Comparative effectiveness and safety of non-vitamin K antagonists for atrial fibrillation in clinical practice: GLORIA-AF Registry.

Autor: Lip GYH; Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart and Chest Hospital, Liverpool, UK. gregory.lip@liverpool.ac.uk.; Department of Cardiology, Congenital Heart Diseases and Electrotherapy, Medical University of Silesia, Silesian Centre for Heart Diseases, Zabrze, Poland. gregory.lip@liverpool.ac.uk.; Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark. gregory.lip@liverpool.ac.uk., Kotalczyk A; Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart and Chest Hospital, Liverpool, UK.; Department of Cardiology, Congenital Heart Diseases and Electrotherapy, Medical University of Silesia, Silesian Centre for Heart Diseases, Zabrze, Poland., Teutsch C; Department of Cardiometabolism and Respiratory Medicine, Boehringer Ingelheim International GmbH, Ingelheim, Germany., Diener HC; Department of Neuroepidemiology, Institute for Medical Informatics, Biometry and Epidemiology (IMIBE), University Duisburg-Essen, Essen, Germany., Dubner SJ; Clínica y Maternidad Suizo Argentina, Buenos Aires, Argentina., Halperin JL; The Cardiovascular Institute, Mount Sinai Medical Center, New York, NY, USA., Ma CS; Cardiology Department, Atrial Fibrillation Center, Beijing Anzhen Hospital, Capital Medical University, Beijing, China., Rothman KJ; RTI Health Solutions, Research Triangle Park, NC, USA., Marler S; Biostatistics and Data Sciences, Boehringer Ingelheim Pharmaceuticals, Inc, Ridgefield, CT, USA., Gurusamy VK; Global Epidemiology, Boehringer Ingelheim International GmbH, Ingelheim, Germany., Huisman MV; Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, The Netherlands.
Jazyk: angličtina
Zdroj: Clinical research in cardiology : official journal of the German Cardiac Society [Clin Res Cardiol] 2022 May; Vol. 111 (5), pp. 560-573. Date of Electronic Publication: 2022 Mar 16.
DOI: 10.1007/s00392-022-01996-2
Abstrakt: Background and Purpose: Prospectively collected data comparing the safety and effectiveness of individual non-vitamin K antagonists (NOACs) are lacking. Our objective was to directly compare the effectiveness and safety of NOACs in patients with newly diagnosed atrial fibrillation (AF).
Methods: In GLORIA-AF, a large, prospective, global registry program, consecutive patients with newly diagnosed AF were followed for 3 years. The comparative analyses for (1) dabigatran vs rivaroxaban or apixaban and (2) rivaroxaban vs apixaban were performed on propensity score (PS)-matched patient sets. Proportional hazards regression was used to estimate hazard ratios (HRs) for outcomes of interest.
Results: The GLORIA-AF Phase III registry enrolled 21,300 patients between January 2014 and December 2016. Of these, 3839 were prescribed dabigatran, 4015 rivaroxaban and 4505 apixaban, with median ages of 71.0, 71.0, and 73.0 years, respectively. In the PS-matched set, the adjusted HRs and 95% confidence intervals (CIs) for dabigatran vs rivaroxaban were, for stroke: 1.27 (0.79-2.03), major bleeding 0.59 (0.40-0.88), myocardial infarction 0.68 (0.40-1.16), and all-cause death 0.86 (0.67-1.10). For the comparison of dabigatran vs apixaban, in the PS-matched set, the adjusted HRs were, for stroke 1.16 (0.76-1.78), myocardial infarction 0.84 (0.48-1.46), major bleeding 0.98 (0.63-1.52) and all-cause death 1.01 (0.79-1.29). For the comparison of rivaroxaban vs apixaban, in the PS-matched set, the adjusted HRs were, for stroke 0.78 (0.52-1.19), myocardial infarction 0.96 (0.63-1.45), major bleeding 1.54 (1.14-2.08), and all-cause death 0.97 (0.80-1.19).
Conclusions: Patients treated with dabigatran had a 41% lower risk of major bleeding compared with rivaroxaban, but similar risks of stroke, MI, and death. Relative to apixaban, patients treated with dabigatran had similar risks of stroke, major bleeding, MI, and death. Rivaroxaban relative to apixaban had increased risk for major bleeding, but similar risks for stroke, MI, and death.
Registration: URL: https://www.
Clinicaltrials: gov . Unique identifiers: NCT01468701, NCT01671007. Date of registration: September 2013.
(© 2022. The Author(s).)
Databáze: MEDLINE
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