Recanalization therapies in acute ischemic stroke patients: impact of prior treatment with novel oral anticoagulants on bleeding complications and outcome.

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.

• Authors: David J Seiffge, Robbert-JanVan Hooff, Christian H Nolte, Yannick Béjot, Guillaume Turc, Benno Ikenberg, Eivind Berge, Malte Persike, Nelly Dequatre-Ponchelle, Daniel Strbian, Waltraud Pfeilschifter, Andrea Zini, Arnstein Tveiten, Halvor Næss, Patrik Michel, Roman Sztajzel, Andreas Luft, Henrik Gensicke, Christopher Traenka, Lisa Hert, Jan F Scheitz, Gian Marco De Marchis, Leo H Bonati, Nils Peters, Andreas Charidimou, David J Werring, Frederick Palm, Matthias Reinhard, Wolf-Dirk Niesen, Takehiko Nagao, Alessandro Pezzini, Valeria Caso, Paul J Nederkoorn, Georg Kägi, Alexander von Hessling, Visnja Padjen, Charlotte Cordonnier, Hebun Erdur, Philippe A Lyrer, Raf Brouns, Thorsten Steiner, Turgut Tatlisumak, Stefan T Engelter, NOACISP Study Group*
• Journal: Circulation (Circulation) Vol. 132 Issue 13 Pg. 1261-9 (Sep 29 2015) ISSN: 1524-4539 [Electronic] United States
• PMID: 26232277 (Publication Type: Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
• Copyright: © 2015 American Heart Association, Inc.

Chemical References

• Anticoagulants
• Antithrombins
• Factor Xa Inhibitors
• Fibrinolytic Agents
• Vitamin K

Topics

• Acute Disease
• Administration, Oral
• Aged
• Aged, 80 and over
• Anticoagulants (administration & dosage, adverse effects, classification, therapeutic use)
• Antithrombins (administration & dosage, adverse effects, therapeutic use)
• Atrial Fibrillation (complications)
• Brain Ischemia (blood, drug therapy)
• Cerebral Hemorrhage (chemically induced, epidemiology)
• Cohort Studies
• Factor Xa Inhibitors (administration & dosage, adverse effects, therapeutic use)
• Female
• Fibrinolytic Agents (therapeutic use)
• Humans
• Incidence
• Male
• Middle Aged
• Pilot Projects
• Thrombolytic Therapy
• Treatment Outcome
• Vitamin K (antagonists & inhibitors)