Efficacy and safety of rivaroxaban in patients with diabetes and nonvalvular atrial fibrillation: The Rivaroxaban Once-daily, Oral, Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF Trial) - 18/09/15
, Anne S. Hellkamp, MS b, Yuliya Lokhnygina, PhD b, Manesh R. Patel, MD b, Richard C. Becker, MD c, Günter Breithardt, MD d, Werner Hacke, MD e, Graeme J. Hankey, MD f, Christopher C. Nessel, MD g, Daniel E. Singer, MD h, Scott D. Berkowitz, MD i, Jonathan P. Piccini, MD b, Kenneth W. Mahaffey, MD j, Keith A.A. Fox, MB, ChB kon behalf of the
ROCKET AF Steering Committee and Investigators
Résumé |
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.
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| William G. Stevenson, MD served as guest editor for this article. |
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| RCT No. NCT00403767 |
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| Previous presentation: These data were previously presented as an abstract poster at the American Heart Association's annual conference in 2012. |
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| Potential conflicts of interest: Bansilal: consulting fees from AstraZeneca; institutional research grants from AstraZeneca. Bloomgarden: consulting fees from Astra Zeneca, Janssen, NovoNordisk, Merck, Amgen, and Novartis; speaker's bureau for Astra Zeneca, Janssen, NovoNordisk, and Merck; and ownership interest in Baxter International, CVS Caremark, Roche Holdings, St Jude Medical, and Novartis. Halperin: consulting fees from AstraZeneca, Bayer AG HealthCare, Biotronik, Boehringer Ingelheim, Boston Scientific, Daiichi Sankyo, Janssen, Johnson & Johnson, Medtronic, Ortho-McNeil-Janssen Pharmaceuticals, Pfizer, and Sanofi Aventis. Hellkamp and Lokhnygina: nothing to report. Patel: consultant/advisory board for Bayer, Janssen, AstraZeneca, and Genzyme; institutional research grant for Johnson & Johnson and AstraZeneca. Becker: consulting fees/honoraria from Portola, Daiichi‐Sankyo, Bristol‐Myers Squibb, and Boehringer Ingelheim; research grants from AstraZeneca and Johnson & Johnson. Breithardt: honoraria from Bayer HealthCare and BMS/Pfizer; consultant/advisory board for Bayer HealthCare, BMS/Pfizer, and Sanofi Aventis. Hacke: consulting fees from Boehringer Ingelheim, Bayer HealthCare, and Daiichi Sankyo; research grants from Boehringer Ingelheim. Hankey: honoraria/consulting fees from Bayer and Medscape (theheart.org). Nessel: employee of Janssen Research & Development. Singer: consulting/advisory board for Bayer HealthCare, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi Sankyo, Johnson & Johnson, Merck, and Pfizer; research grants from Bristol-Myers Squibb and Johnson & Johnson. Berkowitz: employee of Bayer HealthCare Pharmaceuticals. Piccini: research grants from ARCA Biopharma, Boston Scientific, GE Healthcare, Janssen Scientific, Johnson & Johnson, and ResMed; consultant/advisory boards for ChanRx, Johnson & Johnson, and Spectranetics. Mahaffey: full disclosures prior to August 1, 2013, available at www.dcri.org; disclosures after August 1, 2013, available at kenneth_mahaffey. Fox: consulting fees/honoraria from Boehringer Ingelheim, Sanofi‐Aventis, Astra Zeneca, Johnson & Johnson/Bayer, and Janssen; research grants from Eli Lilly. |
Vol 170 - N° 4
P. 675 - octobre 2015 Retour au numéro
Article précédent
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