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Valvular heart disease
Original research
Direct oral anticoagulants versus vitamin K antagonist after transcatheter aortic valve implantation
  1. Christopher Hohmann1,
  2. Roman Pfister1,
  3. Christian Frerker2,3,
  4. Andreas Beckmann4,
  5. Thomas Walther5,6,
  6. Sabine Bleiziffer7,
  7. Stephan Ensminger8,9,
  8. Raffi Bekeredjian10,
  9. Moritz Seiffert3,11,
  10. Jan-Malte Sinning12,
  11. Helge Möllmann13,
  12. Friedhelm Beyersdorf14,15,
  13. Stephan Baldus1,
  14. Andreas Böning16,
  15. Eva Herrmann5,17,
  16. Ümniye Balaban5,17,
  17. Elmar Kuhn16,18
  18. for the GARY Executive Board
  1. 1 Department III of Internal Medicine, Heart Center, Faculty of Medicine and University Hospital of Cologne, Cologne, Germany
  2. 2 Department of Cardiology, Vascular Medicine and Intensive Care, University Hospital Schleswig-Holstein, Lübeck, Germany
  3. 3 German Center for Cardiovascular Research DZHK, Partner Site Hamburg/Kiel/Lübeck, Hamburg, Germany
  4. 4 Department of Cardiac Surgery, Heart Centre Duisburg, Evangelisches Krankenhaus Niederrhein, Heinrich-Heine-Universität Düsseldorf, Dusseldorf, Germany
  5. 5 German Center for Cardiovascular Research, DZHK, Partner Site Rhine-Main, Rhine-Main, Germany
  6. 6 Department of Cardiothoracic Surgery, University Hospital Frankfurt am Main, Frankfurt am Main, Germany
  7. 7 Department of Cardiothoracic Surgery, Heart and Diabetes Center NRW, University Hospital of the Ruhr-University Bochum, Bad Oeynhausen, Germany
  8. 8 Department of Cardiac and Thoracic Vascular Surgery, University Hospital SchleswigHolstein, Lübeck, Germany
  9. 9 German Center for Cardiovascular Research DZHK, Partner Site Hamburg/Kiel/Lübeck, Lübeck, Germany
  10. 10 Department of Cardiology, Robert-Bosch Hospital, Stuttgart, Germany
  11. 11 University Heart and Vascular Center Hamburg, Hamburg, Germany
  12. 12 Department of Cardiology, St. Vinzenz-Hospital Cologne, Cologne, Germany
  13. 13 Department of Cardiology, St. Johannes Hospital, Dortmund, Germany
  14. 14 Department of Cardiovascular Surgery, University Heart Center Freiburg-Bad Krozingen, University Hospital Freiburg, Freiburg, Germany
  15. 15 Medical Faculty of the Albert-Ludwigs-University Freiburg, Freiburg, Germany
  16. 16 Department of Cardiothoracic Surgery, University Hospital Giessen, Giessen, Germany
  17. 17 Institute of Biostatistics and Mathematical Modelling, University Hospital Frankfurt am Main, Frankfurt am Main, Germany
  18. 18 Department of Cardiothoracic Surgery, Heart Center, Faculty of Medicine and University Hospital of Cologne, Cologne, Germany
  1. Correspondence to Dr Christopher Hohmann, University Hospital Cologne, Cologne 50937, Germany; christopher.hohmann{at}uk-koeln.de

Abstract

Objective After transcatheter aortic valve implantation (TAVI), the optimal regimen of anticoagulant therapy in patients with an additional indication for oral anticoagulation remains a matter of debate. This study investigates the efficacy of direct oral anticoagulants (DOACs) versus vitamin K antagonists (VKAs) in patients after TAVI in a real-world population.

Methods The German Aortic Valve RegistrY (GARY) is a prospective, multicentre registry enrolling patients undergoing invasive treatment for aortic valve disease. From January 2011 to December 2019, 1 41 790 patients from 92 hospitals in Germany were enrolled. Anticoagulatory treatment regimens were assessed at hospital discharge for patients after TAVI procedures. All-cause mortality and the combined endpoint ‘cardiac and cerebrovascular events’ containing myocardial infarction, stroke, transient ischaemic attack, aortic prosthesis reintervention and all-cause mortality in the first year after TAVI were examined by treatment regimen.

Results Of 45 598 patients (mean age 80.7±5.7 years, 49.3% males) undergoing TAVI, 16 974 patients (37.2%) received an anticoagulant regimen that included VKA or DOAC. Hereof, the majority of patients were prescribed VKA (n=11 333, 66.8%) compared with DOAC (n=5641, 33.2%) with an increase of DOAC use from 9.4% in 2011 to 69.9% in 2019. During the 1-year follow-up, the absolute event rates per 100 person-years for all-cause mortality and the combined endpoint cardiac and cerebrovascular events were 1.9 and 1.3 for VKA-treated and 1.7 and 1.2 for DOAC-treated patients, respectively. After adjustment for baseline confounders, all-cause mortality (HR 0.95, 95% CI 0.88 to 1.01, p=0.114) and cardiac and cerebrovascular event-free survival (HR 0.93, 95% CI 0.86 to 1.01, p=0.071) did not differ significantly between VKA and DOAC groups.

Conclusions This study supports evidence of the efficacy of DOAC use after TAVI in patients with an indication for oral anticoagulation.

  • heart valve prosthesis
  • transcatheter aortic valve replacement

Data availability statement

All data relevant to the study are included in the article or uploaded as supplementary information. Data of this study may not be available because of the ongoing projects using these data.

https://doi.org/10.1136/heartjnl-2023-322548

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    Data availability statement

    All data relevant to the study are included in the article or uploaded as supplementary information. Data of this study may not be available because of the ongoing projects using these data.

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    Footnotes

    • Presented at Parts of the results of this work were presented at the 89th Annual Meeting of the German Cardiac Society (DGK) in Mannheim, Germany, in April 2023.

    • Contributors CH and RP conceived the idea of this study and formulated the study design. EH and ÜB performed the statistical analysis. CH, RP, CF and AB supervised the analysis. CH drafted the manuscript. All authors critically reviewed the manuscript and approved the final draft. CH, CF and AB accept full responsibility for the work and the conduct of the study, have access to the data and control the decision to publish. CH as the guarantor accepts full responsibility for the work and/or the conduct of the study, had access to the data, and controlled the decision to publish.

    • Funding The German Aortic Valve RegistrY is supported by the DGK and DGTHG and receives unrestricted grants by medical device companies, the German Heart Foundation and the German Centre for Cardiovascular Research (DZHK).

    • Competing interests None declared.

    • Patient and public involvement Patients and/or the public were not involved in the design, conduct, reporting or dissemination plans of this research.

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

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.