Safety and efficacy of thrombolysis in patients with acute mild ischemic stroke with tumor
10.3969/j.issn.1672-5921.2025.01.002
- VernacularTitle:伴有肿瘤的急性轻型缺血性卒中患者静脉溶栓的安全性及有效性分析
- Author:
Yue CAO
1
;
Huisheng CHEN
1
Author Information
1. 110840 沈阳,北部战区总医院神经内科
- Publication Type:Journal Article
- Keywords:
Neoplasms;
Acute ischemic stroke;
Mild acute ischemic stroke;
Intravenous thrombolysis;
Prognosis
- From:
Chinese Journal of Cerebrovascular Diseases
2025;22(1):3-14
- CountryChina
- Language:Chinese
-
Abstract:
Objective To investigate the safety and effectiveness of thrombolysis in patients with acute mild ischemic stroke with tumor.Methods All patients with acute mild(National Institute of Health stroke scale[NIHSS]score≤5 at admission)ischemic stroke who received intravenous thrombolysis with recombinant tissue plasminogen activator(rt-PA)or urokinase from April 1,2017 to July 1,2019 in the effectiveness of intravenous rt-PA versus urokinase for acute ischaemic stroke:a nationwide prospective Chinese registry study(INTRECIS)database were collected retrospectively,and they were divided into two groups according to whether they were accompanied by tumor or not:the combined tumor group and the non-tumor group.Collection of baseline and clinical data for all patients,including sex,age,cerebrovascular disease related risk factors(history of hypertension,diabetes mellitus,coronary artery disease,atrial fibrillation,stroke,smoking history,body mass index),baseline NIHSS score,baseline modified Rankin scale(mRS)score,baseline systolic blood pressure,baseline diastolic blood pressure,premedication use(antiplatelet agents,anticoagulants,lipid-lowering drugs),classification according to the trial of Org 10172 in acute stroke treatment,time from door to needle time,types of thrombolytic drugs(rt-PA and urokinase),and the type of tumor.Having a history of tumor is defined as having been diagnosed with a malignant tumor by a professionally certified oncologist prior to the administration of thrombolytic therapy,with no concurrent oncological treatment being received at the time of thrombolysis.Ninety days post-thrombolysis,patients were followed up through outpatient visits or telephone interviews,and their neurological status was assessed using the mRS.Score of mRS≤1 was considered as a good prognosis,while mRS score ≥ 2 indicated a poor prognosis,with a score of 6 representing death.Compare the baseline characteristics,primary safety endpoints,secondary safety endpoints,primary efficacy endpoints,and secondary efficacy endpoint events before and after 1∶1 propensity score matching(PSM)between the two groups with and without a history of tumor.The primary safety endpoint was symptomatic intracranial hemorrhage(defined as intracranial hemorrhage transformation,including parenchymal hematoma type 1,parenchymal hematoma type 2,hemorrhagic infarction type 1,hemorrhagic infarction type 2,observed on head CT within 36 h after thrombolysis,accompanied by worsening symptoms compared to at the time of thrombolysis and an increase in NIHSS score by ≥4 points from baseline)within 36 h after thrombolysis before and after 1∶1 PSM.The secondary safety endpoint is the incidence of various bleeding events within 36 h after thrombolysis,including asymptomatic intracranial hemorrhage(presence of intracranial hemorrhage without worsening of neurological deficit),systemic bleeding(other bleeding events besides intracranial hemorrhage),and mortality within 90 d after thrombolysis.The primary effectiveness endpoint was the proportion of patients with a good prognosis at 90 d after thrombolysis,and the secondary effectiveness endpoint was the proportion of patients with an NIHSS score≤1 at 1 d after thrombolysis.Before 1∶1 PSM,baseline characteristics that exhibited a P-value＜0.1 when compared between the two groups were included in a multivariate Logistic regression analysis for adjustment.The differences in safety and efficacy endpoint events after intravenous thrombolysis between the two groups were compared before and after adjustment.After 1∶1 PSM,univariate binary Logistic regression analysis was conducted to assess whether there were significant differences in the safety and effectiveness of intravenous thrombolysis among acute mild ischemic stroke patients between those with and without tumor.Results A total of 1 680 patients with acute mild ischemic stroke,aged between 26 and 93 years,with a median age of 63(54,70)years,were included in this study,including 32 patients with tumor(including 3 cases of nasopharyngeal cancer,3 cases of rectal cancer,3 cases of reproductive system cancer,4 cases of breast cancer,5 cases of lung cancer,1 case of liver cancer,and 2 cases of gastric cancer and 11 cases of other tumors)and 1 648 patients without tumor.There were 32 cases in both groups after 1∶1 PSM.(1)Before 1∶1 PSM,patients with tumor group were older than those in the non-tumor group(67[61,74]years vs.62[54,70]years,P=0.01).After 1∶1 PSM,there were no statistically significant differences in baseline characteristics between the two groups(all P＞0.05).(2)Primary safety endpoints:before 1∶1 PSM,there was no patient had symptomatic intracranial hemorrhage,asymptomatic intracranial hemorrhage,systemic bleeding in the group with tumor,while 0.4％(6/1 648),1.0％(17/1 648),0.2％(3/1 648)occurred respectively in the group without tumor.There were no statistically significant differences in both primary and secondary safety endpoints between the two groups(both P=0.99).After 1∶1 PSM,neither group experienced symptomatic intracranial hemorrhage,asymptomatic intracranial hemorrhage,or systemic hemorrhage.No deaths occurred in the tumor group within 90 d after thrombolysis,while one death occurred in the non-tumor group.(3)Primary efficacy endpoints:before 1∶1 PSM,there was no statistically significant difference in the proportion of patients with good prognosis at 90 d after intravenous thrombolysis between the two groups(90.6％[29/32]vs.86.9％[1 432/1 648],P=0.54).After adjusting for confounding factors such as age and coronary heart disease,there was no statistically significant difference(OR,1.58,95％CI0.48-5.26,P=0.45)in the proportion of patients with a good prognosis at 90 d after intravenous thrombolysis between the two groups.After 1∶1 PSM,90.6％(29/32)patients in the tumor group had a good prognosis at 90d after intravenous thrombolysis,while 84.4％(27/32)patients in the non-tumor group,there was no statistically significant difference between the two groups(OR,0.56,95％CI 0.12-2.57,P=0.71).Secondary efficacy endpoint:before 1∶1 PSM,there was no statistically significant difference in the proportion of patients with an NIHSS score≤1 at 1 d after intravenous thrombolysis(37.5％[12/32]vs.48.2％[795/1 648],P=0.23),after adjusting for confounding factors such as age and coronary heart disease,the results suggest that there was no statistically significant difference in the proportion of patients with an NIHSS score≤1 at 1 d after intravenous thrombolysis(OR,0.65,95％CI 0.32-1.34,P=0.24).After 1∶1 PSM,the proportion of patients with an NIHSS score≤1 at 1 d after thrombolysis was 37.5％(12/32)in both patient groups,there was no statistically significant difference between the two groups(OR,1.00,95％CI 0.36-2.75,P=0.99).Conclusions Compared with patients without tumor,acute mild ischemic stroke in China with tumor may exhibit similar safety and effectiveness in receiving intravenous thrombolysis with rt-PA or urokinase.The findings of this study await further validation through randomized controlled trials.
