Patient enrolment into the international Phase IIIb RE-DUAL PCI study is complete. The study is evaluating the safety and efficacy of dabigatran (Pradaxa, Boehringer Ingelheim) in patients with atrial fibrillation undergoing percutaneous coronary intervention (PCI). A press release notes that this is the first time that two dosages of a non-vitamin K antagonist oral anticoagulant (NOAC) already approved for stroke prevention in atrial fibrillation have been evaluated in a dual versus triple antithrombotic regimen after PCI.
Up to two million anticoagulated patients in Europe are candidates for PCI procedures, and these procedures are associated with a risk of serious complications caused by blood clots, including stroke, myocardial infarction, and other major adverse cardiac events. The current standard of care involves taking three antithrombotic treatments together to prevent these complications, but the associated risk of bleeding increases with the number of antithrombotic treatments combined. Therefore, the aim of RE-DUAL PCI is to assess the role of dabigatran in this context.
RE-DUAL PCI lead investigator Christopher Cannon (executive director, Cardiometabolic Trials, Baim Institute for Clinical Research, Boston, USA) says: “Up to 30% of atrial fibrillation patients may have coronary artery disease and require PCI, yet to date only limited data exist on the use of the NOACs during this procedure. The RE-DUAL PCI study will provide new insights into antithrombotic treatment approaches in atrial fibrillation patients requiring PCI. We expect the results to be highly clinically relevant for practicing physicians who treat patients such as these in routine care, as the study uses the two dabigatran doses already internationally approved for stroke risk reduction in atrial fibrialltion.”
RE-DUAL PCI is part of Boehringer Ingelheim’s programme of research into anticoagulation care for patients and physicians. The results of the study are expected during the second half of 2017.