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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

Seiffge, David J. and Traenka, Christopher and Polymeris, Alexandros A. and Thilemann, Sebastian and Wagner, Benjamin and Hert, Lisa and Müller, Mandy D. and Gensicke, Henrik and Peters, Nils and Nickel, Christian H. and Stippich, Christoph and Sutter, Raoul and Marsch, Stephan and Fisch, Urs and Guzman, Raphael and Marchis, Gian Marco De and Lyrer, Philippe A. and Bonati, Leo H. and Tsakiris, Dimitrios A. and Engelter, Stefan T.. (2017) Intravenous Thrombolysis in Patients with Stroke Taking Rivaroxaban Using Drug Specific Plasma Levels: Experience with a Standard Operation Procedure in Clinical Practice. Journal of Stroke, 19 (3). pp. 347-355.

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Official URL: http://edoc.unibas.ch/56438/

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Abstract

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.
Faculties and Departments:03 Faculty of Medicine
03 Faculty of Medicine > Bereich Medizinische Fächer (Klinik)
03 Faculty of Medicine > Departement Klinische Forschung > Bereich Medizinische Fächer (Klinik)
03 Faculty of Medicine > Bereich Medizinische Fächer (Klinik) > Intensivmedizin > Intensivmedizin (Marsch)
03 Faculty of Medicine > Departement Klinische Forschung > Bereich Medizinische Fächer (Klinik) > Intensivmedizin > Intensivmedizin (Marsch)
03 Faculty of Medicine > Bereich Medizinische Fächer (Klinik) > Neurologie
03 Faculty of Medicine > Departement Klinische Forschung > Bereich Medizinische Fächer (Klinik) > Neurologie
UniBasel Contributors:Sutter, Raoul Christian
Item Type:Article, refereed
Article Subtype:Research Article
Publisher:Korean Stroke Society
ISSN:2287-6391
e-ISSN:2287-6405
Note:Publication type according to Uni Basel Research Database: Journal article
Identification Number:
Last Modified:25 Oct 2017 09:20
Deposited On:25 Oct 2017 09:20

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