Abstract 11219: Risk of Major Bleeding in Different Indications for New Oral Anticoagulants: Insights From a Meta- Analysis of Approved Dosages From 48 Randomized Trials
Background: Bleeding is the primary complication of New Oral Anticoagulants (NOACs) therapy. A meta-analysis was performed to evaluate the risk of major bleeding with use of NOACs versus conventional drugs/comparators.
Methods: Randomized controlled trials (RCTs) comparing NOACs (rivaroxaban, dabigatran, apixaban, edoxaban and darexaban) with comparators (LMWH/vitamin K antagonist [VKA]/aspirin/placebo) in patients with different medical and post-surgical indications of anticoagulation were selected.
Results: Forty eight trials included 141,932 patients. Pooled analysis of all NOACs for all indications together showed, there was no significant difference between NOACs and pharmacologically active comparators (PAC) for risk of major bleeding (Odds Ratio [OR] 0.98, 95% CI 0.83- 1.15), and NOACs caused significantly less major bleeding compared to VKA (0.82, 0.69- 0.96). Analysis for individual NOACs showed risk of major bleeding was not different with rivaroxaban, apixaban or dabigatran compared to PAC or VKA. Indication specific analysis showed, NOACs was associated with significantly higher major bleeding after hip surgery (1.43, 1.02 -1.99), in patients with acute coronary syndrome (ACS) (3.27, 2.30-4.66), and for medically ill patients (2.79, 1.69-4.60). For the treatment of acute venous thromboembolism (VTE) or pulmonary embolism (PE), NOACs was associated with significantly less bleeding (0.64, 0.47-0.89). No significant difference was found between NOACs and comparators in treatment of atrial fibrillation and for extended treatment of VTE.
Conclusions: Risk of major bleeding with new oral anticoagulants varies with their indication for use. New agents may be associated with comparatively less major bleeding compared to vitamin K antagonists, they may increase the risk of major bleeding after hip surgery, ACS and acute medically ill patients; but may be associated with less bleeding in treatment of acute VTE/PE.
- © 2013 by American Heart Association, Inc.