Key result
Edoxaban plus P2Y12 inhibition showed consistent safety for bleeding compared to VKA therapy in both ACS (15.2% vs 20.3%; HR 0.73) and CCS (19.0% vs 19.9%; HR 0.94) patients with atrial fibrillation.
Why the study?
To compare the safety and efficacy of edoxaban combined with P2Y12 inhibition after PCI in AF patients presenting with ACS versus CCS.
Does edoxaban plus a P2Y12 inhibitor reduce bleeding compared to VKA plus a P2Y12 inhibitor and aspirin in AF patients undergoing PCI for ACS or CCS?
RCT (n=1,506)
1:1
Does edoxaban plus a P2Y12 inhibitor reduce bleeding compared to VKA plus a P2Y12 inhibitor and aspirin in AF patients undergoing PCI for ACS or CCS?
Hazard Ratio: 0.73 (95% CI 0.59–1.02)
Absolute Event Rate: 15.2% vs 20.3%
p-value: p=0.063
An edoxaban-based dual antithrombotic regimen provides consistent safety and similar efficacy for ischemic events compared to a VKA-based triple regimen in AF patients undergoing PCI, regardless of ACS or CCS presentation.
Supports edoxaban-based dual therapy for bleeding safety in AF patients post-PCI regardless of presentation; extends dual antithrombotic evidence to edoxaban across ACS and CCS.
AIMS: To compare the safety and efficacy of edoxaban combined with P2Y12 inhibition following percutaneous coronary intervention (PCI) in patients with atrial fibrillation (AF) presenting with an acute coronary syndrome (ACS) or chronic coronary syndrome (CCS). METHODS AND RESULTS: In this pre-specified sub-analysis of the ENTRUST-AF PCI trial, participants were randomly assigned 1:1 to edoxaban- or vitamin K antagonist (VKA)-based strategy and randomization was stratified by ACS (edoxaban n = 388, VKA n = 389) vs. CCS (edoxaban n = 363, VKA = 366). Participants received edoxaban 60 mg once-daily plus a P2Y12 inhibitor for 12 months, or VKA combined with a P2Y12 inhibitor and aspirin 100 mg (for 1-12 months). The primary bleeding endpoint at 12 months occurred in 59 (15.2%) vs. 79 (20.3%) ACS patients [hazard ratio (HR): 0.73, 95% confidence interval (CI): 0.59-1.02, P = 0.063], and in 69 (19.0%) vs. 73 (19.9%) CCS patients (HR: 0.94, 95%CI: 0.68-1.31, P = 0.708) with edoxaban- and VKA-based therapy, respectively [P for interaction (P-int) = 0.2741]. The main secondary endpoint (composite of CV death, myocardial infarction, stroke, systemic embolic events, or definite stent thrombosis) in ACS patients was 33 (8.5%) vs. 28 (7.2%) (HR: 1.16, 95%CI: 0.70-1.92), compared with 16 (4.4%) vs. 18 (4.9%) (HR: 0.91, 95%CI: 0.47-1.78) CCS patients with edoxaban and VKA-based therapy, respectively (P-int = 0.5573). CONCLUSIONS: In patients with AF who underwent PCI, the edoxaban-based regimen, as compared with VKA-based regimen, provides consistent safety and similar efficacy for ischaemic events in patients with AF regardless of their clinical presentation.
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Vranckx et al. (2020) conducted an RCT in Atrial fibrillation with percutaneous coronary intervention (n=1,506). Edoxaban combined with P2Y12 inhibition vs. VKA combined with a P2Y12 inhibitor and aspirin 100 mg was evaluated on Primary bleeding endpoint at 12 months (ACS patients) (HR 0.73, 95% CI 0.59-1.02, p=0.063). Edoxaban plus P2Y12 inhibition showed consistent safety for bleeding compared to VKA therapy in both ACS (15.2% vs 20.3%; HR 0.73) and CCS (19.0% vs 19.9%; HR 0.94) patients with atrial fibrillation.
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