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Patrizio Lancellotti - One of the best experts on this subject based on the ideXlab platform.
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pulmonary hypertension with Valvular Heart Disease when to treat the valve Disease and when to treat the pulmonary hypertension
Current Cardiology Reports, 2019Co-Authors: Christophe Martinez, Toshimitsu Tsugu, Tadafumi Sugimoto, Patrizio LancellottiAbstract:This article will review the current guidelines for therapeutic intervention in (pulmonary hypertension) PH related to left Heart Disease (PH-LHD). The 6th World Symposium on Pulmonary Hypertension (WSPH) recommended that the mean pulmonary artery pressure (mPAP) should be lowered to 20 mmHg. In several randomized controlled trials performed in patients with PH-LHD, pulmonary arterial hypertension (PAH)–specific drug therapy demonstrated no evidence of beneficial effects. Furthermore, in the sildenafil for improving outcomes after Valvular correction (SIOVAC) trial, the use of sildenafil in the context of PH post-Valvular Heart Disease (VHD) intervention is associated with an increased risk of clinical deterioration and death. Therefore, medical therapy such as PAH-specific drugs is still not recommended in PH-LHD. The principle of PH-LHD therapy is the treatment of underlying VHD. It is crucial to undergo surgical intervention at an appropriate time prior the development of potentially irreversible PH. Stress echocardiography (SE) is helpful to define symptoms and can be useful to assess the systolic pulmonary artery pressure (SPAP) and stratify severity of VHD. This comprehensive review of the literature highlights the role of SE imaging to assess VHD and is needed for the asymptomatic patients with severe VHD or symptomatic patients with non-severe VHD in the context of PH-LHD. The focus of patient evaluation should be on identifying patients with significant underlying Valvular Heart Disease and referring in a timely manner for VHD treatment per society guidelines as pharmacologic pulmonary vasodilator therapy for PH-LHD has not shown efficacy as seen in other forms of PH.
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drug induced Valvular Heart Disease
2011Co-Authors: Bernard Cosyns, Raphael Rosenhek, Steven Droogmans, Patrizio LancellottiAbstract:Drug-induced Valvular Heart Disease (DIVHD) was first described in the 1960s. Initially, associations with ergot derivatives used for migraine prevention, or with anorectic drugs, were described. Drugs used for the treatment of Parkinson’s Disease and endocrine Diseases, like hyperprolactinemia, may also induce VHD. More recently, the use of 3,4-methylendioxymetamphetamine (MDMA, ‘Ecstasy’) and benfluorexhave been found to be associated with DIVHD. Although some of these drugs were withdrawn from the market, several cases of patients requiring valve surgery even years after the cessation of therapy have been reported. DIVHD is not infrequent, may be severe, and has been described in association with several drugs. Even after drug cessation, long-term implications of this type of VHD may persist. The present review underlines the need for a careful evaluation of the associated clinical and echocardiographic risk factors to allow early recognition so as not to delay appropriate management.
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the emerging role of exercise testing and stress echocardiography in Valvular Heart Disease
Journal of the American College of Cardiology, 2009Co-Authors: Eugenio Picano, Patrizio Lancellotti, Philippe Pibarot, Jean Luc Monin, Robert O BonowAbstract:Exercise testing has an established role in the evaluation of patients with Valvular Heart Disease and can aid clinical decision making. Because symptoms may develop slowly and indolently in chronic valve Diseases and are often not recognized by patients and their physicians, the symptomatic, blood pressure, and electrocardiographic responses to exercise can help identify patients who would benefit from early valve repair or replacement. In addition, stress echocardiography has emerged as an important component of stress testing in patients with Valvular Heart Disease, with relevant established and potential applications. Stress echocardiography has the advantages of its wide availability, low cost, and versatility for the assessment of Disease severity. The versatile applications of stress echocardiography can be tailored to the individual patient with aortic or mitral valve Disease, both before and after valve replacement or repair. Hence, exercise-induced changes in valve hemodynamics, ventricular function, and pulmonary artery pressure, together with exercise capacity and symptomatic responses to exercise, provide the clinician with diagnostic and prognostic information that can contribute to subsequent clinical decisions. Nevertheless, there is a lack of convincing evidence that the results of stress echocardiography lead to clinical decisions that result in better outcomes, and therefore large-scale prospective randomized studies focusing on patient outcomes are needed in the future.
Raffaele De Caterina - One of the best experts on this subject based on the ideXlab platform.
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Valvular Heart Disease patients on edoxaban or warfarin in the engage af timi 48 trial
Journal of the American College of Cardiology, 2017Co-Authors: Raffaele De Caterina, Giulia Renda, Anthony P Carnicelli, Francesco Nordio, Michele Mercuri, Marco Trevisan, Christian T Ruff, Elliott M Antman, Eugene Braunwald, Robert P GiuglianoAbstract:Background The use of non-vitamin K antagonist oral anticoagulants (NOACs) instead of vitamin K antagonists (VKAs) in patients with atrial fibrillation (AF) and coexisting Valvular Heart Disease (VHD) is of substantial interest. Objectives This study explored outcomes in patients with AF with and without VHD in the ENGAGE AF–TIMI 48 (Effective Anticoagulation with factor Xa Next Generation in Atrial Fibrillation-Thrombolysis In Myocardial Infarction 48) trial, comparing edoxaban with warfarin. Methods Valvular Heart Disease was defined as history or baseline echocardiography evidence of at least moderate aortic/mitral regurgitation, aortic stenosis, or prior valve surgery (bioprosthesis replacement, valve repair, valvuloplasty). Patients with moderate to severe mitral stenosis or mechanical Heart valves were excluded from the trial. Comparisons were made of rates of stroke/systemic embolic event (SSEE), major bleeding, additional efficacy and safety outcomes, as well as net clinical outcomes, in patients with or without VHD treated with edoxaban or warfarin, using adjusted Cox proportional hazards. Results After adjustment for multiple baseline characteristics, compared with no-VHD patients (n = 18,222), VHD patients (n = 2,824) had a similar rate of SSEE but higher rates of death (hazard ratio [HR]: 1.40; 95% confidence interval [CI]:1.26 to 1.56; p <0.001), major adverse cardiovascular events (HR: 1.29; 95% CI: 1.16 to 1.43; p <0.001), and major bleeding (HR: 1.21; 95% CI: 1.03 to 1.42; p = 0.02). Higher-dose edoxaban regimen had efficacy similar to warfarin in the presence of VHD (for SSEE, HR: 0.69; 95% CI: 0.44 to 1.07, in patients with VHD, and HR: 0.91; 95% CI: 0.77 to 1.07, in patients without VHD; p interaction [pint] = 0.26; and for less major bleeding, HR: 0.74; 95% CI: 0.53 to 1.02 in patients with VHD, and HR: 0.82; 95% CI: 0.71 to 0.94, in patients with no VHD; pint = 0.57). Conclusions The presence of VHD increased the risk of death, major adverse cardiovascular events, and major bleeding but did not affect the relative efficacy or safety of higher-dose edoxaban versus warfarin in AF. (Global Study to Assess the Safety and Effectiveness of Edoxaban (DU-176b) vs. Standard Practice of Dosing With Warfarin in Patients With Atrial Fibrillation [ENGAGE AF-TIMI 48]; NCT00781391)
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Valvular Heart Disease patients on edoxaban or warfarin in the engage af timi 48 trial
Journal of the American College of Cardiology, 2017Co-Authors: Raffaele De Caterina, Giulia Renda, Anthony P Carnicelli, Francesco Nordio, Michele Mercuri, Marco Trevisan, Christian T Ruff, Elliott M Antman, Eugene Braunwald, Robert P GiuglianoAbstract:Abstract Background The use of non-vitamin K antagonist oral anticoagulants (NOACs) instead of vitamin K antagonists (VKAs) in patients with atrial fibrillation (AF) and coexisting Valvular Heart Disease (VHD) is of substantial interest. Objectives This study explored outcomes in patients with AF with and without VHD in the ENGAGE AF–TIMI 48 (Effective Anticoagulation with factor Xa Next Generation in Atrial Fibrillation-Thrombolysis In Myocardial Infarction 48) trial, comparing edoxaban with warfarin. Methods Valvular Heart Disease was defined as history or baseline echocardiography evidence of at least moderate aortic/mitral regurgitation, aortic stenosis, or prior valve surgery (bioprosthesis replacement, valve repair, valvuloplasty). Patients with moderate to severe mitral stenosis or mechanical Heart valves were excluded from the trial. Comparisons were made of rates of stroke/systemic embolic event (SSEE), major bleeding, additional efficacy and safety outcomes, as well as net clinical outcomes, in patients with or without VHD treated with edoxaban or warfarin, using adjusted Cox proportional hazards. Results After adjustment for multiple baseline characteristics, compared with no-VHD patients (n = 18,222), VHD patients (n = 2,824) had a similar rate of SSEE but higher rates of death (hazard ratio [HR]: 1.40; 95% confidence interval [CI]:1.26 to 1.56; p Conclusions The presence of VHD increased the risk of death, major adverse cardiovascular events, and major bleeding but did not affect the relative efficacy or safety of higher-dose edoxaban versus warfarin in AF. (Global Study to Assess the Safety and Effectiveness of Edoxaban (DU-176b) vs. Standard Practice of Dosing With Warfarin in Patients With Atrial Fibrillation [ENGAGE AF-TIMI 48]; NCT00781391)
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outcomes in 2824 patients with Valvular Heart Disease treated with edoxaban or warfarin in the engage af timi 48 trial
Journal of the American College of Cardiology, 2016Co-Authors: Giulia Renda, Raffaele De Caterina, Anthony P Carnicelli, Francesco Nordio, Michele Mercuri, Christian Ruff, Robert GiuglianoAbstract:Use of NOACs in patients (pts) with atrial fibrillation (AF) and Valvular Heart Disease (VHD) is under scrutiny. We explored outcomes in pts with AF +/- VHD in ENGAGE AF-TIMI 48 comparing edoxaban with warfarin. We defined VHD as mitral/aortic valve surgery (bioprosthetic valve, repair,
Robert P Giugliano - One of the best experts on this subject based on the ideXlab platform.
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Valvular Heart Disease patients on edoxaban or warfarin in the engage af timi 48 trial
Journal of the American College of Cardiology, 2017Co-Authors: Raffaele De Caterina, Giulia Renda, Anthony P Carnicelli, Francesco Nordio, Michele Mercuri, Marco Trevisan, Christian T Ruff, Elliott M Antman, Eugene Braunwald, Robert P GiuglianoAbstract:Abstract Background The use of non-vitamin K antagonist oral anticoagulants (NOACs) instead of vitamin K antagonists (VKAs) in patients with atrial fibrillation (AF) and coexisting Valvular Heart Disease (VHD) is of substantial interest. Objectives This study explored outcomes in patients with AF with and without VHD in the ENGAGE AF–TIMI 48 (Effective Anticoagulation with factor Xa Next Generation in Atrial Fibrillation-Thrombolysis In Myocardial Infarction 48) trial, comparing edoxaban with warfarin. Methods Valvular Heart Disease was defined as history or baseline echocardiography evidence of at least moderate aortic/mitral regurgitation, aortic stenosis, or prior valve surgery (bioprosthesis replacement, valve repair, valvuloplasty). Patients with moderate to severe mitral stenosis or mechanical Heart valves were excluded from the trial. Comparisons were made of rates of stroke/systemic embolic event (SSEE), major bleeding, additional efficacy and safety outcomes, as well as net clinical outcomes, in patients with or without VHD treated with edoxaban or warfarin, using adjusted Cox proportional hazards. Results After adjustment for multiple baseline characteristics, compared with no-VHD patients (n = 18,222), VHD patients (n = 2,824) had a similar rate of SSEE but higher rates of death (hazard ratio [HR]: 1.40; 95% confidence interval [CI]:1.26 to 1.56; p Conclusions The presence of VHD increased the risk of death, major adverse cardiovascular events, and major bleeding but did not affect the relative efficacy or safety of higher-dose edoxaban versus warfarin in AF. (Global Study to Assess the Safety and Effectiveness of Edoxaban (DU-176b) vs. Standard Practice of Dosing With Warfarin in Patients With Atrial Fibrillation [ENGAGE AF-TIMI 48]; NCT00781391)
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Valvular Heart Disease patients on edoxaban or warfarin in the engage af timi 48 trial
Journal of the American College of Cardiology, 2017Co-Authors: Raffaele De Caterina, Giulia Renda, Anthony P Carnicelli, Francesco Nordio, Michele Mercuri, Marco Trevisan, Christian T Ruff, Elliott M Antman, Eugene Braunwald, Robert P GiuglianoAbstract:Background The use of non-vitamin K antagonist oral anticoagulants (NOACs) instead of vitamin K antagonists (VKAs) in patients with atrial fibrillation (AF) and coexisting Valvular Heart Disease (VHD) is of substantial interest. Objectives This study explored outcomes in patients with AF with and without VHD in the ENGAGE AF–TIMI 48 (Effective Anticoagulation with factor Xa Next Generation in Atrial Fibrillation-Thrombolysis In Myocardial Infarction 48) trial, comparing edoxaban with warfarin. Methods Valvular Heart Disease was defined as history or baseline echocardiography evidence of at least moderate aortic/mitral regurgitation, aortic stenosis, or prior valve surgery (bioprosthesis replacement, valve repair, valvuloplasty). Patients with moderate to severe mitral stenosis or mechanical Heart valves were excluded from the trial. Comparisons were made of rates of stroke/systemic embolic event (SSEE), major bleeding, additional efficacy and safety outcomes, as well as net clinical outcomes, in patients with or without VHD treated with edoxaban or warfarin, using adjusted Cox proportional hazards. Results After adjustment for multiple baseline characteristics, compared with no-VHD patients (n = 18,222), VHD patients (n = 2,824) had a similar rate of SSEE but higher rates of death (hazard ratio [HR]: 1.40; 95% confidence interval [CI]:1.26 to 1.56; p <0.001), major adverse cardiovascular events (HR: 1.29; 95% CI: 1.16 to 1.43; p <0.001), and major bleeding (HR: 1.21; 95% CI: 1.03 to 1.42; p = 0.02). Higher-dose edoxaban regimen had efficacy similar to warfarin in the presence of VHD (for SSEE, HR: 0.69; 95% CI: 0.44 to 1.07, in patients with VHD, and HR: 0.91; 95% CI: 0.77 to 1.07, in patients without VHD; p interaction [pint] = 0.26; and for less major bleeding, HR: 0.74; 95% CI: 0.53 to 1.02 in patients with VHD, and HR: 0.82; 95% CI: 0.71 to 0.94, in patients with no VHD; pint = 0.57). Conclusions The presence of VHD increased the risk of death, major adverse cardiovascular events, and major bleeding but did not affect the relative efficacy or safety of higher-dose edoxaban versus warfarin in AF. (Global Study to Assess the Safety and Effectiveness of Edoxaban (DU-176b) vs. Standard Practice of Dosing With Warfarin in Patients With Atrial Fibrillation [ENGAGE AF-TIMI 48]; NCT00781391)
Giulia Renda - One of the best experts on this subject based on the ideXlab platform.
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Valvular Heart Disease patients on edoxaban or warfarin in the engage af timi 48 trial
Journal of the American College of Cardiology, 2017Co-Authors: Raffaele De Caterina, Giulia Renda, Anthony P Carnicelli, Francesco Nordio, Michele Mercuri, Marco Trevisan, Christian T Ruff, Elliott M Antman, Eugene Braunwald, Robert P GiuglianoAbstract:Background The use of non-vitamin K antagonist oral anticoagulants (NOACs) instead of vitamin K antagonists (VKAs) in patients with atrial fibrillation (AF) and coexisting Valvular Heart Disease (VHD) is of substantial interest. Objectives This study explored outcomes in patients with AF with and without VHD in the ENGAGE AF–TIMI 48 (Effective Anticoagulation with factor Xa Next Generation in Atrial Fibrillation-Thrombolysis In Myocardial Infarction 48) trial, comparing edoxaban with warfarin. Methods Valvular Heart Disease was defined as history or baseline echocardiography evidence of at least moderate aortic/mitral regurgitation, aortic stenosis, or prior valve surgery (bioprosthesis replacement, valve repair, valvuloplasty). Patients with moderate to severe mitral stenosis or mechanical Heart valves were excluded from the trial. Comparisons were made of rates of stroke/systemic embolic event (SSEE), major bleeding, additional efficacy and safety outcomes, as well as net clinical outcomes, in patients with or without VHD treated with edoxaban or warfarin, using adjusted Cox proportional hazards. Results After adjustment for multiple baseline characteristics, compared with no-VHD patients (n = 18,222), VHD patients (n = 2,824) had a similar rate of SSEE but higher rates of death (hazard ratio [HR]: 1.40; 95% confidence interval [CI]:1.26 to 1.56; p <0.001), major adverse cardiovascular events (HR: 1.29; 95% CI: 1.16 to 1.43; p <0.001), and major bleeding (HR: 1.21; 95% CI: 1.03 to 1.42; p = 0.02). Higher-dose edoxaban regimen had efficacy similar to warfarin in the presence of VHD (for SSEE, HR: 0.69; 95% CI: 0.44 to 1.07, in patients with VHD, and HR: 0.91; 95% CI: 0.77 to 1.07, in patients without VHD; p interaction [pint] = 0.26; and for less major bleeding, HR: 0.74; 95% CI: 0.53 to 1.02 in patients with VHD, and HR: 0.82; 95% CI: 0.71 to 0.94, in patients with no VHD; pint = 0.57). Conclusions The presence of VHD increased the risk of death, major adverse cardiovascular events, and major bleeding but did not affect the relative efficacy or safety of higher-dose edoxaban versus warfarin in AF. (Global Study to Assess the Safety and Effectiveness of Edoxaban (DU-176b) vs. Standard Practice of Dosing With Warfarin in Patients With Atrial Fibrillation [ENGAGE AF-TIMI 48]; NCT00781391)
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Valvular Heart Disease patients on edoxaban or warfarin in the engage af timi 48 trial
Journal of the American College of Cardiology, 2017Co-Authors: Raffaele De Caterina, Giulia Renda, Anthony P Carnicelli, Francesco Nordio, Michele Mercuri, Marco Trevisan, Christian T Ruff, Elliott M Antman, Eugene Braunwald, Robert P GiuglianoAbstract:Abstract Background The use of non-vitamin K antagonist oral anticoagulants (NOACs) instead of vitamin K antagonists (VKAs) in patients with atrial fibrillation (AF) and coexisting Valvular Heart Disease (VHD) is of substantial interest. Objectives This study explored outcomes in patients with AF with and without VHD in the ENGAGE AF–TIMI 48 (Effective Anticoagulation with factor Xa Next Generation in Atrial Fibrillation-Thrombolysis In Myocardial Infarction 48) trial, comparing edoxaban with warfarin. Methods Valvular Heart Disease was defined as history or baseline echocardiography evidence of at least moderate aortic/mitral regurgitation, aortic stenosis, or prior valve surgery (bioprosthesis replacement, valve repair, valvuloplasty). Patients with moderate to severe mitral stenosis or mechanical Heart valves were excluded from the trial. Comparisons were made of rates of stroke/systemic embolic event (SSEE), major bleeding, additional efficacy and safety outcomes, as well as net clinical outcomes, in patients with or without VHD treated with edoxaban or warfarin, using adjusted Cox proportional hazards. Results After adjustment for multiple baseline characteristics, compared with no-VHD patients (n = 18,222), VHD patients (n = 2,824) had a similar rate of SSEE but higher rates of death (hazard ratio [HR]: 1.40; 95% confidence interval [CI]:1.26 to 1.56; p Conclusions The presence of VHD increased the risk of death, major adverse cardiovascular events, and major bleeding but did not affect the relative efficacy or safety of higher-dose edoxaban versus warfarin in AF. (Global Study to Assess the Safety and Effectiveness of Edoxaban (DU-176b) vs. Standard Practice of Dosing With Warfarin in Patients With Atrial Fibrillation [ENGAGE AF-TIMI 48]; NCT00781391)
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outcomes in 2824 patients with Valvular Heart Disease treated with edoxaban or warfarin in the engage af timi 48 trial
Journal of the American College of Cardiology, 2016Co-Authors: Giulia Renda, Raffaele De Caterina, Anthony P Carnicelli, Francesco Nordio, Michele Mercuri, Christian Ruff, Robert GiuglianoAbstract:Use of NOACs in patients (pts) with atrial fibrillation (AF) and Valvular Heart Disease (VHD) is under scrutiny. We explored outcomes in pts with AF +/- VHD in ENGAGE AF-TIMI 48 comparing edoxaban with warfarin. We defined VHD as mitral/aortic valve surgery (bioprosthetic valve, repair,
Anthony P Carnicelli - One of the best experts on this subject based on the ideXlab platform.
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Valvular Heart Disease patients on edoxaban or warfarin in the engage af timi 48 trial
Journal of the American College of Cardiology, 2017Co-Authors: Raffaele De Caterina, Giulia Renda, Anthony P Carnicelli, Francesco Nordio, Michele Mercuri, Marco Trevisan, Christian T Ruff, Elliott M Antman, Eugene Braunwald, Robert P GiuglianoAbstract:Background The use of non-vitamin K antagonist oral anticoagulants (NOACs) instead of vitamin K antagonists (VKAs) in patients with atrial fibrillation (AF) and coexisting Valvular Heart Disease (VHD) is of substantial interest. Objectives This study explored outcomes in patients with AF with and without VHD in the ENGAGE AF–TIMI 48 (Effective Anticoagulation with factor Xa Next Generation in Atrial Fibrillation-Thrombolysis In Myocardial Infarction 48) trial, comparing edoxaban with warfarin. Methods Valvular Heart Disease was defined as history or baseline echocardiography evidence of at least moderate aortic/mitral regurgitation, aortic stenosis, or prior valve surgery (bioprosthesis replacement, valve repair, valvuloplasty). Patients with moderate to severe mitral stenosis or mechanical Heart valves were excluded from the trial. Comparisons were made of rates of stroke/systemic embolic event (SSEE), major bleeding, additional efficacy and safety outcomes, as well as net clinical outcomes, in patients with or without VHD treated with edoxaban or warfarin, using adjusted Cox proportional hazards. Results After adjustment for multiple baseline characteristics, compared with no-VHD patients (n = 18,222), VHD patients (n = 2,824) had a similar rate of SSEE but higher rates of death (hazard ratio [HR]: 1.40; 95% confidence interval [CI]:1.26 to 1.56; p <0.001), major adverse cardiovascular events (HR: 1.29; 95% CI: 1.16 to 1.43; p <0.001), and major bleeding (HR: 1.21; 95% CI: 1.03 to 1.42; p = 0.02). Higher-dose edoxaban regimen had efficacy similar to warfarin in the presence of VHD (for SSEE, HR: 0.69; 95% CI: 0.44 to 1.07, in patients with VHD, and HR: 0.91; 95% CI: 0.77 to 1.07, in patients without VHD; p interaction [pint] = 0.26; and for less major bleeding, HR: 0.74; 95% CI: 0.53 to 1.02 in patients with VHD, and HR: 0.82; 95% CI: 0.71 to 0.94, in patients with no VHD; pint = 0.57). Conclusions The presence of VHD increased the risk of death, major adverse cardiovascular events, and major bleeding but did not affect the relative efficacy or safety of higher-dose edoxaban versus warfarin in AF. (Global Study to Assess the Safety and Effectiveness of Edoxaban (DU-176b) vs. Standard Practice of Dosing With Warfarin in Patients With Atrial Fibrillation [ENGAGE AF-TIMI 48]; NCT00781391)
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Valvular Heart Disease patients on edoxaban or warfarin in the engage af timi 48 trial
Journal of the American College of Cardiology, 2017Co-Authors: Raffaele De Caterina, Giulia Renda, Anthony P Carnicelli, Francesco Nordio, Michele Mercuri, Marco Trevisan, Christian T Ruff, Elliott M Antman, Eugene Braunwald, Robert P GiuglianoAbstract:Abstract Background The use of non-vitamin K antagonist oral anticoagulants (NOACs) instead of vitamin K antagonists (VKAs) in patients with atrial fibrillation (AF) and coexisting Valvular Heart Disease (VHD) is of substantial interest. Objectives This study explored outcomes in patients with AF with and without VHD in the ENGAGE AF–TIMI 48 (Effective Anticoagulation with factor Xa Next Generation in Atrial Fibrillation-Thrombolysis In Myocardial Infarction 48) trial, comparing edoxaban with warfarin. Methods Valvular Heart Disease was defined as history or baseline echocardiography evidence of at least moderate aortic/mitral regurgitation, aortic stenosis, or prior valve surgery (bioprosthesis replacement, valve repair, valvuloplasty). Patients with moderate to severe mitral stenosis or mechanical Heart valves were excluded from the trial. Comparisons were made of rates of stroke/systemic embolic event (SSEE), major bleeding, additional efficacy and safety outcomes, as well as net clinical outcomes, in patients with or without VHD treated with edoxaban or warfarin, using adjusted Cox proportional hazards. Results After adjustment for multiple baseline characteristics, compared with no-VHD patients (n = 18,222), VHD patients (n = 2,824) had a similar rate of SSEE but higher rates of death (hazard ratio [HR]: 1.40; 95% confidence interval [CI]:1.26 to 1.56; p Conclusions The presence of VHD increased the risk of death, major adverse cardiovascular events, and major bleeding but did not affect the relative efficacy or safety of higher-dose edoxaban versus warfarin in AF. (Global Study to Assess the Safety and Effectiveness of Edoxaban (DU-176b) vs. Standard Practice of Dosing With Warfarin in Patients With Atrial Fibrillation [ENGAGE AF-TIMI 48]; NCT00781391)
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outcomes in 2824 patients with Valvular Heart Disease treated with edoxaban or warfarin in the engage af timi 48 trial
Journal of the American College of Cardiology, 2016Co-Authors: Giulia Renda, Raffaele De Caterina, Anthony P Carnicelli, Francesco Nordio, Michele Mercuri, Christian Ruff, Robert GiuglianoAbstract:Use of NOACs in patients (pts) with atrial fibrillation (AF) and Valvular Heart Disease (VHD) is under scrutiny. We explored outcomes in pts with AF +/- VHD in ENGAGE AF-TIMI 48 comparing edoxaban with warfarin. We defined VHD as mitral/aortic valve surgery (bioprosthetic valve, repair,
