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New oral anticoagulants may increase GI bleeding risk
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Recipients of new oral anticoagulants, including dabigatran and rivaroxaban, may be more likely to experience gastrointestinal bleeding, according to a recent study.
Researchers evaluated data from 43 randomized controlled trials collected from the Medline, Embase and Cochrane Library databases through July 2012. The studies included 151,578 patients within the target population for the drug, and compared the use of new oral anticoagulants (nOAC) with standard care. Rivaroxaban was assessed in 16 included trials, apixaban in 12, dabigatran in 10, edoxaban in four and betrixaban in one trial. No significant publication bias was observed (P=.2).
Across 19 trials included in gastrointestinal bleeding (GIB) analysis, 1,101 incidents of GIB occurred out of 75,081 patients. Pooled analysis of 17 evaluable trials indicated an increased risk for GIB among nOAC recipients (OR=1.45; 95% CI, 1.07-1.97), with significant heterogeneity (I2=61%). Specifically, dabigatran (OR=1.58; 95% CI, 1.29-1.93 across three studies) and rivaroxaban (OR=1.48; 95% CI, 1.21-1.82 across five studies) were associated with increased GIB risk, while edoxaban was associated with reduced risk (OR=0.31; 95% CI, 0.01-7.69).
When studies were divided according to clinical indication for therapy, increased risk for GIB was observed among patients treated for atrial fibrillation (OR=1.2; 95% CI, 0.91-1.61), venous thrombosis (OR=1.59; 95% CI, 1.03-2.44) and acute coronary syndrome (OR=5.21; 95% CI, 2.58-10.53), while risk was reduced among those thromboprophylaxis after orthopedic surgery (OR=0.78; 95% CI, 0.31-1.96).
Major and nonmajor clinically relevant bleeding was assessed in all trials, with a significantly greater risk observed among nOAC users (OR=1.16; 95% CI, 1.00-1.34). Significant heterogeneity was present in this analysis (I2=83%).
“Gastrointestinal bleeding risk associated with nOAC use might be higher compared with standard care,” the researchers concluded. “The current evidence, however, is based on a highly selected patient group with a low bleeding risk, disallowing a true reflection of future patients in daily clinical practice. We recommend that future studies specifically report on the gastrointestinal bleeding risk to further elucidate the true incidence and associated risk.”
Perspective
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Harry S. Jacob, MD, FRCPath(Hon)
These confusing results don't help much in assessing the risk–benefit ratio of new oral anticoagulants, but other recently published studies do. To wit: Major bleeding is no greater — and probably less so — with these agents compared with coumadin. More important, such bleeding is more likely to be gastrointestinal, whereas coumadin bleeds occur predominantly and catastrophically in the CNS.
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