Clemens Küpper1, Katharina Feil1,2,3, Frank Arne Wollenweber4, Steffen Tiedt5, Moriz Herzberg6, Franziska Dorn6,7, Thomas Liebig6, Marianne Dieterich1,2,8, Lars Kellert9. 1. Department of Neurology, Ludwig-Maximilians University, Marchioninistraße 15, 81377, Munich, Germany. 2. German Center for Vertigo and Balance Disorders, Ludwig-Maximilians University, Munich, Germany. 3. Department of Neurology and Stroke, Eberhard-Karls University Tübingen, Universitätsklinikum Tübingen (UKT), Tübingen, Germany. 4. Helios Dr. Horst Schmidt Kliniken Wiesbaden, Wiesbaden, Germany. 5. Institute for Stroke and Dementia Research, University Hospital, Ludwig-Maximilians University, Munich, Germany. 6. Institute of Neuroradiology, Ludwig-Maximilians University, Munich, Germany. 7. Department of Neuroradiology, University of Bonn, Bonn, Germany. 8. Munich Cluster for Systems Neurology (SyNergy), Munich, Germany. 9. Department of Neurology, Ludwig-Maximilians University, Marchioninistraße 15, 81377, Munich, Germany. Lars.Kellert@med.uni-muenchen.de.
Abstract
BACKGROUND: Endovascular treatment (ET) in orally anticoagulated (OAC) patients has not been evaluated in randomized clinical trials and data regarding this issue are sparse. METHODS: We analyzed data from the German Stroke Registry-Endovascular Treatment (GSR-ET; NCT03356392, date of registration: 22 Nov 2017). The primary outcomes were successful reperfusion defined as modified thrombolysis in cerebral infarction (mTICI 2b-3), good outcome at 3 months (modified Rankin scale [mRS] 0-2 or back to baseline), and intracranial hemorrhage (ICH) on follow-up imaging at 24 h analyzed by unadjusted univariate and adjusted binary logistic regression analysis. Additionally, we analyzed mortality at 3 months with adjusted binary logistic regression analysis. RESULTS: Out of 6173 patients, there were 1306 (21.2%) OAC patients, 479 (7.8%) with vitamin K antagonists (VKA) and 827 (13.4%) with non-vitamin K antagonist oral anticoagulation (NOAC). The control group consisted of 4867 (78.8%) non-OAC patients. ET efficacy with the rates of mTICI 2b-3 was similar among the three groups (85.6%, 85.3% vs 84.3%, p = 0.93 and 1). On day 90, good outcome was less frequent in OAC patients (27.8%, 27.9% vs 39.5%, p < 0.005 and < 0.005). OAC status was not associated with ICH at 24 h (NOAC: odd's ratio [OR] 0.89, 95% confidence interval [CI] 0.67-1.20; VKA: OR 1.04, CI 0.75-1.46). Binary logistic regression analysis revealed no influence of OAC status on good outcome at 3 months (NOAC: OR 1.25, CI 0.99-1.59; VKA: OR 1.18, CI 0.89-1.56) and mortality at 3 months (NOAC: OR 1.03, CI 0.81-1.30; VKA: OR 1.04, CI 0.78-1.1.37). CONCLUSIONS: ET can be performed safely and successfully in LVO stroke patients treated with OAC. CLINICAL TRIAL REGISTRATION-URL: http://www.clinicaltrials.gov . Unique identifier: NCT03356392.
BACKGROUND: Endovascular treatment (ET) in orally anticoagulated (OAC) patients has not been evaluated in randomized clinical trials and data regarding this issue are sparse. METHODS: We analyzed data from the German Stroke Registry-Endovascular Treatment (GSR-ET; NCT03356392, date of registration: 22 Nov 2017). The primary outcomes were successful reperfusion defined as modified thrombolysis in cerebral infarction (mTICI 2b-3), good outcome at 3 months (modified Rankin scale [mRS] 0-2 or back to baseline), and intracranial hemorrhage (ICH) on follow-up imaging at 24 h analyzed by unadjusted univariate and adjusted binary logistic regression analysis. Additionally, we analyzed mortality at 3 months with adjusted binary logistic regression analysis. RESULTS: Out of 6173 patients, there were 1306 (21.2%) OACpatients, 479 (7.8%) with vitamin K antagonists (VKA) and 827 (13.4%) with non-vitamin K antagonist oral anticoagulation (NOAC). The control group consisted of 4867 (78.8%) non-OACpatients. ET efficacy with the rates of mTICI 2b-3 was similar among the three groups (85.6%, 85.3% vs 84.3%, p = 0.93 and 1). On day 90, good outcome was less frequent in OACpatients (27.8%, 27.9% vs 39.5%, p < 0.005 and < 0.005). OAC status was not associated with ICH at 24 h (NOAC: odd's ratio [OR] 0.89, 95% confidence interval [CI] 0.67-1.20; VKA: OR 1.04, CI 0.75-1.46). Binary logistic regression analysis revealed no influence of OAC status on good outcome at 3 months (NOAC: OR 1.25, CI 0.99-1.59; VKA: OR 1.18, CI 0.89-1.56) and mortality at 3 months (NOAC: OR 1.03, CI 0.81-1.30; VKA: OR 1.04, CI 0.78-1.1.37). CONCLUSIONS:ET can be performed safely and successfully in LVO strokepatients treated with OAC. CLINICAL TRIAL REGISTRATION-URL: http://www.clinicaltrials.gov . Unique identifier: NCT03356392.
Entities:
Keywords:
Endovascular treatment; Ischemic stroke; Large vessel occlusion; Oral anticoagulation