Daiichi Sankyo Begins Study of Edoxaban in AF Patients Undergoing PCI With Stenting
March 10, 2017—Daiichi Sankyo Company, Inc. announced that the first patient has been enrolled into the ENTRUST-AF PCI study, which will compare a treatment regimen based on the company's oral, once-daily direct factor Xa-inhibitor edoxaban (Savaysa, in the United States; Lixiana, outside the United States) against a vitamin K antagonist–based regimen in patients with atrial fibrillation after successful percutaneous coronary intervention (PCI) with stent placement. The ENTRUST-AF PCI investigators will enroll 1,500 patients from 200 clinical sites across Europe, Korea, Taiwan, and the Ukraine.
According to the company, ENTRUST-AF PCI aims to investigate the incidence of major or clinically relevant nonmajor bleeding, defined by the International Society on Thrombosis and Hemostasis.
This is a prospective, randomized, open-label, blinded-endpoint evaluation parallel-group phase 3b study. Patients will be randomized to receive a 12-month antithrombotic regimen of edoxaban in combination with clopidogrel or another P2Y12 antagonist or a regimen of a vitamin K antagonist in combination with clopidogrel or another P2Y12 antagonist and 1 to 12 months of aspirin.
In the company's announcement, Andreas Goette, MD, the Principal Study Investigator, commented, "ENTRUST AF-PCI is an important study for atrial fibrillation patients undergoing PCI who require antiplatelet therapy and chronic edoxaban for stroke prevention. In this study, edoxaban will be used with the approved dosage regimen for stroke prevention in atrial fibrillation." Dr. Goette is Chief Physician at St. Vincenz-Hospital Paderborn, Germany, in the Department of Cardiology and Intensive Care Medicine.
Pascal Vranckx, MD, added, "The optimal antithrombotic strategy for atrial fibrillation patients undergoing PCI with coronary stent implantation is unknown at this time. 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." Dr. Vranckx is Clinical Consultant in Interventional Cardiology and Medical Director of Cardiac Critical Care Services at the Hartcentrum Hasselt, Belgium.
Edoxaban is currently marketed in the United States, Japan, South Korea, Hong Kong, Taiwan, Switzerland, the United Kingdom, Ireland, the Netherlands, Germany, Italy, Spain, Belgium, Austria, Portugal, and other European countries, advised Daiichi Sankyo.