SAFIR cohort: One-year prospective follow-up of very old and frail patients treated with direct oral anticoagulant, rivaroxaban

Background Direct oral anticoagulants (DOACs) are effective to prevent strokes; however, bleeding risk of DOACs in very old and frail geriatric patients is poorly known. Purpose : To assess bleeding risk in geriatric patients aged ≥ 80 years with AF newly treated with rivaroxaban. Methods Subjects from 33 centers, with non-valvular AF newly treated with rivaroxaban were enrolled and followed-up every 3 months for 12 months. Clinical and biological data were recorded. Major bleedings were recorded at each visit. The cohort was compared with a cohort treated with vitamin K antagonists (VKA) from the same centers (n = 924). Results In total, 995 subjects had a 1-year follow-up. The mean (standard deviation (SD)) age was 86.0 (4.3) years, 23% were aged 90 years and older. 61% were women and 48% had an estimated glomerular filtration rate (eGFR)  Conclusions In this first large-scale prospective study in geriatric population with AF, major bleeding rates were significantly lower with rivaroxaban than with VKAs.