New oral anticoagulants increase risk for gastrointestinal bleeding: a systematic review and meta-analysis.

The authors of this analysis of the literature pooled data from 43 randomized controlled trials (151,578 patients). They compared new oral anticoagulants (NOACs), regardless of the indication studied, with standard care with regard to the risk gastrointestinal (GI) bleeding (reported in 19 trials). The overall odds ratio for GI bleeding among patients taking NOACs was 1.45 (95% confidence interval, 1.07−1.97). The overall odds ratio for clinically relevant bleeding in patients taking NOACs was 1.16 (95% confidence interval, 1.00−1.34). The conclusion is clear-cut: studies on the treatment of venous thrombosis or acute coronary syndromes show that patients treated with NOACs have an increased risk of GI bleeding. These data are not surprising because patients who require therapy with NOACs frequently have significant comorbidities and they are also on aspirin and/or thienopyridines. However, the authors’ findings should be considered as an additional warning when prescribing NOACs. The NOACs story is just beginning!

– Charles-Marc Samama