Brunet-Bernard, Anne, Maréchaux, Sylvestre, Fauchier, Laurent, Guiot, Aurélie, Fournet, Maxime, Reynaud, Amélie, Schnell, Frédéric, Leclercq, Christophe, Mabo, Philippe, Donal, Erwan, Lip, Gregory Y.H., Haguenoer, Ken, Saint-Etienne, Christophe, CIC-IT Rennes, Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Laboratoire Traitement du Signal et de l'Image (LTSI), Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM), Groupement Hospitalier de l'Institut Catholique de Lille, Faculté Libre de Médecine de Lille (FLM), Institut Catholique de Lille (ICL), Université catholique de Lille (UCL)-Université catholique de Lille (UCL)-Institut Catholique de Lille (ICL), Université catholique de Lille (UCL)-Université catholique de Lille (UCL)-UC Lille, Service de Cardiologie B, Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Éducation Éthique Santé EA 7505 (EES), Université de Tours (UT), Service de cardiologie et maladies vasculaires [Rennes] = Cardiac, Thoracic, and Vascular Surgery [Rennes], CHU Pontchaillou [Rennes], Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité (CRESS (U1153 / UMR_A_1125 / UMR_S_1153)), and Institut National de la Recherche Agronomique (INRA)-Université Paris Diderot - Paris 7 (UPD7)-Université Paris Descartes - Paris 5 (UPD5)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)
BACKGROUND The efficacy and safety of anticoagulation with use of vitamin K antagonists (VKAs) is highly dependent on the quality of anticoagulation control as reflected by the average time in a therapeutic range of 2.0 to 3.0. A clinical dilemma is trying to predict which anticoagulation-naive patients with atrial fibrillation (AF) would do well on a VKA (with a time in therapeutic range > 70%) and which are less likely to do well on a VKA but could be managed with novel oral anticoagulants. METHODS The cohort comprised 8,120 patients, among whom 4,637 patients were receiving VKA. We investigated whether the SAMe-TT2 R2(sex female, age RESULTS During a mean follow-up of 1,016 ± 1,108 days, there was a significant increase in risk of severe bleeding events (risk ratio [RR], 1.38; 95% CI, 1.12-2.68;P= .002) and a significant increase in risk of major BARC bleeding (RR, 1.77; 95% CI, 1.29-2.44;P= .0005) in patients with AF with a high SAMe-TT2 R2 score (> 2). Increasing SAMe-TT2 R2 score was associated with an increasing risk of labile INR (P= .004), stroke/TE (P= .007), severe bleeding (P CONCLUSIONS We demonstrate that the SAMe-TT2 R2 score was predictive for an increasing risk of stroke/TE, severe bleeding, major BARC bleeding, and death, reflecting poor anticoagulation control (and labile INRs) among patients with AF given VKAs.