Key result
Direct-acting oral anticoagulants had a similar risk of any gastrointestinal bleeding compared to warfarin (RR 1.04), but were associated with a significantly lower risk of fatal gastrointestinal bleeding (RR 0.36).
Why the study?
DOACs are increasingly used and studies show lower gastrointestinal bleeding risk, but overall data regarding gastrointestinal bleeding risk remain debatable.
Do direct-acting oral anticoagulants (DOACs) reduce the risk of any gastrointestinal bleeding and fatal gastrointestinal bleeding compared to warfarin in patients requiring anticoagulation?
Meta-Analysis (n=87,407)
Do direct-acting oral anticoagulants (DOACs) reduce the risk of any gastrointestinal bleeding and fatal gastrointestinal bleeding compared to warfarin in patients requiring anticoagulation?
DOACs have a similar overall risk of gastrointestinal bleeding compared to warfarin, but are associated with a significantly lower risk of fatal gastrointestinal bleeding.
Answers are grounded in this paper and cite their sources.
DOACs may be preferred for lower fatal GIB risk despite similar overall rates; extends Level 1 meta-analytic safety data versus warfarin.
BACKGROUND: Direct-acting oral anticoagulants (DOACs) are increasingly used, with studies showing a lower risk of gastrointestinal bleeding (GIB), but overall data for GIB risk remains debatable. The objective was to assess non-fatal and fatal GIB risk in patients on DOACs compared with warfarin from randomized clinical trials (RCTs). METHODS: RCTs comparing warfarin and DOACs for various indications (atrial fibrillation, thromboembolism, insertion of mechanical heart valves) were included. The primary endpoint was any GIB event. Other clinical events, such as fatal GIB, and effects of age (≤60 years or older), time in therapeutic range for warfarin, and choice of individual DOACs on GIB risk, were also assessed. RESULTS: 14 RCTs were included, comprising 87,407 participants (DOACs n=46,223, warfarin control n=41,184). The risk of GIB with DOACs was similar to that of warfarin (relative risk [RR] 1.04, 95% confidence interval [CI] 0.85-1.27). Compared with warfarin, rivaroxaban (RR 1.23, 95%CI 1.03-1.48) and dabigatran (RR 1.38, 95%CI 1.12-1.71) had a higher risk of any GIB, whereas fatal GIB risk was lower in the DOACs group (RR 0.36, 95%CI 0.15-0.82). The risk of DOAC-related fatal GIB was lower in patients aged ≤60 years and in those with poor coagulation control (RR 0.39, 95%CI 0.15-0.98). CONCLUSIONS: DOACs compared with warfarin have a lower risk of fatal GIB, especially in those aged <60 years and those with poor coagulation control. However, the risk of GIB was comparable with warfarin and DOACs, except for rivaroxaban and dabigatran.
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Mark M. Aloysius (2021) conducted a meta-analysis in Indications for anticoagulation (atrial fibrillation, venous thromboembolism, pulmonary embolism, mechanical valve thromboprophylaxis) (n=87,407). Direct-acting oral anticoagulants (DOACs) vs. Warfarin was evaluated on Any gastrointestinal bleeding (GIB) event (RR 1.04, 95% CI 0.85-1.27, p=0.73). Direct-acting oral anticoagulants had a similar risk of any gastrointestinal bleeding compared to warfarin (RR 1.04), but were associated with a significantly lower risk of fatal gastrointestinal bleeding (RR 0.36).
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