Significance of the Hemorrhagic Site for Recurrent Bleeding Prespecified Analysis in the Japan Adult Moyamoya Trial
Significance of the Hemorrhagic Site for Recurrent Bleeding Prespecified Analysis in the Japan Adult Moyamoya Trial
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DOI：
10.1161/strokeaha.115.010819
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发表时间：
2016-01-01
期刊：
影响因子：
8.3
通讯作者：
Miyamoto, Susumu
中科院分区：
文献类型：
--
作者：
Takahashi, Jun C.;Funaki, Takeshi;Miyamoto, Susumu
背景和目的日本成人烟雾病试验的初步结果显示，在预防烟雾病再出血方面，搭桥手术相对于单纯药物治疗在统计学上具有边缘优势。本分析的目的是测试预先指定的亚组假设，自然病程和手术效果不同，取决于出血部位onset.Methods，出血部位，分为前部或后部，是唯一的分层变量随机化。统计分析的重点是根据出血部位的效果修改的评估，并根据测试的interaction.Results 42例手术治疗的患者，24被归类为前出血和18后出血; 38例药物治疗的患者，21被归类为前和17后。后路组手术组相对于非手术组的主要终点（所有不良事件）的风险比为0.07（95%置信区间，0.01-0.55），而前路组为1.62（95%置信区间，0.39-6.79）（相互作用P=0.013）。非手术组的分析显示，后路组的主要终点发生率显著高于前路组（每年17.1%对每年3.0%;风险比，5.83; 95%置信区间，（1.60-21.27）结论：对结果的仔细解释表明，后路出血患者再出血的风险较高，手术，有待进一步研究验证。
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.