Edoxaban Versus standard of care and their effects on clinical outcomes in patients having undergone Transcatheter Aortic Valve Implantation in Atrial Fibrillation-Rationale and design of the ENVISAGE-TAVI AF trial.
Am Heart J
; 205: 63-69, 2018 11.
Article
em En
| MEDLINE
| ID: mdl-30172099
ABSTRACT
Transcatheter aortic valve implantation, also called transcatheter aortic valve replacement (TAVR), is the treatment of choice for patients with severe aortic stenosis and intermediate to high operative risk. A significant portion of TAVR patients have atrial fibrillation (AF) requiring chronic oral anticoagulation. In moderate- to high-risk AF patients, the direct factor Xa inhibitor edoxaban is noninferior to vitamin K antagonists (VKAs) for prevention of stroke or systemic embolism with less bleeding and cardiovascular deaths. ENVISAGE-TAVI AF (NCT02943785) is a multinational, multicenter, prospective, randomized, open-label, blinded end point evaluation study comparing edoxaban to VKA-based therapy in approximately 1,400 patients with an indication for chronic oral anticoagulation after successful transfemoral TAVR. The coprimary end points are to assess the differential effects of the 2 treatments (a) on net adverse clinical events (the composite of all-cause death, myocardial infarction, ischemic stroke, systemic thromboembolism, valve thrombosis, and major bleeding events) and (b) on major bleeding. Twelve hours to 5â¯days after successful TAVR, patients will be randomized to 60â¯mg daily oral edoxaban or any VKA (international normalized ratio 2.0-3.0 or 1.6-2.6 [numbers inclusive] in Japan if ageâ¯≥â¯70 years). Antiplatelet therapy may be administered per physician's discretion. Randomization will be stratified by edoxaban dose reduction (per local label). Treatment duration will be up to 36â¯months. The study is powered (80%) to detect noninferiority (margin for the hazard ratio 1.38) for the composite primary end points, followed by superiority testing.
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Estenose da Valva Aórtica
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Piridinas
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Fibrilação Atrial
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Tiazóis
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Tromboembolia
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Terapia Trombolítica
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Padrão de Cuidado
Tipo de estudo:
Clinical_trials
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Etiology_studies
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Observational_studies
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Risk_factors_studies
Limite:
Humans
Idioma:
En
Revista:
Am Heart J
Ano de publicação:
2018
Tipo de documento:
Article
País de afiliação:
Holanda