Abstract: Objective To investigate the effect of antithrombotic therapy before stroke onset on intravenous thrombolysis in patients with acute ischemic stroke (AIS). Methods The data of in-hospital AIS patients who received intravenous thrombolysis from a national, multi-center stroke registry of from January to December, 2018 were collected and retrospectively analyzed. All the patients were divided into observation group (with antithrombotic therapy before stroke onset) and control group (without antithrombotic therapy before stroke onset). Baseline information and in-hospital safety outcomes (symptomatic intracranial hemorrhage and all-cause death) were compared between the two groups, and multivariate logistic regression was used to analyze the correlation between pre-antithrombotic therapy and in-hospital safety outcomes. Results A total of 17 587 eligible patients in 1374 hospitals were included in this study, with 3313 patients (18.8%) in observation group and 14 274 patients (81.2%) in control group. Compared to

the control group, the observation group had higher age (67.7±11.1 years vs 64.8±12.2 years), less

males (63.6% vs 65.7%) and a higher proportion of vascular risk factors, and NIHSS >15 (16.1% vs 13.5%) on admission, with all statistical differences. The incidence of symptomatic intracranial hemorrhage (0.12% vs 0.07%, P =0.156) and all-cause death (1.72% vs 1.16%, P =0.010) in observation group were higher than those in control group. After multivariate adjustment, there was no statistical difference between the two groups in terms of symptomatic intracranial hemorrhage (HR 1.133, 95%CI 0.220-5.822, P =0.881) and in-hospital all-cause death (HR 0.912, 95%CI 0.612- 1.359, P =0.651). Conclusions There were no significant effects of antithrombotic therapy before stroke onset on short-term safety of intravenous thrombolytic therapy in AIS patients, without increasing the risk of symptomatic intracranial hemorrhage and in-hospital all-cause death.

Key words: Ischemic stroke; Intravenous thrombolysis; Antithrombotic therapy; Symptomatic intracranial hemorrhage; Mortality

摘要： 目的 探索发病前口服抗栓药物对急性缺血性卒中患者静脉溶栓安全性的影响。 方法 研究对象为2018年1-12月的全国、多中心、缺血性卒中住院患者登记研究中进行了rt-PA静脉 溶栓的患者。根据患者发病前是否应用抗栓药物，将患者分为观察组（发病前口服抗栓药物）和对照 组（发病前未口服抗栓药物）。比较两组的基线信息、溶栓后症状性颅内出血率和在院全因死亡率的 差异，并采用多因素回归分析发病前应用抗栓药物对患者溶栓后住院期间安全性的影响。 结果 本研究共纳入了全国1374家医院的17 587例rt-PA静脉溶栓的急性缺血性卒中住院患者。其 中，有3313例（18.8%）发病前应用抗栓药物，纳入观察组，14 274例（81.2%）发病前未应用口服抗 栓药物，纳入对照组。与对照组相比，观察组患者年龄较高（67.7±11.1岁 vs 64.8±12.2岁），男 性比例较低（63.6% vs 65.7%），既往血管危险因素比例较高，入院NIHSS＞15分的患者比例较高 （16.1% vs 13.5%），差异均有统计学意义。观察组溶栓后症状性颅内出血的发生率（0.12% vs 0.07%， P =0.156）和在院全因死亡率（1.72% vs 1.16%，P =0.010）均高于对照组，但多因素校正后，两组溶 栓后症状性颅内出血（HR 1.133，95%CI 0.220～5.822，P =0.881）和在院全因死亡（HR 0.912，95%CI 0.612～1.359，P =0.651）方面的差异均未达统计学意义。 结论 发病前应用抗栓药物对急性缺血性卒中患者静脉溶栓的短期安全性无显著影响，不增加 症状性颅内出血的发生率和在院全因死亡率。

关键词: 缺血性卒中; 静脉溶栓; 抗栓药物; 症状性颅内出血; 死亡率