Objective Non-vitamin K oral anticoagulants (NOACs) require dose adjustment for renal function. We sought to investigate change in renal function over time in patients with atrial fibrillation (AF) and whether those on NOACs have appropriate dose adjustments according to its decline.
Methods We included patients with AF enrolled in the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation II registry treated with oral anticoagulation. Worsening renal function (WRF) was defined as a decrease of >20% in creatinine clearance (CrCl) from baseline. The US Food and Drug Administration (FDA)-approved package inserts were used to define the reduction criteria of NOACs dosing.
Results Among 6682 patients with AF from 220 sites (median age (25th, 75th): 72.0 years (65.0, 79.0); 57.1% male; median CrCl at baseline: 80.1 mL/min (57.4, 108.5)), 1543 patients (23.1%) experienced WRF with mean decline in CrCl during 2 year follow-up of −6.63 mL/min for NOACs and −6.16 mL/min for warfarin. Among 4120 patients on NOACs, 154 (3.7%) patients had a CrCl decline sufficient to warrant FDA-recommended dose reductions. Of these, NOACs dosing was appropriately reduced in only 31 (20.1%) patients. Compared with patients with appropriately reduced NOACs, those without were more likely to experience bleeding complications (major bleeding: 1.7% vs 0%; bleeding hospitalisation: 2.6% vs 0%) at 1 year.
Conclusions In the US practice, about one-fourth of patients with AF had >20% decline in CrCl over time during 2 year follow-up. As a result, about 3.7% of those treated with NOACs met guideline criteria for dose reduction, but of these, only 20.1% actually had a reduction.
- atrial fibrillation
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Contributors TI and JPP had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Study concept and design: TI, KP and JPP. Acquisition, analysis or interpretation of data: all authors. Drafting of the manuscript: TI, DNH, KP and JPP. Critical revision of the manuscript for important intellectual content: all authors. Statistical analysis: DNH and KP. Obtained funding: JPP. Administrative, technical or material support: RGB and JPP. Study supervision: KP, EDP and JPP.
Funding The Outcomes Registry for Better Informed Treatment of Atrial Fibrillation is sponsored by Janssen Scientific Affairs LLC.
Disclaimer The funders had no role in the design and conduct of the study; collection, management, analysis and interpretation of the data; preparation, review or approval of the manuscript and decision to submit the manuscript for publication.
Competing interests TI: Research Grant from Boston Scientific. LA: Contract with Janssen and Novartis. GF: Consultant/Advisory Board support from Janssen Pharmaceuticals. BJG: Member of a Data Safety Monitoring Board for Mount Sinai St. Lukes, Boston Scientific Corporation, Teva Pharmaceutical Industries, St. Jude Medical, Janssen Research & Development, Baxter Healthcare Corporation and Cardiovascular Research Foundation. Consultant/Advisory Board for Janssen Scientific Affairs, Cipla Limited, Armetheon Inc and Medtronic. EMH: Consultant: Bayer, Boehringer Ingelheim, Bristol-Myers Squibb/Pfizer, Daiichi-Sankyo, Johnson & Johnson; Research Grant from Bristol-Myers Squibb/Pfizer, Johnson & Johnson. MDE: Consultant/Advisory Board for Boehringer Ingelheim, Daiichi-Sankyo, Pfizer, Bristol-Myers Squibb and Janssen Scientific Affairs. PRK: Consultant for Johnson & Johnson. JAR: Research support from Janssen Pharmaceuticals and Medtronic Inc. Consultancies with Medtronic Inc, Acesion Pharma Aps, and Correvio Pharma Corp. GN: Research Grant from Janssen. Consultant/Advisory Board for Janssen and Daiichi-Sankyo. PC: Employee of Janssen. Consultant for Optum Rx and Johnson & Johnson. KWM: Financial disclosures can be viewed at http://med.stanford.edu/profiles/kenneth-mahaffey. DES: Consultant/Advisory Board for Boehringer Ingelheim, Bristol-Myers Squibb, Merck, Johnson & Johnson, Pfizer and Medtronic. Research Grants from Boehringer Ingelheim and Bristol-Myers Squibb. JF: Consultant/Advisory Board for Janssen Scientific. BAS: Research support from Boston Scientific and Janssen. Consult for Janssen. Speakers’ bureau income Biosense Webster. EDP: Research Grant from Janssen Pharmaceuticals and Eli Lilly. Consultant for Janssen Pharmaceuticals and Boehringer Ingelheim. JPP: Research grant from Agency for Healthcare Research and Quality, ARCA biopharma, Boston Scientific, Gilead Sciences, Janssen Pharmaceuticals, Johnson & Johnson, ResMed, Spectranetics and St Jude Medical. Consultant/Advisory Board for BMS/Pfizer, GlaxoSmithKline, Janssen Pharmaceuticals, Johnson & Johnson, Medtronic and Spectranetics.
Patient consent for publication Not required.
Ethics approval The study was approved by the institutional review board at Duke University (the coordinating centre) and each participating centre obtained local institutional review board approval. Informed consent was obtained from each participant.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement No data are available.
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