Key result
Adding a novel oral anticoagulant to dual antiplatelet therapy after an acute coronary syndrome modestly reduced MACE (HR 0.87; 95% CI 0.80-0.95) but more than doubled bleeding (HR 2.34; 95% CI 2.06-2.66).
Why the study?
Does the addition of a novel oral anticoagulant to single or dual antiplatelet therapy reduce major adverse cardiovascular events in patients with a recent acute coronary syndrome?
Meta-Analysis (n=30,866)
Does the addition of a novel oral anticoagulant to single or dual antiplatelet therapy reduce major adverse cardiovascular events in patients with a recent acute coronary syndrome?
In patients with recent ACS, adding a novel oral anticoagulant to antiplatelet therapy yields a modest reduction in ischemic events at the cost of a substantial increase in bleeding.
Warrants individualized antithrombotic decisions balancing ischemic versus bleeding risks post-ACS; extends RCT evidence on OAC addition to antiplatelet therapy.
BACKGROUND: Oral anticoagulation in addition to antiplatelet treatment after an acute coronary syndrome might reduce ischaemic events but increase bleeding risk. We performed a meta-analysis to evaluate the efficacy and safety of adding direct thrombin or factor-Xa inhibition by any of the novel oral anticoagulants (apixaban, dabigatran, darexaban, rivaroxaban, and ximelagatran) to single (aspirin) or dual (aspirin and clopidogrel) antiplatelet therapy in this setting. METHODS AND RESULTS: All seven published randomized, placebo-controlled phase II and III studies of novel oral anticoagulants in acute coronary syndromes were included. The database consisted of 30 866 patients, 4135 (13.4%) on single, and 26 731 (86.6%) on dual antiplatelet therapy, with a non-ST- or ST-elevation acute coronary syndrome within the last 7-14 days. We defined major adverse cardiovascular events (MACEs) as the composite of all-cause mortality, myocardial infarction, or stroke; and clinically significant bleeding as the composite of major and non-major bleeding requiring medical attention according to the study definitions. When compared with aspirin alone the combination of an oral anticoagulant and aspirin reduced the incidence of MACE [hazard ratio (HR) and 95% confidence interval 0.70; 0.59-0.84], but increased clinically significant bleeding (HR: 1.79; 1.54-2.09). Compared with dual antiplatelet therapy with aspirin and clopidogrel, adding an oral anticoagulant decreased the incidence of MACE modestly (HR: 0.87; 0.80-0.95), but more than doubled the bleeding (HR: 2.34; 2.06-2.66). Heterogeneity between studies was low, and results were similar when restricting the analysis to phase III studies. CONCLUSION: In patients with a recent acute coronary syndrome, the addition of a new oral anticoagulant to antiplatelet therapy results in a modest reduction in cardiovascular events but a substantial increase in bleeding, most pronounced when new oral anticoagulants are combined with dual antiplatelet therapy.
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Oldgren et al. (2013) conducted a meta-analysis in acute coronary syndrome (n=30,866). novel oral anticoagulants vs. single or dual antiplatelet therapy was evaluated on major adverse cardiovascular events (MACEs) (composite of all-cause mortality, myocardial infarction, or stroke) (HR 0.87, 95% CI 0.80-0.95). Adding a novel oral anticoagulant to dual antiplatelet therapy after an acute coronary syndrome modestly reduced MACE (HR 0.87; 95% CI 0.80-0.95) but more than doubled bleeding (HR 2.34; 95% CI 2.06-2.66).
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