Edoxoban dual therapy is non-inferior to triple therapy with vitamin K antagonists after percutaneous coronary intervention (PCI), according to late-breaking trial results presented Tuesday at the European Society of Cardiology Congress in Paris.
Andreas Goette, MD, of Atrial Fibrillation Network, Munster, Germany presented the data on behalf of the ENTRUST-AF PCI study group.
Current European guidelines recommend a one-month period of triple therapy using aspirin, clopidogrel and an oral anticoagulant in atrial fibrillation patients after PCI. Dual therapy (oral anticoagulant plus aspirin or clopidogrel) is recommended thereafter. This strategy is, however, associated with high rates of bleeding. The results presented Tuesday show, for the first time, the effects of the non-vitamin K antagonist (NOAC) edoxaban in combination with antiplatelet therapy.
The ENTRUST-AF PCI study enrolled 1506 patients across 186 sites in 18 countries. Participants were randomly allocated to a 12-month antithrombotic regimen of edoxaban and a P2Y12 inhibitor or standard therapy with a vitamin K antagonist (VKA) and P2Y12 inhibitor plus aspirin for one to 12 months.
Bleeding events were found to be non-inferior in the edoxaban arm compared with standard therapy. The composite primary endpoint of major bleeding or clinically relevant non-major bleeding occurred in 128 patients (17.0%) in the edoxaban group and in 152 patients (20.1%) in the standard therapy group (hazard ratio, 0.83; upper limit of 95% confidence interval, 1.047).
The bleeding outcomes were also comparable, with four intracranial hemorrhages occurring in the edoxaban group and nine in the VKA group. Fatal bleeding occurred in one patient in the edoxaban group and in seven on VKA therapy.
The secondary efficacy outcomes of cardiovascular death, stroke, systemic embolism, myocardial infarction and definite stent thrombosis were found to be numerically similar in both trial arms. Statistically significant differences between the groups were not demonstrated, as the study was underpowered for statistical testing of secondary efficacy outcomes.
“ENTRUST-AF PCI shows that edoxaban-based dual therapy (excluding aspirin) is a safe alternative to VKA-based triple therapy (including aspirin for one to 12 months) in the prevention of major or clinically relevant non-major bleeding in atrial fibrillation patients after successful PCI for acute coronary syndrome or stable coronary artery disease,” Goette said in an ESC press release announcing the results.
The study results were simultaneously published in The Lancet. Funding was provided by Daiichi-Sankyo.