Abstract
The risk of bleeding in atrial fibrillation patients on direct oral anticoagulant treatment increases with age; particularly dabigatran is associated with a higher risk of gastrointestinal bleeding in elderly patients, low body mass ([48 kg) and women due to the induced dyspepsia. We aimed to evaluate the safety of direct oral anticoagulants (DOAC) dabigatran, rivaroxaban and apixaban by comparing each agent with a widely used vitamin K antagonist (VKA)-acenocoumarol in terms of bleeding event rates. A retrospective study regarding bleeding events in atrial fibrillation patients treated with oral anticoagulation (OAC) was performed. Haematuria, epistaxis and haemoptysis were considered minor events and intracranial bleeding, gastrointestinal bleeding (superior or inferior), blood transfusion after haemorrhagic events linked to OAC treatment were considered to be major events. A number of 219 atrial fibrillation patients were included using electronic medical records: 118 patients treated with DOAC s (82 using dabigatran, 28 on rivaroxaban regimen and 8 cases treated with apixaban) and 101 cases had vitamin K antagonists treatment (acenocumarol). A total of 75 bleeding events were encountered (70 minor and 5 major). A higher number of events were encountered in patients treated with DOAC s, but with no statistically significant difference compared to acenocumarol. The associated risk factors did not play a decisive role in bleeding events in the two treatment groups. No statistical significant difference was noted between the occurrence of haemorrhagic events and the class of oral anticoagulant treatment used (DOAC vs. VKA).
Highlights
The risk of bleeding in atrial fibrillation patients on direct oral anticoagulant treatment increases with age; dabigatran is associated with a higher risk of gastrointestinal bleeding in elderly patients, low body mass (< 48 kg) and women due to the induced dyspepsia
The results indicate that direct oral anticoagulants (DOAC) patients had lower death rates after major intracranial bleeding events, compared to warfarin
At baseline, the anticoagulant treatment administered to the patients was as follows: 118 patients (53.8%) had direct oral anticoagulant treatment: 82 patients (37.44%) had dabigatran, 28 patients (12.78%) rivaroxaban and 8 patients (3.65%) apixaban; 101 patients (46.2%) received vitamin K antagonist, with regular INR check
Summary
IONELA SILIVASTRU (COZLEA), GABRIELA KERESZTESI1, ARTHUR ATILLA KERESZTESI2, DANIEL LAURENTIU COZLEA1,3*, CARMEN CALDARARU3,4, DANIELA ECATERINA DOBRU3,5 1Emergency Clinical County Hospital, 50 Gh. The risk of bleeding in atrial fibrillation patients on direct oral anticoagulant treatment increases with age; dabigatran is associated with a higher risk of gastrointestinal bleeding in elderly patients, low body mass (< 48 kg) and women due to the induced dyspepsia. We aimed to evaluate the safety of direct oral anticoagulants (DOAC) dabigatran, rivaroxaban and apixaban by comparing each agent with a widely used vitamin K antagonist (VKA) - acenocoumarol in terms of bleeding event rates. Regarding the GI bleeding events, minor or major, studies suggest a higher number of events in the DOAC patients compared to warfarin treatment, especially among patients aged 75 years or over [6]. The objective of the present study was to evaluate the bleeding event rates in patients treated with DOAC’s (dabigatran, rivaroxaban and apixaban) compared to patients using a vitamin K antagonist - acenocoumarol. The protocol of this study was approved by the Ethics Committee of the University of Medicine and Pharmacy of Tirgu Mures, Romania, in accordance with standards of 1964 Helsinki declaration and its later amendments or comparable ethical standards
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