Improved Prediction of Poor Outcome After Thrombolysis Using Conservative Definitions of Symptomatic Hemorrhage
Improved Prediction of Poor Outcome After Thrombolysis Using Conservative Definitions of Symptomatic Hemorrhage
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DOI：
10.1161/strokeaha.111.623033
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发表时间：
2012-01-01
期刊：
影响因子：
8.3
通讯作者：
Ringleb, Peter
中科院分区：
文献类型：
--
作者：
Gumbinger, Christoph;Gruschka, Philipp;Ringleb, Peter
背景和目的——不同溶栓研究中症状性脑出血 (sICH) 发生率的直接比较因 sICH 定义的可变性而变得复杂。结果的预测仍不清楚。方法——在前瞻性数据库中收集接受溶栓治疗的患者的基线数据和临床病程。使用改良Rankin量表评估3个月的结果。24小时随访成像结果由至少2名独立评估者重新评估。应用了 sICH 的四种常见定义（国家神经疾病和中风研究所 [NINDS]、欧洲急性中风合作研究 [ECASS] 2、中风溶栓的安全实施 [SITS]、ECASS 3）。计算了 Kappa Interter 统计数据。我们的目标是找到对 90 天后死亡率、不良（改良 Rankin 量表 5 或 6）和不利（改良 Rankin 量表 >= 3）临床结果具有最高预测价值的 sICH 定义。结果-分析了 314 名患者的数据。 NINDS 定义显示 sICH 发生率最高（7.7%）； sICH 的 ECASS 3 定义 (3.2%) 的比率最低。 ECASS 2 定义的参与者间一致性最高（kappa 0.85），NINDS 定义的一致性最低（kappa 0.57）。根据 SITS 定义，sICH 患者的死亡风险最高 (OR, 14.4) 和预后不良 (OR, 26.6)。结论 - 不同的定义均不包含死亡率和结果预测的最佳组合以及较高的受试者间一致性率。对于死亡率的临床评估，我们建议使用 SITS 定义；对于需要高参与者间一致率的研究，我们建议使用 ECASS 2 定义。由于缺乏单一的最佳定义，未来的溶栓试验应优先使用不同的定义。 （中风。2012；43：240-242。）
Background and Purpose-Direct comparison of symptomatic intracerebral hemorrhage (sICH) rates among different thrombolysis studies is complicated by the variability of definitions of sICH. The prediction of outcome still remains unclear.Methods-Baseline data and clinical courses of patients treated with thrombolytic therapy were collected in a prospective database. The 3-month outcome was evaluated using the modified Rankin Scale.Results of 24-hour follow-up imaging were reevaluated by at least 2 independent raters. Four common definitions of sICH (National Institute of Neurological Disorders and Stroke [NINDS], European Cooperative Acute Stroke Study [ECASS] 2, Safe Implementation of Thrombolysis in Stroke [SITS], ECASS 3) were applied. Kappa interrater statistics were calculated. Our objective was to find the sICH definition with the highest predictive value for mortality, poor (modified Rankin Scale 5 or 6) and unfavorable (modified Rankin Scale >= 3) clinical outcome after 90 days. Results-The data of 314 patients were analyzed. The NINDS definition revealed the highest sICH rate (7.7%); the lowest rate was found for the ECASS 3 definition (3.2%) of sICH. The highest interrater agreement was found for the ECASS 2 definition (kappa 0.85) and the lowest for the NINDS definition (kappa 0.57). Patients with sICH according to the SITS definition had the highest risk for death (OR, 14.4) and poor outcome (OR, 26.6).Conclusions-None of the different definitions contains an optimal combination of prediction of mortality and outcome and a high interrater agreement rate. For the clinical evaluation of mortality, we recommend using the SITS definition; for studies needing a high interrater agreement rate, we recommend using the ECASS 2 definition. Due to the lack of 1 single optimal definition, future thrombolytic trials should preferably use different definitions. (Stroke. 2012;43:240-242.)