6/28/23, 9:57 PM ENTRUST-AF PCI Pathway Feedback Search Clinical Topics Home Studies ENTRUST AF PCI ENTRUST AF PCI Disease Atrial fibrillation Trial question Is edoxaban-based regimen noninferior to vitamin K antagonist-based antithrombotic regimen in patients with AF? Study design Multi-center Open label RCT Population Characteristics of study participants 26.0% female N = 1506 74.0% male 1506 patients (386 female, 1120 male) Inclusion criteria: adult patients with AF after successful coronary stenting requiring oral anticoagulation Key exclusion criteria: mechanical heart valves; moderate-to-severe mitral stenosis; end-stage renal disease; and other major comorbidities Interventions N=751 edoxaban regimen (at a dose of 60 mg daily plus P2Y12 inhibitor for 12 months) N=755 Vitamin K antagonist regimen (Vitamin K antagonist plus P2Y12 inhibitor and aspirin 100 mg/day for 1-12 months) Primary outcome Rate of major or clinically relevant non-major bleeding within 12 months 20.0 % 20 https://web.pathway.md/studies/reczxAqYegWtl1rR3 1/2 6/28/23, 9:57 PM ENTRUST-AF PCI Pathway 17 15.0 % 10.0 % Difference not exceeding nonferiority margin 5.0 % 0.0 % Edoxaban regimen Vitamin K antagonist regimen Difference not exceeding nonferiority margin in the rate of major or clinically relevant non-major bleeding within 12 months (17% vs. 20%; HR 0.83, 95% CI 0.65 to 1.05) Secondary outcomes No significant difference in composite outcome of cardiovascular death, stroke, systemic embolic events, myocardial infarction, and definite stent thrombosis (7% vs. 6%; HR 1.06, 95% CI 0.71 to 1.69) No significant difference in major bleeding (6% vs. 6%; HR 0.95, 95% CI 0.63 to 1.42) Conclusion In adult patients with AF after successful coronary stenting requiring oral anticoagulation, edoxaban regimen was noninferior to Vitamin K antagonist regimen with respect to the rate of major or clinically relevant non-major bleeding within 12 months. Reference Pascal Vranckx, Marco Valgimigli, Lars Eckardt et al. Edoxaban-based versus vitamin K antagonist-based antithrombotic regimen after successful coronary stenting in patients with atrial fibrillation (ENTRUST-AF PCI): a randomised, open-label, phase 3b trial. Lancet. 2019 Oct 12;394(10206):1335-1343. Open reference URL https://web.pathway.md/studies/reczxAqYegWtl1rR3 2/2