Department of Medicine and Neurology, Royal Melbourne Hospital, University of Melbourne, Melbourne, Australia.
Institute of Neuroscience and Psychology, University of Glasgow, Queen Elizabeth University Hospital, Glasgow, Scotland, UK.
Int J Stroke. 2020 Jul;15(5):507-515. doi: 10.1177/1747493019884529. Epub 2019 Nov 4.
Currently there are multiple variations of imaging-based patient selection mismatch methods in ischemic stroke. In the present study, we sought to compare the two most common mismatch methods and identify if there were different effects on the outcome of a randomized clinical trial depending on the mismatch method used.
Investigate the effect of clinical and imaging-based mismatch criteria on patient outcomes of a pooled cohort from randomized trials of intravenous tenecteplase versus alteplase.
Baseline clinical and imaging scores were used to categorize patients as meeting either the DAWN mismatch (baseline NIHSS ≥ 10, and age cut-offs for ischemic core volume) or DEFUSE 2 mismatch criteria (mismatch volume > 15 mL, mismatch ratio > 1.8 and ischemic core < 70 mL). We then investigated whether tenecteplase-treated patients had favorable odds of less disability (on modified Rankin scale, mRS) compared to those treated with alteplase, for clinical and imaging mismatch, respectively.
From 146 pooled patients, 71 received alteplase and 75 received tenecteplase. The overall pooled group did not show improved patient outcomes when treated with tenecteplase (mRS 0-1 OR 1.77, 95% CI 0.89-3.51, = 0.102) compared with alteplase. A total of 39 (27%) patients met both clinical and imaging mismatch criteria, 25 (17%) patients met only imaging criteria, 36 (25%) met only clinical mismatch criteria and, finally, 46 (31%) did not meet either of imaging or mismatch criteria. Patients treated with tenecteplase had more favorable outcomes when they met either imaging mismatch (mRS 0-1, OR 2.33, 95% CI 1.13-5.94, = 0.032) or clinical mismatch criteria (mRS 0-1, OR 2.15, 95% CI 1.142, 8.732, = 0.027) but with differing proportions.
Target mismatch selection was more inclusive and exhibited in a larger treatment effect between tenecteplase and alteplase.
目前,缺血性脑卒中的影像学患者选择不匹配方法有多种变化。本研究旨在比较两种最常见的不匹配方法,并确定使用不同的不匹配方法是否会对随机临床试验的结果产生不同的影响。
调查基于临床和影像学的不匹配标准对静脉注射替奈普酶与阿替普酶的随机试验汇总队列患者结局的影响。
使用基线临床和影像学评分将患者归类为符合 DAWN 不匹配(基线 NIHSS≥10,和缺血核心体积的年龄截止值)或 DEFUSE 2 不匹配标准(不匹配体积>15mL,不匹配比>1.8 和缺血核心<70mL)。然后,我们研究了替奈普酶治疗的患者与接受阿替普酶治疗的患者相比,在临床和影像学不匹配方面是否具有更好的残疾(改良 Rankin 量表,mRS)的优势。
从 146 例汇总患者中,71 例接受阿替普酶治疗,75 例接受替奈普酶治疗。总体汇总组在接受替奈普酶治疗时并未显示出患者结局改善(mRS 0-1 OR 1.77,95%CI 0.89-3.51, = 0.102)与阿替普酶相比。共有 39 名(27%)患者符合临床和影像学双重不匹配标准,25 名(17%)患者仅符合影像学标准,36 名(25%)患者仅符合临床不匹配标准,最后,46 名(31%)患者不符合影像学或不匹配标准。当符合影像学不匹配标准(mRS 0-1,OR 2.33,95%CI 1.13-5.94, = 0.032)或临床不匹配标准(mRS 0-1,OR 2.15,95%CI 1.142,8.732, = 0.027)时,接受替奈普酶治疗的患者具有更有利的结局,但比例不同。
替奈普酶的目标匹配选择更加包容,并在替奈普酶和阿替普酶之间表现出更大的治疗效果。