RIDGEFIELD, Conn., Aug. 27, 2017 /PRNewswire/ -- Boehringer Ingelheim today announced that the RE-DUAL PCI trial evaluating Pradaxa (dabigatran etexilate mesylate) dual therapy for people with non-valvular atrial fibrillation who have undergone percutaneous coronary intervention (PCI) with stenting met its primary endpoint, showing favorable new safety data on Pradaxa. The findings were presented today at a late-breaking spotlight session at the European Society of Cardiology (ESC) Congress 2017 in Barcelona, Spain and simultaneously published in the New England Journal of Medicine.

PCI, also known as angioplasty, is a medical intervention where stents may be used when widening arteries of the heart in patients with coronary artery disease. This intervention is conducted to restore or improve blood flow to the heart muscle.

"As many as 30 percent of people with atrial fibrillation have coronary artery disease that may require percutaneous coronary intervention with stenting. Before now, there has been limited research on the use of novel oral anticoagulants (NOACs) in this setting," said Christopher Cannon, MD, cardiologist at Brigham and Women's Hospital, lead investigator of RE-DUAL PCI, and executive director of the Cardiometabolic Trials at the Baim Institute for Clinical Research. "Because a rising number of these patients are already on NOAC treatment – we believe these results will provide important new insights for healthcare providers performing this procedure."
The RE-DUAL PCI trial compared dual therapy with triple therapy after PCI with stent placement in approximately 2,500 adults with atrial fibrillation. Patients were either treated with Pradaxa and a single antiplatelet agent or with the vitamin K antagonist warfarin and two antiplatelets. The primary safety endpoint of the trial was defined by time to major bleeding events and clinically-relevant non-major bleeding events, when compared to triple therapy with warfarin.

"We believe that these results from the RE-DUAL PCI trial add to the growing body of evidence on Pradaxa and may help fill an unmet clinical need," said Sabine Luik, M.D., senior vice president, Medicine & Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. "The safety and efficacy of Pradaxa have been well-established through one of the largest stroke prevention trials, and it has the longest real-world experience of any available NOAC."

To learn more about results from the RE-DUAL PCI trial, please refer to the publication in the New England Journal of Medicine.

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