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)
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 observation...
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BMJ Publishing Group
2019-03-01
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| author | Raffaele De Caterina Kurt Huber Richard Schilling Miklos Rohla Thomas W Weiss Ladislav Pecen Giuseppe Patti Jolanta M Siller-Matula Renate B Schnabel Dipak Kotecha Markus Lucerna Paulus Kirchhof |
| author_facet | Raffaele De Caterina Kurt Huber Richard Schilling Miklos Rohla Thomas W Weiss Ladislav Pecen Giuseppe Patti Jolanta M Siller-Matula Renate B Schnabel Dipak Kotecha Markus Lucerna Paulus Kirchhof |
| author_sort | Raffaele De Caterina |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-00c84c7694034da5a411fcec05dc63ee |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2019-03-01 |
| publisher | BMJ Publishing Group |
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| spelling | doaj-art-00c84c7694034da5a411fcec05dc63ee2025-02-12T03:10:15ZengBMJ Publishing GroupBMJ Open2044-60552019-03-019310.1136/bmjopen-2018-022478Risk 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)Raffaele De Caterina0Kurt Huber1Richard Schilling2Miklos Rohla3Thomas W Weiss4Ladislav Pecen5Giuseppe Patti6Jolanta M Siller-Matula7Renate B Schnabel8Dipak Kotecha9Markus Lucerna10Paulus Kirchhof1111 University of Pisa and Division of Cardiology, Pisa University Hospital, Pisa, Italy10 Medical School, Sigmund Freud University, Vienna, AustriaDepartment of Cardiac Electrophysiology, Barts Health NHS Trust, London, UK1 3rd Medical Department, Cardiology and Intensive Care Medicine, Wilhelminen Hospital, Vienna, Austria2 Institute for Cardiometabolic Diseases, Karl Landsteiner Society, St. Pölten, Austria4 Cardiology, Medical Faculty Pilsen, Charles University, Pilsen, Czech RepublicDipartimento di MedicinaTraslazionale, Università del Piemonte Orientale, Novara, ItalyDepartment of Clinical Pharmacology, Medical University of Vienna, Austria7 University Heart Center Hamburg, Clinic for General and Interventional Cardiology, Hamburg, Germany and DZHK (German Center for Cardiovascular Research), partner site Hamburg/Kiel/Luebeck, Hamburg, GermanyDepartment of Cardiovascular Sciences, University of Birmingham, Birmingham, UK10 Daiichi Sankyo Europe, Munich, Germany9 University of Birmingham Institute of Cardiovascular Sciences, University of Birmingham, UHB and SWBH NHS Trusts, Birmingham, UKObjectives 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.https://bmjopen.bmj.com/content/9/3/e022478.full |
| spellingShingle | Raffaele De Caterina Kurt Huber Richard Schilling Miklos Rohla Thomas W Weiss Ladislav Pecen Giuseppe Patti Jolanta M Siller-Matula Renate B Schnabel Dipak Kotecha Markus Lucerna Paulus Kirchhof 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) BMJ Open |
| title | 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) |
| title_full | 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) |
| title_fullStr | 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) |
| title_full_unstemmed | 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) |
| title_short | 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) |
| title_sort | 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 |
| url | https://bmjopen.bmj.com/content/9/3/e022478.full |
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