Effects of Extracranial-Intracranial Bypass for Patients With Hemorrhagic Moyamoya Disease Results of the Japan Adult Moyamoya Trial
Effects of Extracranial-Intracranial Bypass for Patients With Hemorrhagic Moyamoya Disease Results of the Japan Adult Moyamoya Trial
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DOI：
10.1161/strokeaha.113.004386
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发表时间：
2014-05-01
期刊：
影响因子：
8.3
通讯作者：
Takahashi, Jun C.
中科院分区：
文献类型：
--
作者：
Miyamoto, Susumu;Yoshimoto, Takashi;Takahashi, Jun C.
背景和目的成人型烟雾病患者中约有一半发生颅内出血。尽管再出血发作的频率极高且预后不良，但尚未建立预防再出血的措施。本研究的目的是确定颅外-颅内分流术是否可以减少再出血的发生率，改善患者预后。在前一年内发生颅内出血的成人烟雾病患者接受保守治疗或双侧颅外-颅内直接搭桥术，并观察5年。主要和次要终点被定义为所有不良事件和再出血attacks.Results 80例患者（手术，42;非手术，38）。在手术组6例患者（14.3%）和非手术组13例患者（34.2%）中观察到导致显著发病率的不良事件。Kaplan-Meier生存分析显示两组之间存在显著差异（3.2%/年vs 8.2%/年; P=0.048）。考克斯回归分析计算的手术组风险比为0.391（95%置信区间，0.148-1.029）。手术组5例患者（11.9%）和非手术组12例患者（31.6%）观察到再出血发作，Kaplan-Meier生存分析中存在显著差异（2.7%/年vs 7.6%/年; P=0.042）。手术组的危险比为0.355（95%可信区间，0.125-1.009）。结论Kaplan-Meier分析显示手术组与非手术组的再出血发生率有显著性差异，提示直接转流术对再出血的预防作用。http://www.umin.ac.jp/ctr/index.htm唯一标识符：C 000000166。
Background and Purpose About one half of those who develop adult-onset moyamoya disease experience intracranial hemorrhage. Despite the extremely high frequency of rebleeding attacks and poor prognosis, measures to prevent rebleeding have not been established. The purpose of this study is to determine whether extracranial-intracranial bypass can reduce incidence of rebleeding and improve patient prognosis.Methods This study was a multicentered, prospective, randomized, controlled trial conducted by 22 institutes in Japan. Adult patients with moyamoya disease who had experienced intracranial hemorrhage within the preceding year were given either conservative care or bilateral extracranial-intracranial direct bypass and were observed for 5 years. Primary and secondary end points were defined as all adverse events and rebleeding attacks, respectively.Results Eighty patients were enrolled (surgical, 42; nonsurgical, 38). Adverse events causing significant morbidity were observed in 6 patients in the surgical group (14.3%) and 13 patients in the nonsurgical group (34.2%). Kaplan-Meier survival analysis revealed significant differences between the 2 groups (3.2%/y versus 8.2%/y; P=0.048). The hazard ratio of the surgical group calculated by Cox regression analysis was 0.391 (95% confidence interval, 0.148-1.029). Rebleeding attacks were observed in 5 patients in the surgical group (11.9%) and 12 in the nonsurgical group (31.6%), significantly different in the Kaplan-Meier survival analysis (2.7%/y versus 7.6%/y; P=0.042). The hazard ratio of the surgical group was 0.355 (95% confidence interval, 0.125-1.009).Conclusions Although statistically marginal, Kaplan-Meier analysis revealed the significant difference between surgical and nonsurgical group, suggesting the preventive effect of direct bypass against rebleeding.Clinical Trial Registration URL: http://www.umin.ac.jp/ctr/index.htm. Unique identifier: C000000166.