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Intravenous Thrombolysis in Patients with Stroke Taking Rivaroxaban Using Drug Specific Plasma Levels: Experience with a Standard Operation Procedure in Clinical Practice
BACKGROUND AND PURPOSE: Standard operating procedures (SOP) incorporating plasma levels of rivaroxaban might be helpful in selecting patients with acute ischemic stroke taking rivaroxaban suitable for IVthrombolysis (IVT) or endovascular treatment (EVT). METHODS: This was a single-center explorative...
Autores principales: | , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Korean Stroke Society
2017
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5647628/ https://www.ncbi.nlm.nih.gov/pubmed/28877563 http://dx.doi.org/10.5853/jos.2017.00395 |
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author | Seiffge, David J. Traenka, Christopher Polymeris, Alexandros A. Thilemann, Sebastian Wagner, Benjamin Hert, Lisa Müller, Mandy D. Gensicke, Henrik Peters, Nils Nickel, Christian H. Stippich, Christoph Sutter, Raoul Marsch, Stephan Fisch, Urs Guzman, Raphael Marchis, Gian Marco De Lyrer, Philippe A. Bonati, Leo H. Tsakiris, Dimitrios A. Engelter, Stefan T. |
author_facet | Seiffge, David J. Traenka, Christopher Polymeris, Alexandros A. Thilemann, Sebastian Wagner, Benjamin Hert, Lisa Müller, Mandy D. Gensicke, Henrik Peters, Nils Nickel, Christian H. Stippich, Christoph Sutter, Raoul Marsch, Stephan Fisch, Urs Guzman, Raphael Marchis, Gian Marco De Lyrer, Philippe A. Bonati, Leo H. Tsakiris, Dimitrios A. Engelter, Stefan T. |
author_sort | Seiffge, David J. |
collection | PubMed |
description | BACKGROUND AND PURPOSE: Standard operating procedures (SOP) incorporating plasma levels of rivaroxaban might be helpful in selecting patients with acute ischemic stroke taking rivaroxaban suitable for IVthrombolysis (IVT) or endovascular treatment (EVT). METHODS: This was a single-center explorative analysis using data from the Novel-Oral-Anticoagulants-in-Stroke-Patients-registry (clinicaltrials.gov:NCT02353585) including acute stroke patients taking rivaroxaban (September 2012 to November 2016). The SOP included recommendation, consideration, and avoidance of IVT if rivaroxaban plasma levels were <20 ng/mL, 20‒100 ng/mL, and >100 ng/mL, respectively, measured with a calibrated anti-factor Xa assay. Patients with intracranial artery occlusion were recommended IVT+EVT or EVT alone if plasma levels were ≤100 ng/mL or >100 ng/mL, respectively. We evaluated the frequency of IVT/EVT, door-to-needle-time (DNT), and symptomatic intracranial or major extracranial hemorrhage. RESULTS: Among 114 acute stroke patients taking rivaroxaban, 68 were otherwise eligible for IVT/EVT of whom 63 had plasma levels measured (median age 81 years, median baseline National Institutes of Health Stroke Scale 6). Median rivaroxaban plasma level was 96 ng/mL (inter quartile range [IQR] 18‒259 ng/mL) and time since last intake 11 hours (IQR 4.5‒18.5 hours). Twenty-two patients (35%) received IVT/EVT (IVT n=15, IVT+EVT n=3, EVT n=4) based on SOP. Median DNT was 37 (IQR 30‒60) minutes. None of the 31 patients with plasma levels >100 ng/mL received IVT. Among 14 patients with plasma levels ≤100 ng/mL, the main reason to withhold IVT was minor stroke (n=10). No symptomatic intracranial or major extracranial bleeding occurred after treatment. CONCLUSIONS: Determination of rivaroxaban plasma levels enabled IVT or EVT in one-third of patients taking rivaroxaban who would otherwise be ineligible for acute treatment. The absence of major bleeding in our pilot series justifies future studies of this approach. |
format | Online Article Text |
id | pubmed-5647628 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2017 |
publisher | Korean Stroke Society |
record_format | MEDLINE/PubMed |
spelling | pubmed-56476282017-10-23 Intravenous Thrombolysis in Patients with Stroke Taking Rivaroxaban Using Drug Specific Plasma Levels: Experience with a Standard Operation Procedure in Clinical Practice Seiffge, David J. Traenka, Christopher Polymeris, Alexandros A. Thilemann, Sebastian Wagner, Benjamin Hert, Lisa Müller, Mandy D. Gensicke, Henrik Peters, Nils Nickel, Christian H. Stippich, Christoph Sutter, Raoul Marsch, Stephan Fisch, Urs Guzman, Raphael Marchis, Gian Marco De Lyrer, Philippe A. Bonati, Leo H. Tsakiris, Dimitrios A. Engelter, Stefan T. J Stroke Original Article BACKGROUND AND PURPOSE: Standard operating procedures (SOP) incorporating plasma levels of rivaroxaban might be helpful in selecting patients with acute ischemic stroke taking rivaroxaban suitable for IVthrombolysis (IVT) or endovascular treatment (EVT). METHODS: This was a single-center explorative analysis using data from the Novel-Oral-Anticoagulants-in-Stroke-Patients-registry (clinicaltrials.gov:NCT02353585) including acute stroke patients taking rivaroxaban (September 2012 to November 2016). The SOP included recommendation, consideration, and avoidance of IVT if rivaroxaban plasma levels were <20 ng/mL, 20‒100 ng/mL, and >100 ng/mL, respectively, measured with a calibrated anti-factor Xa assay. Patients with intracranial artery occlusion were recommended IVT+EVT or EVT alone if plasma levels were ≤100 ng/mL or >100 ng/mL, respectively. We evaluated the frequency of IVT/EVT, door-to-needle-time (DNT), and symptomatic intracranial or major extracranial hemorrhage. RESULTS: Among 114 acute stroke patients taking rivaroxaban, 68 were otherwise eligible for IVT/EVT of whom 63 had plasma levels measured (median age 81 years, median baseline National Institutes of Health Stroke Scale 6). Median rivaroxaban plasma level was 96 ng/mL (inter quartile range [IQR] 18‒259 ng/mL) and time since last intake 11 hours (IQR 4.5‒18.5 hours). Twenty-two patients (35%) received IVT/EVT (IVT n=15, IVT+EVT n=3, EVT n=4) based on SOP. Median DNT was 37 (IQR 30‒60) minutes. None of the 31 patients with plasma levels >100 ng/mL received IVT. Among 14 patients with plasma levels ≤100 ng/mL, the main reason to withhold IVT was minor stroke (n=10). No symptomatic intracranial or major extracranial bleeding occurred after treatment. CONCLUSIONS: Determination of rivaroxaban plasma levels enabled IVT or EVT in one-third of patients taking rivaroxaban who would otherwise be ineligible for acute treatment. The absence of major bleeding in our pilot series justifies future studies of this approach. Korean Stroke Society 2017-09 2017-09-06 /pmc/articles/PMC5647628/ /pubmed/28877563 http://dx.doi.org/10.5853/jos.2017.00395 Text en Copyright © 2017 Korean Stroke Society This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted noncommercial use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Original Article Seiffge, David J. Traenka, Christopher Polymeris, Alexandros A. Thilemann, Sebastian Wagner, Benjamin Hert, Lisa Müller, Mandy D. Gensicke, Henrik Peters, Nils Nickel, Christian H. Stippich, Christoph Sutter, Raoul Marsch, Stephan Fisch, Urs Guzman, Raphael Marchis, Gian Marco De Lyrer, Philippe A. Bonati, Leo H. Tsakiris, Dimitrios A. Engelter, Stefan T. Intravenous Thrombolysis in Patients with Stroke Taking Rivaroxaban Using Drug Specific Plasma Levels: Experience with a Standard Operation Procedure in Clinical Practice |
title | Intravenous Thrombolysis in Patients with Stroke Taking Rivaroxaban Using Drug Specific Plasma Levels: Experience with a Standard Operation Procedure in Clinical Practice |
title_full | Intravenous Thrombolysis in Patients with Stroke Taking Rivaroxaban Using Drug Specific Plasma Levels: Experience with a Standard Operation Procedure in Clinical Practice |
title_fullStr | Intravenous Thrombolysis in Patients with Stroke Taking Rivaroxaban Using Drug Specific Plasma Levels: Experience with a Standard Operation Procedure in Clinical Practice |
title_full_unstemmed | Intravenous Thrombolysis in Patients with Stroke Taking Rivaroxaban Using Drug Specific Plasma Levels: Experience with a Standard Operation Procedure in Clinical Practice |
title_short | Intravenous Thrombolysis in Patients with Stroke Taking Rivaroxaban Using Drug Specific Plasma Levels: Experience with a Standard Operation Procedure in Clinical Practice |
title_sort | intravenous thrombolysis in patients with stroke taking rivaroxaban using drug specific plasma levels: experience with a standard operation procedure in clinical practice |
topic | Original Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5647628/ https://www.ncbi.nlm.nih.gov/pubmed/28877563 http://dx.doi.org/10.5853/jos.2017.00395 |
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