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Major GI bleeding risk similar between NOACS and conventional anticoagulation

19 May 2017

Nonvitamin K antagonist oral anticoagulants (NOACs) appear to pose a risk of major gastrointestinal (GI) bleeding that is similar to that with conventional anticoagulation, according to a systematic review and meta-analysis. On the other hand, dabigatran and rivaroxaban are associated with increased risk of major GI bleeding.

Researchers searched electronic databases for randomized trials evaluating NOACs vs conventional anticoagulants for approved indications. A total of 43 trials were included, yielding a population of 166,289 patients. The main outcome was major GI bleeding, while secondary outcomes were clinically relevant nonmajor bleeding and upper and lower GI bleeding.

Pooled data showed no difference between NOACs and conventional anticoagulants in the risk of major bleeding (1.5 vs 1.3 percent; odds ratio [OR], 0.98; 95 percent CI, 0.80 to 1.21), clinically relevant nonmajor bleeding (0.6 vs 0.6 percent; OR, 0.93; 0.64 to 1.36), upper GI bleeding (1.5 vs 1.6 percent; OR, 0.96; 0.77 to 1.20) or lower GI bleeding (1.0 vs 1.0 percent; OR, 0.88; 0.67 to 1.15).

However, both dabigatran and rivaroxaban were found to have greater odds of major GI bleeding compared with conventional anticoagulation (dabigatran: 2.0 vs 1.4 percent; OR, 1.27; 1.04 to 1.55 and rivaroxaban: 1.7 vs 1.3 percent; OR, 1.40; 1.15 to 1.70). No difference was observed with apixaban (0.6 vs 0.7 percent; OR, 0.81; 0.64 to 1.02) or edoxaban (1.9 vs 1.6; OR, 0.93; 0.78 to 1.11). These subgroup findings did not persist in other sensitivity analyses.

The present data suggest that while NOACs do not differ with conventional anticoagulation in terms of major GI bleeding risk, dabigatran and rivaroxaban may particularly be associated with greater odds of major GI bleeding. In light of this, additional high-quality studies are needed to characterize GI bleeding risk among NOACs, researchers said.

Unlike vitamin K antagonists, NOACs (eg, apixaban, dabigatran, edoxaban and rivaroxaban) are convenient, as they dismiss the need of regular checking of haemostatic parameters. Moreover, NOACs have been shown to reduce the risk of major bleeding, intracranial haemorrhage in particular. GI bleeding is the most frequent cause of major bleeding, attributed to 30 to 40 percent of such events. [Aliment Pharmacol Ther 2015;42:1239–1249]

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4 days ago
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