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)
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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). / 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.
in: BMJ OPEN, Jahrgang 9, Nr. 3, 30.03.2019, S. e022478.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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T1 - 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)
AU - Rohla, Miklos
AU - Weiss, Thomas W
AU - Pecen, Ladislav
AU - Patti, Giuseppe
AU - Siller-Matula, Jolanta M
AU - Schnabel, Renate B
AU - Schilling, Richard
AU - Kotecha, Dipak
AU - Lucerna, Markus
AU - Huber, Kurt
AU - De Caterina, Raffaele
AU - Kirchhof, Paulus
N1 - © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
PY - 2019/3/30
Y1 - 2019/3/30
N2 - 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.
AB - 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.
KW - Administration, Oral
KW - Aged
KW - Aged, 80 and over
KW - Anticoagulants/adverse effects
KW - Atrial Fibrillation/complications
KW - Europe/epidemiology
KW - Female
KW - Follow-Up Studies
KW - Heart Failure/epidemiology
KW - Hemorrhage/chemically induced
KW - Humans
KW - International Normalized Ratio
KW - Ischemic Attack, Transient/epidemiology
KW - Logistic Models
KW - Male
KW - Middle Aged
KW - Multivariate Analysis
KW - Prospective Studies
KW - Registries
KW - Risk Assessment
KW - Risk Factors
KW - Stroke/etiology
KW - Thromboembolism/etiology
U2 - 10.1136/bmjopen-2018-022478
DO - 10.1136/bmjopen-2018-022478
M3 - SCORING: Journal article
C2 - 30928922
VL - 9
SP - e022478
JO - BMJ OPEN
JF - BMJ OPEN
SN - 2044-6055
IS - 3
ER -