Major bleeding in users of direct oral anticoagulants in atrial fibrillation: A pooled analysis of results from multiple population-based cohort studies

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Standard

Major bleeding in users of direct oral anticoagulants in atrial fibrillation: A pooled analysis of results from multiple population-based cohort studies. / van den Ham, Hendrika A.; Souverein, Patrick C.; Klungel, Olaf H.; Platt, Robert W.; Ernst, Pierre; Dell'Aniello, Sophie; Schmiedl, Sven; Grave, Birgit; Rottenkolber, Marietta; Huerta, Consuelo; Martin Merino, Elisa; Leon-Munoz, Luz M.; Montero, Dolores; Andersen, Morten; Aakjaer, Mia; De Bruin, Marie L.; Gardarsdottir, Helga.

I: Pharmacoepidemiology and Drug Safety, Bind 30, Nr. 10, 2021, s. 1339-1352.

Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt

Harvard

van den Ham, HA, Souverein, PC, Klungel, OH, Platt, RW, Ernst, P, Dell'Aniello, S, Schmiedl, S, Grave, B, Rottenkolber, M, Huerta, C, Martin Merino, E, Leon-Munoz, LM, Montero, D, Andersen, M, Aakjaer, M, De Bruin, ML & Gardarsdottir, H 2021, 'Major bleeding in users of direct oral anticoagulants in atrial fibrillation: A pooled analysis of results from multiple population-based cohort studies', Pharmacoepidemiology and Drug Safety, bind 30, nr. 10, s. 1339-1352. https://doi.org/10.1002/pds.5317

APA

van den Ham, H. A., Souverein, P. C., Klungel, O. H., Platt, R. W., Ernst, P., Dell'Aniello, S., Schmiedl, S., Grave, B., Rottenkolber, M., Huerta, C., Martin Merino, E., Leon-Munoz, L. M., Montero, D., Andersen, M., Aakjaer, M., De Bruin, M. L., & Gardarsdottir, H. (2021). Major bleeding in users of direct oral anticoagulants in atrial fibrillation: A pooled analysis of results from multiple population-based cohort studies. Pharmacoepidemiology and Drug Safety, 30(10), 1339-1352. https://doi.org/10.1002/pds.5317

Vancouver

van den Ham HA, Souverein PC, Klungel OH, Platt RW, Ernst P, Dell'Aniello S o.a. Major bleeding in users of direct oral anticoagulants in atrial fibrillation: A pooled analysis of results from multiple population-based cohort studies. Pharmacoepidemiology and Drug Safety. 2021;30(10):1339-1352. https://doi.org/10.1002/pds.5317

Author

van den Ham, Hendrika A. ; Souverein, Patrick C. ; Klungel, Olaf H. ; Platt, Robert W. ; Ernst, Pierre ; Dell'Aniello, Sophie ; Schmiedl, Sven ; Grave, Birgit ; Rottenkolber, Marietta ; Huerta, Consuelo ; Martin Merino, Elisa ; Leon-Munoz, Luz M. ; Montero, Dolores ; Andersen, Morten ; Aakjaer, Mia ; De Bruin, Marie L. ; Gardarsdottir, Helga. / Major bleeding in users of direct oral anticoagulants in atrial fibrillation: A pooled analysis of results from multiple population-based cohort studies. I: Pharmacoepidemiology and Drug Safety. 2021 ; Bind 30, Nr. 10. s. 1339-1352.

Bibtex

@article{8093c113537a48c08f92b80884f537bc,
title = "Major bleeding in users of direct oral anticoagulants in atrial fibrillation: A pooled analysis of results from multiple population-based cohort studies",
abstract = "ObjectiveTo establish the risk of major bleeding in direct oral anticoagulant (DOAC) users (overall and by class) versus vitamin K antagonist (VKA) users, using health care databases from four European countries and six provinces in Canada.MethodsA retrospective cohort study was performed according to a similar protocol. First-users of VKAs or DOACs with a diagnosis of non-valvular atrial fibrillation (NVAF) were included. The main outcome of interest was major bleeding and secondary outcomes included gastrointestinal (GI) bleeding and intracranial haemorrhage (ICH). Incidence rates of events per 1000 person years were calculated. Hazard ratios (HRs) and 95% confidence intervals (95% CI) were estimated using a Cox proportional hazard regression model. Exposure and confounders were measured and analysed in a time-dependant way. Risk estimates were pooled using a random effect model.Results421 523 patients were included. The risk of major bleeding for the group of DOACs compared to VKAs showed a pooled HR of 0.94 (95% CI: 0.87–1.02). Rivaroxaban showed a modestly increased risk (HR 1.11, 95% CI: 1.06–1.16). Apixaban and dabigatran showed a decreased risk of respectively HR 0.76 (95% CI: 0.69–0.84) and HR 0.85 (95% CI: 0.75–0.96).ConclusionsThis study confirms that the risk of major bleeding of DOACs compared to VKAs is not increased when combining all DOACs. However, we observed a modest higher risk of major bleeding for rivaroxaban, whereas for apixaban and dabigatran lower risks of major bleeding were observed compared to VKAs.",
keywords = "atrial fibrillation, cohort studies, directoral anticoagulants, major bleeding, oral anticoagulants, vitamin K antagonists",
author = "{van den Ham}, {Hendrika A.} and Souverein, {Patrick C.} and Klungel, {Olaf H.} and Platt, {Robert W.} and Pierre Ernst and Sophie Dell'Aniello and Sven Schmiedl and Birgit Grave and Marietta Rottenkolber and Consuelo Huerta and {Martin Merino}, Elisa and Leon-Munoz, {Luz M.} and Dolores Montero and Morten Andersen and Mia Aakjaer and {De Bruin}, {Marie L.} and Helga Gardarsdottir",
year = "2021",
doi = "10.1002/pds.5317",
language = "English",
volume = "30",
pages = "1339--1352",
journal = "Pharmacoepidemiology and Drug Safety",
issn = "1053-8569",
publisher = "JohnWiley & Sons Ltd",
number = "10",

}

RIS

TY - JOUR

T1 - Major bleeding in users of direct oral anticoagulants in atrial fibrillation: A pooled analysis of results from multiple population-based cohort studies

AU - van den Ham, Hendrika A.

AU - Souverein, Patrick C.

AU - Klungel, Olaf H.

AU - Platt, Robert W.

AU - Ernst, Pierre

AU - Dell'Aniello, Sophie

AU - Schmiedl, Sven

AU - Grave, Birgit

AU - Rottenkolber, Marietta

AU - Huerta, Consuelo

AU - Martin Merino, Elisa

AU - Leon-Munoz, Luz M.

AU - Montero, Dolores

AU - Andersen, Morten

AU - Aakjaer, Mia

AU - De Bruin, Marie L.

AU - Gardarsdottir, Helga

PY - 2021

Y1 - 2021

N2 - ObjectiveTo establish the risk of major bleeding in direct oral anticoagulant (DOAC) users (overall and by class) versus vitamin K antagonist (VKA) users, using health care databases from four European countries and six provinces in Canada.MethodsA retrospective cohort study was performed according to a similar protocol. First-users of VKAs or DOACs with a diagnosis of non-valvular atrial fibrillation (NVAF) were included. The main outcome of interest was major bleeding and secondary outcomes included gastrointestinal (GI) bleeding and intracranial haemorrhage (ICH). Incidence rates of events per 1000 person years were calculated. Hazard ratios (HRs) and 95% confidence intervals (95% CI) were estimated using a Cox proportional hazard regression model. Exposure and confounders were measured and analysed in a time-dependant way. Risk estimates were pooled using a random effect model.Results421 523 patients were included. The risk of major bleeding for the group of DOACs compared to VKAs showed a pooled HR of 0.94 (95% CI: 0.87–1.02). Rivaroxaban showed a modestly increased risk (HR 1.11, 95% CI: 1.06–1.16). Apixaban and dabigatran showed a decreased risk of respectively HR 0.76 (95% CI: 0.69–0.84) and HR 0.85 (95% CI: 0.75–0.96).ConclusionsThis study confirms that the risk of major bleeding of DOACs compared to VKAs is not increased when combining all DOACs. However, we observed a modest higher risk of major bleeding for rivaroxaban, whereas for apixaban and dabigatran lower risks of major bleeding were observed compared to VKAs.

AB - ObjectiveTo establish the risk of major bleeding in direct oral anticoagulant (DOAC) users (overall and by class) versus vitamin K antagonist (VKA) users, using health care databases from four European countries and six provinces in Canada.MethodsA retrospective cohort study was performed according to a similar protocol. First-users of VKAs or DOACs with a diagnosis of non-valvular atrial fibrillation (NVAF) were included. The main outcome of interest was major bleeding and secondary outcomes included gastrointestinal (GI) bleeding and intracranial haemorrhage (ICH). Incidence rates of events per 1000 person years were calculated. Hazard ratios (HRs) and 95% confidence intervals (95% CI) were estimated using a Cox proportional hazard regression model. Exposure and confounders were measured and analysed in a time-dependant way. Risk estimates were pooled using a random effect model.Results421 523 patients were included. The risk of major bleeding for the group of DOACs compared to VKAs showed a pooled HR of 0.94 (95% CI: 0.87–1.02). Rivaroxaban showed a modestly increased risk (HR 1.11, 95% CI: 1.06–1.16). Apixaban and dabigatran showed a decreased risk of respectively HR 0.76 (95% CI: 0.69–0.84) and HR 0.85 (95% CI: 0.75–0.96).ConclusionsThis study confirms that the risk of major bleeding of DOACs compared to VKAs is not increased when combining all DOACs. However, we observed a modest higher risk of major bleeding for rivaroxaban, whereas for apixaban and dabigatran lower risks of major bleeding were observed compared to VKAs.

KW - atrial fibrillation

KW - cohort studies

KW - directoral anticoagulants

KW - major bleeding

KW - oral anticoagulants

KW - vitamin K antagonists

U2 - 10.1002/pds.5317

DO - 10.1002/pds.5317

M3 - Journal article

C2 - 34173286

VL - 30

SP - 1339

EP - 1352

JO - Pharmacoepidemiology and Drug Safety

JF - Pharmacoepidemiology and Drug Safety

SN - 1053-8569

IS - 10

ER -

ID: 275015536