Article Text
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.
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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.
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