 were classified as anterior hemorrhage and 18 as posterior hemorrhage; of 38 medically treated patients, 21 were classified as anterior and 17 as posterior. The hazard ratio of the primary end points (all adverse events) for the surgical group relative to the nonsurgical group was 0.07 (95% confidence interval, 0.01-0.55) for the posterior group, as compared with 1.62 (95% confidence interval, 0.39-6.79) for the anterior group (P=0.013 for interaction). Analysis within the nonsurgical group revealed that the incidence of the primary end point was significantly higher in the posterior group than in the anterior group (17.1% per year versus 3.0% per year; hazard ratio, 5.83; 95% confidence interval, 1.60-21.27). CONCLUSIONS: Careful interpretation of the results suggests that patients with posterior hemorrhage are at higher risk of rebleeding and accrue greater benefit from surgery, subject to verification in further studies. CLINICAL TRIAL REGISTRATION: URL: http://www.umin.ac.jp/ctr/index.htm. Unique identifier: C000000166.
Authors: Qing-Shun Zhao; Gang Wang; Hao-Jiang Xiao; Wen-Feng Feng; Guo-Zhong Zhang; Ming-Zhou Li; Yong-Hong Liao; Yun-Yu Wen; Song-Tao Qi Journal: Nan Fang Yi Ke Da Xue Xue Bao Date: 2018-04-20
Authors: T Funaki; A Miyakoshi; H Kataoka; J C Takahashi; Y Takagi; K Yoshida; T Kikuchi; Y Mineharu; M Okawa; Y Yamao; Y Fushimi; S Miyamoto Journal: AJNR Am J Neuroradiol Date: 2022-08-25 Impact factor: 4.966