Galinovic Ivana, Boutitie Florent, Fiebach Jochen B, Villringer Kersten, Cheng Bastian, Ebinger Martin, Endres Matthias, Fiehler Jens, Ford Ian, Thijs Vincent, Lemmens Robin, Muir Keith W, Nighoghossian Norbert, Pedraza Salvador, Simonsen Claus Z, Roy Pascal, Gerloff Christian, Thomalla Götz
Center for Stroke Research Berlin (CSB), Charité-Universitätsmedizin Berlin, Berlin, Germany.
Hospices Civils de Lyon, Service de Biostatistique, Lyon, France.
Front Neurol. 2019 Sep 11;10:983. doi: 10.3389/fneur.2019.00983. eCollection 2019.
In WAKE-UP (Efficacy and Safety of MRI-based Thrombolysis in Wake-Up Stroke), patients with an acute stroke of unknown onset time were randomized to treatment with intravenous alteplase or placebo, guided by MRI. In this exploratory secondary analysis we compared clinical and imaging data, as well as treatment effects and safety of intravenous thrombolysis between patients with infra- vs. supratentorial stroke. Forty-eight out of 503 randomized patients (9.5%) presented with a stroke involving the cerebellum or brainstem. Patients with infratentorial stroke were younger compared to patients with supratentorial stroke (mean age 60 vs. 66 years), more frequently male (85 vs. 62%), and less severely affected (median NIHSS 4.5 vs. 6.0). There was no heterogeneity for treatment effect between supratentorial (OR 1.67 95% CI 1.11-2.51) and infratentorial (OR 1.31 95% CI 0.41-4.22) sub-groups (test for interaction = 0.70). In patients with infratentorial stroke, favorable outcome [a score of 0-1 on the modified Rankin scale (mRS) at 90 days] was observed in 12/22 patients (54.5%) in the alteplase group and in 13/25 patients (52.0%) in the placebo group ( = 0.59). The primary safety endpoint (death or mRS 4-6 at day 90) occurred in three patients of the alteplase group (13.6%) and three patients in the placebo group (12.0%); = 0.74. WAKE-UP was underpowered for demonstrating treatment effect in subgroup analyses however, based on our current results, there is no evidence to recommend withholding MRI-guided thrombolysis in patients with unknown onset stroke of infratentorial localization.
在“清醒状态下急性卒中基于MRI的溶栓治疗的疗效与安全性（WAKE-UP）”研究中，发病时间不明的急性卒中患者被随机分为接受静脉注射阿替普酶治疗组或安慰剂组，治疗以MRI为指导。在这项探索性的二次分析中，我们比较了幕下与幕上卒中患者的临床和影像数据，以及静脉溶栓的治疗效果和安全性。503例随机分组患者中有48例（9.5%）出现累及小脑或脑干的卒中。幕下卒中患者比幕上卒中患者更年轻（平均年龄60岁对66岁），男性比例更高（85%对62%），病情严重程度更低（美国国立卫生研究院卒中量表[NIHSS]中位数4.5对6.0）。幕上亚组（比值比[OR]1.67，95%置信区间[CI]1.11 - 2.51）和幕下亚组（OR 1.31，95% CI 0.41 - 4.22）之间的治疗效果无异质性（交互检验P = 0.70）。在幕下卒中患者中，阿替普酶组22例患者中有12例（54.5%）在90天时获得良好预后[改良Rankin量表（mRS）评分为0 - 1分]，安慰剂组25例患者中有13例（52.0%）（P = 0.59）。主要安全终点（90天时死亡或mRS为4 - 6分）在阿替普酶组3例患者中出现（13.6%），安慰剂组3例患者中出现（12.0%）；P = 0.74。然而，WAKE-UP研究在亚组分析中显示治疗效果的效能不足，基于我们目前的结果，没有证据建议对幕下部位发病时间不明的卒中患者不进行MRI引导下的溶栓治疗。
