From the Institute for Stroke and Dementia Research (F.A.W., S.T., M.D.), Klinikum der Universität München, Ludwig-Maximilians-Universität LMU, Munich, Germany.
Department of Neurology (F.A.W., L. Kellert), Klinikum der Universität München, Ludwig-Maximilians-Universität LMU, Munich, Germany.
Stroke. 2019 Sep;50(9):2500-2506. doi: 10.1161/STROKEAHA.119.026005. Epub 2019 Jul 24.
Background and Purpose- Endovascular treatment for large vessel occlusion in ischemic stroke has proven to be effective in large clinical trials. We aimed to provide real-world estimates of endovascular treatment reperfusion rates and functional outcome on a countrywide scale. Methods- Two thousand seven hundred ninety-four patients with large vessel occlusion were included into an investigator-initiated, industry-independent, prospective registry in 25 sites in Germany between June 2015 and April 2018. The primary outcome was the score on the modified Rankin Scale ranging from zero (no symptoms) to 6 (death) at 3 months. Secondary analyses included the prediction of a good outcome (modified Rankin Scale, 0-2). Dichotomized analyses of predictors were performed using logistic regression adjusted for potential confounders. Results- Median age was 75 years (interquartile range, 64-82); median National Institutes of Health Stroke Scale score was 15 (interquartile range, 10-19). Vessel occlusion was in the anterior circulation in 2265 patients (88%) and in the posterior circulation in 303 patients (12%). Intravenous alteplase before endovascular treatment was given in 1457 patients (56%). Successful reperfusion was achieved in 2143 subjects (83%). At 3 months, 854 patients (37%) showed a good outcome; mortality was 29%. There was no difference between anterior and posterior circulation occlusions (P=0.27). Significant predictors for a good outcome were younger age (odds ratio [OR], 1.06; 95% CI, 1.05-1.07), no interhospital transfer (OR, 1.39; 95% CI, 1.03-1.88), lower stroke severity (OR, 1.10; 95% CI, 1.08-1.13), smaller infarct size (OR, 1.26; 95% CI, 1.15-1.39), alteplase use (OR, 1.49; 95% CI, 1.08-2.06), and reperfusion success (OR, 1.69; 95% CI, 1.45-1.96). Conclusions- High rates of favorable outcome can be achieved on a countrywide scale by endovascular treatment. Mortality appears to be greater in the daily routine than otherwise reported by authors of large randomized trials. There were no outcome differences between the anterior and posterior circulation. Clinical Trial Registration- URL: https://www.clinicaltrials.gov. Unique identifier: NCT03356392.
背景与目的- 在大型临床试验中，血管内治疗缺血性脑卒中的大血管闭塞已被证明是有效的。我们旨在提供全国范围内血管内治疗再灌注率和功能结果的真实世界估计。
方法- 2015 年 6 月至 2018 年 4 月，在德国 25 个地点进行了一项由研究人员发起的、与工业无关的、前瞻性的注册研究，共纳入 2794 例大血管闭塞患者。主要结局是改良 Rankin 量表（范围从 0 分[无症状]到 6 分[死亡]）在 3 个月时的评分。次要分析包括对良好结局（改良 Rankin 量表，0-2 分）的预测。使用调整潜在混杂因素的逻辑回归对预测因素进行二分法分析。
结果- 中位年龄为 75 岁（四分位间距，64-82）；中位美国国立卫生研究院卒中量表评分为 15 分（四分位间距，10-19）。2265 例（88%）患者血管闭塞在前循环，303 例（12%）在后循环。1457 例（56%）患者在血管内治疗前给予静脉内阿替普酶。2143 例（83%）患者成功再灌注。3 个月时，854 例（37%）患者预后良好；死亡率为 29%。前循环和后循环闭塞之间无差异（P=0.27）。良好结局的显著预测因素包括年龄较小（比值比[OR]，1.06；95%置信区间[CI]，1.05-1.07）、无院内转院（OR，1.39；95%CI，1.03-1.88）、较低的卒中严重程度（OR，1.10；95%CI，1.08-1.13）、较小的梗死灶大小（OR，1.26；95%CI，1.15-1.39）、阿替普酶使用（OR，1.49；95%CI，1.08-2.06）和再灌注成功（OR，1.69；95%CI，1.45-1.96）。
结论- 通过血管内治疗可以在全国范围内获得良好的预后。死亡率在日常实践中似乎比大型随机试验的作者报告的要高。前循环和后循环之间没有结果差异。
临床试验注册- 网址：https://www.clinicaltrials.gov。唯一标识符：NCT03356392。
