Key result
NOACs show no difference in upper GI bleeding versus warfarin at 3 months.
Why the study?
Although NOAC treatment is linked to fewer hemorrhagic complications than warfarin overall, the incidence of gastrointestinal bleeding remains contradictory.
Does treatment with NOACs (dabigatran, rivaroxaban, apixaban) compared to warfarin affect the incidence of upper gastrointestinal bleeding in patients without pre-existing lesions?
RCT (n=80)
Randomized
Does treatment with NOACs (dabigatran, rivaroxaban, apixaban) compared to warfarin affect the incidence of upper gastrointestinal bleeding in patients without pre-existing lesions?
p-value: p=0.41608
In patients without pre-existing upper gastrointestinal lesions, short-term treatment with NOACs or warfarin showed no significant difference in endoscopic or clinical bleeding, suggesting the safety of these agents and of endoscopic biopsy during treatment.
Comparable upper GI bleeding risk with NOACs versus warfarin; extends short-term safety data for endoscopic biopsy during anticoagulation.
Background and objectives: Although treatment with novel oral non-vitamin K antagonist 3anticoagulants (NOACs) is associated with an overall decrease in hemorrhagic complications compared to warfarin, the incidence of gastrointestinal bleeding remains contradictory. Materials and Methods: After the exclusion of patients with pre-existing pathological lesions in the upper gastrointestinal tract (GIT) on esophageal-gastroduodenoscopy (EGD) at entry, a cohort of 80 patients (mean age of 74.8 ± 2.0 years) was randomly divided into four equivalent groups, treated with dabigatran, rivaroxaban, apixaban, or warfarin. Patients were prospectively followed up for three months of treatment, with a focus on anamnestic and endoscopic signs of bleeding. In addition, bleeding risk factors were evaluated. Results: In none of the patients treated with warfarin or NOACs was any serious or clinically significant bleeding recorded within the follow-up period. The incidence of clinical bleeding and endoscopically detected bleeding in the upper GT after three months of treatment was not statistically different among groups (χ2 = 2.8458; p = 0.41608). The presence of Helicobacter pylori (HP) was a risk factor for upper GIT bleeding (p < 0.05), while the use of proton pump inhibitors (PPIs) was a protective factor (p = 0.206; Spearman’s correlation coefficient = 0.205). We did not record any post-biopsy continued bleeding. Conclusions: No significant GIT bleeding was found in any of the treatment groups, so we consider it beneficial to perform routine EGD before the initiation of any anticoagulant therapy in patients with an increased risk of upper GIT bleeding. Detection and eradication of HP as well as preventive PPI treatment may mitigate the occurrence of endoscopic bleeding. Endoscopic biopsy during the NOAC treatment is safe.
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Mihalkanin et al. (2020) conducted an RCT in Patients requiring anticoagulation (n=80). NOACs (dabigatran, rivaroxaban, apixaban) vs. Warfarin was evaluated on Clinical bleeding and endoscopically detected bleeding in the upper gastrointestinal tract (p=0.41608). NOACs (dabigatran, rivaroxaban, apixaban) showed no significant difference in clinical and endoscopically detected upper gastrointestinal bleeding compared to warfarin at 3 months (p=0.41608).
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