Menno V Huisman1, Gregory Y H Lip2, Hans C Diener3, Sergio J Dubner4, Jonathan L Halperin5, Chang S Ma6, Kenneth J Rothman7, Christine Teutsch8, Kristina Zint9, Diana Ackermann9, Andreas Clemens8, Dorothee B Bartels10. 1. Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, The Netherlands. Electronic address: M.V.Huisman@lumc.nl. 2. University of Birmingham Centre for Cardiovascular Sciences, City Hospital, Birmingham, United Kingdom. 3. Department of Neurology and Stroke Center, University Hospital Essen, Essen, Germany. 4. Arrhythmias and Electrophysiology Service, Clinica y Maternidad Suizo Argentina, Buenos Aires, Argentina. 5. The Cardiovascular Institute, Mount Sinai Medical Center, New York, NY. 6. Cardiology Department Atrial Fibrillation Center, Beijing An Zhen Hospital, Beijing, China. 7. RTI Health Solutions, Research Triangle Institute, Research Triangle Park, NC; Department of Epidemiology, Boston University School of Public Health, Boston, MA. 8. Corporate Division Medicine, TA Cardiovascular, Boehringer Ingelheim GmbH, Ingelheim, Germany. 9. Corporate Department Global Epidemiology, Boehringer Ingelheim GmbH, Ingelheim, Germany. 10. Corporate Department Global Epidemiology, Boehringer Ingelheim GmbH, Ingelheim, Germany; Hannover Medical School, Hannover, Germany.
Abstract
BACKGROUND: Atrial fibrillation (AF) is the most common cardiac arrhythmia, affecting 1% to 2% of the population and raising the risk of stroke 5-fold. Until recently, the only treatment choices for stroke prevention in patients with AF have been vitamin K antagonists (VKA) or antiplatelet drugs. With approval of novel oral anticoagulants (NOACs) antithrombotic treatment, patterns are changing. The Global Registry on Long-Term Oral Antithrombotic Treatment in Patients with Atrial Fibrillation is designed to investigate patient characteristics influencing choice of antithrombotic treatment of stroke prevention in patients with nonvalvular AF and to collect data on outcomes of antithrombotic therapy in clinical practice. METHODS: The GLORIA-AF is a large, international, observational registry involving patients with newly diagnosed nonvalvular AF at risk for stroke, enrolling up to 56,000 patients in nearly 50 countries. We will collect and analyze data from routine care using an inception cohort design. Phase I includes patients before approval of NOACs. Phase II, beginning early after approval of dabigatran, monitors dabigatran safety and addresses potential channeling across treatment options based on propensity scoring to assess comparability of baseline characteristics of patients treated with dabigatran or VKA. Phase III entails analysis of large treatment groups, adjusting for differences in propensity score, to provide information about the relative effectiveness and safety of NOACs and VKA in routine clinical care. CONCLUSIONS: Novel features of this registry program will add data from clinical practice to those from randomized trials to expand knowledge of antithrombotic treatment in patients with AF.
BACKGROUND:Atrial fibrillation (AF) is the most common cardiac arrhythmia, affecting 1% to 2% of the population and raising the risk of stroke 5-fold. Until recently, the only treatment choices for stroke prevention in patients with AF have been vitamin K antagonists (VKA) or antiplatelet drugs. With approval of novel oral anticoagulants (NOACs) antithrombotic treatment, patterns are changing. The Global Registry on Long-Term Oral Antithrombotic Treatment in Patients with Atrial Fibrillation is designed to investigate patient characteristics influencing choice of antithrombotic treatment of stroke prevention in patients with nonvalvular AF and to collect data on outcomes of antithrombotic therapy in clinical practice. METHODS: The GLORIA-AF is a large, international, observational registry involving patients with newly diagnosed nonvalvular AF at risk for stroke, enrolling up to 56,000 patients in nearly 50 countries. We will collect and analyze data from routine care using an inception cohort design. Phase I includes patients before approval of NOACs. Phase II, beginning early after approval of dabigatran, monitors dabigatran safety and addresses potential channeling across treatment options based on propensity scoring to assess comparability of baseline characteristics of patients treated with dabigatran or VKA. Phase III entails analysis of large treatment groups, adjusting for differences in propensity score, to provide information about the relative effectiveness and safety of NOACs and VKA in routine clinical care. CONCLUSIONS: Novel features of this registry program will add data from clinical practice to those from randomized trials to expand knowledge of antithrombotic treatment in patients with AF.
Authors: Benjamin A Steinberg; Rosalia G Blanco; Donna Ollis; Sunghee Kim; DaJuanicia N Holmes; Peter R Kowey; Gregg C Fonarow; Jack Ansell; Bernard Gersh; Alan S Go; Elaine Hylek; Kenneth W Mahaffey; Laine Thomas; Paul Chang; Eric D Peterson; Jonathan P Piccini Journal: Am Heart J Date: 2014-04-18 Impact factor: 4.749
Authors: Vincenzo Russo; Anna Rago; Riccardo Proietti; Federica Di Meo; Andrea Antonio Papa; Paolo Calabrò; Antonio D'Onofrio; Gerardo Nigro; Ahmed AlTurki Journal: Ther Adv Drug Saf Date: 2016-10-24