David J Seiffge1, Robbert-JanVan Hooff1, Christian H Nolte1, Yannick Béjot1, Guillaume Turc1, Benno Ikenberg1, Eivind Berge1, Malte Persike1, Nelly Dequatre-Ponchelle1, Daniel Strbian1, Waltraud Pfeilschifter1, Andrea Zini1, Arnstein Tveiten1, Halvor Næss1, Patrik Michel1, Roman Sztajzel1, Andreas Luft1, Henrik Gensicke1, Christopher Traenka1, Lisa Hert1, Jan F Scheitz1, Gian Marco De Marchis1, Leo H Bonati1, Nils Peters1, Andreas Charidimou1, David J Werring1, Frederick Palm1, Matthias Reinhard1, Wolf-Dirk Niesen1, Takehiko Nagao1, Alessandro Pezzini1, Valeria Caso1, Paul J Nederkoorn1, Georg Kägi1, Alexander von Hessling1, Visnja Padjen1, Charlotte Cordonnier1, Hebun Erdur1, Philippe A Lyrer1, Raf Brouns1, Thorsten Steiner1, Turgut Tatlisumak1, Stefan T Engelter1. 1. From Stroke Center and Neurology, University Hospital Basel, Switzerland (D.J.S., H.G., C.T., L.H., G.M.D.M., L.H.B., N.P., P.A.L., S.T.E.); Department of Neurology, Universitair Ziekenhuis Brussel and Center for Neurosciences (C4N), Vrije Universiteit Brussel (VUB), Belgium (R.-J.V.H., R.B.); Department of Neurology and Center for Stroke Research Charité, Berlin, Germany (C.H.N., J.F.S., H.E.); Department of Neurology, University Hospital, Dijon, France (Y.B.); Department of Neurology, Sainte-Anne Hospital, Paris, France (G.T.); Department of Neurology, Frankfurt Höchst Hospital, Germany (B.I., T.S.); Department of Internal Medicine, Oslo University Hospital, Norway (E.B.); Department of Statistical Methods, Gutenberg University, Mainz, Germany (M.P.); Department of Neurology, University Hospital, Lille, France (N.D.-P., C.C.); Department of Neurology, Helsinki University Central Hospital, Finland (D.S., T.T.); Department of Neurology, University Hospital, Frankfurt am Main, Germany (W.P.); Stroke Unit, Department of Neuroscience, S'Agostino-Estense Hospital, AUSL Modena, Italy (A.Z.); Department of Neurology, Sorlandet Sykehus Kristiansand, Norway (A.T.); Department of Neurology and Centre for Neurovascular Diseases, Haukeland University Hospital, Bergen, Norway (H.N.); Department of Neurology, University Hospital Lausanne, Switzerland (P.M.); Department of Neurology, University Hospital of Geneva and Medical School, Switzerland (R.S.); Department of Neurology, University Hospital Zurich, Switzerland (A.L.); Stroke Research Group, Department of Brain Repair and Rehabilitation, UCL Institute of Neurology and The National Hospital for Neurology and Neurosurgery, Queen Square, London, United Kingdom (A.C., D.J.W.); Department of Neurology, Municipal Hospital, Ludwigshafen, Germany (F.P.); Department of Neurology, University Hospital Freiburg, Germany (M.R., W.-D.N.); Department of Neurology, Tokyo Women's Medical University Hospital, Japan (T.N.); Department of Cli
Abstract
BACKGROUND: We explored the safety of intravenous thrombolysis (IVT) or intra-arterial treatment (IAT) in patients with ischemic stroke on non-vitamin K antagonist oral anticoagulants (NOACs, last intake <48 hours) in comparison with patients (1) taking vitamin K antagonists (VKAs) or (2) without previous anticoagulation (no-OAC). METHODS AND RESULTS: This is a multicenter cohort pilot study. Primary outcome measures were (1) occurrence of intracranial hemorrhage (ICH) in 3 categories: any ICH (ICHany), symptomatic ICH according to the criteria of the European Cooperative Acute Stroke Study II (ECASS-II) (sICHECASS-II) and the National Institute of Neurological Disorders and Stroke (NINDS) thrombolysis trial (sICHNINDS); and (2) death (at 3 months). Cohorts were compared by using propensity score matching. Our NOAC cohort comprised 78 patients treated with IVT/IAT and the comparison groups of 441 VKA patients and 8938 no-OAC patients. The median time from last NOAC intake to IVT/IAT was 13 hours (interquartile range, 8-22 hours). In VKA patients, median pre-IVT/IAT international normalized ratio was 1.3 (interquartile range, 1.1-1.6). ICHany was observed in 18.4% NOAC patients versus 26.8% in VKA patients and 17.4% in no-OAC patients. sICHECASS-II and sICHNINDS occurred in 2.6%/3.9% NOAC patients, in comparison with 6.5%/9.3% of VKA patients and 5.0%/7.2% of no-OAC patients, respectively. At 3 months, 23.0% of NOAC patients in comparison with 26.9% of VKA patients and 13.9% of no-OAC patients had died. Propensity score matching revealed no statistically significant differences. CONCLUSIONS: IVT/IAT in selected patients with ischemic stroke under NOAC treatment has a safety profile similar to both IVT/IAT in patients on subtherapeutic VKA treatment or in those without previous anticoagulation. However, further prospective studies are needed, including the impact of specific coagulation tests.
BACKGROUND: We explored the safety of intravenous thrombolysis (IVT) or intra-arterial treatment (IAT) in patients with ischemic stroke on non-vitamin K antagonist oral anticoagulants (NOACs, last intake <48 hours) in comparison with patients (1) taking vitamin K antagonists (VKAs) or (2) without previous anticoagulation (no-OAC). METHODS AND RESULTS: This is a multicenter cohort pilot study. Primary outcome measures were (1) occurrence of intracranial hemorrhage (ICH) in 3 categories: any ICH (ICHany), symptomatic ICH according to the criteria of the European Cooperative Acute Stroke Study II (ECASS-II) (sICHECASS-II) and the National Institute of Neurological Disorders and Stroke (NINDS) thrombolysis trial (sICHNINDS); and (2) death (at 3 months). Cohorts were compared by using propensity score matching. Our NOAC cohort comprised 78 patients treated with IVT/IAT and the comparison groups of 441 VKA patients and 8938 no-OACpatients. The median time from last NOAC intake to IVT/IAT was 13 hours (interquartile range, 8-22 hours). In VKA patients, median pre-IVT/IAT international normalized ratio was 1.3 (interquartile range, 1.1-1.6). ICHany was observed in 18.4% NOACpatients versus 26.8% in VKA patients and 17.4% in no-OACpatients. sICHECASS-II and sICHNINDS occurred in 2.6%/3.9% NOACpatients, in comparison with 6.5%/9.3% of VKA patients and 5.0%/7.2% of no-OACpatients, respectively. At 3 months, 23.0% of NOACpatients in comparison with 26.9% of VKA patients and 13.9% of no-OACpatients had died. Propensity score matching revealed no statistically significant differences. CONCLUSIONS: IVT/IAT in selected patients with ischemic stroke under NOAC treatment has a safety profile similar to both IVT/IAT in patients on subtherapeutic VKA treatment or in those without previous anticoagulation. However, further prospective studies are needed, including the impact of specific coagulation tests.
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