Schellinger Peter D, Thomalla Götz, Fiehler Jens, Köhrmann Martin, Molina Carlos A, Neumann-Haefelin Tobias, Ribo Marc, Singer Oliver C, Zaro-Weber Olivier, Sobesky Jan
Department of Neurology, University of Erlangen, Schwabachanlage 6, D-91054 Erlangen, Germany.
Stroke. 2007 Oct;38(10):2640-5. doi: 10.1161/STROKEAHA.107.483255. Epub 2007 Aug 16.
The use of intravenous thrombolysis is restricted to a minority of patients by the rigid 3-hour time window. This window may be extended by using modern imaging-based selection algorithms. We assessed safety and efficacy of MRI-based thrombolysis within and beyond 3 hours compared with standard CT-based thrombolysis.
Five European stroke centers pooled the core data of their CT- and MRI-based prospective thrombolysis databases. Safety outcomes were predefined as symptomatic intracranial hemorrhage and mortality. Primary efficacy outcome was a favorable outcome (modified Rankin Scale 0 to 1). We performed univariate and multivariate analyses for all end points, including age, National Institutes of Health Stroke Scale, treatment group (CT <3 hours, MRI <3 hours and >3 hours), and onset to treatment time as variables.
A total of 1210 patients were included (CT <3 hours: N=714; MRI <3 hours: N=316; MRI >3 hours: N=180). Median age, National Institutes of Health Stroke Scale, and onset to treatment time were 69, 67, and 68.5 years (P=0.66); 12, 13, and 14 points (P=0.019); and 130, 135, and 240 minutes (P<0.001). Symptomatic intracranial hemorrhage rates were 5.3%, 2.8%, and 4.4% (P=0.213); mortality was 13.7%, 11.7%, and 13.3% (P=0.68). Favorable outcome occurred in 35.4%, 37.0%, and 40% (P=0.51). Age and National Institutes of Health Stroke Scale were independent predictors for all safety and efficacy outcomes. The overall use of MRI significantly reduced symptomatic intracranial hemorrhage (OR: 0.520, 95% CI: 0.270 to 0.999, P=0.05). Beyond 3 hours, the use of MRI significantly predicted a favorable outcome (OR: 1.467; 95% CI: 1.017 to 2.117, P=0.040). Within 3 hours and for all secondary end points, there was a trend in favor of MRI-based selection over standard <3-hour CT-based treatment.
Despite significantly longer time windows and significantly higher baseline National Institutes of Health Stroke Scale scores, MRI-based thrombolysis is safer and potentially more efficacious than standard CT-based thrombolysis.
静脉溶栓疗法因严格的3小时时间窗而仅适用于少数患者。通过使用基于现代影像学的选择算法,这个时间窗可能得以延长。我们评估了基于磁共振成像(MRI)的溶栓疗法在3小时内及超过3小时时与基于标准计算机断层扫描(CT)的溶栓疗法相比的安全性和有效性。
五个欧洲卒中中心汇总了其基于CT和MRI的前瞻性溶栓数据库的核心数据。安全性结局预先定义为症状性颅内出血和死亡率。主要有效性结局为良好结局(改良Rankin量表评分0至1分)。我们对所有终点进行单因素和多因素分析,将年龄、美国国立卫生研究院卒中量表评分、治疗组(CT治疗<3小时、MRI治疗<3小时和>3小时)以及发病至治疗时间作为变量。
共纳入1210例患者(CT治疗<3小时:N = 714;MRI治疗<3小时:N = 316;MRI治疗>3小时:N = 180)。年龄中位数、美国国立卫生研究院卒中量表评分以及发病至治疗时间分别为69岁、67岁和68.5岁(P = 0.66);12分、13分和14分(P = 0.019);以及130分钟、135分钟和240分钟(P < 0.001)。症状性颅内出血发生率分别为5.3%、2.8%和4.4%(P = 0.213);死亡率分别为13.7%、11.7%和13.3%(P = 0.68)。良好结局发生率分别为35.4%、37.0%和40%(P = 0.51)。年龄和美国国立卫生研究院卒中量表评分是所有安全性和有效性结局的独立预测因素。MRI的总体应用显著降低了症状性颅内出血(比值比:0.520,95%置信区间:0.270至0.999,P = 0.05)。超过3小时时,MRI的应用显著预测了良好结局(比值比:1.467;95%置信区间:1.017至2.117,P = 0.040)。在3小时内以及所有次要终点方面,与标准的基于<3小时CT的治疗相比,基于MRI的选择有更优趋势。
尽管时间窗显著更长且基线美国国立卫生研究院卒中量表评分显著更高,但基于MRI的溶栓疗法比基于标准CT的溶栓疗法更安全且可能更有效。