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Edoxaban vs. warfarin in vitamin K antagonist experienced and naive patients with atrial
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TLDR
In this article, the efficacy and safety of edoxaban vs. warfarin in patients who were vitamin K antagonist (VKA) naive or experienced were compared in patients with atrial fibrillation.Abstract:
Edoxaban is an oral, once-daily factor Xa inhibitor that is non-inferior to well-managed warfarin in patients with atrial fibrillation (AF) for the prevention of stroke and systemic embolic events (SEEs). We examined the efficacy and safety of edoxaban vs. warfarin in patients who were vitamin K antagonist (VKA) naive or experienced. Methods and results ENGAGE AF-TIMI 48 randomized 21 105 patients with AF at moderate-to-high risk of stroke to once-daily edoxaban vs. warfarin. Subjects were followed for a median of 2.8 years. The primary efficacy endpoint was stroke or SEE. As a pre- specified subgroup, we analysed outcomes for those with or without prior VKA experience (.60 consecutive days). Higher-dose edoxaban significantly reduced the risk of stroke or SEE in patients who were VKA naive (hazard ratio (HR) 0.71, 95% confidence interval (CI) 0.56-0.90) and was similar to warfarin in the VKA experienced (HR 1.01, 95% CI 0.82-1.24; P interaction ¼ 0.028). Lower-dose edoxaban was similar to warfarin for stroke or SEE prevention in patients who were VKA naive (HR 0.92, 95% CI 0.73-1.15), but was inferior to warfarin in those who were VKA experi- enced (HR 1.31, 95% 1.08-1.60; P interaction ¼ 0.019). Both higher-dose and lower-dose edoxaban regimens signifi- cantly reduced the risk of major bleeding regardless of prior VKA experience (P interaction ¼ 0.90 and 0.71, respectively). Conclusion In patients with AF, edoxaban appeared to demonstrate greater efficacy compared with warfarin in patients who were VKA naive than VKA experienced. Edoxaban significantly reduced major bleeding compared with warfarin regardless of prior VKA exposure.read more
Citations
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Efficacy and Safety of Edoxaban in Patients With Active Malignancy and Atrial Fibrillation: Analysis of the ENGAGE AF - TIMI 48 Trial.
Christina L. Fanola,Christian T. Ruff,Sabina A. Murphy,James Jin,Anil Duggal,Noe A. Babilonia,Piyamitr Sritara,Michele Mercuri,Pieter W. Kamphuisen,Elliott M. Antman,Eugene Braunwald,Robert P. Giugliano +11 more
TL;DR: In patients with atrial fibrillation who develop malignancy, the efficacy and safety profile of edoxaban relative to warfarin is preserved, and it may represent a more practical alternative.
Journal ArticleDOI
Improved risk stratification of patients with atrial fibrillation: an integrated GARFIELD-AF tool for the prediction of mortality, stroke and bleed in patients with and without anticoagulation
Keith A.A. Fox,Joseph E. Lucas,Karen S. Pieper,Jean-Pierre Bassand,A. John Camm,David Fitzmaurice,Samuel Z. Goldhaber,Shinya Goto,Sylvia Haas,Werner Hacke,Gloria Kayani,Ali Oto,Lorenzo G. Mantovani,Frank Misselwitz,Jonathan P. Piccini,Alexander G.G. Turpie,Freek W.A. Verheugt,Ajay K Kakkar +17 more
TL;DR: The GARFIELD-AF risk tool was superior to CHA2DS2-VASc in predicting stroke and mortality and superior to HAS-BLED for bleeding, overall and in lower risk patients, and has the potential for incorporation in routine electronic systems.
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Edoxaban: A Comprehensive Review of the Pharmacology and Clinical Data for the Management of Atrial Fibrillation and Venous Thromboembolism
TL;DR: This review examines the pharmacology and clinical data of edoxaban as a therapeutic alternative and may provide clinicians with an additional option in patients requiring chronic anticoagulation.
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A novel risk prediction score in atrial fibrillation for a net clinical outcome from the ENGAGE AF-TIMI 48 randomized clinical trial.
Christina L. Fanola,Robert P. Giugliano,Christian T. Ruff,Marco Trevisan,Francesco Nordio,Michele Mercuri,Elliott M. Antman,Eugene Braunwald +7 more
TL;DR: In VKA naive patients with AF, the TIMI-AF score can assist in the prediction of a poor composite outcome and guide selection of anticoagulant therapy by identifying a differential clinical benefit with a NOAC or VKA.
Journal ArticleDOI
Effects of Regional Differences in Asia on Efficacy and Safety of Edoxaban Compared With Warfarin – Insights From the ENGAGE AF-TIMI 48 Trial –
Yuichi J. Shimada,Takeshi Yamashita,Yukihiro Koretsune,Tetsuya Kimura,Kenji Abe,Shunichi Sasaki,Michele Mercuri,Christian T. Ruff,Robert P. Giugliano +8 more
TL;DR: HEDE had a greater relative efficacy and safety in EA compared with Japan that was only partially explained by differences in baseline characteristics and TTR.
References
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Edoxaban versus warfarin in patients with atrial fibrillation
Robert P. Giugliano,Christian T. Ruff,Eugene Braunwald,Sabina A. Murphy,Stephen D. Wiviott,Jonathan L. Halperin,Albert L. Waldo,Michael D. Ezekowitz,Jeffrey I. Weitz,Witold Rużyłło,Mikhail Ruda,Yukihiro Koretsune,Joshua Betcher,Minggao Shi,Laura T. Grip,Laura T. Grip,Shirali P. Patel,Indravadan Patel,James J. Hanyok,Michele Mercuri,Elliott M. Antman,Elliott M. Antman,Abstr Act,Abstr Act +23 more
TL;DR: Both once-daily regimens of edoxaban were noninferior to warfarin with respect to the prevention of stroke or systemic embolism and were associated with significantly lower rates of bleeding and death from cardiovascular causes.
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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.
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Clopidogrel plus aspirin versus oral anticoagulation for atrial fibrillation in the Atrial fibrillation Clopidogrel Trial with Irbesartan for prevention of Vascular Events (ACTIVE W): a randomised controlled trial.
Stuart J. Connolly,J Pogue,Robert G. Hart,Marc A. Pfeffer,S H Hohnloser,Susan Chrolavicius,Salim Yusuf +6 more
TL;DR: Oral anticoagulation therapy is superior to clopidogrel plus aspirin for prevention of vascular events in patients with atrial fibrillation at high risk of stroke, especially in those already taking oral anticoAGulation therapy.
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Warfarin versus aspirin for stroke prevention in an elderly community population with atrial fibrillation (the Birmingham Atrial Fibrillation Treatment of the Aged Study, BAFTA): a randomised controlled trial
Jonathan Mant,FD Richard Hobbs,Kate Fletcher,Andrea K Roalfe,David Fitzmaurice,Gregory Y.H. Lip,Ellen Murray +6 more
TL;DR: These data support the use of anticoagulation therapy for people aged over 75 who have atrial fibrillation, unless there are contraindications or the patient decides that the benefits are not worth the inconvenience.
Journal ArticleDOI
Benefit of Oral Anticoagulant Over Antiplatelet Therapy in Atrial Fibrillation Depends on the Quality of International Normalized Ratio Control Achieved by Centers and Countries as Measured by Time in Therapeutic Range
Stuart J. Connolly,Janice Pogue,John W. Eikelboom,Gregory C. Flaker,Patrick J. Commerford,Maria Grazia Franzosi,Jeff S. Healey,Salim Yusuf +7 more
TL;DR: For centers and countries, a target threshold TTR exists (estimated between 58% and 65%) below which there appears to be little benefit of OAC over antiplatelet therapy, and a wide variation exists in international normalized ratio control, as measured by TTR, between clinical centers and between countries.