Risk factors for thromboembolic and bleeding events in anticoagulated patients with atrial fibrillation: the prospective, multicentre observational PREvention oF thromboembolic events - European Registry in Atrial Fibrillation (PREFER in AF)

• Published in: BMJ open 2019-03, Vol.9 (3), p.e022478
• Main Authors: Rohla, Miklos, Weiss, Thomas W, Pecen, Ladislav, Patti, Giuseppe, Siller-Matula, Jolanta M, Schnabel, Renate B, Schilling, Richard, Kotecha, Dipak, Lucerna, Markus, Huber, Kurt, De Caterina, Raffaele, Kirchhof, Paulus
• Format: Article
• Language: English
• Subjects: Administration, Oral; Aged; Aged, 80 and over; Anticoagulants; Anticoagulants - adverse effects; Anticoagulants - therapeutic use; Atrial Fibrillation - complications; Atrial Fibrillation - drug therapy; Cardiac arrhythmia; Cardiovascular Medicine; Disease prevention; Embolisms; Europe - epidemiology; Female; Follow-Up Studies; Health risk assessment; Heart; Heart Failure - epidemiology; Heart Failure - etiology; Hemorrhage - chemically induced; Hemorrhage - epidemiology; Humans; Hypertension; International Normalized Ratio; Ischemic Attack, Transient - epidemiology; Ischemic Attack, Transient - etiology; Logistic Models; Male; Middle Aged; Multivariate Analysis; Patients; Prospective Studies; Registries; Risk Assessment; Risk Factors; Stroke; Stroke - etiology; Stroke - prevention & control; Thromboembolism; Thromboembolism - etiology; Thromboembolism - prevention & control
• ISSN: 2044-6055; 2044-6055
• DOI: 10.1136/bmjopen-2018-022478

ObjectivesWe identified factors associated with thromboembolic and bleeding events in two contemporary cohorts of anticoagulated patients with atrial fibrillation (AF), treated with either vitamin K antagonists (VKA) or non-VKA oral anticoagulants (NOACs).DesignProspective, multicentre observational study.Setting461 centres in seven European countries.Participants5310 patients receiving a VKA (PREvention oF thromboembolic events - European Registry in Atrial Fibrillation (PREFER in AF), derivation cohort) and 3156 patients receiving a NOAC (PREFER in AF Prolongation, validation cohort) for stroke prevention in AF.Outcome measuresRisk factors for thromboembolic events (ischaemic stroke, systemic embolism) and major bleeding (gastrointestinal bleeding, intracerebral haemorrhage and other life-threatening bleeding).ResultsThe mean age of patients enrolled in the PREFER in AF registry was 72±10 years, 40% were female and the mean CHA2DS2-VASc Score was 3.5±1.7. The incidence of thromboembolic and major bleeding events was 2.34% (95% CI 1.93% to 2.74%) and 2.84% (95% CI 2.41% to 3.33%) after 1-year of follow-up, respectively.Abnormal liver function, prior stroke or transient ischaemic attack, labile international normalised ratio (INR), concomitant therapy with antiplatelet or non-steroidal anti-inflammatory drugs, heart failure and older age (≥75 years) were independently associated with both thromboembolic and major bleeding events.With the exception of unstable INR values, these risk factors were validated in patients treated with NOACs (PREFER in AF Prolongation Study, 72±9 years, 40% female, CHA2DS2-VASc 3.3±1.6). For each single point decrease on a modifiable bleeding risk scale we observed a 30% lower risk for major bleeding events (OR 0.70, 95% CI 0.64 to 0.76, p