Association of outcome with early stroke treatment: pooled analysis of ATLANTIS, ECASS, and NINDS rt-PA stroke trials
Association of outcome with early stroke treatment: pooled analysis of ATLANTIS, ECASS, and NINDS rt-PA stroke trials
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DOI：
10.1016/s0140-6736(04)15692-4
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发表时间：
2004-03
期刊：
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通讯作者：
W. Hacke;G. Donnan;C. Fieschi;M. Kaste;R. Kummer;J. Broderick;T. Brott;Michael R. Frankel;J. Grotta;E. Haley;T. Kwiatkowski;S. Levine;C. Lewandowski;M. Lu;P. Lyden;J. Marler;Suresh Patel;B. Tilley;G. Albers;E. Bluhmki;M. Wilhelm;S. Hamilton;Atlantis Trials Investigators;Ecass Trials Investigators
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文献类型：
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作者：
W. Hacke;G. Donnan;C. Fieschi;M. Kaste;R. Kummer;J. Broderick;T. Brott;Michael R. Frankel;J. Grotta;E. Haley;T. Kwiatkowski;S. Levine;C. Lewandowski;M. Lu;P. Lyden;J. Marler;Suresh Patel;B. Tilley;G. Albers;E. Bluhmki;M. Wilhelm;S. Hamilton;Atlantis Trials Investigators;Ecass Trials Investigators
背景：在以前的试验中，卒中后快速静脉注射重组组织纤溶酶原激活剂（rt-PA）改善了预后。我们的目的是分析合并数据，为个别患者，以确认快速treatment.METHODSWe汇集的重要性，从六个随机安慰剂对照试验静脉rt-PA的共同数据元素。使用多变量logistic回归，我们评估了从中风发作到开始治疗（OTT）的时间间隔对3个月的良好结局和临床相关的实质出血的发生的关系。在2775例随机分配到rt-PA或安慰剂组的患者中，在中风发作后360分钟内开始治疗。中位年龄为68岁，中位基线国立卫生研究院卒中量表（NIHSS）为11，中位OTT为243分钟。随着OTT降低，3个月良好结局的几率增加（p= 0.005）。0-90 min、9 - 1 -180 min、181-270 min和271-360 min的比值分别为2.8（95% CI 1.8 - 4.5）、1.6（1.1 - 2.2）、1.4（1.1 - 1.9）和1.2（0.9 - 1.5），rt-PA组更优。对于0-90、91-180和181-270 min间期，根据基线NIHSS校正的死亡风险比与1·0无差异;对于271-360 min间期，其为1·45（1·02-2·07）。82例（5.9%）rt-PA患者和15例（1.1%）对照组出现出血（p<0.0001）。出血与OTT无关，但与rt-PA治疗（p= 0.0001）和年龄（p= 0.0002）有关。解释：对卒中患者给予rt-PA越早，获益越大，特别是在90分钟内开始。我们的结果表明，超过3小时的潜在获益，但这种潜在获益可能伴随着一些风险。
BACKGROUNDQuick administration of intravenous recombinant tissue plasminogen activator (rt-PA) after stroke improved outcomes in previous trials. We aimed to analyse combined data for individual patients to confirm the importance of rapid treatment.METHODSWe pooled common data elements from six randomised placebo-controlled trials of intravenous rt-PA. Using multivariable logistic regression we assessed the relation of the interval from stroke onset to start of treatment (OTT) on favourable 3-month outcome and on the occurrence of clinically relevant parenchymal haemorrhage.FINDINGSTreatment was started within 360 min of onset of stroke in 2775 patients randomly allocated to rt-PA or placebo. Median age was 68 years, median baseline National Institute of Health Stroke Scale (NIHSS) 11, and median OTT 243 min. Odds of a favourable 3-month outcome increased as OTT decreased (p=0·005). Odds were 2·8 (95% CI 1·8–4·5) for 0–90 min, 1·6 (1·1–2·2) for 91–180 min, 1·4 (1·1–1·9) for 181–270 min, and 1·2 (0·9–1·5) for 271–360 min in favour of the rt-PA group. The hazard ratio for death adjusted for baseline NIHSS was not different from 1·0 for the 0–90, 91–180, and 181–270 min intervals; for 271–360 min it was 1·45 (1·02–2·07). Haemorrhage was seen in 82 (5·9%) rt-PA patients and 15 (1·1%) controls (p<0·0001). Haemorrhage was not associated with OTT but was with rt-PA treatment (p=0·0001) and age (p=0·0002).INTERPRETATIONThe sooner that rt-PA is given to stroke patients, the greater the benefit, especially if started within 90 min. Our results suggest a potential benefit beyond 3 h, but this potential might come with some risks.