Skip to main content
SpringerLink
Log in

Direct Oral Anticoagulation Versus Warfarin in Patients with Atrial Fibrillation and Bioprosthetic Heart Valves: a Retrospective, Real-World Cohort Study

  • Original Article
  • Published:
Cardiovascular Drugs and Therapy Aims and scope Submit manuscript

Abstract

Objective

In this retrospective cohort study of consecutive patients with atrial fibrillation and surgical or transcatheter bioprosthetic valve, we compared the efficacy and safety of direct oral anticoagulants with warfarin.

Methods

Using linked health administrative databases housed at the Institute for Clinical Evaluative Sciences, we identified consecutive patients in Ontario (Canada) 65 years of age or older with AF who underwent bioprosthetic valve replacement between 1 April 2012 and 31 March 2017. We created a time-varying Cox model to examine the relationship between the type of anticoagulant and time to thrombotic or bleeding events after adjustment for baseline risk of thrombosis using the CHA2DS2-VASc score and risk of bleeding using the HAS-BLED scores. We conducted prespecified subgroup analyses according to whether valve implantation was surgical or transcatheter.

Results

We identified 2245 eligible patients. The mean age was 79 years, 41% were female, and 39% had transcatheter aortic valve replacement. Risk of death or thrombosis was not different between direct oral anticoagulants and warfarin after adjustment for CHA2DS2-VASc score (hazard ratio [HR] 1.02, 95% confidence interval [CI], 0.83–1.25). Risk of death or bleeding was not different between direct oral anticoagulants and warfarin after adjustment for HAS-BLED score (HR 0.89, 95% CI 0.75–1.07). Subgroup analyses of surgical or transcatheter valves were consistent with overall results.

Conclusions

In a real-world population of patients with atrial fibrillation and bioprosthetic valve replacement, we found no difference between direct oral anticoagulants and warfarin with regard to the risk of thrombosis or bleeding.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1

Similar content being viewed by others

Data Availability

Available upon request.

Code Availability

Not applicable.

References

  1. Kornej J, Börschel CS, Benjamin EJ, Schnabel RB. Epidemiology of atrial fibrillation in the 21st century: novel methods and new insights. Circ Res. 2020;127(1):4–20.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  2. Heart & Stroke. Atrial fibrillation. Available from: http://www.heartandstroke.ca/heart/conditions/atrial-fibrillation. Accessed 16 March 2022

  3. Kozieł M, Teutsch C, Bayer V, et al. Changes in anticoagulant prescription patterns over time for patients with atrial fibrillation around the world. J Arrhythm. 2021;37(4):990–1006.

    Article  PubMed  PubMed Central  Google Scholar 

  4. Ruff CT, Giugliano RP, Braunwald E, et al. Comparison of the efficacy and safety of new oral anticoagulants with warfarin in patients with atrial fibrillation: a meta-analysis of randomised trials. Lancet. 2014;383(9921):955–62.

    Article  CAS  PubMed  Google Scholar 

  5. Thomas KL, Jackson LR 2nd, Shrader P, et al. Prevalence, characteristics, and outcomes of valvular heart disease in patients with atrial fibrillation: insights from the ORBIT-AF (outcomes registry for better informed treatment for atrial fibrillation). J Am Heart Assoc. 2017;6(12).

  6. Banerjee A, Allan V, Denaxas S, et al. Subtypes of atrial fibrillation with concomitant valvular heart disease derived from electronic health records: phenotypes, population prevalence, trends and prognosis. Europace. 2019;21(12):1776–84.

    Article  PubMed  PubMed Central  Google Scholar 

  7. Eikelboom JW, Connolly SJ, Brueckmann M, et al. Dabigatran versus warfarin in patients with mechanical heart valves. N Engl J Med. 2013;369(13):1206–14.

    Article  CAS  PubMed  Google Scholar 

  8. Olesen JB, Lip GY, Hansen ML, et al. Validation of risk stratification schemes for predicting stroke and thromboembolism in patients with atrial fibrillation: nationwide cohort study. BMJ. 2011;342:d124.

    Article  PubMed  PubMed Central  Google Scholar 

  9. Pisters R, Lane DA, Nieuwlaat R, de Vos CB, Crijns HJ, Lip GY. A novel user-friendly score (HAS-BLED) to assess 1-year risk of major bleeding in patients with atrial fibrillation: the Euro Heart Survey. Chest. 2010;138(5):1093–100.

    Article  PubMed  Google Scholar 

  10. Otto CM, Nishimura RA, Bonow RO, et al. 2020 ACC/AHA guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2021;77(4):e25–197.

    Article  PubMed  Google Scholar 

  11. Vahanian A, Beyersdorf F, Praz F, et al. 2021 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2022;43(7):561–632.

    Article  PubMed  Google Scholar 

  12. Guimarães HP, Lopes RD, de Barros E, et al. Rivaroxaban in patients with atrial fibrillation and a bioprosthetic mitral valve. N Engl J Med. 2020;383(22):2117–26.

    Article  PubMed  Google Scholar 

  13. Afilalo J, Eisenberg MJ, Morin JF, et al. Gait speed as an incremental predictor of mortality and major morbidity in elderly patients undergoing cardiac surgery. J Am Coll Cardiol. 2010;56(20):1668–76.

    Article  PubMed  Google Scholar 

  14. Shim CY, Seo J, Kim YJ, et al. Efficacy and safety of edoxaban in patients early after surgical bioprosthetic valve implantation or valve repair: a randomized clinical trial. J Thorac Cardiovasc Surg. 2021.

  15. Van Mieghem NM, Unverdorben M, Valgimigli M, et al. Edoxaban versus standard of care and their effects on clinical outcomes in patients having undergone transcatheter aortic valve implantation in atrial fibrillation-rationale and design of the ENVISAGE-TAVI AF trial. Am Heart J. 2018;205:63–9.

    Article  PubMed  Google Scholar 

  16. Collet JP, Van Belle E, Thiele H, et al. Apixaban vs. standard of care after transcatheter aortic valve implantation: the ATLANTIS trial. Eur Heart J. 2022.

  17. Izumi C, Miyake M, Fujita T, et al. Antithrombotic therapy for patients with atrial fibrillation and bioprosthetic valves- real-world data from the multicenter, prospective, observational BPV-AF registry. Circ J. 2022;86(3):440–8.

    Article  PubMed  Google Scholar 

  18. Izumi C, Miyake M, Amano M, et al. Registry of antithrombotic therapy in atrial fibrillation patients with bioprosthetic valves: a retrospective observational study. J Cardiol. 2020;76(1):44–50.

    Article  PubMed  Google Scholar 

  19. Giugliano RP, Ruff CT, Braunwald E, et al. Edoxaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2013;369(22):2093–104.

    Article  CAS  PubMed  Google Scholar 

  20. Granger CB, Alexander JH, McMurray JJ, et al. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2011;365(11):981–92.

    Article  CAS  PubMed  Google Scholar 

  21. Kawashima H, Watanabe Y, Hioki H, et al. Direct oral anticoagulants versus vitamin K antagonists in patients with atrial fibrillation after TAVR. JACC Cardiovasc Interv. 2020;13(22):2587–97.

    Article  PubMed  Google Scholar 

  22. Young MN, Kearing S, Malenka D, Goodney PP, Skinner J, Iribarne A. Geographic and demographic variability in transcatheter aortic valve replacement dispersion in the United States. J Am Heart Assoc. 2021;10(12):e019588.

    Article  PubMed  PubMed Central  Google Scholar 

  23. Ranasinghe MP, Peter K, McFadyen JD. Thromboembolic and bleeding complications in transcatheter aortic valve implantation: insights on mechanisms, prophylaxis and therapy. J Clin Med. 2019;8(2).

Download references

Funding

This study was supported by ICES, which is funded by an annual grant from the Ontario Ministry of Health (MOH) and the Ministry of Long-Term Care (MLTC).

Author information

Authors and Affiliations

  1. Department of Surgery, Max Rady College of Medicine, University of Manitoba, Winnipeg, MB, Canada

    Rachel Eikelboom

  2. Division of Cardiac Surgery, Department of Surgery, McMaster University, Hamilton, ON, Canada

    Rachel Eikelboom & Richard P. Whitlock

  3. Dipartimento Di Cardiochirurgia, Istituto Clinico Sant’Ambrogio, Milan, Lombardy, Italy

    Serena Sibilio

  4. Institute for Clinical Evaluative Sciences McMaster, McMaster University, Hamilton, ON, Canada

    Francis Nguyen & Richard Perez

  5. Department of Medicine, McMaster University, Hamilton, ON, Canada

    Jeffrey I. Weitz

  6. Department of Biochemistry and Biomedical Sciences, McMaster University, Hamilton, ON, Canada

    Jeffrey I. Weitz

  7. Thrombosis and Atherosclerosis Research Institute, McMaster University, Hamilton, ON, Canada

    Jeffrey I. Weitz

  8. Division of Cardiology, Department of Medicine, McMaster University, Hamilton, ON, Canada

    Emilie Belley-Cote

Authors
  1. Rachel Eikelboom
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Richard P. Whitlock
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Serena Sibilio
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Francis Nguyen
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Richard Perez
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Jeffrey I. Weitz
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Emilie Belley-Cote
    View author publications

    You can also search for this author in PubMed Google Scholar

Contributions

Study conception and design, all authors. Data analysis, FN and RP. Draft manuscript preparation, RE. All authors reviewed the results and approved the final version of the manuscript.

Corresponding author

Correspondence to Rachel Eikelboom.

Ethics declarations

This study was supported by ICES, which is funded by an annual grant from the Ontario Ministry of Health (MOH) and the Ministry of Long-Term Care (MLTC). Parts of this material are based on data and information compiled and provided by CIHI and by the Ontario MOH. The analyses, conclusions, opinions, and statements expressed herein are solely those of the authors and do not reflect those of the funding or data sources; no endorsement is intended or should be inferred. The authors acknowledge that the clinical registry data used in this manuscript is from participating hospitals through CorHealth Ontario, which serves as an advisory body to the Ministry of Health (MOH), is funded by the MOH, and is dedicated to improving the quality, efficiency, access, and equity in the delivery of the continuum of adult cardiac, vascular, and stroke services in Ontario, Canada. We thank IQVIA Solutions Canada Inc. for use of their Drug Information File.

Ethics Approval

The study was approved by the Hamilton Integrated Research Ethics Board (Hamilton, Ontario, Canada).

Consent to Participate

Individual patient consent was not required because only anonymized administrative data were interrogated.

Competing Interests

The authors declare no competing interests.

Additional information

Publisher's Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

This paper was presented at the American Association for Thoracic Surgery 102nd Annual Meeting, May 14–17, 2022, Boston, MA.

Rights and permissions

Springer Nature or its licensor holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Eikelboom, R., Whitlock, R.P., Sibilio, S. et al. Direct Oral Anticoagulation Versus Warfarin in Patients with Atrial Fibrillation and Bioprosthetic Heart Valves: a Retrospective, Real-World Cohort Study. Cardiovasc Drugs Ther 38, 109–117 (2024). https://doi.org/10.1007/s10557-022-07381-5

Download citation

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s10557-022-07381-5

Keywords

Search

Navigation