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Comparative effectiveness of novel oral anticoagulants in UK patients with non-valvular atrial fibrillation and chronic kidney disease: a matched cohort study
  1. Simone Y Loo1,2,
  2. Janie Coulombe1,2,
  3. Sophie Dell’Aniello2,
  4. James M Brophy3,
  5. Samy Suissa1,2,
  6. Christel Renoux1,2,4
  1. 1 Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, Quebec, Canada
  2. 2 Centre for Clinical Epidemiology, Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada
  3. 3 Division of Cardiology, Department of Medicine, McGill University Health Centre, Montreal, Quebec, Canada
  4. 4 Department of Neurology and Neurosurgery, McGill University, Montreal, Quebec, Canada
  1. Correspondence to Dr Christel Renoux; christel.renoux{at}mcgill.ca

Abstract

Objectives To evaluate the effectiveness and safety of novel oral anticoagulants (NOACs) compared with vitamin K antagonists (VKAs) among patients with non-valvular atrial fibrillation (NVAF), particularly those with chronic kidney disease (CKD).

Design Population-based matched cohort study.

Setting Over 670 primary care practices in the UK, contributing to the Clinical Practice Research Datalink.

Participants Up to 6818 adult patients newly treated with NOACs between 2011 and 2016, matched 1:1 to new users of VKAs on age, sex and high-dimensional propensity score.

Interventions Current exposure to NOACs compared with current exposure to VKAs.

Main outcome measures HRs of ischaemic stroke and systemic embolism (SE), major bleeding, gastrointestinal (GI) bleeding, intracranial bleeding, myocardial infarction and all-cause mortality.

Results In as-treated analyses, the rates of ischaemic stroke/SE were similar between NOACs and VKAs (HR 0.94; 95% CI 0.62 to 1.42), as were the rates of major bleeding (HR 0.86; 95% CI 0.56 to 1.33). NOACs also significantly increased the risk of GI bleeding (HR 1.78; 95% CI 1.27 to 2.48). In patients with NVAF and CKD, NOACs and VKAs remained comparable with respect to the risk of ischaemic stroke/SE (HR 0.79; 95% CI 0.40 to 1.58) and major bleeding (HR 0.88; 95% CI 0.47 to 1.62), with no difference in the risk of GI bleeding (HR 0.99; 95% CI 0.63 to 1.55). Similar results were obtained in on-treatment analyses using a time-dependent exposure definition.

Conclusions Our results suggest that in the UK primary care, NOACs are overall effective and safe alternatives to VKAs, among patients with NVAF altogether, as well as in patients with NVAF and CKD.

  • cohort study
  • chronic kidney disease
  • novel oral anticoagulants
  • non-valvular atrial fibrillation
  • vitamin-k antagonist

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

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Footnotes

  • Contributors SYL contributed to the study design, conducted statistical analyses, interpreted the data, wrote the first draft of the manuscript and revised the manuscript for important intellectual content. JC conducted supplementary statistical analyses, supervised the conduct of the statistical analyses, interpreted the data and revised the manuscript for important intellectual content. SD contributed to the study design, supervised the conduct of the statistical analyses, interpreted the data and revised the manuscript for important intellectual content. JMB contributed to the study design, interpreted the data and revised the manuscript for important intellectual content. SS contributed to the study design, interpreted the data and revised the manuscript for important intellectual content. CR conceived and designed the study, supervised the conduct of the statistical analyses, interpreted the data, revised the manuscript for important intellectual content and provided supervision and funding.

  • Funding This work was supported by the Canadian Institutes of Health Research (MOP-341510). SYL is the recipient of a Frederick Banting and Charles Best Canada Graduate Scholarship from the Canadian Institutes of Health Research.

  • Competing interests SS has received research grants, participated in advisory board meetings and/or was a speaker at conferences for Bayer, Boehringer-Ingelheim and Bristol-Myers-Squibb.

  • Patient consent Not required.

  • Ethics approval This study protocol (No: 16_271R) was approved by the Independent Scientific Advisory Committee of the CPRD and the Research Ethics Committee of the Jewish General Hospital (Montreal, Canada), and was made available to journal reviewers.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data sharing statement No additional data are available.