Prevention of stroke and systemic embolism with rivaroxaban compared with warfarin in patients with non-valvular atrial fibrillation and moderate renal impairment
Keith A.A. Fox,Jonathan P. Piccini,Daniel Wojdyla,Richard C. Becker,Jonathan L. Halperin,Christopher C. Nessel,John F. Paolini,Graeme J. Hankey,Kenneth W. Mahaffey,Manesh R. Patel,Daniel E. Singer,Robert M. Califf +11 more
TLDR
Dose adjustment in ROCKET-AF yielded results consistent with the overall trial in comparison with dose-adjusted warfarin, and there was no evidence of heterogeneity in treatment effect across dosing groups.Abstract:
Patients with non-valvular atrial fibrillation (AF) and renal insufficiency are at increased risk for ischaemic stroke and bleeding during anticoagulation. Rivaroxaban, an oral, direct factor Xa inhibitor metabolized predominantly by the liver, preserves the benefit of warfarin for stroke prevention while causing fewer intracranial and fatal haemorrhages. Methods and results We randomized 14 264 patients with AF in a double-blind trial to rivaroxaban 20 mg/day (15 mg/day if creatinine clearance (CrCl) 30-49 mL/min) or dose-adjusted warfarin (target international normalized ratio 2.0-3.0). Com- pared with patients with CrCl .50 mL/min (mean age 73 years), the 2950 (20.7%) patients with CrCl 30-49 mL/ min were older (79 years) and had higher event rates irrespective of study treatment. Among those with CrCl 30-49 mL/min, the primary endpoint of stroke or systemic embolism occurred in 2.32 per 100 patient-years with rivaroxaban 15 mg/day vs. 2.77 per 100 patient-years with warfarin (hazard ratio (HR) 0.84; 95% confidence interval (CI) 0.57-1.23) in the per-protocol population. Intention-to-treat analysis yielded similar results (HR 0.86; 95% CI 0.63-1.17) to the per-protocol results. Rates of the principal safety endpoint (major and clinically relevant non-major bleeding: 17.82 vs. 18.28 per 100 patient-years; P ¼ 0.76) and intracranial bleeding (0.71 vs. 0.88 per 100 patient-years; P ¼ 0.54) were similar with rivaroxaban or warfarin. Fatal bleeding (0.28 vs. 0.74% per 100 patient-years; P ¼ 0.047) occurred less often with rivaroxaban.read more
Citations
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2013 ACCF/AHA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines
Clyde W. Yancy,Mariell Jessup,Biykem Bozkurt,Javed Butler,Donald E. Casey,Mark H. Drazner,Gregg C. Fonarow,Stephen A. Geraci,Tamara B. Horwich,James L. Januzzi,Maryl R. Johnson,Edward K. Kasper,Wayne C. Levy,Frederick A. Masoudi,Patrick E. McBride,John J.V. McMurray,Judith E. Mitchell,Pamela N. Peterson,Barbara Riegel,Flora Sam,Lynne W. Stevenson,W.H. Wilson Tang,Emily J. Tsai,Bruce L. Wilkoff +23 more
TL;DR: In this article, Anderson et al. proposed a new FAHA Chair, Jeffrey L. Anderson, MD, FACC, FAHA, Chair-Elect, Alice K. Jacobs et al., this article and Biykem Bozkurt.
Journal ArticleDOI
2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS
Paulus Kirchhof,Stefano Benussi,Dipak Kotecha,Anders Ahlsson,Dan Atar,Barbara Casadei,Manuel Castellá,Hans-Christoph Diener,Hein Heidbuchel,Jeroen M.L. Hendriks,Gerhard Hindricks,Antonis S. Manolis,Jonas Oldgren,Bogdan A. Popescu,Ulrich Schotten,Bart P. Van Putte,Panagiotis Vardas,Stefan Agewall,John Camm,Gonzalo Barón Esquivias,Werner Budts,Scipione Carerj,Filip Casselman,Antonio Coca,Raffaele De Caterina,Spiridon Deftereos,Dobromir Dobrev,José M. Ferro,Gerasimos Filippatos,Donna Fitzsimons,Bulent Gorenek,Maxine Guenoun,Stefan H. Hohnloser,Philippe Kolh,Gregory Y.H. Lip,Athanasios J. Manolis,John J.V. McMurray,Piotr Ponikowski,Raphael Rosenhek,Frank Ruschitzka,Irina Savelieva,Sanjay Sharma,Piotr Suwalski,Juan Tamargo,Clare J Taylor,Isabelle C. Van Gelder,Adriaan A. Voors,Stephan Windecker,José Luis Zamorano,Katja Zeppenfeld +49 more
TL;DR: The Task Force for the management of atrial fibrillation of the European Society of Cardiology has been endorsed by the European Stroke Organisation (ESO).
Journal ArticleDOI
2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS: The Task Force for the management of atrial fibrillation of the European Society of Cardiology (ESC). Developed with the special contribution of the European Heart Rhythm Association (EHRA) of the ESC. Endorsed by the European Stroke Organisation (ESO)
Journal ArticleDOI
2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS).
Gerhard Hindricks,Tatjana S. Potpara,Nikolaos Dagres,Elena Arbelo,Jeroen J. Bax,Carina Blomström-Lundqvist,Giuseppe Boriani,Manuel Castellá,Gheorghe Andrei Dan,Polychronis Dilaveris,Laurent Fauchier,Gerasimos Filippatos,Jonathan M. Kalman,Jonathan M. Kalman,Mark La Meir,Deirdre A. Lane,Jean-Pierre Lebeau,Maddalena Lettino,G. Y. H. Lip,Fausto J. Pinto,G. Neil Thomas,Marco Valgimigli,Isabelle C. Van Gelder,Isabelle C. Van Gelder,Bart P. Van Putte,Caroline L Watkins +25 more
TL;DR: The content of these European Society of Cardiology (ESC) Guidelines has been published for personal and educational use only and no commercial use is authorized.
Journal ArticleDOI
2012 focused update of the ESC Guidelines for the management of atrial fibrillation: An update of the 2010 ESC Guidelines for the management of atrial fibrillation * Developed with the special contribution of the European Heart Rhythm Association
A. John Camm,Jeroen J. Bax,Robert Fagard,Christian Funck-Brentano,David Hasdai,Theresa McDonagh,Bogdan A. Popescu,Udo Sechtem,Stephan Windecker,Ottavio Alfieri,Annalisa Angelini,Andreas Goette,Robert Hatala,Philippe Kolh,Piotr Ponikowski,Frans H. Rutten,Isabelle C. Van Gelder +16 more
TL;DR: An update of the 2010 ESC Guidelines for the management of atrial fibrillation with the special contribution of the European Heart Rhythm Association is developed.
References
More filters
Journal ArticleDOI
Prediction of Creatinine Clearance from Serum Creatinine
Donald W. Cockcroft,M H Gault +1 more
TL;DR: A formula has been developed to predict Creatinine clearance from serum creatinine (Scr) in adult males: Ccr = (140 – age) (wt kg)/72 × Scr (mg/100ml) (15% less i).
Journal ArticleDOI
Dabigatran versus warfarin in patients with atrial fibrillation
Stuart J. Connolly,Michael D. Ezekowitz,John W. Eikelboom,Jonas Oldgren,Amit Parekh,Janice Pogue,Paul A. Reilly,Ellison Themeles,Jeanne Varrone,Susan Wang,Marco Alings,Denis Xavier,Jun Zhu,Rafael Diaz,Basil S. Lewis,Harald Darius,Hans-Christoph Diener,Campbell D. Joyner,Lars Wallentin +18 more
TL;DR: In patients with atrial fibrillation, dabigatran given at a dose of 110 mg was associated with rates of stroke and systemic embolism that were similar to those associated with warfarin, as well as lower rates of major hemorrhage.
Journal ArticleDOI
Rivaroxaban versus Warfarin in Nonvalvular Atrial Fibrillation
Manesh R. Patel,Kenneth W. Mahaffey,Jyotsna Garg,Guohua Pan,Daniel E. Singer,Werner Hacke,Günter Breithardt,Jonathan L. Halperin,Graeme J. Hankey,Jonathan P. Piccini,Richard C. Becker,Christopher C. Nessel,John F. Paolini,Scott D. Berkowitz,Robert M. Califf +14 more
TL;DR: In patients with atrial fibrillation, rivaroxaban was noninferior to warfarin for the prevention of stroke or systemic embolism and there was no significant between-group difference in the risk of major bleeding, although intracranial and fatal bleeding occurred less frequently in the rivroxaban group.
Journal ArticleDOI
A novel user-friendly score (HAS-BLED) to assess 1-year risk of major bleeding in patients with atrial fibrillation: the Euro Heart Survey.
Ron Pisters,Deirdre A. Lane,Robby Nieuwlaat,Cees B. de Vos,Harry J.G.M. Crijns,Gregory Y.H. Lip +5 more
TL;DR: This simple, novel bleeding risk score (HAS-BLED) provides a practical tool to assess the individual bleeding risk of real-world patients withAF, potentially supporting clinical decision making regarding antithrombotic therapy in patients with AF.
Journal ArticleDOI
Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients: Definitions of major bleeding in clinical studies
S. Schulman,C. Kearon +1 more
TL;DR: A definition of major bleeding in non‐surgical patients was developed that should be applicable to studies with all agents that interfere with hemostasis, including anticoagulants, platelet function inhibitors and fibrinolytic drugs.
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