Effect of impaired kidney function on outcomes and treatment effects of oral anticoagulant regimes in patients with atrial fibrillation in a real-world registry

The impact of impaired kidney function on outcomes and treatment benefits of vitamin-K antagonists (VKA) versus direct oral anticoagulants (DOAC) in patients with atrial fibrillation (AF) has insufficiently been investigated in randomized controlled studies (RCTs). Most studies and registries are ei...

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Published inPloS one Vol. 19; no. 9; p. e0310838
Main Authors Salbach, Christian, Milles, Barbara Ruth, Hund, Hauke, Biener, Moritz, Mueller-Hennessen, Matthias, Frey, Norbert, Katus, Hugo, Giannitsis, Evangelos, Yildirim, Mustafa
Format Journal Article
LanguageEnglish
Published United States Public Library of Science 23.09.2024
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ISSN1932-6203
1932-6203
DOI10.1371/journal.pone.0310838

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Summary:The impact of impaired kidney function on outcomes and treatment benefits of vitamin-K antagonists (VKA) versus direct oral anticoagulants (DOAC) in patients with atrial fibrillation (AF) has insufficiently been investigated in randomized controlled studies (RCTs). Most studies and registries are either biased due to incomplete enrolment of consecutive patients in large pharma industry sponsored registries, or due to short recruitment periods or incomplete assessment of important variables in national registries. This study uses data from the Heidelberg Registry of Atrial Fibrillation (HERA-FIB), a retrospective single-center registry of 10,222 consecutive patients with AF presenting to the emergency department of University Hospital of Heidelberg from June 2009 until March 2020. Rates of all-cause mortality, stroke, major bleeding and myocardial infarction (MI) were related to the presence and severity of impaired presenting kidney function, as well as to assigned treatment with VKA vs. DOAC. The risks for all-cause mortality (HR: 3.26, p<0.001), stroke (HR: 1.58, p<0.001), major bleeding (HR: 2.28, p<0.001) and MI (HR: 2.48, p<0.001) were significantly higher in patients with an eGFR<60 ml/min at admission and increased with decreasing eGFR. After adjustment for variables of CHA2DS2VASc-score, presence of eGFR <60 ml/min remained as an independent predictor for all-cause mortality, major bleeding and MI. The hazard ratio (HR) for all-cause mortality, major bleedings and MI was significantly lower in patients receiving DOAC compared to VKA. Findings from our large real-life registry confirm the data from RCTs and extend our knowledge on the effectiveness and safety of DOACs to subjects that were underrepresented in RCTs.
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Competing Interests: MMH received research funding from BRAHMS, Thermo Fisher Scientific and Roche Diagnostics. MB received research support from AstraZeneca outside the submitted work. EG received honoraria for lectures from Roche Diagnostics, AstraZeneca, Bayer, Daiichi-Sankyo, Lilly Eli Deutschland. He serves as a consultant for Roche Diagnostics, BRAHMS Thermo Fisher Scientific, Boehringer Ingelheim and has received research funding from BRAHMS Thermo Fisher Scientific, Roche Diagnostics, Bayer Vital and Daiichi Sankyo. NF has received speaker honoraria from Daiichi Sankyo, Astra Zeneca, Boehringer Ingelheim and Bayer Vital. He serves as a consultant for ZOLL CMS. BRM, received research funding from Daiichi Sankyo. There are no disclosures for MY, HH and CS. We also state that the competing interests’ statement does not alter our adherence to PLOS ONE policies on sharing data and materials. All co-authors have approved the revised version of the manuscript.
ISSN:1932-6203
1932-6203
DOI:10.1371/journal.pone.0310838