Efficacy and safety of oral factor Xa inhibitors versus vitamin-K antagonists in the early phase after acute ischemic stroke or TIA in the real-world setting: The PRODAST study.

Autor:	Diener HC; Institute for Medical Informatics, Biometry and Epidemiology, Medical Faculty, University Duisburg-Essen, Essen, Germany., Grosse GM; Institute for Medical Informatics, Biometry and Epidemiology, Medical Faculty, University Duisburg-Essen, Essen, Germany.; Department of Neurology, Hannover Medical School, Hannover, Germany.; Department of Neurology and Stroke Center, University Hospital Basel, Basel, Switzerland., Hüsing A; Institute for Medical Informatics, Biometry and Epidemiology, Medical Faculty, University Duisburg-Essen, Essen, Germany., Stang A; Institute for Medical Informatics, Biometry and Epidemiology, Medical Faculty, University Duisburg-Essen, Essen, Germany.; School of Public Health, Department of Epidemiology Boston University, Boston, MA, United States of America., Kuklik N; Institute for Medical Informatics, Biometry and Epidemiology, Medical Faculty, University Duisburg-Essen, Essen, Germany., Brinkmann M; Institute for Medical Informatics, Biometry and Epidemiology, Medical Faculty, University Duisburg-Essen, Essen, Germany.; Center for Clinical Trials Essen, University Hospital Essen, Essen, Germany., Maurer GD; Department of Neurology, University Hospital Frankfurt, Goethe University Frankfurt, Germany., Soda H; Klinik für Akutneurologie mit Überregionaler Stroke Unit, Klinischer Neurophysiologie und Intensivmedizin, Rhön-Klinikum Campus Bad Neustadt, Bad Neustadt, Germany., Pohlmann C; Department of Neurology, Asklepios Klinik Barmbek, Hamburg, Germany., Hilker-Roggendorf R; Department of Neurology, Klinikum Vest, Recklinghausen.; Ruhr-University, Bochum, Germany., Popovic N; Department of Neurology, Evangelisches Krankenhaus Hattingen, Hattingen, Germany., Kraft P; Klinikum Main-Spessart Lohr, Germany., Mackert BM; Department of Neurology, Vivantes Auguste-Viktoria Hospital, Berlin, Germany., Eschenfelder CC; Human Pharma Germany, Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany., Weimar C; Institute for Medical Informatics, Biometry and Epidemiology, Medical Faculty, University Duisburg-Essen, Essen, Germany.; BDH Clinic Elzach, Elzach, Germany.
Jazyk:	angličtina
Zdroj:	European stroke journal [Eur Stroke J] 2024 Sep; Vol. 9 (3), pp. 696-703. Date of Electronic Publication: 2024 Apr 03.
DOI:	10.1177/23969873241242239
Abstrakt:	Introduction: Factor Xa (FXa) inhibitors are superior to vitamin K antagonists (VKAs) in terms of avoiding hemorrhagic complications. However, no robust data are available to date as to whether this also applies to the early phase after stroke. In this prospective registry study, we aimed to investigate whether anticoagulation with FXa inhibitors in the early phase after acute ischemic stroke or transient ischemic attack (TIA) is associated with a lower risk of major bleeding events compared with VKAs. Materials and Methods: The Prospective Record of the Use of Dabigatran in Patients with Acute Stroke or TIA (PRODAST) study is a prospective, multicenter, observational, post-authorization safety study at 86 German stroke units between July 2015 and November 2020. Primary outcome was a major bleeding event during hospital stay. Secondary endpoints were recurrent strokes, recurrent ischemic strokes, TIA, systemic/pulmonary embolism, myocardial infarction, death and the composite endpoint of stroke, systemic embolism, life-threatening bleeding and death. Results: In total, 10,039 patients have been recruited. 5,874 patients were treated with FXa inhibitors and 1,050 patients received VKAs and were eligible for this analysis. Overall, event rates were low. We observed 49 major bleeding complications during 33,297 treatment days with FXa-inhibitors (rate of 14.7 cases per 10,000 treatment days) and 16 cases during 7,714 treatment days with VKAs (rate of 20.7 events per 10,000 treatment days), translating into an adjusted hazard ratio (aHR) of 0.70 (95% confidence interval (95% CI): 0.37-1.32) in favor of FXa inhibitors. Hazards for ischemic endpoints (63 vs 17 strokes, aHR: 0.96 (95% CI: 0.53-1.74), mortality (33 vs 6 deaths, aHR: 0.87 (95% CI: 0.33-2.34)) and the combined endpoint (154 vs 39 events, aHR: 0.99 (95% CI: 0.65-1.41) were not substantially different. Discussion and Conclusion: This large real-world study shows that FXa inhibitors appear to be similarly effective in terms of bleeding events and ischemic endpoints compared to VKAs in the early post-stroke phase of hospitalization. However, the results need to be interpreted with caution due to the low precision of the estimates. Competing Interests: Declaration of conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: H-CD has received honoraria for participation in clinical trials, contribution to advisory boards or oral presentations from: Abbott, BMS, Boehringer Ingelheim, Daiichi-Sankyo, Novo-Nordisk, Pfizer, Portola, and WebMD Global. Boehringer Ingelheim provided financial support for research projects. H-CD received research grants from the German Research Council (DFG) and German Ministry of Education and Research (BMBF). H-CD serves as editor of Neurologie up2date, Info Neurologie & Psychiatrie and Arzneimitteltherapie, as co-editor of Cephalalgia, and on the editorial board of Lancet Neurology and Drugs. GR received speaker’s honoraria and reimbursement for congress traveling and accommodation from Boehringer-Ingelheim, Bristol-Myers Squibb, Daiichi Sankyo and Pfizer. GMG has received research grants from the German Ministry of Education and Research (BMBF), the European Commission and the Lower Saxony Ministry of Science and Culture (MWK) and received honoraria from Boehringer Ingelheim. PK reports lecture honoraria and/or study grants from Daiichi Sankyo and Pfizer, outside the submitted work. CCE is an employee of Boehringer Ingelheim. The other authors declare no conflicts of interest related to the content of the presented work.
Databáze:	MEDLINE
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