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Am Heart J. 2018 Feb;196:105-112. doi: 10.1016/j.ahj.2017.10.009. Epub 2017 Oct 23.

Evaluation of the safety and efficacy of an edoxaban-based antithrombotic regimen in patients with atrial fibrillation following successful percutaneous coronary intervention (PCI) with stent placement: Rationale and design of the ENTRUST-AF PCI trial.

Author information

1
Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, Stadsomvaart 11, 3500 Hasselt, Belgium and Faculty of Medicine and Life Sciences Hasselt University, Hasselt, Belgium.
2
Department of Medicine-Cardiology and Intensive Care, Hospital Munich-Thalkirchen, Peter Osypka Heart Center Munich, Am Isarkanal 36, Munich, Germany.
3
Swiss Cardiovascular Center Bern, Bern University Hospital, Freiburgstrasse 8, Bern, Switzerland.
4
Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.
5
Daiichi Sankyo Europe GmbH, Zielstattstr. 48, Munich, Germany.
6
Division of Electrophysiology, Department of Cardiology and Angiology, University of Muenster, Muenster, Germany.
7
St. Vincenz-Hospital, Paderborn, Am Busdorf 2, Paderborn, Nordrhein-Westfalen, 33098, Germany and Working Group: Molecular Electrophysiology, University Hospital Magdeburg, Magdeburg, Germany. Electronic address: Andreas.Goette@vincenz.de.

Abstract

BACKGROUND:

The optimal antithrombotic treatment after percutaneous coronary intervention (PCI) with stenting in patients with atrial fibrillation (AF) is unknown. In the ENGAGE AF-TIMI 48 trial, edoxaban was noninferior to a vitamin K antagonist (VKA) with respect to the prevention of stroke or systemic embolism and was associated with significantly lower rates of bleeding and cardiovascular death in patients with nonvalvular AF. The effects of edoxaban in combination with single- or dual-antiplatelet therapy in the setting of PCI are unexplored.

DESIGN:

The ENTRUST-AF PCI trial is a multinational, multicenter, randomized, open-label phase 3b trial with blinded end point evaluation involving 1,500 patients on oral anticoagulation for AF. Patients are randomized between 4 hours and 5 days after successful PCI to either an edoxaban-based strategy (experimental arm; 60 mg [or 30 mg according to dose reduction criteria] once daily plus a P2Y12 antagonist [default clopidogrel, 75 mg once daily] for 12 months) or a VKA-based strategy (control arm; VKA plus a P2Y12 antagonist [as above] plus acetylsalicylic acid [100 mg once daily] for 30 days to 12 months). The primary safety end point is the incidence of International Society on Thrombosis and Haemostasis-defined major or clinically relevant nonmajor bleeding. The main efficacy end point is the composite of cardiovascular death, stroke, systemic embolic events, spontaneous myocardial infarction, and definite stent thrombosis.

SUMMARY:

The ENTRUST-AF PCI trial tests the hypothesis that an edoxaban-based antithrombotic strategy reduces the risk of bleeding complications after PCI compared with VKA plus conventional dual-antiplatelet therapy in patients with AF in need of oral anticoagulation. The relative risk of ischemic events between groups will be compared.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT02866175.

PMID:
29421002
DOI:
10.1016/j.ahj.2017.10.009
[Indexed for MEDLINE]
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