Major bleeding risk associated with oral anticoagulant in real clinical practice. A multicentre 3‐year period population‐based prospective cohort study
| Autor: | Emmanuel Oger, Lucie-Marie Scailteux, Maxime Maignan, Laure Pavageau, Jacques Bouget, Emmanuel Nowak, Karine Lacut, Pierre-Marie Roy, Frédéric Balusson |
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| Přispěvatelé: | Recherche en Pharmaco-épidémiologie et Recours aux Soins (REPERES), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-École des Hautes Études en Santé Publique [EHESP] (EHESP), CHU Grenoble, Centre hospitalier universitaire de Nantes (CHU Nantes), Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM), CIC Brest, Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Hôpital de la Cavale Blanche, Université de Rennes (UR)-École des Hautes Études en Santé Publique [EHESP] (EHESP) |
| Rok vydání: | 2020 |
| Předmět: |
Adult
medicine.medical_specialty Gastrointestinal bleeding Vitamin K [SDV]Life Sciences [q-bio] Population Administration Oral Hemorrhage 030226 pharmacology & pharmacy Dabigatran Cohort Studies 03 medical and health sciences 0302 clinical medicine Rivaroxaban oral anticoagulant Internal medicine Atrial Fibrillation medicine Humans Pharmacology (medical) Prospective Studies 030212 general & internal medicine education Prospective cohort study Aged Pharmacology education.field_of_study real-world data business.industry Hazard ratio Anticoagulants Atrial fibrillation Original Articles [SDV.SP]Life Sciences [q-bio]/Pharmaceutical sciences medicine.disease 3. Good health Stroke major bleeding Female Apixaban business medicine.drug |
| Zdroj: | Br J Clin Pharmacol British Journal of Clinical Pharmacology British Journal of Clinical Pharmacology, Wiley, 2020, 86 (12), pp.2519-2529. ⟨10.1111/bcp.14362⟩ British Journal of Clinical Pharmacology, 2020, 86 (12), pp.2519-2529. ⟨10.1111/bcp.14362⟩ |
| ISSN: | 1365-2125 0306-5251 |
| DOI: | 10.1111/bcp.14362 |
| Popis: | International audience; Aims: The objective was to compare major bleeding risk of direct oral anticoagulants (DOACs; per type and dose) with vitamin K antagonists (VKAs), irrespective of indication, using real-world data.Methods: A population-based prospective cohort study, using the French national health data system (SNIIRAM), identified 47 469 adults living within 5 well-defined geographical areas, who were new users of oral anticoagulants in the period 2013-2015: 20 205 VKA users, 19 579 rivaroxaban users, 4225 dabigatran users and 3460 apixaban users. From all emergency departments within these areas, clinical data for all adults referred for bleeding was collected and medically validated. The databases were linked for common key variables. The main outcome measure was major bleeding: intracranial haemorrhage, major gastrointestinal bleeding and other major bleeding events. Hazard ratios were derived from adjusted Cox proportional hazard models. We used propensity score weighting as a sensitivity analysis, with separate analyses according to indications (atrial fibrillation or venous thromboembolism).Results: Compared to VKAs, high and low-dose DOACs were associated with a reduced risk of intracranial haemorrhage (adjusted hazard ratio 0.55, 95% confidence interval 0.37-0.82 and 0.54, 0.26-1.12 respectively), and a reduced risk of other major bleeding events (0.41, 0.29-0.58 and 0.41, 0.22-0.79 respectively), irrespective of duration and indication. Neither DOAC dose evidenced any significant difference from VKAs in terms of risk of major gastrointestinal bleeding.Conclusion: There is a clear benefit of using DOACs with regard to intracranial haemorrhage. The study provides new insight into major gastrointestinal and other major bleeding events. |
| Databáze: | OpenAIRE |
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