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Relation of Stroke and Bleeding Risk Profiles to Efficacy and Safety of Edoxaban for Cardioversion of Atrial Fibrillation (From the Edoxaban Versus Warfarin in Subjects Undergoing Cardioversion of Atrial Fibrillation ENSURE-AF Study)
In the ENSURE-AF study, edoxaban was compared to enoxaparin –warfarin in patients undergoing electrical cardioversion of nonvalvular atrial fibrillation, showing comparable low rates of bleeding and thromboembolism. This ancillary analysis investigated differences in relation to stroke and bleeding risk profiles. Secondly, we determined clinical risk profi les to quality of anticoagulation control in the warfarin arm. Primary efficacy (composite of stroke, systemic embolic event, myocardial infarction, and cardiovascular death) and safety (composite of major and clinically relevant nonmajor bleeding) outcomes and time to...
Source: The American Journal of Cardiology - October 26, 2017 Category: Cardiology Authors: Gregory Y.H. Lip, Jose L. Merino, G. Andrei Dan, Sakis Themistoclakis, Kenneth A. Ellenbogen, Raffaele De Caterina, Assen Goudev, James Jin, Michael Melino, Shannon M. Winters, Andreas Goette Source Type: research

Abstract 203: Outcomes Comparison of Low Risk Medical and Surgical Patients Treated with Unfractionated Heparin vs. Enoxaparin Poster Session II
Conclusions: In low-risk medical and general surgical patients, UFH was as effective as enoxaparin in the prevention of thromboembolic events, with no difference in the incidence of HIT. When compared to UFH, enoxaparin was associated with lower MI and mortality rates, and shorter LOS and ICU LOS, at the expense of higher rates of stroke and TIA. Enoxaparin was associated with lower total inpatient costs than UFH.
Source: Circulation: Cardiovascular Quality and Outcomes - May 15, 2013 Category: Cardiology Authors: Corbelli, J., Zammit, K., Griffiths, B., Ma, C., Tung, Y., Graves, C., Genena, D., Boyd, D., Meyer, F., Arbogast, P., Bourji, M. Tags: Poster Session II Source Type: research

Edoxaban: Review of Pharmacology and Key Phase I to III Clinical Trials
Vitamin K antagonists (VKAs) remain the standard therapy for anticoagulation in prevention and treatment of venous thromboembolism (VTE) and for the prevention of stroke in atrial fibrillation (AF). Due to numerous limitations of VKAs, target-specific oral anticoagulants have been developed. Edoxaban is a direct activated factor X inhibitor with attractive features among which are once daily dosing, no need for routine monitoring, and minimal drug–drug interactions. In patients undergoing orthopedic surgery, edoxaban was superior to enoxaparin in preventing VTE. Furthermore, a recent large-scale phase III trial in pa...
Source: Journal of Cardiovascular Pharmacology and Therapeutics - August 13, 2014 Category: Cardiology Authors: Plitt, A., Giugliano, R. P. Tags: Reviews Source Type: research

Effect of concomitant antiplatelet agents on clinical outcomes in the edoxaban vs warfarin in subjects undergoing cardioversion of atrial fibrillation (ENSURE-AF) randomized trial
ConclusionIn ENSURE-AF, thromboembolic events were rare and absolute bleeding event rates were higher with concomitant APT. These findings may be relevant for AF-patients considered for dual therapy; even for a short treatment duration of 1  month.
Source: Clinical Research in Cardiology - March 30, 2020 Category: Cardiology Source Type: research

Rivaroxaban and risk of myocardial infarction: insights from a meta-analysis and trial sequential analysis of randomized clinical trials
ConclusionRivaroxaban is associated with a significantly lower risk of MI in a broad spectrum of patients when tested against different controls.
Source: Coronary Artery Disease - November 8, 2013 Category: Cardiology Tags: Original Research Source Type: research

A prospective evaluation of edoxaban compared to warfarin in subjects undergoing cardioversion of atrial fibrillation: The EdoxabaN vs. warfarin in subjectS UndeRgoing cardiovErsion of Atrial Fibrillation (ENSURE-AF STUDY)
Publication date: Available online 21 February 2015 Source:American Heart Journal Author(s): Gregory Y.H. Lip , Jose Merino , Michael Ezekowitz , Kenneth Ellenbogen , Dmitry Zamoryakhin , Hans Lanz , James Jin , Naab Al-Saadi , Michele Mercuri , Andreas Goette We designed a prospective, randomized, open-label, blinded endpoint evaluation(PROBE) parallel group Phase 3b clinical trial comparing edoxaban (a new oral factor Xa inhibitor) with enoxaparin/warfarin followed by warfarin alone in subjects undergoing planned electrical cardioversion of non-valvular AF. The primary efficacy endpoint is the composite endpoints of st...
Source: American Heart Journal - February 25, 2015 Category: Cardiology Source Type: research

Reversing the Effect of Oral Anticoagulant Drugs: Established and Newer Options
Abstract The vitamin K antagonists (VKAs) have been the standard (and only) oral anticoagulants used for the long-term treatment or prevention of venous thromboembolism or stroke in patients with atrial fibrillation. The coagulopathy induced by VKAs can be reversed with vitamin K, and in urgent situations, the vitamin K-dependent coagulation factors can be replaced by transfusion. In the last decade, a new class of oral anticoagulants has been developed, direct oral anticoagulants that bind to a specific coagulation factor and neutralize it. These compounds were shown to be effective and safe compared with the VKA...
Source: American Journal of Cardiovascular Drugs - February 12, 2016 Category: Cardiology Source Type: research

Anticoagulation Control in Warfarin Treated Patients Undergoing Cardioversion for Atrial Fibrillation (From the ENSURE-AF Trial)
In the ENSURE-AF study (NCT 02072434), edoxaban was compared to enoxaparin –warfarin in 2199 patients undergoing electrical cardioversion of non-valvular atrial fibrillation (AF). In this multicenter PROBE trial, we analyzed patients randomized to enoxaparin–warfarin. We determined time to achieve therapeutic range (TtTR), time in therapeutic range (TiTR), their clinic al determinants, relation to SAMe-TT2R2 score, and impact on primary endpoints (composite of stroke, systemic embolic event [SEE], myocardial infarction [MI], and cardiovascular death [CVD] and composite of major + clinically relevant non-major [CRNM] bleeding).
Source: The American Journal of Cardiology - June 15, 2017 Category: Cardiology Authors: Gregory Y H Lip, Naab Al-Saady, James Jin, Ming Sun, Michael Melino, Shannon M Winters, Dmitry Zamoryakhin, Andreas Goette Source Type: research

Anticoagulation Control in Warfarin-Treated Patients Undergoing Cardioversion of Atrial Fibrillation (from the Edoxaban Versus Enoxaparin –Warfarin in Patients Undergoing Cardioversion of Atrial Fibrillation Trial)
In the Edoxaban Versus Enoxaparin –Warfarin in Patients Undergoing Cardioversion of Atrial Fibrillation (ENSURE-AF) study (NCT 02072434), edoxaban was compared with enoxaparin–warfarin in 2,199 patients undergoing electrical cardioversion of nonvalvular atrial fibrillation (AF). In this multicenter prospective randomized open bl inded end-point trial, we analyzed patients randomized to enoxaparin–warfarin. We determined time to achieve therapeutic range (TtTR); time in therapeutic range (TiTR); their clinical determinants; relation to sex, age, medical history, treatment, tobacco use, race risk (SAMe-TT2R2) score; an...
Source: The American Journal of Cardiology - June 15, 2017 Category: Cardiology Authors: Gregory Y.H. Lip, Naab Al-Saady, James Jin, Ming Sun, Michael Melino, Shannon M. Winters, Dmitry Zamoryakhin, Andreas Goette Tags: Arrhythmias and Conduction Disturbances Source Type: research

Impact of Body Mass Index on Outcomes in the Edoxaban Versus Warfarin Therapy Groups in Patients Undergoing Cardioversion of Atrial Fibrillation (From ENSURE-AF)
In the EdoxabaN versus warfarin in subjectS UndeRgoing cardiovErsion of Atrial Fibrillation (ENSURE-AF) study (NCT 02072434), edoxaban showed similar efficacy and safety vs enoxaparin –warfarin in patients undergoing electrical cardioversion of nonvalvular atrial fibrillation. In this ancillary analysis, we compared the primary efficacy (composite of stroke, systemic embolic event, myocardial infarction, and cardiovascular [CV] death, overall study period) and safety (composite of major and clinically relevant nonmajor [CRNM] bleeding, on-treatment) endpoints in relation to body mass index (BMI;
Source: The American Journal of Cardiology - November 24, 2018 Category: Cardiology Authors: Gregory Y.H. Lip, Jose L. Merino, Maciej Banach, Joris R. de Groot, Lars S. Maier, Sakis Themistoclakis, Giuseppe Boriani, James Jin, Michael Melino, Shannon M. Winters, Andreas Goette Source Type: research

Edoxaban versus warfarin in vitamin K antagonist experienced and na ïve patients from the edoxaban versus warfarin in subjects undergoing cardioversion of atrial fibrillation (ENSURE-AF) randomised trial
ConclusionsEdoxaban had comparable efficacy and safety to optimized anticoagulation with enox –warf. The primary efficacy and safety endpoint outcomes were broadly similar between VKA experienced or naïve patients.
Source: Clinical Research in Cardiology - January 7, 2020 Category: Cardiology Source Type: research

Thrombocytopenia-Related Problems in Patients with Concomitant Atrial Fibrillation Requiring Antithrombotic Prevention: A Retrospective Cohort Study
Resumo Baixas doses de edoxabana e enoxaparina s ódica foram objeto de uma comparação retrospectiva implementada com a técnica do escore de propensão a fim de mitigar os efeitos das diferenças nas características clínicas basais de duas coortes e minimizar o risco de viés. Posteriormente, usando um modelo de riscos proporcionais de Cox, a valiou-se a associação de cada tipo de terapia com o risco do composto de morte por todas as causas, acidente vascular cerebral/ataque isquêmico transitório, hospitalizações e ocorrência de sangramentos maiores. Para essa análise, um valor de p< 0,05 foi considerado es...
Source: Arquivos Brasileiros de Cardiologia - October 23, 2020 Category: Cardiology Source Type: research