Edoxaban for stroke prevention in atrial fibrillation and age-adjusted predictors of clinical outcomes in routine clinical care

Abstract Aims Patients with atrial fibrillation (AF) treated with oral anticoagulation still suffer from cardiovascular complications including cardiovascular death, stroke, and major bleeding. To identify risk factors for predicting stroke and bleeding outcomes in anticoagulated patients, we assess...

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Veröffentlicht in:European heart journal. Cardiovascular pharmacotherapy 2023-01, Vol.9 (1), p.47-57
Hauptverfasser: Kirchhof, Paulus, Pecen, Ladislav, Bakhai, Ameet, de Asmundis, Carlo, de Groot, Joris R, Deharo, Jean Claude, Kelly, Peter, Levy, Pierre, Lopez-de-Sa, Esteban, Monteiro, Pedro, Steffel, Jan, Waltenberger, Johannes, Weiss, Thomas W, Laeis, Petra, Manu, Marius Constantin, Souza, José, De Caterina, Raffaele
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container_title European heart journal. Cardiovascular pharmacotherapy
container_volume 9
creator Kirchhof, Paulus
Pecen, Ladislav
Bakhai, Ameet
de Asmundis, Carlo
de Groot, Joris R
Deharo, Jean Claude
Kelly, Peter
Levy, Pierre
Lopez-de-Sa, Esteban
Monteiro, Pedro
Steffel, Jan
Waltenberger, Johannes
Weiss, Thomas W
Laeis, Petra
Manu, Marius Constantin
Souza, José
De Caterina, Raffaele
description Abstract Aims Patients with atrial fibrillation (AF) treated with oral anticoagulation still suffer from cardiovascular complications including cardiovascular death, stroke, and major bleeding. To identify risk factors for predicting stroke and bleeding outcomes in anticoagulated patients, we assessed 2-year outcomes in patients with AF treated with edoxaban in routine care. We also report the age-adjusted risk predictors of clinical outcomes. Methods and results The Edoxaban Treatment in Routine Clinical Practice for Patients With Non-Valvular Atrial Fibrillation (ETNA-AF) Europe (NCT02944019) is a prospective, multi-centre, post-authorisation, observational study with an overall 4-year follow-up conducted in 825 centres enrolling edoxaban-treated patients in 10 European countries. Of the 13 133 patients with AF (mean age: 73.6 ± 9.5 years), 5682 (43.3%) were female. At the 2-year follow-up, 9017/13 133 patients were still on edoxaban; 1830 discontinued treatment including 937 who died (annualised event rate of all-cause death was 3.87%). 518 (2.14%) patients died of cardiovascular causes; 234 (0.97%) experienced major bleeding and 168 (0.70%) experienced stroke or systemic embolic events (SEE). Intracranial haemorrhage was noted in 49 patients (0.20%). History of transient ischaemic attack (TIA) at baseline was the strongest predictor of ischaemic stroke or SEE (Wald χ2: 73.63; P 
doi_str_mv 10.1093/ehjcvp/pvac042
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To identify risk factors for predicting stroke and bleeding outcomes in anticoagulated patients, we assessed 2-year outcomes in patients with AF treated with edoxaban in routine care. We also report the age-adjusted risk predictors of clinical outcomes. Methods and results The Edoxaban Treatment in Routine Clinical Practice for Patients With Non-Valvular Atrial Fibrillation (ETNA-AF) Europe (NCT02944019) is a prospective, multi-centre, post-authorisation, observational study with an overall 4-year follow-up conducted in 825 centres enrolling edoxaban-treated patients in 10 European countries. Of the 13 133 patients with AF (mean age: 73.6 ± 9.5 years), 5682 (43.3%) were female. At the 2-year follow-up, 9017/13 133 patients were still on edoxaban; 1830 discontinued treatment including 937 who died (annualised event rate of all-cause death was 3.87%). 518 (2.14%) patients died of cardiovascular causes; 234 (0.97%) experienced major bleeding and 168 (0.70%) experienced stroke or systemic embolic events (SEE). Intracranial haemorrhage was noted in 49 patients (0.20%). History of transient ischaemic attack (TIA) at baseline was the strongest predictor of ischaemic stroke or SEE (Wald χ2: 73.63; P &lt; 0.0001). Low kidney function at baseline was the strongest predictor of major bleeding (Wald χ2: 30.68; P &lt; 0.0001). History of heart failure (HF) was the strongest predictor of all-cause (Wald χ2: 146.99; P &lt; 0.0001) and cardiovascular death (Wald χ2: 100.38; P &lt; 0.0001). Conclusion Patients treated with edoxaban in ETNA-AF-Europe reported low 2-year event rates in unselected AF patients. Prior stroke, reduced kidney function, and HF identify patients at high risk of stroke, bleeding and all-cause/cardiovascular death, respectively. 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Cardiovascular pharmacotherapy, 2023-01, Vol.9 (1), p.47-57</ispartof><rights>The Author(s) 2022. Published by Oxford University Press on behalf of the European Society of Cardiology. 2022</rights><rights>The Author(s) 2022. 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Cardiovascular pharmacotherapy</title><addtitle>Eur Heart J Cardiovasc Pharmacother</addtitle><description>Abstract Aims Patients with atrial fibrillation (AF) treated with oral anticoagulation still suffer from cardiovascular complications including cardiovascular death, stroke, and major bleeding. To identify risk factors for predicting stroke and bleeding outcomes in anticoagulated patients, we assessed 2-year outcomes in patients with AF treated with edoxaban in routine care. We also report the age-adjusted risk predictors of clinical outcomes. Methods and results The Edoxaban Treatment in Routine Clinical Practice for Patients With Non-Valvular Atrial Fibrillation (ETNA-AF) Europe (NCT02944019) is a prospective, multi-centre, post-authorisation, observational study with an overall 4-year follow-up conducted in 825 centres enrolling edoxaban-treated patients in 10 European countries. Of the 13 133 patients with AF (mean age: 73.6 ± 9.5 years), 5682 (43.3%) were female. At the 2-year follow-up, 9017/13 133 patients were still on edoxaban; 1830 discontinued treatment including 937 who died (annualised event rate of all-cause death was 3.87%). 518 (2.14%) patients died of cardiovascular causes; 234 (0.97%) experienced major bleeding and 168 (0.70%) experienced stroke or systemic embolic events (SEE). Intracranial haemorrhage was noted in 49 patients (0.20%). History of transient ischaemic attack (TIA) at baseline was the strongest predictor of ischaemic stroke or SEE (Wald χ2: 73.63; P &lt; 0.0001). Low kidney function at baseline was the strongest predictor of major bleeding (Wald χ2: 30.68; P &lt; 0.0001). History of heart failure (HF) was the strongest predictor of all-cause (Wald χ2: 146.99; P &lt; 0.0001) and cardiovascular death (Wald χ2: 100.38; P &lt; 0.0001). Conclusion Patients treated with edoxaban in ETNA-AF-Europe reported low 2-year event rates in unselected AF patients. Prior stroke, reduced kidney function, and HF identify patients at high risk of stroke, bleeding and all-cause/cardiovascular death, respectively. Graphical Abstract Graphical Abstract Age-adjusted predictors of clinical outcomes in the ETNA-AF-Europe Registry.</description><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Anticoagulants</subject><subject>Anticoagulants - adverse effects</subject><subject>Atrial fibrillation</subject><subject>Atrial Fibrillation - complications</subject><subject>Atrial Fibrillation - diagnosis</subject><subject>Atrial Fibrillation - drug therapy</subject><subject>Brain Ischemia - prevention &amp; control</subject><subject>Cardiac arrhythmia</subject><subject>Care and treatment</subject><subject>Clinical outcomes</subject><subject>Embolism</subject><subject>Factor Xa Inhibitors</subject><subject>Female</subject><subject>Heart Failure - drug therapy</subject><subject>Hemorrhage - chemically induced</subject><subject>Humans</subject><subject>Ischemia</subject><subject>Male</subject><subject>Medical equipment and supplies industry</subject><subject>Medical research</subject><subject>Medical test kit industry</subject><subject>Medicine, Experimental</subject><subject>Middle Aged</subject><subject>Patient outcomes</subject><subject>Pharmaceutical industry</subject><subject>Prevention</subject><subject>Prospective Studies</subject><subject>Stroke</subject><subject>Stroke (Disease)</subject><subject>Stroke - diagnosis</subject><subject>Stroke - epidemiology</subject><subject>Stroke - prevention &amp; 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Pecen, Ladislav ; Bakhai, Ameet ; de Asmundis, Carlo ; de Groot, Joris R ; Deharo, Jean Claude ; Kelly, Peter ; Levy, Pierre ; Lopez-de-Sa, Esteban ; Monteiro, Pedro ; Steffel, Jan ; Waltenberger, Johannes ; Weiss, Thomas W ; Laeis, Petra ; Manu, Marius Constantin ; Souza, José ; De Caterina, Raffaele</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c464t-4041e8b22a9c26d01f36e862e24fa19715f49291d9c4acab75e09acba88cb343</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Anticoagulants</topic><topic>Anticoagulants - adverse effects</topic><topic>Atrial fibrillation</topic><topic>Atrial Fibrillation - complications</topic><topic>Atrial Fibrillation - diagnosis</topic><topic>Atrial Fibrillation - drug therapy</topic><topic>Brain Ischemia - prevention &amp; control</topic><topic>Cardiac arrhythmia</topic><topic>Care and treatment</topic><topic>Clinical outcomes</topic><topic>Embolism</topic><topic>Factor Xa Inhibitors</topic><topic>Female</topic><topic>Heart Failure - drug therapy</topic><topic>Hemorrhage - chemically induced</topic><topic>Humans</topic><topic>Ischemia</topic><topic>Male</topic><topic>Medical equipment and supplies industry</topic><topic>Medical research</topic><topic>Medical test kit industry</topic><topic>Medicine, Experimental</topic><topic>Middle Aged</topic><topic>Patient outcomes</topic><topic>Pharmaceutical industry</topic><topic>Prevention</topic><topic>Prospective Studies</topic><topic>Stroke</topic><topic>Stroke (Disease)</topic><topic>Stroke - diagnosis</topic><topic>Stroke - epidemiology</topic><topic>Stroke - prevention &amp; 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Cardiovascular pharmacotherapy</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Kirchhof, Paulus</au><au>Pecen, Ladislav</au><au>Bakhai, Ameet</au><au>de Asmundis, Carlo</au><au>de Groot, Joris R</au><au>Deharo, Jean Claude</au><au>Kelly, Peter</au><au>Levy, Pierre</au><au>Lopez-de-Sa, Esteban</au><au>Monteiro, Pedro</au><au>Steffel, Jan</au><au>Waltenberger, Johannes</au><au>Weiss, Thomas W</au><au>Laeis, Petra</au><au>Manu, Marius Constantin</au><au>Souza, José</au><au>De Caterina, Raffaele</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Edoxaban for stroke prevention in atrial fibrillation and age-adjusted predictors of clinical outcomes in routine clinical care</atitle><jtitle>European heart journal. Cardiovascular pharmacotherapy</jtitle><addtitle>Eur Heart J Cardiovasc Pharmacother</addtitle><date>2023-01-01</date><risdate>2023</risdate><volume>9</volume><issue>1</issue><spage>47</spage><epage>57</epage><pages>47-57</pages><issn>2055-6837</issn><issn>2055-6845</issn><eissn>2055-6845</eissn><abstract>Abstract Aims Patients with atrial fibrillation (AF) treated with oral anticoagulation still suffer from cardiovascular complications including cardiovascular death, stroke, and major bleeding. To identify risk factors for predicting stroke and bleeding outcomes in anticoagulated patients, we assessed 2-year outcomes in patients with AF treated with edoxaban in routine care. We also report the age-adjusted risk predictors of clinical outcomes. Methods and results The Edoxaban Treatment in Routine Clinical Practice for Patients With Non-Valvular Atrial Fibrillation (ETNA-AF) Europe (NCT02944019) is a prospective, multi-centre, post-authorisation, observational study with an overall 4-year follow-up conducted in 825 centres enrolling edoxaban-treated patients in 10 European countries. Of the 13 133 patients with AF (mean age: 73.6 ± 9.5 years), 5682 (43.3%) were female. At the 2-year follow-up, 9017/13 133 patients were still on edoxaban; 1830 discontinued treatment including 937 who died (annualised event rate of all-cause death was 3.87%). 518 (2.14%) patients died of cardiovascular causes; 234 (0.97%) experienced major bleeding and 168 (0.70%) experienced stroke or systemic embolic events (SEE). Intracranial haemorrhage was noted in 49 patients (0.20%). History of transient ischaemic attack (TIA) at baseline was the strongest predictor of ischaemic stroke or SEE (Wald χ2: 73.63; P &lt; 0.0001). Low kidney function at baseline was the strongest predictor of major bleeding (Wald χ2: 30.68; P &lt; 0.0001). History of heart failure (HF) was the strongest predictor of all-cause (Wald χ2: 146.99; P &lt; 0.0001) and cardiovascular death (Wald χ2: 100.38; P &lt; 0.0001). Conclusion Patients treated with edoxaban in ETNA-AF-Europe reported low 2-year event rates in unselected AF patients. Prior stroke, reduced kidney function, and HF identify patients at high risk of stroke, bleeding and all-cause/cardiovascular death, respectively. Graphical Abstract Graphical Abstract Age-adjusted predictors of clinical outcomes in the ETNA-AF-Europe Registry.</abstract><cop>England</cop><pub>Oxford University Press</pub><pmid>35881467</pmid><doi>10.1093/ehjcvp/pvac042</doi><tpages>11</tpages><orcidid>https://orcid.org/0000-0002-2417-9880</orcidid><orcidid>https://orcid.org/0000-0002-1881-0197</orcidid><orcidid>https://orcid.org/0000-0002-1477-9153</orcidid><orcidid>https://orcid.org/0000-0001-9827-3178</orcidid><orcidid>https://orcid.org/0000-0003-1637-574X</orcidid><oa>free_for_read</oa></addata></record>
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ispartof European heart journal. Cardiovascular pharmacotherapy, 2023-01, Vol.9 (1), p.47-57
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source MEDLINE; Oxford University Press Journals All Titles (1996-Current); PubMed Central
subjects Aged
Aged, 80 and over
Anticoagulants
Anticoagulants - adverse effects
Atrial fibrillation
Atrial Fibrillation - complications
Atrial Fibrillation - diagnosis
Atrial Fibrillation - drug therapy
Brain Ischemia - prevention & control
Cardiac arrhythmia
Care and treatment
Clinical outcomes
Embolism
Factor Xa Inhibitors
Female
Heart Failure - drug therapy
Hemorrhage - chemically induced
Humans
Ischemia
Male
Medical equipment and supplies industry
Medical research
Medical test kit industry
Medicine, Experimental
Middle Aged
Patient outcomes
Pharmaceutical industry
Prevention
Prospective Studies
Stroke
Stroke (Disease)
Stroke - diagnosis
Stroke - epidemiology
Stroke - prevention & control
Treatment Outcome
title Edoxaban for stroke prevention in atrial fibrillation and age-adjusted predictors of clinical outcomes in routine clinical care
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