Analyses on safety and efficacy of non-standard dose of r-tPA in intravenous thrombolysis-treated AIS patients

BackgroundIntravenous 0.9 mg/kg recombinant tissue plasminogen activator (r-tPA) is one of the most effective treatments in acute ischemic stroke patients. Practically, the dose of r-tPA is still a topic that is constantly being discussed.MethodsFor this observational study, data were obtained from...

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Main Authors: Jiawen Yuan, Ruxing Wu, Jingyan Xiang, Jiangshan Deng, Xiaojie Zhang, Kaili Lu, Fengya Cao, Fei Zhao, Yuwu Zhao, Feng Wang
Format: Article
Language:English
Published: Frontiers Media S.A. 2022-11-01
Series:Frontiers in Neurology
Subjects:
Online Access:https://www.frontiersin.org/articles/10.3389/fneur.2022.1007167/full
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author Jiawen Yuan
Ruxing Wu
Jingyan Xiang
Jiangshan Deng
Xiaojie Zhang
Kaili Lu
Fengya Cao
Fei Zhao
Yuwu Zhao
Feng Wang
author_facet Jiawen Yuan
Ruxing Wu
Jingyan Xiang
Jiangshan Deng
Xiaojie Zhang
Kaili Lu
Fengya Cao
Fei Zhao
Yuwu Zhao
Feng Wang
author_sort Jiawen Yuan
collection DOAJ
description BackgroundIntravenous 0.9 mg/kg recombinant tissue plasminogen activator (r-tPA) is one of the most effective treatments in acute ischemic stroke patients. Practically, the dose of r-tPA is still a topic that is constantly being discussed.MethodsFor this observational study, data were obtained from 537 patients who received r-tPA thrombolysis at Shanghai Sixth People's Hospital stroke center over 5 years (2014–2019). Patients were divided into two groups: a non-standard dose group (0.6 mg/kg ≤ dose < 0.9 mg/kg) and a standard dose group (0.9 mg/kg). Different outcomes were observed: efficacy: 3 months mRS 0-1 (3m-mRS0-1); safety: symptomatic intracranial hemorrhage within 24 h (24h-sICH) and 3 months mortality (3m-death). We also observed the effect of r-tPA dose coefficient on outcomes in different age groups and baseline National Institute of Health stroke scale (NIHSS) score subgroups.ResultsThere were 265 patients who gave the standard dose treatment and 272 gave the nonstandard dose. There was no significant difference between the non-standard dose group and the standard dose group in 3m-mRS0-1, 3m-death, and 24h-sICH (p = 0.567, 0.327, and 0.415, respectively). The dose coefficient presents a significant negative correlation (p = 0.034, B = −4.290) with 3m-death in NIHSS < 16 sub-group. Door-to-needle time (DNT) is the most important independent outcome-influential factor (MIOIF) in the NIHSS ≥16 sub-group. The diabetes history and baseline NIHSS score were the MIOIF in the age ≥80-year sub-group.ConclusionsThe non-standard dose group (0.6 mg/kg ≤ dose < 0.9 mg/kg) shows no difference in safety and effectiveness than the standard dose group (0.9 mg/kg) in our study. The standard dose should be considered first according to current evidence and Guidelines, but the non-standard dose (0.6 mg/kg ≤ dose < 0.9 mg/kg) might be an option in the actual diagnosis and treatment process considering the patient's clinical profile and financial condition.
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spelling doaj.art-ae13d130adf04fdb9573fe0a3bdf19d42022-12-22T04:14:30ZengFrontiers Media S.A.Frontiers in Neurology1664-22952022-11-011310.3389/fneur.2022.10071671007167Analyses on safety and efficacy of non-standard dose of r-tPA in intravenous thrombolysis-treated AIS patientsJiawen Yuan0Ruxing Wu1Jingyan Xiang2Jiangshan Deng3Xiaojie Zhang4Kaili Lu5Fengya Cao6Fei Zhao7Yuwu Zhao8Feng Wang9Department of Neurology, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, ChinaSchool of Nursing, Shanghai Jiao Tong University, Shanghai, ChinaDepartment of Neurology, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, ChinaDepartment of Neurology, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, ChinaDepartment of Neurology, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, ChinaDepartment of Neurology, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, ChinaDepartment of Neurology, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, ChinaDepartment of Neurology, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, ChinaDepartment of Neurology, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, ChinaDepartment of Neurology, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, ChinaBackgroundIntravenous 0.9 mg/kg recombinant tissue plasminogen activator (r-tPA) is one of the most effective treatments in acute ischemic stroke patients. Practically, the dose of r-tPA is still a topic that is constantly being discussed.MethodsFor this observational study, data were obtained from 537 patients who received r-tPA thrombolysis at Shanghai Sixth People's Hospital stroke center over 5 years (2014–2019). Patients were divided into two groups: a non-standard dose group (0.6 mg/kg ≤ dose < 0.9 mg/kg) and a standard dose group (0.9 mg/kg). Different outcomes were observed: efficacy: 3 months mRS 0-1 (3m-mRS0-1); safety: symptomatic intracranial hemorrhage within 24 h (24h-sICH) and 3 months mortality (3m-death). We also observed the effect of r-tPA dose coefficient on outcomes in different age groups and baseline National Institute of Health stroke scale (NIHSS) score subgroups.ResultsThere were 265 patients who gave the standard dose treatment and 272 gave the nonstandard dose. There was no significant difference between the non-standard dose group and the standard dose group in 3m-mRS0-1, 3m-death, and 24h-sICH (p = 0.567, 0.327, and 0.415, respectively). The dose coefficient presents a significant negative correlation (p = 0.034, B = −4.290) with 3m-death in NIHSS < 16 sub-group. Door-to-needle time (DNT) is the most important independent outcome-influential factor (MIOIF) in the NIHSS ≥16 sub-group. The diabetes history and baseline NIHSS score were the MIOIF in the age ≥80-year sub-group.ConclusionsThe non-standard dose group (0.6 mg/kg ≤ dose < 0.9 mg/kg) shows no difference in safety and effectiveness than the standard dose group (0.9 mg/kg) in our study. The standard dose should be considered first according to current evidence and Guidelines, but the non-standard dose (0.6 mg/kg ≤ dose < 0.9 mg/kg) might be an option in the actual diagnosis and treatment process considering the patient's clinical profile and financial condition.https://www.frontiersin.org/articles/10.3389/fneur.2022.1007167/fullacute ischemic strokeintravenous thrombolysisr-tPAdosesub-group analyses
spellingShingle Jiawen Yuan
Ruxing Wu
Jingyan Xiang
Jiangshan Deng
Xiaojie Zhang
Kaili Lu
Fengya Cao
Fei Zhao
Yuwu Zhao
Feng Wang
Analyses on safety and efficacy of non-standard dose of r-tPA in intravenous thrombolysis-treated AIS patients
Frontiers in Neurology
acute ischemic stroke
intravenous thrombolysis
r-tPA
dose
sub-group analyses
title Analyses on safety and efficacy of non-standard dose of r-tPA in intravenous thrombolysis-treated AIS patients
title_full Analyses on safety and efficacy of non-standard dose of r-tPA in intravenous thrombolysis-treated AIS patients
title_fullStr Analyses on safety and efficacy of non-standard dose of r-tPA in intravenous thrombolysis-treated AIS patients
title_full_unstemmed Analyses on safety and efficacy of non-standard dose of r-tPA in intravenous thrombolysis-treated AIS patients
title_short Analyses on safety and efficacy of non-standard dose of r-tPA in intravenous thrombolysis-treated AIS patients
title_sort analyses on safety and efficacy of non standard dose of r tpa in intravenous thrombolysis treated ais patients
topic acute ischemic stroke
intravenous thrombolysis
r-tPA
dose
sub-group analyses
url https://www.frontiersin.org/articles/10.3389/fneur.2022.1007167/full
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