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Who may benefit from lower dosages of intravenous tissue plasminogen activator? Results from a cluster data analysis

BACKGROUND: The risk of symptomatic intracranial haemorrhage (sICH) after thrombolysis is low but severe. Lower dose of alteplase may reduce the risk of sICH. We aim to identify subsets of patients who could benefit from lower dose of alteplase compared with standard dose. METHODS: Data from two obse...

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Autores principales: Dong, Yi, Han, Ye, Shen, Haipeng, Wang, Yilong, Ma, Frank, Li, Hao, Wang, Yongjun, Dong, Qiang
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7804063/
https://www.ncbi.nlm.nih.gov/pubmed/32611728
http://dx.doi.org/10.1136/svn-2020-000388
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author Dong, Yi
Han, Ye
Shen, Haipeng
Wang, Yilong
Ma, Frank
Li, Hao
Wang, Yongjun
Dong, Qiang
author_facet Dong, Yi
Han, Ye
Shen, Haipeng
Wang, Yilong
Ma, Frank
Li, Hao
Wang, Yongjun
Dong, Qiang
author_sort Dong, Yi
collection PubMed
description BACKGROUND: The risk of symptomatic intracranial haemorrhage (sICH) after thrombolysis is low but severe. Lower dose of alteplase may reduce the risk of sICH. We aim to identify subsets of patients who could benefit from lower dose of alteplase compared with standard dose. METHODS: Data from two observational registries were pooled together. A total of 3479 patients who had acute ischaemic stroke were entered into the interaction tree model. The response variable was the rate of sICH per the definition of the National Institute of Neurological Disorders and Stroke Study. Clinical improvement was measured by the National Institutes of Health Stroke Scale (NIHSS) and defined as NIHSS 0 or 1 or an improvement of more than 4 points (within 7 days or at discharge). Rare event logistic regression was performed to analyse the OR of safety outcome. RESULTS: To optimise the interaction effect between tissue plasminogen activator (tPA) dosage (standard/lower) and patient subgroups, three subgroups based on the severity of stroke were identified: (1) NIHSS ≤4, (2) NIHSS between 5 and 14, and (3) NIHSS ≥15. The estimated difference of OR of having sICH was 2.71 (95% CI 0.80 to 7.69, p=0.10) for mild, 0.13 (95% CI 0.02 to 0.68, p=0.01) for moderate, and 0.65 (95% CI 0.19 to 2.55, p=0.52) for severe, respectively. In addition, patients who had moderate stroke treated with lower dose had comparable efficacy outcome (OR 1.23, 95% CI 0.71 to 2.13, p=0.45). CONCLUSION: Our analysis demonstrated that in patients who had moderate stroke, lower doses of alteplase are associated with significant sICH reduction and non-inferior performance in efficacy, compared with those in the standard dose group. TRIAL REGISTRATION NUMBER: The TIMS-China was a national prospective stroke registry on thrombolytic therapy using intravenous tPA in patients who had acute ischaemic stroke. The results were initially published in 2012 without a clinical trial registration number. The Shanghai Stroke Service System was registered at www.clinicaltrial.gov (NCT02735226).
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spelling pubmed-78040632021-01-19 Who may benefit from lower dosages of intravenous tissue plasminogen activator? Results from a cluster data analysis Dong, Yi Han, Ye Shen, Haipeng Wang, Yilong Ma, Frank Li, Hao Wang, Yongjun Dong, Qiang Stroke Vasc Neurol Original Research BACKGROUND: The risk of symptomatic intracranial haemorrhage (sICH) after thrombolysis is low but severe. Lower dose of alteplase may reduce the risk of sICH. We aim to identify subsets of patients who could benefit from lower dose of alteplase compared with standard dose. METHODS: Data from two observational registries were pooled together. A total of 3479 patients who had acute ischaemic stroke were entered into the interaction tree model. The response variable was the rate of sICH per the definition of the National Institute of Neurological Disorders and Stroke Study. Clinical improvement was measured by the National Institutes of Health Stroke Scale (NIHSS) and defined as NIHSS 0 or 1 or an improvement of more than 4 points (within 7 days or at discharge). Rare event logistic regression was performed to analyse the OR of safety outcome. RESULTS: To optimise the interaction effect between tissue plasminogen activator (tPA) dosage (standard/lower) and patient subgroups, three subgroups based on the severity of stroke were identified: (1) NIHSS ≤4, (2) NIHSS between 5 and 14, and (3) NIHSS ≥15. The estimated difference of OR of having sICH was 2.71 (95% CI 0.80 to 7.69, p=0.10) for mild, 0.13 (95% CI 0.02 to 0.68, p=0.01) for moderate, and 0.65 (95% CI 0.19 to 2.55, p=0.52) for severe, respectively. In addition, patients who had moderate stroke treated with lower dose had comparable efficacy outcome (OR 1.23, 95% CI 0.71 to 2.13, p=0.45). CONCLUSION: Our analysis demonstrated that in patients who had moderate stroke, lower doses of alteplase are associated with significant sICH reduction and non-inferior performance in efficacy, compared with those in the standard dose group. TRIAL REGISTRATION NUMBER: The TIMS-China was a national prospective stroke registry on thrombolytic therapy using intravenous tPA in patients who had acute ischaemic stroke. The results were initially published in 2012 without a clinical trial registration number. The Shanghai Stroke Service System was registered at www.clinicaltrial.gov (NCT02735226). BMJ Publishing Group 2020-07-01 /pmc/articles/PMC7804063/ /pubmed/32611728 http://dx.doi.org/10.1136/svn-2020-000388 Text en © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. http://creativecommons.org/licenses/by-nc/4.0/ http://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
spellingShingle Original Research
Dong, Yi
Han, Ye
Shen, Haipeng
Wang, Yilong
Ma, Frank
Li, Hao
Wang, Yongjun
Dong, Qiang
Who may benefit from lower dosages of intravenous tissue plasminogen activator? Results from a cluster data analysis
title Who may benefit from lower dosages of intravenous tissue plasminogen activator? Results from a cluster data analysis
title_full Who may benefit from lower dosages of intravenous tissue plasminogen activator? Results from a cluster data analysis
title_fullStr Who may benefit from lower dosages of intravenous tissue plasminogen activator? Results from a cluster data analysis
title_full_unstemmed Who may benefit from lower dosages of intravenous tissue plasminogen activator? Results from a cluster data analysis
title_short Who may benefit from lower dosages of intravenous tissue plasminogen activator? Results from a cluster data analysis
title_sort who may benefit from lower dosages of intravenous tissue plasminogen activator? results from a cluster data analysis
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7804063/
https://www.ncbi.nlm.nih.gov/pubmed/32611728
http://dx.doi.org/10.1136/svn-2020-000388
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