Stanford Stroke Center, Stanford University School of Medicine, Stanford, CA, USA.
Lancet Neurol. 2012 Oct;11(10):860-7. doi: 10.1016/S1474-4422(12)70203-X. Epub 2012 Sep 4.
Whether endovascular stroke treatment improves clinical outcomes is unclear because of the paucity of data from randomised placebo-controlled trials. We aimed to establish whether MRI can be used to identify patients who are most likely to benefit from endovascular reperfusion.
In this prospective cohort study we consecutively enrolled patients scheduled to have endovascular treatment within 12 h of onset of stroke at eight centres in the USA and one in Austria. Aided by an automated image analysis computer program, investigators interpreted a baseline MRI scan taken before treatment to establish whether the patient had an MRI profile (target mismatch) that suggested salvageable tissue was present. Reperfusion was assessed on an early follow-up MRI scan (within 12 h of the revascularisation procedure) and defined as a more than 50% reduction in the volume of the lesion from baseline on perfusion-weighted MRI. The primary outcome was favourable clinical response, defined as an improvement of 8 or more on the National Institutes of Health Stroke Scale between baseline and day 30 or a score of 0-1 at day 30. The secondary clinical endpoint was good functional outcome, defined as a modified Rankin scale score of 2 or less at day 90. Analyses were adjusted for imbalances in baseline predictors of outcome. Investigators assessing outcomes were masked to baseline data.
138 patients were enrolled. 110 patients had catheter angiography and of these 104 had an MRI profile and 99 could be assessed for reperfusion. 46 of 78 (59%) patients with target mismatch and 12 of 21 (57%) patients without target mismatch had reperfusion after endovascular treatment. The adjusted odds ratio (OR) for favourable clinical response associated with reperfusion was 8·8 (95% CI 2·7-29·0) in the target mismatch group and 0·2 (0·0-1·6) in the no target mismatch group (p=0·003 for difference between ORs). Reperfusion was associated with increased good functional outcome at 90 days (OR 4·0, 95% CI 1·3-12·2) in the target mismatch group, but not in the no target mismatch group (1·9, 0·2-18·7).
Target mismatch patients who had early reperfusion after endovascular stroke treatment had more favourable clinical outcomes. No association between reperfusion and favourable outcomes was present in patients without target mismatch. Our data suggest that a randomised controlled trial of endovascular treatment for patients with the target mismatch profile is warranted.
National Institute for Neurological Disorders and Stroke.
由于随机安慰剂对照试验数据的缺乏,血管内卒中介入治疗是否能改善临床结局仍不清楚。我们旨在确定 MRI 是否可用于识别最有可能从血管内再灌注中获益的患者。
在这项前瞻性队列研究中,我们连续纳入了在美国的 8 个中心和奥地利的 1 个中心,在卒中发病后 12 小时内计划进行血管内治疗的患者。通过自动图像分析计算机程序,研究者对治疗前的基线 MRI 扫描进行解读,以确定患者是否存在 MRI 特征(靶区不匹配)提示存在可挽救的组织。再灌注通过早期随访 MRI 扫描(血管再通术后 12 小时内)进行评估,并定义为灌注加权 MRI 上基线病变体积减少超过 50%。主要结局是有利的临床反应,定义为 NIHSS 评分基线和第 30 天之间提高 8 分或更多,或第 30 天评分为 0-1 分。次要临床终点为 90 天时改良 Rankin 量表评分 2 分或更低。对结局的基线预测因素不平衡进行了调整分析。评估结局的研究者对基线数据设盲。
共纳入 138 例患者。110 例行导管血管造影术,其中 104 例行 MRI 特征检查,99 例可评估再灌注。血管内治疗后,78 例靶区不匹配患者中有 46 例(59%)和 21 例无靶区不匹配患者中有 12 例(57%)发生再灌注。靶区不匹配组中,与再灌注相关的有利临床反应的调整后比值比(OR)为 8.8(95%CI 2.7-29.0),无靶区不匹配组为 0.2(0.0-1.6)(OR 差异的 p 值=0.003)。靶区不匹配组中,再灌注与 90 天时良好的功能结局相关(OR 4.0,95%CI 1.3-12.2),而无靶区不匹配组中则不相关(1.9,0.2-18.7)。
血管内卒中治疗后早期再灌注的靶区不匹配患者具有更有利的临床结局。无靶区不匹配患者中,再灌注与有利结局之间无关联。我们的数据表明,对于靶区不匹配特征的患者,进行血管内治疗的随机对照试验是有必要的。
美国国立神经病学与卒中研究所。