Implementation and outcome of thrombolysis with alteplase 3-4.5 h after an acute stroke: an updated analysis from SITS-ISTR
Implementation and outcome of thrombolysis with alteplase 3-4.5 h after an acute stroke: an updated analysis from SITS-ISTR
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DOI：
10.1016/s1474-4422(10)70165-4
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发表时间：
2010-09-01
期刊：
影响因子：
48
通讯作者：
Ringleb, Peter
中科院分区：
文献类型：
--
作者：
Ahmed, Niaz;Wahlgren, Nils;Ringleb, Peter
背景2008年9月，欧洲急性卒中研究III（ECASS III）随机试验和安全实施卒中治疗-国际卒中溶栓登记研究（SITS-ISTR）观察性研究报告了将静脉阿替普酶治疗时间窗从卒中发作后3小时内延长至4. 5小时内的疗效和安全性。我们的目的是评估实施更广泛的时间窗，其影响入院治疗的时间，安全性和功能性的结果记录在SITS-ISTR.Methods的患者根据欧洲产品特性概要的标准，除了时间窗，被包括在内。根据患者是否在2008年10月之前或之后登记入SITS-ISTR进行分组。我们测量了入院治疗时间和率的症状性脑出血，死亡率和功能独立性在3 months.Findings 23 942例患者被纳入SITS-ISTR之间，2002年12月，2010年2月，其中2376人治疗3-4.5小时后症状发作。截至2009年底，在3-4.5小时内接受治疗的患者比例是2008年前三个季度的三倍（282/1293 [22%] vs 67/1023 [7%]）。在2008年10月之前和之后登记的患者的中位入院至治疗时间均为65分钟（p=0.94）。在卒中后3小时内接受治疗的21204例患者中有352例（2%）和在卒中后3-4.5小时内接受治疗的2317例患者中有52例（2%）在3个月时出现症状性脑出血（校正比值比[OR] 1.44，95% CI 105-1.97; p=0.02）。在3个月随访时，在3小时内接受治疗的18583例患者中有2287例（12%）死亡，在3-4.5小时内接受治疗的1817例患者中有218例（12%）死亡（调整后OR 1.26，95% CI 1.07-1.四十九岁; p=0.005）; 18317例卒中后3小时内接受治疗的患者中有10531例（57%）和1784例卒中后3-4.5小时内接受治疗的患者中有1075例（60%）在3个月时功能独立（校正OR 0.84，95% CI 0.75-0.95; p=0.005）。解释自2008年10月以来，卒中后3-4.5 h内的溶栓已迅速实施，在3小时内治疗的患者数量同时增加;入院治疗时间没有增加。3小时后的安全性和功能结局较差，但更宽的时间窗现在为无法早期治疗的患者提供了治疗机会。溶栓应在缺血性卒中发作后4.5小时内开始，尽管应尽一切努力在症状发作后尽早治疗患者。
Background In September, 2008, the European Acute Stroke Study III (ECASS III) randomised trial and the Safe Implementation of Treatment in Stroke-International Stroke Thrombolysis Registry (SITS-ISTR) observational study reported the efficacy and safety of the extension of the time window for intravenous alteplase treatment from within 3 h to within 4.5 h after stroke onset. We aimed to assess the implementation of the wider time window, its effect on the admission-to-treatment time, and safety and functional outcome in patients recorded in SITS-ISTR.Methods Patients treated according to the criteria of the European Summary of Product Characteristics, except for the time window, were included. Patients were grouped according to whether they were registered into SITS-ISTR before or after October, 2008. We measured admission-to-treatment time and rates of symptomatic intracerebral haemorrhage, mortality, and functional independence at 3 months.Findings 23 942 patients were included in SITS-ISTR between December, 2002, and February, 2010, of whom 2376 were treated 3-4.5 h after symptom onset. The proportion of patients treated within 3-4.5 h by the end of 2009 was three times higher than in the first three quarters of 2008 (282 of 1293 [22%] vs 67 of 1023 [7%]). The median admission-to-treatment time was 65 min both for patients registered before and after October, 2008 (p=0.94). 352 (2%) of 21 204 patients treated within 3 h and 52 (2%) of 2317 treated within 3-4.5 h of stroke had symptomatic intracerebral haemorrhage at 3 months (adjusted odds ratio [OR] 1.44, 95% CI 105-1.97; p=0.02). 2287 (12%) of 18 583 patients who were treated within 3 h and 218 (12%) of 1817 who were treated within 3-4.5 h had died by the 3-month follow-up (adjusted OR 1.26, 95% CI 1.07-1. 49; p=0.005); 10 531 (57%) of 18 317 patients treated within 3 h of stroke and 1075 (60%) of 1784 who were treated within 3-4.5 h were functionally independent at 3 months (adjusted OR 0.84, 95% CI 0.75-0.95; p=0.005).Interpretation Since October, 2008, thrombolysis within 3-4.5 h after stroke has been implemented rapidly, with a simultaneous increase in the number of patients treated within 3 h; admission-to-treatment time has not increased. Safety and functional outcomes are less favourable after 3 h, but the wider time window now offers an opportunity for treatment of those patients who cannot be treated earlier. Thrombolysis should be initiated within 4.5 h after onset of ischaemic stroke, although every effort should be made to treat patients as early as possible after symptom onset.