OBJECTIVES: We 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). DESIGN: Prospective, multicentre observational study. SETTING: 461 centres in seven European countries. PARTICIPANTS: 5310 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 MEASURES: Risk factors for thromboembolic events (ischaemic stroke, systemic embolism) and major bleeding (gastrointestinal bleeding, intracerebral haemorrhage and other life-threatening bleeding). RESULTS: The 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<0.01) and a 28% lower rate of thromboembolic events (OR 0.72, 95% CI 0.66 to 0.82, p<0.01). CONCLUSION: Attending to modifiable risk factors is an important treatment target in anticoagulated AF patients to reduce thromboembolic and bleeding events. Initiation of anticoagulation in those at risk of stroke should not be prevented by elevated bleeding risk scores.

3rd Medical Department Cardiology and Intensive Care Medicine Wilhelminen Hospital Vienna Austria Cardiology Sigmund Freud University Medical School Vienna Austria

3rd Medical Department Cardiology and Intensive Care Medicine Wilhelminen Hospital Vienna Austria Institute for Cardiometabolic Diseases Karl Landsteiner Society St Pölten Austria

Cardiology Medical Faculty Pilsen Charles University Pilsen Czech Republic

Daiichi Sankyo Europe Munich Germany

Department of Cardiology Medical University of Vienna Vienna Austria

Department of Cardiology St Bartholomew's Hospital London UK

Department of Cardiovascular Sciences Campus Bio Medico University of Rome Rome Italy

Institute for Cardiometabolic Diseases Karl Landsteiner Society St Pölten Austria Cardiology Sigmund Freud University Medical School Vienna Austria

University Heart Center Hamburg Clinic for General and Interventional Cardiology Hamburg Germany and DZHK partner site Hamburg Kiel Luebeck Hamburg Germany

University of Birmingham Institute of Cardiovascular Sciences University of Birmingham UHB and SWBH NHS Trusts Birmingham UK

University of Pisa and Division of Cardiology Pisa University Hospital Pisa Italy

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