The first patient has been enrolled into Daiichi Sankyo’s ENTRUST-AF PCI study. The multinational, randomised phase 3b study will evaluate a treatment regimen based on the company’s oral, once-daily direct factor Xa-inhibitor edoxaban (Lixiana/Savaysa) against a vitamin K antagonist-based regimen in patients with atrial fibrillation following successful percutaneous coronary intervention (PCI) with stent placement to investigate the incidence of major or clinically relevant non-major ISTH-defined bleeding (MCRB). One thousand-five hundred patients are to be enrolled in ENTRUST-AF PCI from 200 clinical sites across Europe, Korea, Taiwan and the Ukraine.
“The optimal antithrombotic strategy for atrial fibrillation patients undergoing PCI with coronary stent implantation is unknown at this time,” says Pascal Vranckx, clinical consultant in interventional cardiology and medical director of Cardiac Critical Care Services at the Hartcentrum Hasselt, Belgium. “The ENTRUST-AF PCI study will evaluate the role of edoxaban as part of a dual antithrombotic treatment strategy compared to a vitamin K antagonist based antithrombotic strategy as recommended by current guidelines.”
“ENTRUST AF-PCI is an important study for atrial fibrillation patients undergoing PCI who require antiplatelet therapy and chronic edoxaban for stroke prevention,” says Andreas Goette, chief physician, St Vincenz-Hospital Paderborn, Germany, Department of Cardiology and Intensive Care Medicine and principal study investigator. “In this study, edoxaban will be used with the approved dosage regimen for stroke prevention in atrial fibrillation.”