Bleeding risk with rivaroxaban compared with vitamin K antagonists in patients aged 80 years or older with atrial fibrillation. Issue 17 (1st December 2020)

• Record Type: Journal Article
• Authors: Hanon, Olivier; Vidal, Jean-Sébastien; Pisica-Donose, George; Orvoën, Galdric; David, Jean-Philippe; Chaussade, Edouard; Caillard, Laure; de Jong, Laura W; Boulloche, Nicolas; Vinsonneau, Ulric; Bouée, Stéphane; Krolak-Salmon, Pierre; Fauchier, Laurent; Jouanny, Pierre; Sacco, Guillaume; Bellarbre, Fabienne; Belmin, Joël; Puisieux, François; Lilamand, Matthieu; Paillaud, Elena; Boureau, Anne Sophie
• Other Names: author non-byline.; Hanon Olivier author non-byline.; Boureau Anne-Sophie author non-byline.; Berrut Gilles author non-byline.; Galdric Orvoën author non-byline.; David Jean-Philippe author non-byline.; Chaussade Édouard author non-byline.; Caillard Laure author non-byline.; Boulloche Nicolas author non-byline.; Vinsonneau Ulric author non-byline.; Villejoubert Olivier author non-byline.; Krolak-Salmon Pierre author non-byline.; Joseph Thierry author non-byline.; Fauchier Laurent author non-byline.; Pinzani Alain author non-byline.; Mottier Dominique author non-byline.; Trinh Olivier author non-byline.; Boully Clémence author non-byline.; Crawford-Achour Émilie author non-byline.; Range Gregoire author non-byline.; Jouanny Pierre author non-byline.; Sacco Guillaume author non-byline.; Galimard Xavier author non-byline.; Lilamand Matthieu author non-byline.; Paillaud Elena author non-byline.; Le Maitre Thierry author non-byline.; Guerin Olivier author non-byline.; Bonnefoy Marc author non-byline.; Mahe Isabelle author non-byline.; Boudali Yasmina author non-byline.; Hallet-Lezy Anne-Marie author non-byline.; Belmin Joël author non-byline.; Toulza Olivier author non-byline.; Debray Mathieu author non-byline.; Aimouch Naceur author non-byline.; Barone-Rochette Gilles author non-byline.; Routon Xavier author non-byline.; Chachoua Karim author non-byline.; Merceron Martine author non-byline.; Lenoir Hermine author non-byline.; Assemat Éric author non-byline.; Delcourt Amélie author non-byline.; Paccalin Marc author non-byline.; Bellarbre Fabienne author non-byline.; Dauffy-Allain Agnès author non-byline.; Mage Évelyne author non-byline.; Michel Jean-Marc author non-byline.; Duron-Garnier Emmanuelle author non-byline.; Dubail Delphine author non-byline.; Antakly-Hanon Yara author non-byline.; Alaoui Youssef author non-byline.; Cayre-Portron Florence author non-byline.; Poncelet Pascal author non-byline.; Desormais Ileana author non-byline.; Deharo Jean-Claude author non-byline.; Joly Laure author non-byline.; Labourée Florian author non-byline.; Anard-Michelot Hélène author non-byline.; Friocourt Patrick author non-byline.; Diop Aminata author non-byline.; Chahwakilian Anne author non-byline.; Kerzazi Mohammed author non-byline.; Cailleaux Pierre-Emmanuel author non-byline.; Roche Nicolas author non-byline.; Standish-Chesnel Brigitte author non-byline.; Despres Jérémie author non-byline.; Lambert Sybile author non-byline.; Puisieux François author non-byline.; Vidal Jean-Sébastien author non-byline.; de Jong Laura W author non-byline.; Pisica-Donose George author non-byline.; Mismetti Patrick author non-byline.;
• Is Part Of: Heart. Volume 107:Issue 17(2021)
• Page Start: 1376
• Page End: 1382
• Publication Date: 2020-12-01
• Subjects: atrial fibrillation -- epidemiology -- pharmacology; Heart -- Diseases -- Treatment -- Periodicals; Cardiology -- Periodicals; 616.12
• DOI: 10.1136/heartjnl-2020-317923
• Languages: English
• ISSNs: 1355-6037

Abstract

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.