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Arrhythmias and sudden death
Original research
Bleeding risk with rivaroxaban compared with vitamin K antagonists in patients aged 80 years or older with atrial fibrillation
  1. Olivier Hanon1,
  2. Jean-Sébastien Vidal1,
  3. George Pisica-Donose1,2,
  4. Galdric Orvoën1,
  5. Jean-Philippe David3,
  6. Edouard Chaussade1,
  7. Laure Caillard1,
  8. Laura W de Jong4,
  9. Nicolas Boulloche5,
  10. Ulric Vinsonneau6,
  11. Stéphane Bouée7,
  12. Pierre Krolak-Salmon8,
  13. Laurent Fauchier9,
  14. Pierre Jouanny10,
  15. Guillaume Sacco11,
  16. Fabienne Bellarbre12,
  17. Joël Belmin13,
  18. François Puisieux14,
  19. Matthieu Lilamand15,
  20. Elena Paillaud16,
  21. Anne Sophie Boureau17
  22. SAFIR study group
    1. 1 Hôpital Broca, Service de Gérontologie, Assistance Publique – Hopitaux de Paris and EA 4468, Université de Paris, F-75013 Paris, France
    2. 2 Medalice, F-78560 Le Port Marly, France
    3. 3 Hôpital Henri Mondor, Service de Gériatrie, Assistance Publique – Hopitaux de Paris and Inserm U955, Université Paris Est Créteil (UPEC), F-94000 Créteil, France
    4. 4 Service de Radiologie, Groupe hospitalier Sainte-Anne, F-75014 Paris, France
    5. 5 Centre Hospitalier de Montauban, F-82000 Montauban, France
    6. 6 Service de Cardiologie, Hôpital d'Instruction des Armées Clermont-Tonnerre, F-29240 Brest, France
    7. 7 CEMKA, F-92340 Bourg-la-Reine, France
    8. 8 Centre de Recherche Clinique Vieillissement Cerveau - Fragilité, CHU Lyon, F-69000 Lyon, France
    9. 9 Service de Cardiologie, Hôpital Trousseau and Université François-Rabelais, F-37170 Chambray-les-Tours, France
    10. 10 Centre Champmaillot, Service de Médecine Interne Gériatrie, CHU de Dijon, F-21000 Dijon, France
    11. 11 Hôpital de Cimiez, Pole de Gérontologie, CHU de Nice, F-06003 Nice, France
    12. 12 Hôpital de la Milétrie, Service de Gériatrie, CHU de Poitiers, F-86000 Poitiers, France
    13. 13 Hôpital Charles Foix, Service de Gériatrie, Assistance Publique – Hôpitaux de Paris and Université de Paris, F-94400 Ivry-sur-Seine, France
    14. 14 Hôpital Gériatrique Les Bateliers, Pôle de gérontologie, CHRU de Lille, F-59000 Lille, France
    15. 15 Hôpital Bichat, Service de Gériatrie, Assistance Publique – Hôpitaux de Paris and Université de Paris, F-75018 Paris, Paris
    16. 16 Hôpital Européen Georges Pompidou, Service de Gériatrie, Assistance Publique – Hôpitaux de Paris and Université de Paris, F-75015 Paris, France
    17. 17 Hôpital Bellier, Pole Hospitalo-Universitaire de Gérontologie Clinique, CHU de Nantes, F-44000 Nantes, France
    1. Correspondence to Professor Olivier Hanon, Service de Gérontologie, Hôpital Broca, 75013 Paris, France; olivier.hanon{at}aphp.fr

    Abstract

    Objective Direct oral anticoagulants have been evaluated in the general population, but proper evidence for their safe use in the geriatric population is still missing. We compared the bleeding risk of a direct oral anticoagulant (rivaroxaban) and vitamin K antagonists (VKAs) among French geriatric patients with non-valvular atrial fibrillation (AF) aged ≥80 years.

    Methods We performed a sequential observational prospective cohort study, using data from 33 geriatric centres. The sample comprised 908 patients newly initiated on VKAs between September 2011 and September 2014 and 995 patients newly initiated on rivaroxaban between September 2014 and September 2017. Patients were followed up for up to 12 months. One-year risks of major, intracerebral, gastrointestinal bleedings, ischaemic stroke and all-cause mortality were compared between rivaroxaban-treated and VKA-treated patients with propensity score matching and Cox models.

    Results Major bleeding risk was significantly lower in rivaroxaban-treated patients (7.4/100 patient-years) compared with VKA-treated patients (14.6/100 patient-years) after multivariate adjustment (HR 0.66; 95% CI 0.43 to 0.99) and in the propensity score–matched sample (HR 0.53; 95% CI 0.33 to 0.85). Intracerebral bleeding occurred less frequently in rivaroxaban-treated patients (1.3/100 patient-years) than in VKA-treated patients (4.0/100 patient-years), adjusted HR 0.59 (95% CI 0.24 to 1.44) and in the propensity score–matched sample HR 0.26 (95% CI 0.09 to 0.80). Major lower bleeding risk was largely driven by lower risk of intracerebral bleeding.

    Conclusions Our study findings indicate that bleeding risk, largely driven by lower risk of intracerebral bleeding, is lower with rivaroxaban than with VKA in stroke prevention in patients ≥80 years old with non-valvular AF.

    • atrial fibrillation
    • epidemiology
    • pharmacology

    Data availability statement

    Data are available on reasonable request. The data underlying this article are subject to an embargo of 24 months from the publication date of the article. Once the embargo expires, the data underlying this article will be shared on reasonable request to the corresponding author.

    https://doi.org/10.1136/heartjnl-2020-317923

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      Data availability statement

      Data are available on reasonable request. The data underlying this article are subject to an embargo of 24 months from the publication date of the article. Once the embargo expires, the data underlying this article will be shared on reasonable request to the corresponding author.

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      Footnotes

      • Contributors OH: conception and design, acquisition of data, interpretation of data; drafting the article; final approval of the version to be published. J-SV: analysis and interpretation of data; drafting the article; final approval of the version to be published. GP-D: conception and design; revising the article critically for important intellectual content; final approval of the version to be published. GO: acquisition of data; revising the article critically for important intellectual content; final approval of the version to be published. J-PD: acquisition of data; revising the article critically for important intellectual content; final approval of the version to be published. EC: acquisition of data; revising the article critically for important intellectual content; final approval of the version to be published. LC: acquisition of data; revising the article critically for important intellectual content; final approval of the version to be published. LWdJ: interpretation of data; revising the article critically for important intellectual content; final approval of the version to be published. NB: acquisition of data; revising the article critically for important intellectual content; final approval of the version to be published. UV: acquisition of data; revising the article critically for important intellectual content; final approval of the version to be published. SB: conception and design; revising the article critically for important intellectual content; final approval of the version to be published. PK-S, acquisition of data; revising the article critically for important intellectual content; final approval of the version to be published. LF: acquisition of data; revising the article critically for important intellectual content; final approval of the version to be published. PJ: acquisition of data; revising the article critically for important intellectual content; final approval of the version to be published. GS: acquisition of data; revising the article critically for important intellectual content; final approval of the version to be published. FB: acquisition of data; revising the article critically for important intellectual content; final approval of the version to be published. JB: acquisition of data; revising the article critically for important intellectual content; final approval of the version to be published. FP: acquisition of data; revising the article critically for important intellectual content; final approval of the version to be published. ML: acquisition of data; revising the article critically for important intellectual content; final approval of the version to be published. EP: acquisition of data; revising the article critically for important intellectual content; final approval of the version to be published. ASB: conception and design, acquisition of data; revising the article critically for important intellectual content; final approval of the version to be published.

      • Funding This work was supported by an unrestricted grant from Bayer HealthCare, France.

      • Competing interests OH received personal fees from Bayer Healthcare, Servier, Astra-Zeneca, Boston Scientific, Vifor, BMS, Pfizer and Boehringer Ingelheim. J-SV received fees from Bayer for non-profit medical association. SB received grant from Bayer. LF received personal fees from Bayer Healthcare, Boehringer Ingelheim, BMS – Pfizer, Medtronic and Novartis. PJ received personal fees from Pfizer. GS received fees from Smeka for non-profit medical association. FB received non-financial support from Bristol-Myers Squibb and Bayer Healthcare. JB received personal fees and non-financial support from Pfizer and Novartis. FP received personal fees from Bayer Healthcare, BMS – Pfizer, Boehringer Ingelheim, Daiichi Sankyo and Novartis. EP received personal fees from Bayer Healthcare, LeoPharma, BMS – Pfizer and received non-financial support from Nutrica. ML, J-PD, EC, GO, GP-D, NB, LWdJ, LC, PK-S, ASB and UV have nothing to disclose.

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

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

      • Author note SAFIR study group: bleeding risk in elderly Subjects Aged more than 80 years in atrial FIbrillation treated by Rivaroxaban