Sameer Bansilal1, Zachary Bloomgarden1, Jonathan L Halperin2, Anne S Hellkamp3, Yuliya Lokhnygina3, Manesh R Patel3, Richard C Becker4, Günter Breithardt5, Werner Hacke6, Graeme J Hankey7, Christopher C Nessel8, Daniel E Singer9, Scott D Berkowitz10, Jonathan P Piccini3, Kenneth W Mahaffey11, Keith A A Fox12. 1. Icahn School of Medicine at Mount Sinai, New York, NY. 2. Icahn School of Medicine at Mount Sinai, New York, NY. Electronic address: jonathan.halperin@mssm.edu. 3. Duke Clinical Research Institute, Duke University Medical Center, Durham, NC. 4. University of Cincinnati College of Medicine, Cincinnati, OH. 5. Department of Cardiovascular Medicine, Division of Electrophysiology, University Hospital Münster, Münster, Germany. 6. Ruprecht-Karls University, Heidelberg, Germany. 7. School of Medicine and Pharmacology, University of Western Australia, Crawley, Australia. 8. Janssen Research & Development, Raritan, NJ. 9. Massachusetts General Hospital and Harvard Medical School, Boston, MA. 10. Bayer HealthCare Pharmaceuticals, Whippany, NJ. 11. Department of Medicine, Stanford University, Stanford, CA. 12. University of Edinburgh and Royal Infirmary of Edinburgh, Edinburgh, United Kingdom.
Abstract
BACKGROUND: The prevalence of both atrial fibrillation (AF) and diabetes mellitus (DM) are rising, and these conditions often occur together. Also, DM is an independent risk factor for stroke in patients with AF. We aimed to examine the safety and efficacy of rivaroxaban vs warfarin in patients with nonvalvular AF and DM in a prespecified secondary analysis of the ROCKET AF trial. METHODS: We stratified the ROCKET AF population by DM status, assessed associations with risk of outcomes by DM status and randomized treatment using Cox proportional hazards models, and tested for interactions between randomized treatments. For efficacy, primary outcomes were stroke (ischemic or hemorrhagic) or non-central nervous system embolism. For safety, the primary outcome was major or nonmajor clinically relevant bleeding. RESULTS: The 5,695 patients with DM (40%) in ROCKET AF were younger, were more obese, and had more persistent AF, but fewer had previous stroke (the CHADS2 score includes DM and stroke). The relative efficacy of rivaroxaban and warfarin for prevention of stroke and systemic embolism was similar in patients with (1.74 vs 2.14/100 patient-years, hazard ratio [HR] 0.82) and without (2.12 vs 2.32/100 patient-years, HR 0.92) DM (interaction P = .53). The safety of rivaroxaban vs warfarin regarding major bleeding (HRs 1.00 and 1.12 for patients with and without DM, respectively; interaction P = .43), major or nonmajor clinically relevant bleeding (HRs 0.98 and 1.09; interaction P = .17), and intracerebral hemorrhage (HRs 0.62 and 0.72; interaction P = .67) was independent of DM status. Adjusted exploratory analyses suggested 1.3-, 1.5-, and 1.9-fold higher 2-year rates of stroke, vascular mortality, and myocardial infarction in DM patients. CONCLUSIONS AND RELEVANCE: The relative efficacy and safety of rivaroxaban vs warfarin was similar in patients with and without DM, supporting use of rivaroxaban as an alternative to warfarin in diabetic patients with AF.
RCT Entities:
BACKGROUND: The prevalence of both atrial fibrillation (AF) and diabetes mellitus (DM) are rising, and these conditions often occur together. Also, DM is an independent risk factor for stroke in patients with AF. We aimed to examine the safety and efficacy of rivaroxaban vs warfarin in patients with nonvalvular AF and DM in a prespecified secondary analysis of the ROCKET AF trial. METHODS: We stratified the ROCKET AF population by DM status, assessed associations with risk of outcomes by DM status and randomized treatment using Cox proportional hazards models, and tested for interactions between randomized treatments. For efficacy, primary outcomes were stroke (ischemic or hemorrhagic) or non-central nervous system embolism. For safety, the primary outcome was major or nonmajor clinically relevant bleeding. RESULTS: The 5,695 patients with DM (40%) in ROCKET AF were younger, were more obese, and had more persistent AF, but fewer had previous stroke (the CHADS2 score includes DM and stroke). The relative efficacy of rivaroxaban and warfarin for prevention of stroke and systemic embolism was similar in patients with (1.74 vs 2.14/100 patient-years, hazard ratio [HR] 0.82) and without (2.12 vs 2.32/100 patient-years, HR 0.92) DM (interaction P = .53). The safety of rivaroxaban vs warfarin regarding major bleeding (HRs 1.00 and 1.12 for patients with and without DM, respectively; interaction P = .43), major or nonmajor clinically relevant bleeding (HRs 0.98 and 1.09; interaction P = .17), and intracerebral hemorrhage (HRs 0.62 and 0.72; interaction P = .67) was independent of DM status. Adjusted exploratory analyses suggested 1.3-, 1.5-, and 1.9-fold higher 2-year rates of stroke, vascular mortality, and myocardial infarction in DMpatients. CONCLUSIONS AND RELEVANCE: The relative efficacy and safety of rivaroxaban vs warfarin was similar in patients with and without DM, supporting use of rivaroxaban as an alternative to warfarin in diabeticpatients with AF.
Authors: Luca Di Lullo; Giovanni Tripepi; Claudio Ronco; Antonio De Pascalis; Vincenzo Barbera; Antonio Granata; Domenico Russo; Biagio Raffaele Di Iorio; Ernesto Paoletti; Maura Ravera; Maria Fusaro; Antonio Bellasi Journal: J Nephrol Date: 2018-06-07 Impact factor: 3.902
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