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)

Abstract

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<0.01) and a 28% lower rate of thromboembolic events (OR 0.72, 95% CI 0.66 to 0.82, p<0.01).ConclusionAttending 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.

The Impact of Novel Anticoagulants on the Upper Gastrointestinal Tract Mucosa

“…Age over 75 years is generally reported as a risk factor for increased GIT bleeding [2,8,22,25], but this trend was not observed in our series. We also did not record an increased incidence of bleeding depending on the dose of NOACs.…”

“…The risk factors for bleeding are considered previous bleeding in the GIT, history of gastroduodenal ulcer, age, hypertension, heart failure, smoking, male gender, anemia, chronic obstructive bronchopulmonary disease, impaired renal and liver function, and concomitant use of antiplatelets agents or non-steroidal anti-inflammatory drugs. The risk of GIT bleeding is the highest within the first three months of treatment [2,3,7,8].…”

Direct Anticoagulants Versus Vitamin K Antagonists in Patients Aged 80 Years or Older With Atrial Fibrillation in a “Real-world” Nationwide Registry: Insights From the FANTASIIA Study

“…We found that only age and coronary artery disease were associated with embolic events in this sample of anticoagulated patients with AF aged 80 years. Previous observational and post hoc analysis of clinical trials including octogenarians 13 and a wider spectrum of age 23,24 have found those variables to be associated with this outcome, as well as other factors, as chronic kidney disease, 13 that we have not been able to confirm, possibly due to lack of statistical power. Renal failure, previous severe bleeding, and EHRA functional class II were independently associated with severe bleeding in our study.…”

A retrospective cohort study of oral anticoagulant treatment in patients with acute coronary syndrome and atrial fibrillation

“…Atrial fibrillation (AF) is the most common arrhythmia worldwide 1. It is associated with a fourfold to fivefold increased risk of ischaemic stroke 2 3. Known or new-onset AF is a common comorbidity in patients with acute coronary syndrome (ACS).…”