Design and Rationale of the RE‐DUAL PCI Trial: A Prospective,Randomized, Phase 3b Study Comparing the Safety and Efficacy of Dual Antithrombotic Therapy With Dabigatran Etexilate Versus Warfarin Triple Therapy in Patients With Nonvalvular Atrial Fibrillation Who Have Undergone Percutaneous Coronary Intervention With Stenting |
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| Authors: | Christopher P. Cannon,Savion Gropper,Deepak L. Bhatt,Stephen G. Ellis,Takeshi Kimura,Gregory Y.H. Lip,Ph. Gabriel Steg,Jurrië n M. ten Berg,Jenny Manassie,J rg Kreuzer,Jon Blatchford,Joseph M. Massaro,Martina Brueckmann,Ernesto Ferreiros Ripoll,Jonas Oldgren,Stefan H. Hohnloser |
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| Affiliation: | 1. Harvard Clinical Research Institute, Boston, Massachusetts;2. Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts;3. Harvard Medical School, Boston, Massachusetts;4. Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany;5. Cleveland Clinic, Cleveland, Ohio;6. Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University, Kyoto, Japan;7. University of Birmingham Institute of Cardiovascular Sciences, City Hospital, Birmingham, United Kingdom;8. FACT (French Alliance for Cardiovascular Trials), an F‐CRIN network, Département Hospitalo‐Universitaire FIRE, AP‐HP, H?pital Bichat, Université Paris‐Diderot, Sorbonne Paris‐Cité, INSERM U‐1148, Paris, France;9. NHLI Imperial College, ICMS Royal Brompton Hospital, London, United Kingdom;10. St. Antonius Hospital, Nieuwegein, The Netherlands;11. Medical Division Boehringer Ingelheim Ltd, Bracknell, Berkshire, United Kingdom;12. Faculty of Medicine, University of Heidelberg, Heidelberg, Germany;13. Boston University School of Public Health, Boston, Massachusetts;14. Faculty of Medicine Mannheim of the University of Heidelberg, Mannheim, Germany;15. Department of Medical Sciences and Uppsala Clinical Research Centre, Uppsala University Hospital, Uppsala, Sweden;16. Department of Cardiology, J.W. Goethe University, Frankfurt, Germany |
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| Abstract: | Antithrombotic management of patients with atrial fibrillation (AF) undergoing coronary stenting is complicated by the need for anticoagulant therapy for stroke prevention and dual antiplatelet therapy for prevention of stent thrombosis and coronary events. Triple antithrombotic therapy, typically comprising warfarin, aspirin, and clopidogrel, is associated with a high risk of bleeding. A modest‐sized trial of oral anticoagulation with warfarin and clopidogrel without aspirin showed improvements in both bleeding and thrombotic events compared with triple therapy, but large trials are lacking. The RE‐DUAL PCI trial (NCT 02164864) is a phase 3b, a strategy of prospective, randomized, open‐label, blinded‐endpoint trial. The main objective is to evaluate dual antithrombotic therapy with dabigatran etexilate (110 or 150 mg twice daily) and a P2Y12 inhibitor (either clopidogrel or ticagrelor) compared with triple antithrombotic therapy with warfarin, a P2Y12 inhibitor (either clopidogrel or ticagrelor, and low‐dose aspirin (for 1 or 3 months, depending on stent type) in nonvalvular AF patients who have undergone percutaneous coronary intervention with stenting. The primary endpoint is time to first International Society of Thrombosis and Hemostasis major bleeding event or clinically relevant nonmajor bleeding event. Secondary endpoints are the composite of all cause death or thrombotic events (myocardial infarction, or stroke/systemic embolism) and unplanned revascularization; death or thrombotic events; individual outcome events; death, myocardial infarction, or stroke; and unplanned revascularization. A hierarchical procedure for multiple testing will be used. The plan is to randomize ～ 2500 patients at approximately 550 centers worldwide to try to identify new treatment strategies for this patient population. |
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| Keywords: | Arrhythmia/all management Clinical trials General clinical cardiology Stroke prevention Thrombosis/hypercoagulable states Pharmacology Anti platelet therapy Cardiac catheterization/diagnostic interventional |
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