Feasibility of rapid measurement of Rivaroxaban plasma levels in patients with acute stroke
- 329 Downloads
Plasma levels of Rivaroxaban (RivLev) might be useful to guide therapeutic decisions in patients with acute stroke under Rivaroxaban. A prerequisite for the potential clinical usefulness is their rapid availability in emergency situations. Single-center explorative analysis from the Novel-Oral-Anticoagulants-in-Stroke-Patients-registry (NOACISP, cinicaltrials.gov:NCT02353585). We included consecutive patients with acute ischemic or hemorrhagic stroke under Rivaroxaban (last intake <48 h) in which RivLev determined by an automated anti-factor Xa-based chromogenic assay (Hyphen-Biomed, France) are available. Primary endpoint was the turnaround time (TAT), defined as time from registration of the blood sample in the lab to first result published. Furthermore, we studied, whether TAT is influenced by (1) on- and off-hour-measurements and (2) early versus later patient arrival (cut-off: 270 min after symptom onset). Thirty-eight patients met the eligibility criteria (mean age 77 years, 44 % female). TAT was 34 min (IQR 29–65 min). TATs were similar for on- (n = 14; median 34 min; IQR 30–56 min) and off-hours-TATs (n = 24; median 35 min; IQR 29–75 min) as well as for early (n = 16; median 33 min; IQR 30–40 min) and late patient arrival (n = 22, median 34 min, IQR 28–58 min; all nonsignificant.). Taking into account RivLev in the decision process about the use of intravenous thrombolysis, three patients received intravenous thrombolysis on an individualized basis, none of them with bleeding complications. Emergency measurement of RivLev among patients with acute stroke is available within a median of 34 min and therefore feasible for ED use. Due to the rapid availability, further research to evaluate the role of RivLev in order to guide acute treatment decisions is warranted.
KeywordsRivaroxaban Stroke Plasma levels Emergency measurement
The NOACISP registry was supported by a grant from the Swiss Heart Foundation. David J. Seiffge was supported by a fellowship for excellent young researchers from the University of Basel.
Study concept and design: David J. Seiffge, Dimitrios Tsakiris and Stefan Engelter. Funding: David J. Seiffge and Stefan Engelter. Data acquisition: all authors. Data analysis and interpretation: David J. Seiffge, Dimitrios Tsakiris and Stefan Engelter. Drafting of the manuscript: David J. Seiffge and Stefan Engelter. Critical review of manuscript for important intellectual content: all authors. Supervision of the study/registry: Dimitrios Tsakiris and Stefan Engelter.
Compliance with ethical standards
Conflict of interest
Christopher Traenka, Lisa Hert, Alexandros Polymeris, Christian H. Nickel, Urs Fisch, Raphael Guzman and Dimitrios Tsakiris have no conflicts of interest.
David J. Seiffge has received funding from the Swiss Heart Foundation, the Science Funds of the University Hospital Basel and the University of Basel and served on a scientific advisory board for Bayer. Nils Peters has received travel honoraria from Boehringer-Ingelheim, honoraria for advisory board from Bayer, Boehringer-Ingelheim and BMS/Pfizer as well as funding from Bayer, Boehringer-Ingelheim, BMS/Pfizer, CSL Behring, Covidien and Eisai. Leo H Bonati has received funding from the Swiss National Science Foundation, the University of Basel, and the Swiss Heart Foundation, received travel honoraria from Bayer and served on scientific advisory boards for Bayer. Gian Marco De Marchis was supported by the following grants: Swiss National Science Foundation; Swisslife Jubiläumsstiftung for Medical Research; Swiss Neurological Society; Bangerter-Rhyner-Stiftung; Fondazione Dr. Ettore Balli (Switzerland); travel honoraria by Bayer; De Quervain research grant for young clinical investigators of the Clinical Trial Unit, University of Bern (Switzerland). Philipp A. Lyrer has served on scientific advisory boards for Bayer, Daiichi-Sankyo, Schering Pharma, and Boehringer Ingelheim has received funding for travel or speaker honoraria from Bayer Schering Pharma, Boehringer Ingelheim, and Shire plc; he has received research support from AstraZeneca, Boehringer Ingelheim, Sanofi-aventis, PhotoThera, the Swiss National Science Foundation, and the Swiss Heart Foundation. Stefan Engelter has received funding for travel or speaker honoraria from Bayer and Boehringer Ingelheim, he has served on scientific advisory boards for Bayer, Boehringer Ingelheim, BMS/Pfizer, and Covidien and on the editorial board of Stroke. He has received an educational grant from Pfizer and research support from the Science Funds [Wissenschaftsfonds] of the University Hospital Basel, the University Basel, the Swiss Heart Foundation, and the Swiss National Science Foundation.
- 8.Mueck W, Lensing AW, Agnelli G, Decousus H, Prandoni P, Misselwitz F (2011) Rivaroxaban: population pharmacokinetic analyses in patients treated for acute deep-vein thrombosis and exposure simulations in patients with atrial fibrillation treated for stroke prevention. Clin Pharmacokinet 50:675–686CrossRefPubMedGoogle Scholar
- 15.Reilly PA, Lehr T, Haertter S et al (2014) The effect of dabigatran plasma concentrations and patient characteristics on the frequency of ischemic stroke and major bleeding in atrial fibrillation patients: the RE-LY Trial (randomized evaluation of long-term anticoagulation therapy). J Am Coll Cardiol 63:321–328CrossRefPubMedGoogle Scholar